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Official Journal of the American Association for the Study of Liver Diseases
HEPATOLOGY
VOLUME 60, NUMBER 1 (SUPPL) — OCTOBER 2014
HEPATOLOGYOctober2014—Pages1–1266VOLUME60,NUMBER1(SUPPL)
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Over 9 years of prescribing
experience in the US
More than 9 million
prescriptions filled
worldwide1
All individuals depicted are
models and not actual patients.
Over 99 years of prescribing
experience in the US
Important Safety Information
WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS
CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY
• Severe acute exacerbations of hepatitis B have been reported in patients
who have discontinued anti-hepatitis B therapy, including entecavir.
Hepatic function should be monitored closely with both clinical and
laboratory follow-up for at least several months in patients who
discontinue anti-hepatitis B therapy. If appropriate, initiation of
anti-hepatitis B therapy may be warranted.
• Limited clinical experience suggests there is a potential for the
development of resistance to HIV (human immunodeficiency virus)
nucleoside reverse transcriptase inhibitors if BARACLUDE (entecavir) is
used to treat chronic HBV infection in patients with HIV infection that is
not being treated. Therapy with BARACLUDE is not recommended for
HIV/HBV co-infected patients who are not also receiving highly active
antiretroviral therapy (HAART).
• Lactic acidosis and severe hepatomegaly with steatosis, including
fatal cases, have been reported with the use of nucleoside analogues,
alone or in combination with antiretrovirals.
Please see Brief Summary of
Full Prescribing Information,
Including Boxed WARNINGS,
following the next pages.
Indication
BARACLUDE (entecavir) is indicated for the treatment of chronic hepatitis B
virus (HBV) infection in adults with evidence of active viral replication
and either evidence of persistent elevations in serum aminotransferases
(ALT or AST) or histologically active disease. The following points should be
considered when initiating BARACLUDE:
• This indication is based on histologic, virologic, biochemical, and serologic
responses in nucleoside-treatment-naïve and lamivudine-resistant adult
subjects with HBeAg-positive or HBeAg-negative chronic HBV infection
and compensated liver disease.
• Virologic, biochemical, serologic, and safety data are available from
a controlled study in adult subjects with chronic HBV infection
and decompensated liver disease.
• Virologic, biochemical, serologic, and safety data are available for a
limited number of adult subjects with HIV/HBV co-infection who have
received prior lamivudine therapy.
(continued on the following pages)
BARACLUDE®
(entecavir) is a
recommended first-line option
in CHB guidelines in the
US and around the world2-8
BAR
reco
in C
US a
American Association
for the Study of Liver
Diseases (AASLD)
US Algorithm European
Association for
the Study of the
Liver (EASL)
Japanese Ministry
of Health, Labour
and Welfare Study
Group Guideline
for CHB
The Korean
Association
for the Study
of the Liver
Chinese
Medical
Association
Asian Pacific
Association
for the Study
of the Liver
For nucleoside-naïve chronic hepatitis B (CHB) adults with evidence of active virus and
either evidence of persistent elevations in ALT or AST or histologically active disease
Warnings and Precautions
• Before initiating BARACLUDE (entecavir)
therapy, HIV antibody testing should be
offered to all patients. BARACLUDE has not
been studied as a treatment for HIV infection
and is not recommended for this use.
• Lactic acidosis with BARACLUDE use has been
reported, often in association with hepatic
decompensation, other serious medical
conditions, or drug exposures. Patients with
decompensated liver disease may be at higher
risk for lactic acidosis. BARACLUDE should
be suspended in any patient who develops
clinical or laboratory findings suggestive of
lactic acidosis or pronounced hepatotoxicity.
Adverse Reactions
• In clinical trials in patients with compensated
liver disease, the most common (≥3%) adverse
reactions of any severitywithatleast a possible
relation to study drug for BARACLUDE-
treated subjects were headache, fatigue,
dizziness, and nausea. In these trials, the most
common adverse reactions of moderate to
severe intensity (grades 2-4) were diarrhea,
dyspepsia, nausea, vomiting, fatigue,
headache, dizziness, somnolence, and
insomnia.
• In the decompensated liver disease trial,
the most common adverse reactions of
any severity among patients treated with
BARACLUDE, regardless of causality,
included: peripheral edema (16%),
ascites (15%), pyrexia (14%), hepatic
encephalopathy (10%), and upper respiratory
infection (10%). In this trial, 18% (18/102) of
BARACLUDE patients and 20% (18/89) of
adefovir patients died during the first 48
weeks of therapy. The majority of those
deaths were due to liver related causes.
Drug Interactions
BARACLUDE is primarily eliminated by
the kidneys, therefore coadministration of
BARACLUDE with drugs that reduce renal
function or compete for active tubular secretion
may increase serum concentrations of either
entecavir or the coadministered drug. Patients
should be monitored closely when receiving
BARACLUDE with other renally-eliminated
drugs.
Pregnancy and Nursing Mothers
• There are no adequate and well-controlled
studies of BARACLUDE in pregnant women.
BARACLUDE should be used during
pregnancy only if clearly needed and after
careful consideration of the risks and benefits.
• There are no studies on the effect of
BARACLUDE on transmission of HBV from
mother to infant. Therefore, appropriate
interventions should be used to prevent
neonatal acquisition of HBV.
• It is not known whether BARACLUDE is
excreted into human milk; however, many
drugs are excreted into breast milk. Due to
the potential for serious adverse reactions
in nursing infants from BARACLUDE, risks
and benefits should be considered when
deciding whether to discontinue breast-
feeding or discontinue BARACLUDE in
nursing women.
Pediatric Use
• Safety and effectiveness of BARACLUDE in
pediatric patients below the age of 16 years
have not been established.
Renal Impairment
• Dosage adjustment of BARACLUDE is
recommended for patients with a creatinine
clearance <50 mL/min, including those on
Please see Brief Summary of Full Prescribing Information,
including Boxed WARNINGS, following the next pages.
Important Safety Information about BARACLUDE®
(entecavir) TABLETS:
(continued from previous page)
(continued on the following page)
APASL
BARACLUDE (entecavir) is also recommended
as a first-line therapy in the publication:
The Management of Chronic Hepatitis B
in Asian Americans9
BARACLUDE is a registered trademark of Bristol-Myers Squibb Company.
©2014 Bristol-Myers Squibb Company, Princeton, NJ 08543 USA
686US14BR01544-02-01 07/14
For nucleoside-naïve chronic hepatitis B (CHB) adults with evidence of active virus and
either evidence of persistent elevations in ALT or AST or histologically active disease
REFERENCES: 1. IMS Health Custom Analysis (February 13, 2013), LifeLINK, MIDAS. 2. Lok ASF, McMahon BJ. AASLD Guidelines.
Chronic hepatitis B: update 2009. Hepatology. 2009;50(3):1–36. 3. Keeffe EB, Dieterich DT, Han SHB, et al. A treatment algorithm for
the management of chronic hepatitis B virus infection in the United States: 2008 update. Clin Gastroenterol Hepatol. 2008;6(12):1315–
1341. 4. European Association for the Study of the Liver. EASL clinical practice guidelines: management of chronic hepatitis B.
J Hepatol. 2012;57:167–185. 5. Liaw YF, Leung N, Kao JH, et al; for the chronic hepatitis B guideline working party of the Asian-Pacific
Association for the Study of Liver. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2008 update.
Hepatol Int. 2008;2(3):263–283. 6. Chinese Society of Hepatology, Chinese Medical Association and Chinese Society of Infectious
Diseases, Chinese Medical Association. Guideline on prevention and treatment of chronic hepatitis B in China (2005). Chin Med
J. 2007;120(24):2159–2173. 7. Lee KS, Kim DJ. The Korean Association for the Study of Liver (KASL) Guidelines. Chronic hepatitis B
treatment. Korean J Hepatol. 2007;13(4):447–488. 8. Kumada H, Okanoue T, Onji M, et al. Guidelines for the treatment of chronic
hepatitis and cirrhosis due to hepatitis B virus infection for the fiscal year 2008 in Japan. Hepatol Res. 2010;40(1):1-7. 9. Tong MJ, Pan
CQ, Hann HW, et al. The management of chronic hepatitis B in Asian Americans. Dig Dis Sci. 2011;56(11):3143–3162.
hemodialysis or continuous ambulatory
peritoneal dialysis.
Liver Transplant Recipients
• Renal function must be carefully monitored
both before and during treatment with
BARACLUDE (entecavir) in a liver transplant
recipient who has received or is receiving an
immunosuppressant that may affect renal
function, such as cyclosporine or tacrolimus.
Dosage and Administration
BARACLUDE should be administered on an
empty stomach (at least 2 hours after a meal
and at least 2 hours before the next meal).
The recommended dose of BARACLUDE:
• in nucleoside-naïve adult s and
adolescents (16+ yrs) with compensated
liver disease is 0.5 mg once daily
• in adults and adolescents (16+ yrs) with
compensated liver disease, and refractory
to lamivudine or with known lamivudine
or telbivudine resistance mutations
(rtM204I/V with or without rtL180M,
rtL80I/V, or rtV173L) is 1 mg once daily
• in adults with decompensated liver
disease is 1 mg once daily
The optimal duration of treatment with
BARACLUDE for patients with chronic HBV
infection and the relationship between
treatment and long-term outcomes such as
cirrhosis and hepatocellular carcinoma are
unknown.
Additional Information
BARACLUDE is not a cure for HBV. Patients
should be advised that treatment with
BARACLUDE has not been shown to reduce the
risk of transmission of HBV to others through
sexual contact or blood contamination.
Please see following pages for Brief Summary of Full Prescribing Information,
including Boxed WARNINGS.
Important Safety Information (continued)
Renal Impairment (continued)
Approved and available for CHB in
over 50 countries and regions worldwide
BARACLUDE®
(entecavir)BARACLUDE®
(entecavir) tablets, for oral use
BARACLUDE®
(entecavir) oral solution
Brief Summary of Prescribing Information. For complete prescribing information consult official
package insert.
WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED
WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY
Severe acute exacerbations of hepatitis B have been reported in patients who have
discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should
be monitored closely with both clinical and laboratory follow-up for at least several
months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of
anti-hepatitis B therapy may be warranted [see Warnings and Precautions].
Limited clinical experience suggests there is a potential for the development of
resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase
inhibitors if BARACLUDE (entecavir) is used to treat chronic hepatitis B virus (HBV)
infection in patients with HIV infection that is not being treated. Therapy with
BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also
receiving highly active antiretroviral therapy (HAART) [see Warnings and Precautions].
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been
reported with the use of nucleoside analogue inhibitors alone or in combination with
antiretrovirals [see Warnings and Precautions].
CONTRAINDICATIONS: None.
WARNINGS AND PRECAUTIONS: Severe Acute Exacerbations of Hepatitis B - Severe acute
exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B
therapy, including entecavir [see Adverse Reactions]. Hepatic function should be monitored closely
with both clinical and laboratory follow-up for at least several months in patients who discontinue
anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Patients Co-infected with HIV and HBV - BARACLUDE has not been evaluated in HIV/HBV co-infected
patients who were not simultaneously receiving effective HIV treatment. Limited clinical experience
suggests there is a potential for the development of resistance to HIV nucleoside reverse transcriptase
inhibitors if BARACLUDE is used to treat chronic hepatitis B virus infection in patients with HIV infection
that is not being treated [see Microbiology (12.4) in full Prescribing Information]. Therefore, therapy
with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving
HAART. Before initiating BARACLUDE therapy, HIV antibody testing should be offered to all patients.
BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use.
Lactic Acidosis and Severe Hepatomegaly with Steatosis - Lactic acidosis and severe hepatomegaly
with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors,
including BARACLUDE, alone or in combination with antiretrovirals. A majority of these cases have been
in women. Obesity and prolonged nucleoside inhibitor exposure may be risk factors. Particular caution
should be exercised when administering nucleoside analogue inhibitors to any patient with known risk
factors for liver disease; however, cases have also been reported in patients with no known risk factors.
Lactic acidosis with BARACLUDE use has been reported, often in association with hepatic
decompensation, other serious medical conditions, or drug exposures. Patients with decompensated
liver disease may be at higher risk for lactic acidosis. Treatment with BARACLUDE should be suspended
in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced
hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked
transaminase elevations).
ADVERSE REACTIONS: The following adverse reactions are discussed in other sections of the labeling:
• Exacerbations of hepatitis after discontinuation of treatment [see Boxed Warning, Warnings and
Precautions].
• Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning, Warnings and
Precautions].
Clinical Trial Experience in Adults - Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared
to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Compensated Liver Disease - Assessment of adverse reactions is based on four studies (AI463014,
AI463022, AI463026, and AI463027) in which 1720 subjects with chronic hepatitis B virus infection
and compensated liver disease received double-blind treatment with BARACLUDE 0.5 mg/day (n=679),
BARACLUDE 1 mg/day (n=183), or lamivudine (n=858) for up to 2 years. Median duration of therapy
was 69 weeks for BARACLUDE-treated subjects and 63 weeks for lamivudine-treated subjects in
Studies AI463022 and AI463027 and 73 weeks for BARACLUDE-treated subjects and 51 weeks for
lamivudine-treated subjects in Studies AI463026 and AI463014. The safety profiles of BARACLUDE and
lamivudine were comparable in these studies.
The most common adverse reactions of any severity (≥3%) with at least a possible relation to
study drug for BARACLUDE-treated subjects were headache, fatigue, dizziness, and nausea. The
most common adverse reactions among lamivudine-treated subjects were headache, fatigue, and
dizziness. One percent of BARACLUDE-treated subjects in these four studies compared with 4% of
lamivudine-treated subjects discontinued for adverse events or abnormal laboratory test results.
Clinical adverse reactions of moderate-severe intensity and considered at least possibly related to
treatment occurring during therapy in four clinical studies in which BARACLUDE was compared with
lamivudine are presented in Table 1.
Table 1: Clinical Adverse Reactionsa
of Moderate-Severe Intensity (Grades 2-4) Reported in
Four Entecavir Clinical Trials Through 2 Years
Nucleoside-Inhibitor-Naïveb
Lamivudine-Refractoryc
Body System/
Adverse Reaction
BARACLUDE
0.5 mg
n=679
LVD
100 mg
n=668
BARACLUDE
1 mg
n=183
LVD
100 mg
n=190
Any Grade 2-4
adverse reactiona
Gastrointestinal
Diarrhea
Dyspepsia
Nausea
Vomiting
General
Fatigue
Nervous System
Headache
Dizziness
Somnolence
Psychiatric
Insomnia
15%
<1%
<1%
<1%
<1%
1%
2%
<1%
<1%
<1%
18%
0
<1%
<1%
<1%
1%
2%
<1%
<1%
<1%
22%
1%
1%
<1%
<1%
3%
4%
0
0
0
23%
0
0
2%
0
3%
1%
1%
0
<1%
a
Includes events of possible, probable, certain, or unknown relationship to treatment regimen. b
Studies
AI463022 and AI463027. c
Includes Study AI463026 and the BARACLUDE 1 mg and lamivudine treatment
arms of Study AI463014, a Phase 2 multinational, randomized, double-blind study of three doses of
BARACLUDE (0.1, 0.5, and 1 mg) once daily versus continued lamivudine 100 mg once daily for up to 52
weeks in subjects who experienced recurrent viremia on lamivudine therapy. LVD = Lamivudine.
Laboratory Abnormalities - Frequencies of selected treatment-emergent laboratory abnormalities
reportedduringtherapyinfourclinicaltrialsofBARACLUDEcomparedwithlamivudinearelistedinTable2.
Table 2: Selected Treatment-Emergenta
Laboratory Abnormalities Reported in Four Entecavir
Clinical Trials Through 2 Years
Nucleoside-Inhibitor-Naïveb
Lamivudine-Refractoryc
Test
BARACLUDE
0.5 mg
n=679
LVD
100 mg
n=668
BARACLUDE
1 mg
n=183
LVD
100 mg
n=190
Any Grade 3-4
laboratory
abnormalityd
ALT >10 x ULN and
>2 x baseline
ALT >5 x ULN
Albumin <2.5 g/dL
Total bilirubin
>2.5 x ULN
Lipase ≥2.1 x ULN
Creatinine >3 x ULN
Confirmed creatinine
increase ≥0.5 mg/dL
Hyperglycemia, fasting
>250 mg/dL
Glycosuriae
Hematuriaf
Platelets <50,000/mm3
35%
2%
11%
<1%
2%
7%
0
1%
2%
4%
9%
<1%
36%
4%
16%
<1%
2%
6%
0
1%
1%
3%
10%
<1%
37%
2%
12%
0
3%
7%
0
2%
3%
4%
9%
<1%
45%
11%
24%
2%
2%
7%
0
1%
1%
6%
6%
<1%
a
On-treatment value worsened from baseline to Grade 3 or Grade 4 for all parameters except albumin
(any on-treatment value <2.5 g/dL), confirmed creatinine increase ≥0.5 mg/dL, and ALT >10 x ULN
and >2 x baseline. b
Studies AI463022 and AI463027. c
Includes Study AI463026 and the BARACLUDE
1 mg and lamivudine treatment arms of Study AI463014, a Phase 2 multinational,
randomized, double-blind study of three doses of BARACLUDE (0.1, 0.5, and 1 mg)
once daily versus continued lamivudine 100 mg once daily for up to 52 weeks in subjects who experienced
recurrent viremia on lamivudine therapy. d
Includes hematology, routine chemistries, renal and liver
function tests, pancreatic enzymes, and urinalysis. e
Grade 3 = 3+, large, ≥500 mg/dL; Grade 4 = 4+,
marked, severe. f
Grade 3 = 3+, large; Grade 4 = ≥4+, marked, severe, many. LVD = Lamivudine, ULN
= upper limit of normal.
Among BARACLUDE-treated subjects in these studies, on-treatment ALT elevations greater than
10 times the upper limit of normal (ULN) and greater than 2 times baseline generally resolved with
continued treatment. A majority of these exacerbations were associated with a ≥2 log10
/mL reduction
in viral load that preceded or coincided with the ALT elevation. Periodic monitoring of hepatic function
is recommended during treatment.
Exacerbations of Hepatitis after Discontinuation of Treatment - An exacerbation of hepatitis
or ALT flare was defined as ALT >10 x ULN and >2 x the subject’s reference level (minimum
of the baseline or last measurement at end of dosing). For all subjects who discontinued
treatment (regardless of reason), the proportion of subjects who experienced post-treatment
ALT flares was as follows: 2% (4/174) in the BARACLUDE-treated group and 9% (13/147)
in the lamivudine-treated group in nucleoside-inhibitor-naïve, HBeAg-positive subjects
in study AI463022; 8% (24/302) in the BARACLUDE-treated group and 11% (30/270) in the
lamivudine-treated group in nucleoside-inhibitor-naïve HBeAg-negative subjects in study AI463027;
12% (6/52) in the BARACLUDE-treated group and 0% (0/16) in the lamivudine-treated group among
lamivudine-refractory subjects in study AI463026. The median time to off-treatment exacerbation
was 23 weeks for BARACLUDE-treated subjects and 10 weeks for lamivudine-treated subjects.
In these studies, a subset of subjects was allowed to discontinue treatment at or after 52 weeks if
they achieved a protocol-defined response to therapy. If BARACLUDE is discontinued without regard to
treatment response, the rate of post-treatment flares could be higher. [See Warnings and Precautions.]
Decompensated Liver Disease - Study AI463048 was a randomized, open-label study of
BARACLUDE 1 mg once daily versus adefovir dipivoxil 10 mg once daily given for up to 48 weeks
in adult subjects with chronic HBV infection and evidence of hepatic decompensation, defined as
a Child-Turcotte-Pugh (CTP) score of 7 or higher [see Clinical Studies (14.1) in full Prescribing
Information]. Among the 102 subjects receiving BARACLUDE, the most common treatment-emergent
adverse events of any severity, regardless of causality, occurring through Week 48 were peripheral
edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection
(10%). Clinical adverse reactions not listed in Table 1 that were observed through Week 48 include blood
bicarbonate decreased (2%) and renal failure (<1%).
Eighteen of 102 (18%) subjects treated with BARACLUDE and 18/89 (20%) subjects treated with adefovir
dipivoxil died during the first 48 weeks of therapy. The majority of deaths (11 in the BARACLUDE group
and 16 in the adefovir dipivoxil group) were due to liver-related causes such as hepatic failure, hepatic
encephalopathy, hepatorenal syndrome, and upper gastrointestinal hemorrhage. The rate of hepatocellular
carcinoma (HCC) through Week 48 was 6% (6/102) for subjects treated with BARACLUDE and 8% (7/89)
for subjects treated with adefovir dipivoxil. Five percent of subjects in either treatment arm discontinued
therapy due to an adverse event through Week 48.
No subject in either treatment arm experienced an on-treatment hepatic flare (ALT >2 x baseline and >10
x ULN) through Week 48. Eleven of 102 (11%) subjects treated with BARACLUDE and 11/89 (13%) subjects
treated with adefovir dipivoxil had a confirmed increase in serum creatinine of 0.5 mg/dL through Week 48.
HIV/HBV Co-infected - The safety profile of BARACLUDE 1 mg (n=51) in HIV/HBV co-infected subjects
enrolled in Study AI463038 was similar to that of placebo (n=17) through 24 weeks of blinded treatment
and similar to that seen in non-HIV infected subjects [see Warnings and Precautions].
Liver Transplant Recipients - Among 65 subjects receiving BARACLUDE in an open-label, post-liver
transplant trial [see Use in Specific Populations], the frequency and nature of adverse events were
consistent with those expected in patients who have received a liver transplant and the known safety
profile of BARACLUDE.
Clinical Trial Experience in Pediatric Subjects - Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly
compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of BARACLUDE in pediatric subjects 2 to less than 18 years of age is based on two ongoing
clinical trials in subjects with chronic HBV infection (one Phase 2 pharmacokinetic trial [AI463028] and
one Phase 3 trial [AI463189]). These trials provide experience in 168 HBeAg-positive subjects treated with
BARACLUDE for a median duration of 72 weeks. The adverse reactions observed in pediatric subjects who
received treatment with BARACLUDE were consistent with those observed in clinical trials of BARACLUDE in
adults. Adverse drug reactions reported in greater than 1% of pediatric subjects included abdominal pain,
rash events, poor palatability (“product taste abnormal”), nausea, diarrhea, and vomiting.
Postmarketing Experience - The following adverse reactions have been reported during postmarketing
use of BARACLUDE. Because these reactions were reported voluntarily from a population of unknown
size, it is not possible to reliably estimate their frequency or establish a causal relationship to
BARACLUDE exposure. Immune system disorders: Anaphylactoid reaction. Metabolism and nutrition
disorders: Lactic acidosis. Hepatobiliary disorders: Increased transaminases. Skin and subcutaneous
tissue disorders: Alopecia, rash.
DRUG INTERACTIONS: Since entecavir is primarily eliminated by the kidneys [see Clinical Pharmacology
(12.3) in full Prescribing Information], coadministration of BARACLUDE with drugs that reduce renal
function or compete for active tubular secretion may increase serum concentrations of either entecavir
or the coadministered drug. Coadministration of entecavir with lamivudine, adefovir dipivoxil, or tenofovir
disoproxil fumarate did not result in significant drug interactions. The effects of coadministration of
BARACLUDE with other drugs that are renally eliminated or are known to affect renal function have
not been evaluated, and patients should be monitored closely for adverse events when BARACLUDE is
coadministered with such drugs.
USE IN SPECIFIC POPULATIONS: Pregnancy - Pregnancy Category C. There are no adequate and well-
controlled studies of BARACLUDE in pregnant women. Because animal reproduction studies are not always
predictive of human response, BARACLUDE should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Antiretroviral Pregnancy Registry: To monitor fetal outcomes of pregnant women exposed to
BARACLUDE, an Antiretroviral Pregnancy Registry has been established. Healthcare providers are
encouraged to register patients by calling 1-800-258-4263.
Animal Data - Animal reproduction studies with entecavir in rats and rabbits revealed no evidence of
teratogenicity. Developmental toxicity studies were performed in rats and rabbits. There were no signs
of embryofetal or maternal toxicity when pregnant animals received oral entecavir at approximately
28 (rat) and 212 (rabbit) times the human exposure achieved at the highest recommended human dose
of 1 mg/day. In rats, maternal toxicity, embryofetal toxicity (resorptions), lower fetal body weights, tail and
vertebral malformations, reduced ossification (vertebrae, sternebrae, and phalanges), and extra lumbar
vertebrae and ribs were observed at exposures 3100 times those in humans. In rabbits, embryofetal
toxicity (resorptions), reduced ossification (hyoid), and an increased incidence of 13th rib were observed at
exposures 883 times those in humans. In a peri-postnatal study, no adverse effects on offspring occurred
when rats received oral entecavir at exposures greater than 94 times those in humans.
Labor and Delivery - There are no studies in pregnant women and no data on the effect of BARACLUDE on
transmission of HBV from mother to infant. Therefore, appropriate interventions should be used to prevent
neonatal acquisition of HBV.
Nursing Mothers - It is not known whether BARACLUDE is excreted into human milk; however, entecavir
is excreted into the milk of rats. Because many drugs are excreted into human milk and because of the
potential for serious adverse reactions in nursing infants from BARACLUDE, a decision should be made to
discontinue nursing or to discontinue BARACLUDE taking into consideration the importance of continued
hepatitis B therapy to the mother and the known benefits of breastfeeding.
Pediatric Use - BARACLUDE was evaluated in two clinical trials of pediatric subjects 2 years of age
and older with HBeAg-positive chronic HBV infection and compensated liver disease. The exposure of
BARACLUDE in nucleoside-inhibitor-treatment-naïve and lamivudine-experienced pediatric subjects
2 years of age and older with HBeAg-positive chronic HBV infection and compensated liver disease
receiving 0.015 mg/kg (up to 0.5 mg once daily) or 0.03 mg/kg (up to 1 mg once daily), respectively,
was evaluated in Study AI463028. Safety and efficacy of the selected dose in treatment-naïve pediatric
subjects were confirmed in Study AI463189, a randomized, placebo-controlled treatment trial [see Adverse
Reactions and Indications and Usage (1), Dosage and Administration (2.3), Clinical Pharmacology (12.3),
and Clinical Studies (14.2) in full Prescribing Information].
There are limited data available on the use of BARACLUDE in lamivudine-experienced pediatric patients;
BARACLUDE should be used in these patients only if the potential benefit justifies the potential risk to
the child. Since some pediatric patients may require long-term or even lifetime management of chronic
active hepatitis B, consideration should be given to the impact of BARACLUDE on future treatment options
[see Microbiology (12.4) in full Prescribing Information].
The efficacy and safety of BARACLUDE have not been established in patients less than 2 years of age.
Use of BARACLUDE in this age group has not been evaluated because treatment of HBV in this age group
is rarely required.
BARACLUDE®
(entecavir) BARACLUDE®
(entecavir)
Geriatric Use - Clinical studies of BARACLUDE did not include sufficient numbers of subjects aged
65 years and over to determine whether they respond differently from younger subjects. Entecavir
is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater
in patients with impaired renal function. Because elderly patients are more likely to have decreased
renal function, care should be taken in dose selection, and it may be useful to monitor renal function
[see Dosage and Administration (2.4) in full Prescribing Information].
Racial/Ethnic Groups - There are no significant racial differences in entecavir pharmacokinetics.
The safety and efficacy of BARACLUDE 0.5 mg once daily were assessed in a single-arm, open-label
trial of HBeAg-positive or -negative, nucleoside-inhibitor-naïve, Black/African American (n=40) and
Hispanic (n=6) subjects with chronic HBV infection. In this trial, 76% of subjects were male, the mean
age was 42 years, 57% were HBeAg-positive, the mean baseline HBV DNA was 7.0 log10
IU/mL,
and the mean baseline ALT was 162 U/L. At Week 48 of treatment, 32 of 46 (70%) subjects had
HBV DNA <50 IU/mL (approximately 300 copies/mL), 31 of 46 (67%) subjects had ALT normalization
(≤1 × ULN), and 12 of 26 (46%) HBeAg-positive subjects had HBe seroconversion. Safety data were
similar to those observed in the larger controlled clinical trials.
Because of low enrollment, safety and efficacy have not been established in the US Hispanic population.
Renal Impairment - Dosage adjustment of BARACLUDE is recommended for patients with creatinine
clearance less than 50 mL/min, including patients on hemodialysis or CAPD [see Dosage and
Administration (2.4) and Clinical Pharmacology (12.3) in full Prescribing Information].
Liver Transplant Recipients - The safety and efficacy of BARACLUDE were assessed in a single-arm,
open-label trial in 65 subjects who received a liver transplant for complications of chronic HBV infection.
Eligible subjects who had HBV DNA less than 172 IU/mL (approximately 1000 copies/mL) at the time
of transplant were treated with BARACLUDE 1 mg once daily in addition to usual post-transplantation
management, including hepatitis B immune globulin. The trial population was 82% male, 39% Caucasian,
and 37% Asian, with a mean age of 49 years; 89% of subjects had HBeAg-negative disease at the time
of transplant.
Four of the 65 subjects received 4 weeks or less of BARACLUDE (2 deaths, 1 retransplantation, and
1 protocol violation) and were not considered evaluable. Of the 61 subjects who received more
than 4 weeks of BARACLUDE, 60 received hepatitis B immune globulin post-transplant. Fifty-three
subjects (82% of all 65 subjects treated) completed the trial and had HBV DNA measurements at or
after 72 weeks treatment post-transplant. All 53 subjects had HBV DNA <50 IU/mL (approximately
300 copies/mL). Eight evaluable subjects did not have HBV DNA data available at 72 weeks, including 3
subjects who died prior to study completion. No subjects had HBV DNA values ≥50 IU/mL while receiving
BARACLUDE (plus hepatitis B immune globulin). All 61 evaluable subjects lost HBsAg post-transplant;
2 of these subjects experienced recurrence of measurable HBsAg without recurrence of HBV viremia.
This trial was not designed to determine whether addition of BARACLUDE to hepatitis B immune
globulin decreased the proportion of subjects with measurable HBV DNA post-transplant compared to
hepatitis B immune globulin alone.
If BARACLUDE treatment is determined to be necessary for a liver transplant recipient who has received
or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus,
renal function must be carefully monitored both before and during treatment with BARACLUDE [see
Dosage and Administration (2.4) and Clinical Pharmacology (12.3) in full Prescribing Information].
OVERDOSAGE: There is limited experience of entecavir overdosage reported in patients. Healthy subjects
who received single entecavir doses up to 40 mg or multiple doses up to 20 mg/day for up to 14 days
had no increase in or unexpected adverse events. If overdose occurs, the patient must be monitored for
evidence of toxicity, and standard supportive treatment applied as necessary.
Following a single 1 mg dose of entecavir, a 4-hour hemodialysis session removed approximately 13%
of the entecavir dose.
NONCLINICAL TOXICOLOGY: Carcinogenesis, Mutagenesis, Impairment of Fertility.
Carcinogenesis - Long-term oral carcinogenicity studies of entecavir in mice and rats were carried
out at exposures up to approximately 42 times (mice) and 35 times (rats) those observed in humans
at the highest recommended dose of 1 mg/day. In mouse and rat studies, entecavir was positive for
carcinogenic findings.
In mice, lung adenomas were increased in males and females at exposures 3 and 40 times those in
humans. Lung carcinomas in both male and female mice were increased at exposures 40 times those
in humans. Combined lung adenomas and carcinomas were increased in male mice at exposures 3
times and in female mice at exposures 40 times those in humans. Tumor development was preceded
by pneumocyte proliferation in the lung, which was not observed in rats, dogs, or monkeys administered
entecavir, supporting the conclusion that lung tumors in mice may be a species-specific event.
Hepatocellular carcinomas were increased in males and combined liver adenomas and carcinomas were
also increased at exposures 42 times those in humans. Vascular tumors in female mice (hemangiomas
of ovaries and uterus and hemangiosarcomas of spleen) were increased at exposures 40 times those
in humans. In rats, hepatocellular adenomas were increased in females at exposures 24 times those in
humans; combined adenomas and carcinomas were also increased in females at exposures 24 times
those in humans. Brain gliomas were induced in both males and females at exposures 35 and 24 times
those in humans. Skin fibromas were induced in females at exposures 4 times those in humans.
It is not known how predictive the results of rodent carcinogenicity studies may be for humans.
Mutagenesis - Entecavir was clastogenic to human lymphocyte cultures. Entecavir was not mutagenic
in the Ames bacterial reverse mutation assay using S. typhimurium and E. coli strains in the presence
or absence of metabolic activation, a mammalian-cell gene mutation assay, and a transformation assay
with Syrian hamster embryo cells. Entecavir was also negative in an oral micronucleus study and an oral
DNA repair study in rats.
Impairment of Fertility - In reproductive toxicology studies, in which animals were administered
entecavir at up to 30 mg/kg for up to 4 weeks, no evidence of impaired fertility was seen in male or
female rats at systemic exposures greater than 90 times those achieved in humans at the highest
recommended dose of 1 mg/day. In rodent and dog toxicology studies, seminiferous tubular degeneration
was observed at exposures 35 times or greater than those achieved in humans. No testicular changes
were evident in monkeys.
1323583 Rev May 2014
686US14BR01514-02-01
OFFIC IAL JOURNAL OF THE AMERI CAN A SSOCIATION F OR THE STUDY OF LI VER DISEASES
Editor
Michael H. Nathanson, New Haven, CT
SENIOR ASSOCIATE EDITORS
James L. Boyer, New Haven, CT
Roberto J. Groszmann, New Haven, CT
ASSOCIATE EDITORS
Frank A. Anania, Atlanta, GA
Jorge A. Bezerra, Cincinnati, OH
Guadalupe Garcia-Tsao, New Haven, CT
Stephen A. Harrison, Fort Sam Houston, TX
Donald M. Jensen, Chicago, IL
Brett Lindenbach, New Haven, CT
Jacquelyn Maher, San Francisco, CA
Wajahat Mehal, New Haven, CT
Lola M. Reid, Chapel Hill, NC
Mario Strazzabosco, New Haven, CT
Norah Terrault, San Francisco, CA
Snorri S. Thorgeirsson, Bethesda, MD
Michael Trauner, Vienna, Austria
CONSULTING BIOSTATISTICIAN
James Dziura, New Haven, CT
HEPATOLOGY ELSEWHERE
Yasuko Iwakiri, New Haven, CT
Tamar H. Taddei, New Haven, CT
EDITORS EMERITUS
Irwin M. Arias, Boston, MA, Founding Editor
Steven Schenker, San Antonio, TX
Paul D. Berk, New York, NY
D. Montgomery Bissell, San Francisco, CA
Andres T. Blei, Chicago, IL
Keith D. Lindor, Rochester, MN
CLINICAL OBSERVATIONS IN HEPATOLOGY
Victor J. Navarro, Philadelphia, PA
Simona Jakab, New Haven, CT
HEPATOLOGY HIGHLIGHTS
Jean-Franc¸ois Dufour, Bern, Switzerland
PRODUCTION STAFF
Ann Haran, Managing Editor
Kareytis Martinez, Editorial Assistant
Tazeen Shirazi, Editorial Assistant
Dana Lombardi, Editorial Assistant
Kara Cheatham, Editorial Assistant
EDITORIAL BOARD
Manal Abdelmalek, Durham, NC
Juan Abraldes, Alberta, Canada
Gianfranco Alpini, Temple, TX
Raul Andrade, Ma´laga, Spain
Mario Angelico, Rome, Italy
Paul Angulo, Lexington, KY
Meena Bansal, New York, NY
Ulrich Beuers, Amsterdam, Netherlands
Jordi Bruix, Barcelona, Spain
Elizabeth Brunt, St. Louis, MO
John Bucuvalas, Cincinatti, OH
Michael Charlton, Rochester, MN
John Chiang, Rootstown, OH
David Cohen, Boston, MA
Kenneth Cusi, San Antonio, TX
Mark Czaja, New York, NY
Gennaro D’Amico, Palermo, Italy
Gary Davis, Dallas, TX
Anna Mae Diehl, Durham, NC
Alvaro Domenico, Rome, Italy
Jean Dubuisson, Lille, France
Ronald Oude Elferink, Amsterdam, Netherlands
Jeff Esko, Manchester, United Kingdom
Michael Fallon, Houston, TX
Jordan Feld, Toronto, Canada
Ariel Feldstein, Cleveland, OH
Andrew Feranchak, Dallas, TX
Peter Ferenci, Vienna, Austria
Jose Fernandez-Checa, Barcelona, Spain
Peter Fickert, Graz, Austria
Stuart Forbes, Edinburgh, United Kingdom
Michael Fried, Chapel Hill, NC
Mark Furth, Winston-Salem, NC
Bin Gao, Bethesda, MD
Juan Carlos Garcia-Paga´n, Barcelona, Spain
Eugenio Gaudio, Rome, Italy
Eric Gershwin, Sacramento, CA
Jim D Gorham, Lebanon, NH
Arash Grakoui, Atlanta, GA
Ivo Graziadei, Innsbruck, Austria
Kenichi Ikejima, Tokyo, Japan
Ira Jacobson, New York, NY
Dhanpat Jain, New Haven, CT
Harmut Jaeschke, Kansas City, KS
Peter Jansen, Netherlands
Harry Janssen, Rotterdam, Netherlands
Cynthia Ju, Denver, CO
Patrick Kamath, Rochester, MN
Neil Kaplowitz, Los Angeles, CA
Tom Karlsen, Oslo, Norway
Saul Karpen, Atlanta, GA
W. Ray Kim, Rochester, MN
Curtis Klaassen, Kansas City, KS
Percy Knolle, Bonn, Germany
Sanjay Kulkarni, New Haven, CT
William Lee, Dallas, TX
Stanley Lemon, Chapel Hill, NC
Massimo Levrero, Rome, Italy
Joseph Lim, New Haven, CT
Maribel Lucena, Ma´laga, Spain
Derek Mann, Newcastle Upon Tyne, United Kingdom
M. Michele Manos, Oakland, CA
Fabio Marra, Florence, Italy
Jane McKeating, Birmingham, United Kingdom
Brian McMahon, Anchorage, Alaska
Philip Meuleman, Ghent, Belgium
Pram Mistry, New Haven, CT
Atsushi Miyajima, Tokyo, Japan
Satdarshan Monga (Paul) Singh, Pittsburgh, PA
Richard Moreau, Beaujon, France
Masaki Mori, Osaka, Japan
Antonio Moschetta, Bari, Italy
Andrew Muir, Durham, NC
Kevin Mullen, Cleveland, OH
Laura Nagy, Cleveland, OH
David Nelson, Bethesda, MD
James Neuberger, Birmingham, United Kingdom
Young-Nyun Park, Yonsei, Korea
Markus Peck-Radosavljevic, Vienna, Austria
Robert Perrillo, Dallas, TX
Massimo Pinzani, Florence, Italy
Jeffrey Pollak, New Haven, CT
Fred Poordad, Los Angeles, CA
Elizabeth Powell, Brisbane, Australia
Nancy Reau, Chicago, IL
K. Rajender Reddy, Philadelphia, PA
Mary Rinella, Chicago, IL
Cristina Ripoll, Halle an der Saale, Germany
Lewis R. Roberts, Rochester, MN
Sammy Saab, Los Angeles, CA
Francesco Salerno, Milan, Italy
Peter Schirmacher, Heidelberg, Germany
Robert Schwabe, New York, NY
Gamel Shiha, Almansoura, Egypt
Ben Shneider, Pittsburgh, PA
Ron Sokol, Aurora, CO
Bruno Stieger, Zurich, Switzerland
Fred Suchy, Denver, CO
Mark Sulkowski, Baltimore, MD
Gyongyi Szabo, Worchester, MA
Puneeta Tandon, Edmonton, Canada
Neil Theise, New York, NY
Zhigang Tian, Hefei, China
Dawn Torres, Baltimore, MD
Augusto Villanueva, Barcelona, Spain
Miriam Vos, Atlanta, GA
Fu-Sheng Wang, Beijing, China
Yunfang Wang, Beijing, China
Xin Wei Wang, Bethesda, MD
Rebecca Wells, Philadelphia, PA
Brian West, New Haven, CT
Reiner Wiest, Regensberg, Germany
Florence Wong, Toronto, Canada
Hushan Yang, Philadelphia, PA
Min You, San Francisco, CA
Nizar Zein, Cleveland, OH
Jessica Zucman-Rossi, Paris, France
American Association for the Study of Liver Diseases—Governing Board 2014
President
Adrian M. Di Bisceglie, St. Louis, MO
President-Elect
Gyongi Szabo, Worcester, MA
Secretary
Gary L. Davis, Simpsonville, SC
Past President
J. Gregory Fitz, Dallas, TX
Councilors
Keith D. Lindor, Tempe, AZ
Anna S.F. Lok, Ann Arbor, MI
Ronald J. Sokol, Aurora, CO
Councilors-at-Large
Raymond T. Chung, Boston, MA
Susan Orloff, Portland, OR
K. Rajender Reddy, Philadelphia, PA
Publications Committee Chair
Theo Heller, Bethesda, MD
Treasurer
W. Ray Kim, Stanford, CA
AASLD National Headquarters: 1001 North Fairfax Street, Suite 400, Alexandria, VA 22314. Phone: 703-299-9766; Fax: 703-299-9622; E-mail: AASLD@AASLD.org.
Chief Executive Officer, Steven Echard
Editorial Office: 1001 North Fairfax Street, Suite 400, Alexandria, VA 22314. Phone: 703-299-9766; Fax: 703-299-9676; E-mail: hepatology@aasld.org
HEPATOLOGY (Print ISSN 0270-9139; Online ISSN 1527-3350 at Wiley Online Library (wileyonlinelibrary.com)) is published monthly in two indexed volumes through Wiley Subscription
Services, a Wiley Company, 111 River St., Hoboken, NJ 07030. Subscription rates for Volumes 59-60, 2014. Institution (includes Liver Transplantation, Volume 20, 2014) Print only: in U.S.,
$2,440. For all other prices please consult the journal’s website at onlinelibrary.wiley.com/journal/10.1002/(ISSN)1527-3352. Prices subject to change without notice. Periodicals postage paid
at Hoboken, NJ, and at additional mailing offices.
Delivery Terms and Legal Title: Where the subscription price includes print issues and delivery is to the recipient’s address, delivery terms are Delivered at Place (DAP); the recipient is
responsible for paying any import duty or taxes. Title to all issues transfers FOB our shipping point, freight prepaid. We will endeavor to fulfill claims for missing or damaged copies within
six months of publication, within our reasonable discretion and subject to availability. POSTMASTER: Send all address changes to HEPATOLOGY, John Wiley & Sons Inc., c/o The Sheridan
Press, PO Box 465, Hanover, PA 17331. Copyright VC 2014 by the American Association for the Study of Liver Diseases. All rights reserved. Printed in the United States of America by Cadmus
Communications, a Cenveo company. Printed on acid-free paper effective with Volume 11, Number 2, 1990.
2015 Research and Career Development Awards
We understand the phenomenal return on investment that research can provide. Several
young investigators began their careers in biomedical research thanks to funding from
our program, demonstrating the importance of these awards not only to investigators and
practitioners, but to the very endeavor of medical and hepatobiliary research itself.
Application Deadline:
DECEMBER 4, 2014
*NP/PA Clinical Hepatology
Fellowship Application Deadline:
FEBRUARY 5, 2015
Recipient Notification:
MAY 2015
Award Start Date:
JULY 1, 2015
Research Awards
Pinnacle Research Award in Liver Disease
$300,000—3 year award
NEW IN 2015
Clinical and Translational Research Awards in Liver Diseases
$150,000—2 year award
Career Development Award in Liver Transplantation
$90,000—2 year award
Career Development Awards
NP/PA Clinical Hepatology Fellowship*
$78,000—1 year award
AASLD/LIFER Clinical and Translational Research Fellowship
$75,000—1 year award
Advanced/Transplant Hepatology Fellowship
$60,000—1 year award
Awards applications
are available at
WWW.AASLD.ORG/AWARDS
iiA
The overall goal of The Liver Meeting® is to provide a forum
for the exchange of ground breaking research and clinical
information in diseases of the liver and biliary tract and in liver
transplantation.
Target Audience
Groups include clinical hepatologists, gastroenterologists,
other health care providers (midlevel providers, internists,
pediatricians, family practitioners), and trainees (students,
residents, and specialty fellows). The target audience also
encompasses scientists studying the development, physiology,
pathology, translational medicine, and clinical trials related to
the liver and biliary tract and liver transplantation.
AASLD takes responsibility for the content, quality, and scientific
integrity of this live activity.
Learning Objectives
Upon participation in this live educational activity, learners will
be able to:
•	Incorporate new scientific evidence into clinical care
protocols and improve the outcome of adults and children
with acute and chronic diseases of the liver and biliary tract.
•	Establish new collaborations, implement new clinical trials,
develop comparative effectiveness projects, and complete
investigative efforts that will improve the outcome of adults
and children with acute and chronic diseases of the liver and
biliary tract.
•	Implement effective care plans to improve the long-term
outcome of the transplanted patient.
Continuing Medical Education (CME)
Accreditation Statement
The American Association for the Study of Liver Diseases
(AASLD) is accredited by the Accreditation Council for
Continuing Medical Education (ACCME) to provide continuing
medical education for physicians.
Credit Designation Statement
AASLD designates these live activities for AMA PRA Category 1
Credits™. Physicians should claim only the credit commensurate
with the extent of their participation in the activity.
Maximum Credits Available
Annual Meeting (State-of-the-Art Lectures; President’s Choice;
General Hepatology Update; Advances for Practitioners;
Plenaries and Parallel Sessions; Global Forum; MOC Session;
Value-Based Medicine in Hepatology; and
Emerging Trends) . . . . . . . . . . . . . . . . . .  20.5 CME Credits
Postgraduate Course. . . . . . . . . . . . . . . .  12.0 CME Credits
Basic Research Workshop . . . . . . . . . . . . .  4.0 CME Credits
Hepatology Associates Course . . . . . . . . . .  5.5 CME Credits
AASLD/ILTS Transplant Course* . . . . . . . . .  6.5 CME Credits
AASLD/NASPGHAN
  Pediatric Symposium**. . . . . . . . . . . . . .  3.0 CME Credits
AASLD/ASGE Endoscopy Course** . . . . . . .  7.0 CME Credits
Transplant Surgery Workshop . . . . . . . . . .  3.5 CME Credits
*This activity has been planned and implemented in accordance
with the Essential Areas and Policies of the Accreditation Council for
Continuing Medical Education through the joint providership of the
American Association for the Study of Liver Diseases (AASLD), and the
International Liver Transplantation Society (ILTS). AASLD is accredited
by the ACCME to provide continuing medical education for physicians.
**Co-sponsored activity: The American Association for the Study of
Liver Diseases (AASLD) is accredited by the Accreditation Council for
Continuing Medical Education to provide continuing medical education
for physicians.
Please note: As an accredited provider, AASLD ensures the content of
all CME activities and related materials will promote improvements or
quality in health care, and not a specific proprietary business interest
of a commercial interest. As such, some sessions or ticketed activities
may not offer CME credits.
Continuing Education (CE)
The Institute for Advancement of Human Behavior (IAHB) is accredited
as a provider of continuing nursing education by the American Nurses
Credentialing Center’s Commission on Accreditation. These activities
are co-provided by IAHB and AASLD. Maximum 20 contact hours.
The following ticketed activities will award nurse continuing education
contact hours:
•	 AASLD/ILTS Transplant Course – 5 contact hours
•	 Postgraduate Course – 10 contact hours
•	 Hepatology Associates Course – 5 contact hours
Faculty Disclosure
It is the policy of AASLD to ensure balance, independence,
objectivity, and scientific rigor in all its individually or jointly
sponsored educational programs.
All faculty/authors participating in any AASLD sponsored
programs, as well as planners and committee members are
expected to disclose any real or apparent conflict(s) of interest
that may have a direct bearing on the subject matter of the
continuing medical education program.
When an unlabeled use of a commercial product, or an
investigational use not yet approved for any purpose is
discussed during an educational activity, the speaker shall
disclose to the audience that the product is not labeled for the
use under discussion or that the product is still investigational.
All disclosure information is provided to the activity participant
prior to the start of the educational activity. In addition,
disclosure slides will be the first slide in each oral presentation
viewed by participants. AASLD will identify and resolve all
conflicts of interest prior to program implementation.
Accreditation and Continuing Education Information
iiiA
Accreditation and Continuing Education Information
Disclaimer Statement
Statements, opinions, and results of studies presented at The
Liver Meeting® are solely those of the authors and do not reflect
the policy or position of AASLD. AASLD does not provide any
warranty to the accuracy or reliability of information presented
either verbally or in writing by presenters. No responsibility is
assumed by AASLD for any injury and/or damage to persons
or property resulting from any use of such information.
Use of AASLD Scientific Program Content
Information presented during the 65th Annual Meeting is the
property of AASLD and the presenter. Information may not
be recorded, photographed, copied, photocopied, transferred
to electronic format, reproduced, or distributed without the
written permission of AASLD and the presenter. Any use of
the program content, which includes, but is not limited to oral
presentations, audiovisual materials used by speakers, and
program handouts, without the written consent of AASLD is
prohibited.
Claiming CME/CE Credit and
Certificates of Attendance
The CME/CE evaluations are electronic and can be completed
using the following options:
•	Upon download, use the meeting app to evaluate the
sessions in real-time
•	Using your personal device, link to the CME and/or CE
evaluation on The Liver Meeting® website
•	Visit Tech Connect to access the evaluation from any
available kiosk
CME and CE credit will be awarded upon completion of the
electronic evaluation. You will have the ability to download
and/or print a certificate for your records once you have
completed the CME and/or CE evaluations.
Certificates of Attendance are also available. Certificates may
be downloaded and/or printed upon completion of The Liver
Meeting® evaluation.
Outcomes Follow-up Survey
A follow-up survey will be sent to all attendees within three
months of the conclusion of the meeting to assess the new skills
and competencies learned as a result of participating in this
live activity.
ivA
Future Meetings 2015
Digestive Disease Week® (DDW)
May 16 – 19
Walter E. Washington Convention Center
Washington, DC
Clinical Hepatology: State-of-the-Art Management
June 27 – 28
The Westin Chicago River North
Chicago, Illinois
Emerging Trends Conference
AASLD Industry Colloquium: Novel Targets and Therapies in Liver Disease
Spring 2015
Location TBD
The Liver Meeting®
November 13 – 17
Moscone West Convention Center
San Francisco, California
Postgraduate Course
Managing Liver Disease - From the Clinic to the Community
November 14
Moscone West Convention Center
San Francisco, California
vA
THE AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES
65th ANNUAL MEETING AND POSTGRADUATE COURSE
N O V E M B E R 7 – N O V E M B E R 1 1   •   B O S T O N , M A
The Liver Meeting®
2O14
Table of Contents
Meeting-at-a-Glance  . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  2A
General Meeting Information . . . . . . . . . . . . . . . . . . . . . . .  5A
Limited License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  7A
Disclosure Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  8A
Oral Sessions
Friday, November 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . .  32A
Saturday, November 8  . . . . . . . . . . . . . . . . . . . . . . . . . .  39A
Sunday, November 9  . . . . . . . . . . . . . . . . . . . . . . . . . . .  43A
Monday, November 10 . . . . . . . . . . . . . . . . . . . . . . . . . .  65A
Tuesday, November 11 . . . . . . . . . . . . . . . . . . . . . . . . . .  85A
Poster Sessions
Saturday, November 8  . . . . . . . . . . . . . . . . . . . . . . . . . .  92A
Sunday, November 9  . . . . . . . . . . . . . . . . . . . . . . . . . .  119A
Monday, November 10 . . . . . . . . . . . . . . . . . . . . . . . . .  146A
Tuesday, November 11 . . . . . . . . . . . . . . . . . . . . . . . . .  169A
Abstracts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  197A
Author Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1206A
Category Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1256A
The Scientific Program Committee has created an exciting
and diverse scientific program that highlights new technology,
current clinical issues and hot topics facing the hepatology
community. Members include:
Adrian M. Di Bisceglie, MD, FACP, Co-Chair
Gary L. Davis, MD, Co-Chair
Carla W. Brady, MD
Kenneth D. Chavin, MD, PhD
Mark J. Czaja, MD
Marc G. Ghany, MD
Saul J. Karpen, MD, PhD
Keith D. Lindor, MD
Gyongyi Szabo, MD, PhD
Rebecca T. Wells, MD
NP/PA Clinical Hepatology Fellowship Program
$
78,000, One Year*
Pursue a full year of training in clinical hepatology—apply for the NP/PA Clinical
Hepatology Fellowship. If you are new to the field or interested in a shift in focus to
clinical hepatology—the NP/PA Clinical Hepatology Fellowship provides $78,000* for
one year of clinical training for those committed to the field of hepatology and better
treatment for patients with liver disease.
The application is available at www.aasld.org/awards
Application Deadline:
FEBRUARY 5, 2015
Award Start Date:
JULY 1, 2015
*Salary and benefit support only—AASLD provides equal opportunity for all
research and fellowship award applicants without regard to race, color, creed,
religion, gender, sexual orientation, national origin, age, marital status, mental
or physical disability, pregnancy, military or veteran status, or any other basis
prohibited by state or federal law.
Earn CME and prepare for your internal medicine,
gastroenterology, or transplant hepatology exam
with board-style practice questions from Clinical
Liver Disease (CLD). Each question set helps
you identify areas for further review and links to
free online resources—articles, videos, webinars,
and podcasts—that can help you update your
knowledge on a variety of hepatology topics.
Nurses and physician assistants will also
benefit from the review questions and from the
full spectrum of clinical education available
through CLD.
Visit cldlearning.com/questions to start today.
CLD is an online learning resource of the American
Association for the Study of Liver Diseases.
Free Board Review
Questions
YOU CAN ALSO DOWNLOAD THESE
PRACTICE GUIDELINE TOPICS FOR LIVER DISEASE
■■ Acute Liver Failure
■■ Alcoholic Liver
Disease
■■ Ascites due
to Cirrhosis
■■ Autoimmune
Hepatitis
■■ Gastroesophageal
Varices and Variceal
Hemorrhage
in Cirrhosis
■■ Hemochromatosis
■■ Hepatitis B, Chronic
■■ Hepatocellular
Carcinoma
■■ Liver Biopsy
■■ Long-Term
Management of
Adult Patients
After Liver
Transplantation
■■ Long-Term
Management
of Pediatric
Patients After Liver
Transplantation
■■ Non-alcoholic Fatty
Liver Disease
■■ Primary Biliary
Cirrhosis
■■ Primary Sclerosing
Cholangitis
■■ TIPS in
Management of
Portal Hypertension
■■ Vascular Disorders
of the Liver
■■ Wilson Disease
NEW Practice
Guidelines in 2014
Available at www.aasld.org
■■ Hepatic Encephalopathy in Chronic Liver Disease
■■ Evaluation for Liver Transplantation in Adults
■■ Evaluation of the Pediatric Patient for Liver Transplantation
These evidence-based guidelines are developed and
updated regularly by a committee of experts and include
recommendations of preferred approaches to the diagnostic,
therapeutic, and preventative aspects of care.
FIND OUT MORE
AT
THE PAVILION
Visit the AASLD Pavilion
Just outside registration
2A
Meeting-at-a-Glance
The majority of events during The Liver Meeting® will take place in the Hynes Convention Center. Those events not taking
place at the convention center will be noted. Sessions marked with an asterisk * require a ticket for entrance.
Day/Time	Activity	 Location	 Page
Friday, November 7
7:55 am – 3:00 pm	 AASLD/ASGE Endoscopy Course *	 Room 302	 32A
8:00 am – 2:45 pm	 AASLD/ ILTS Transplant Course * 	 Ballroom B/C	 33A
10:00 am – Noon	 Career Development Workshop *	 Room 311	 34A
Noon – 3:00 pm	 AASLD/NASPGHAN Pediatric Symposium *	 Room 312	 35A
12:30 – 2:45 pm	 Competency Training Workshop	 Room 309	 36A
12:30 – 3:30 pm	 Clinical Research Workshop *	 Room 304/306	 37A
3:30 – 7:30 pm	 Postgraduate Course *	 Auditorium	 38A
Saturday, November 8
8:00 am – 5:00 pm	 Postgraduate Course *	 Auditorium	 39A
9:00 am – Noon	 SIG Program: Outreach in Liver Transplant	 Room 302	 40A
12:20 – 1:40 pm	 Meet-the-Professor Luncheons *	 Check your Ticket 	 41A
2:00 – 7:30 pm	 Poster Session I 	 Hall C
•	Ascites, Renal Dysfunction and Hepatorenal Syndrome		 92A
•	Behavioral, Quality of Life, and Practice Issues		 93A
•	Cholangiocyte Biology		 93A
•	Cholestasis and Autoimmune Liver Disease		 94A
•	Donor Factors and Allocation		 97A
•	Encephalopathy and Other Complications		 98A
•	Experimental Cholestasis		 101A
•	Fibrosis: Clinical and Translational		 101A
•	Hemochromatosis, Wilson Disease, a-1 Antitrypsin Deficiency		 104A
•	Imaging in Cancer		 104A
•	Imaging in Fibrosis		 105A
•	Immunosuppression		 106A
•	Infections and Acute on Chronic Liver Failure		 110A
•	Inflammation and Immunobiology: Animal Models		 112A
•	Innate Immunity and Adaptive		 113A
•	Living Donor and Split Transplant		 114A
•	Mechanisms of Injury		 115A
•	Metabolic and Genetic Diseases		 115A
•	Viral and Autoimmune Hepatitis		 116A
•	Viral Hepatitis and Liver Transplant		 116A
3:30 – 7:00 pm	 Transplant Surgery Workshop *	 Room 302	 42A
5:15 – 6:15 pm	 AASLD Business Meeting (Members Only)	 Auditorium	 42A
5:00 – 7:30 pm	 Exhibits Open	 Hall D	 41A
5:00 – 7:30 pm	 Opening Reception	 Hall C/D	 41A
Sunday, November 9
6:45 – 7:45 am	 Early Morning Workshops *	 Check your ticket	 43A
8:00 – 9:30 am	 Transplant Plenary I	 Auditorium	 44A
8:00 am – Noon	 Basic Research Workshop *	 Ballroom A	 45A
8:00 am – 1:30 pm	 Hepatology Associates Course *	 Room 304/306	 46A
8:00 am – 5:30 pm	 Poster Session II	 Hall C
•	Acute Liver Failure		 119A
•	Basic Fibrosis		 121A
•	Clinical Steatohepatitis		 123A
•	Experimental Hepatocarcinogenesis		 129A
•	Hepatitis C: Approved Therapeutic Agents		 132A
•	Hepatotoxicity: Drug Metabolism		 138A
•	Hepatotoxicity: Mechanisms		 139A
•	Imaging of Steatohepatitis		 140A
•	Steatohepatitis		 140A
•	Transport, Bilirubin, Cholesterol, Lipids and Bile Salts		 145A
3A
Sunday, November 9
9:30 – 10:00 am	 Thomas E. Starzl Transplant Surgery State-of-the-Art Lecture	 Auditorium	 47A
9:30 am – 3:00 pm	 Exhibits Open	 Hall D	 44A
10:00 – 10:30 am	 Coffee Break	 Hall D	 47A
10:00 – 11:30 am	 Emerging Trends Symposium	 Room 312	 48A
10:30 am – Noon	 Transplant Plenary II	 Auditorium	 49A
Noon – 12:30 pm	 Hans Popper Basic Science State-of-the-Art Lecture	 Auditorium	 50A
1:00 – 3:00 pm	 Value-based Medicine in Hepatology	 Room 302	 50A
1:15 – 2:45 pm	 Maintenance of Certification (MOC) Update	 Room 210	 51A
1:30 – 2:00 pm	 Snack Break	 Hall D 	 51A
2:00 – 2:30 pm	 Ethics and Humanities State-of-the-Art Lecture	 Auditorium	 52A
2:45 – 3:00 pm	 Distinguished Clinician Educator / Mentor Award	 Auditorium	 52A
3:00 – 4:30 pm	 General Hepatology Update 	 Ballroom A/B/C	 52A
3:00 – 4:30 pm	 Parallel Sessions
1. Advances in Fibrosis Imaging	 Room 309	 53A
2. Antivirals, Acute Liver Failure in Liver Transplantation	 Room 312	 53A
3. Basic Mechanisms of Liver Fibrosis	 Sheraton, Republic Ballroom	 54A
4. Cholestatic and Autoimmune Liver Disease	 Room 302	 54A
5. Experimental Hepatocarcinogenesis	 Sheraton, Back Bay Ballroom C	 55A
6. Hepatitis C: Currently Approved Drugs	 Auditorium	 55A
7. Mechanisms of Hepatotoxicity	 Room 210	 56A
8. Novel Approaches in Diagnosis and Treatment
in NAFLD and NASH	 Room 304/306	 56A
9. Tissue Damage in Liver Disease and Inflammatory and Viral	 Room 311	 57A
4:45 – 6:15 pm	 Parallel Sessions
10. HBV Diagnosis, Epidemiology, Prevention and Natural History	 Room 312	 57A
11. Hepatitis C: Health Economics and Cost-effectiveness	 Room 304/306	 58A
12. Hepatitis C: New Agents – Part 1	 Auditorium	 58A
13. Machine Perfusion and Cellular Therapy	 Room 309	 59A
14. Outcomes in Cirrhosis	 Ballroom A/B/C	 59A
15. Steatohepatitis: Experimental	 Room 311	 60A
4:45 – 6:45 pm	 SIG Program: Pharmacogenomic Approaches in DILI Research	 Room 210	 61A
4:45 – 7:00 pm	 SIG Program: Primary Liver Carcinomas with Intermediate/Stem Cell
	 Features: Microscopic to Genomic Evidence and Back	 Sheraton, Back Bay Ballroom C	 62A
4:45 – 7:00 pm	 SIG Program: Controversies in the Management
	 of PSC in Children and Adults	 Room 302	 63A
4:45 – 7:45 pm	 SIG Program: The Cell Biology of Hepatic Disease	 Sheraton, Republic Ballroom	 64A
Monday, November 10
6:45 – 7:45 am	 Early Morning Workshops *	 Check your ticket	 65A
8:00 – 9:30 am	 Basic Plenary	 Auditorium	 66A
8:00 am – 5:30 pm	 Poster Session III 	 Hall C
•	Alcohol: Clinical and Basic Mechanisms		 146A
•	Basic Hepatobiliary Neoplasia		 148A
•	Biliary Atresia and Cholestasis		 150A
•	Cellular and Molecular Biology		 150A
•	Cellular Immunobiology		 152A
•	Clinical Hepatobiliary Neoplasia		 153A
•	Cost-effectiveness		 160A
•	HCV: Diagnostics, Epidemiology, and Natural History		 160A
•	Health Care Delivery		 166A
•	Pediatric Liver Disease – Basic Science		 168A
•	Pediatric Liver Transplantation		 168A
9:30 – 10:00 am	 Distinguished Service and Achievement Awards	 Auditorium	 66A
9:30 am – 3:00 pm	 Exhibits Open	 Hall D	 66A
10:00 – 10:30 am	 Hyman J. Zimmerman Hepatotoxicity State-of-the-Art Lecture	 Auditorium	 67A
10:30 – 11:00 am 	 Coffee Break 	 Hall D	 67A
11:00 am – 12:30 pm	 Clinical Plenary	 Auditorium	 68A
11:00 am – 12:30 pm	 Advances for Practitioners	 Ballroom A/B/C	 69A
11:45 am – 1:15 pm	 Professional Development Workshop *	 Sheraton, Republic Ballroom	 70A
Meeting-at-a-Glance (continued)
Day/Time	Activity	 Location	 Page
4A
Meeting-at-a-Glance (continued)
Day/Time	Activity	 Location	 Page
Monday, November 10
1:30 – 2:00 pm	 Snack Break 	 Hall D	 70A
2:00 – 4:00 pm	 Global Forum	 Room 304/306	 71A
2:15 – 2:45 pm	 President’s Choice	 Auditorium	 72A
2:45 – 4:30 pm	 Late-breaking Abstract Session	 Auditorium	 72A
3:00 – 4:30 pm	 Parallel Sessions
16. Access, Delivery, and Cost of Care	 Room 210	 73A
17. Allocation, MELD, and Liver Transplantation	 Room 312	 73A
18. Basic Hepatobiliary Neoplasia	 Room 310	 74A
19. Cholestatic Liver Disease	 Room 302	 74A
20. Mechanisms and Mortality in Alcoholic Liver Disease	 Room 313	 75A
21. Molecular and Cellular Biology	 Room 309	 75A
22. Pediatric Liver Diseases: Models, Modifiers, Mechanisms,
and Markers	 Room 311	 76A
23. Pharmacologic Therapies for Cirrhosis Complications	 Ballroom A/B/C	 76A
4:45 – 6:15 pm	 HCV Symposium: #What’s Trending in Hepatitis C?	 Auditorium	 77A
4:45 – 6:15 pm	 Parallel Sessions
24. Clinical Hepatobiliary Neoplasia	 Room 302	 78A
25. Hepatitis C: Diagnosis, Epidemiology and Natural History	 Room 312	 78A
26. Living Donor and Split Liver Transplantation, Hepatobiliary Surgery	 Room 210	 79A
27. Pediatric Liver Diseases: Clinical and Translational Studies	 Room 311	 79A
28. The Good and Bad of Innate Immunity in Liver Disease	 Room 309	 80A
4:45 – 6:50 pm	 SIG Program: Non-invasive Methods to Stratify Risk in Patients
	 with Compensated Cirrhosis	 Ballroom A/B/C	 81A
4:45 – 6:55 pm	 SIG Program: Immunity and Lipids as New Drivers in Inflammation
	 and Fibrosis of Non-Alcoholic Steatohepatitis	 Sheraton, Back Bay Ballroom C	 82A
4:45 – 7:25 pm	 SIG Program: Renal Dysfunction in Cirrhosis: Should We Change
	 the Way we Manage These Patients?	 Sheraton, Republic Ballroom	 83A
4:45 – 7:50 pm	 SIG Program: The Next Generation of HBV Therapy:
	 From Discovery to Cure	 Room 304/306	 84A
Tuesday, November 11
6:45 – 7:45 am	 Early Morning Workshops *	 Check your ticket 	 85A
8:00 – 9:30 am	 Hepatitis Plenary	 Auditorium	 86A
8:00 am – Noon	 Poster Session IV	 Hall C
•	HBV: Diagnostics, Epidemiology, and Natural History		 169A
•	HBV: Virology and Pathogenesis		 174A
•	HCV: Health Economics and Cost-effectiveness		 177A
•	HCV: Virology, Pathogenesis and Immunology		 178A
•	Hepatitis B Therapy		 182A
•	Hepatitis C: New Agents (Not Approved)		 187A
•	Hepatitis C: Preclinical Development		 191A
•	Portal Hypertension: Experimental		 192A
•	Stem Cell Biology		 194A
•	Varices and Bleeding		 194A
9:45 – 10:30 am	 Hepatitis Debrief	 Auditorium	 86A
10:30 – 11:00 am	 Leon Schiff State-of-the-Art Lecture	 Auditorium	 87A
11:15 am – 12:45 pm	 Parallel Sessions
29. Biliary Biology and Pathobiology: Mechanisms and Treatments	 Room 210	 88A
30. Correlates of Complications in Cirrhosis	 Room 302	 88A
31. Emerging Trends in NASH	 Room 304/306	 89A
32. HBV Basic Virology	 Room 311	 89A
33. HCV Pathogenesis: Is the Battle Over?	 Room 312	 90A
34. Hepatitis B: Outcomes of Approved Therapy	 Ballroom A/B/C	 90A
35. Hepatitis C: New Agents – Part 2	 Auditorium	 91A
*Indicates a ticket is required for entrance.
5A
Abstracts
Abstract information and text selected for presentation at The
Liver Meeting® are available in many formats:
•	USB drive distributed at registration*
•	Online Itinerary Planner*
•	LiverLearning®
•	ePosters*
•	October supplement to Hepatology (members and sub-
scribers) – in order to minimize waste, additional copies
of this supplement will not be available at the meeting.
•	Meeting app*
*The Abstracts on USB Flash-drive is supported by AbbVie
*The online Itinerary Planner is supported by Bristol-Myers
Squibb
*ePosters are supported by Merck
* Meeting app supported by Bayer HealthCare and
Onyx Pharmaceuticals
Abstract Embargo
Accepted abstracts are made available to the public on the
AASLD website and are published in the October supplement of
Hepatology. Information contained in those abstracts may not
be released until the abstracts appear on the AASLD website.
Academic institutions, private organizations, and companies
with products whose values may be influenced by information
contained in an abstract may issue a press release to coincide
with the availability of an abstract on the AASLD website. How-
ever, information beyond that contained in the abstract, e.g.,
discussion of the abstract done as part of a scientific presenta-
tion or presentation of additional or new information that will be
available at the time of the meeting is embargoed from release
to the general public until the first day of The Liver Meeting®.
Information released prior to this day is a violation of the AASLD
Abstract Embargo Policy and the abstract is subject to with-
drawal from The Liver Meeting® program. Authors are responsi-
ble for notifying financial and other sponsors about this policy.
AASLD may allow for exceptions, on a case-by-case basis, to
the Abstract Embargo Policy for compelled disclosures man-
dated by federal securities laws. However, AASLD requires the
company President, General Counsel, or other appropriate offi-
cial of a company seeking such an exception to attest in writing
to the specific facts in support of the request, including exactly
how the securities laws are implicated, with statutory citation(s).
General statements of the need to comply with the law will not
be considered sufficient. Requests for an exception must be
sent to the AASLD CEO. AASLD requires a minimum of five
(5) days from receipt of the request to evaluate the request. In
granting an exception, AASLD requires the company to state in
their public disclosure that the complete and final results will be
presented at The Liver Meeting®. AASLD will also require the
inclusion of unreleased and unique data in such a presentation
at The Liver Meeting®.
Public release of a journal article relevant to the abstract will be
considered an exception to the Embargo Policy if at the time of
the abstract submission deadline, the decision concerning the
manuscript had not been revealed to the authors.
ADA Compliance
The Hynes Convention Center and all participating hotels at
The Liver Meeting® are fully accessible to the physically chal-
lenged. Anyone who has a need for special assistance should
notify the appropriate hotel or the Hynes Convention Center
and indicate the type of assistance needed. AASLD cannot
ensure the availability of appropriate assistance without prior
notice.
Exhibit Hall • Hall D
The Exhibit Hall, an informative and important component of
The Liver Meeting®, provides you with a valuable opportunity
to meet with representatives from various organizations that
are committed to the field of hepatology. A complete listing of
exhibitors and their product descriptions can be found on our
website at www.thelivermeeting.org/exhibitors
Exhibit Hours
Saturday, November 8	 5:00 – 7:30 pm
Sunday, November 9	 9:30 am – 3:00 pm
Monday, November 10	 9:30 am – 3:00 pm
Posters • Hall C
The Poster Sessions are an important event during The Liver
Meeting®. Approximately 470 posters will be displayed daily.
The top 10% of posters accepted are designated in the pro-
gram as a “Presidential Poster of Distinction”.
Posters should be set-up and viewed during the following times:
Poster Session I
Saturday, November 8
	 Set-up:	 8:00 am – 2:00 pm
	 Viewing Time:	 2:00 – 7:30 pm
	 Presentation Time:	 5:30 – 7:00 pm*
	 *Posters must be displayed until 7:30 pm
	 Dismantle Time:	 7:30 – 8:00 pm
General Information
6A
Poster Session II
Sunday, November 9
	 Set-up:	 6:30 – 8:00 am
	 Viewing Time:	 8:00 am – 5:30 pm
	 Presentation Time:	 12:30 – 2:00 pm*
	 *Posters must be displayed until 5:30 pm
	 Dismantle Time:	 5:30 – 6:00 pm
Poster Session III
Monday, November 10
	 Set-up:	 6:30 – 8:00 am
	 Viewing Time:	 8:00 am – 5:30 pm
	 Presentation Time:	 12:30 – 2:00 pm*
	 *Posters must be displayed until 5:30 pm
	 Dismantle Time:	 5:30 – 6:00 pm
Poster Session IV
Tuesday, November 11
	 Set-up:	 6:30 – 8:00 am
	 Viewing Time:	 8:00 am – Noon
	 Presentation Time:	 10:30 am – Noon*
	 *Posters must be displayed until Noon
	 Dismantle Time:	 Noon – 12:30 pm
Posters must be dismantled immediately following the viewing
time. Posters left on the boards will be removed and discarded.
Note: No CME will be provided for Poster Sessions.
ePosters • AASLD Pavilion
ePosters are an interactive technologically advanced viewing
system that brings posters to virtual life for all of The Liver Meet-
ing® attendees and archived in LiverLearning®. ePosters will
be available from the first day of the meeting in the AASLD
Pavilion.
ePosters are supported by Merck
Press Room • Room 208
Friday, November 7	 1:00 pm – 5:00 pm
Saturday, November 8	 8:00 am – 6:00 pm
Sunday, November 9	 8:00 am – 5:00 pm
Monday, November 10	 8:00 am – 5:00 pm
Tuesday, November 11	 8:00 am – Noon
The official press contact for The Liver Meeting® is:
Ann Haran
AASLD
1001 N. Fairfax Street, Suite 400
Alexandria, VA 22314-2720
Telephone: 703-299-9766
Fax: 703-299-9676
Email: aharan@aasld.org
Website: www.thelivermeeting.org/press
Registration Hours • Hall A
Thursday, November 6	 2:00 – 8:00 pm
Friday, November 7	 6:30 am – 7:30 pm
Saturday, November 8	 6:30 am – 7:30 pm
Sunday, November 9	 6:30 am – 6:00 pm
Monday, November 10	 6:30 am – 6:00 pm
Tuesday, November 11	 6:30 am – 12:30 pm
Speaker Ready Room • Room 207
Presenters should check-in 24 hours in advance, or no later than
2 hours prior to your session. If you are a speaker/presenter,
review the presenter tab at www.thelivermeeting.org prior to
the meeting for presentation tips, instructions, and guidelines.
Friday, November 7	 6:30 am – 7:30 pm
Saturday, November 8	 6:30 am – 7:30 pm
Sunday, November 9	 6:30 am – 6:00 pm
Monday, November 10	 6:30 am – 6:00 pm
Tuesday, November 11	 6:30 am – 12:30 pm
General Information (continued)
When citing an abstract, please use the following format:
Desai RJ, Schnitzler MA, Di Bisceglie AM. Estimated impact of screening and anitviral treatment on
prevention of HBV reactivation associated with cancer chemotherapy [Abstract]. Hepatology 2014,
60(4Suppl.1):[Page]A.
7A
Limited License for Use
The Liver Meeting® is protected by copyright, trademark, and/
or other applicable laws. Any use of The Liver Meeting®,
including recordings and the development of derivative works,
is prohibited. The name, logo and acronym of the American
Association for the Study of Liver Diseases and The Liver Meet-
ing® are the exclusive property of and are trademarked by
AASLD. They may not be used in any way, for any purpose,
or at any time (including but not limited to announcements,
invitations, emails, Web publications, etc.) without the express
written permission of AASLD.
Without limiting the foregoing, Information presented during
The Liver Meeting® is the property of AASLD and the presenter.
Information may not be recorded, photographed, copied,
photocopied, transferred to electronic format, reproduced, or
distributed without the written permission of AASLD and the
presenter. Any use of the program content which includes,
but is not limited to, oral presentations, audiovisual materials
used by speakers, and program handouts, without the written
consent of AASLD is prohibited.
Notwithstanding the above, AASLD grants a non-exclusive,
non-transferable, royalty-free license to nonprofit, §501(c) (3),
AAMC-accredited educational institutions to conduct a “Best of
AASLD” conference or similar event (“Event”) of up to eight (8)
hours in length that features highlights from AASLD sessions at
the most recent occurrence of The Liver Meeting® and to utilize
the name of AASLD in connection with the same. No Event
may be held, nor may the name of AASLD be utilized, except
pursuant to this Limited License or as otherwise authorized by
AASLD in writing.
When using the term “AASLD” or “The Liver Meeting®”, you
must attribute AASLD’s trademark as follows: The Liver Meet-
ing® and AASLD are registered trademarks of the American
Association for the Study of Liver Diseases. You may not use
the AASLD trademark(s):
•	In, as, or as part of your own trademarks
•	To identify products or services that do not belong to AASLD
•	In a manner likely to cause confusion, including colors and
fonts
•	In a manner that implies inaccurately that AASLD sponsors or
endorses, or is otherwise connected with your own activities,
products and services
The content of an Event shall be of the highest quality and
shall accurately reflect material and information presented at
the AASLD sessions. No Event shall include any statements or
other communication that maligns or disparages AASLD or any
AASLD session, presenter, or representative.
All Event announcements, brochures, descriptions, and mate-
rials, whether in print or electronic form, shall clearly identify
the content as being derived from AASLD sessions by including
the following statement: “All content is derived from presenta-
tions and similar offerings made at The Liver Meeting® 2014
and is presented with permission of the American Association
for the Study of Liver Diseases.” As between AASLD and any
institution, AASLD is the owner of all AASLD programming and
AASLD does not relinquish any such ownership rights by virtue
of this Limited License.
AASLD disclaims all warranties, express and implied, as to
any information or materials presented in connection with any
AASLD session or meeting, including as to intellectual property
ownership. AASLD shall not be liable for any direct, indirect,
punitive, consequential, or other damages in any way arising
or resulting from the Event or the use of information or materi-
als from AASLD sessions by any institution. Should any claim
or suit be brought against AASLD arising from an Event, the
institution shall indemnify and hold AASLD harmless for any
damages, liability, and costs, including attorney fees, suffered
or incurred by AASLD in defense and satisfaction thereof.
This Limited License does not create a partnership, joint ven-
ture, or similar relationship between AASLD and any institution.
This Limited License is non-transferable, including by sale or
sublicense.
This Limited License shall terminate automatically upon violation
of any of its terms. In addition, AASLD may terminate, or mod-
ify the terms of, this Limited License in its discretion, generally
or with respect to any particular institution.
This Limited License shall be construed in accordance with
the laws of the Commonwealth of Virginia, without regard
to conflicts principles, and, as applicable, federal copyright
and trademark laws. A court of competent jurisdiction in or
for Alexandria, Virginia shall be the exclusive forum for the
resolution of any dispute between AASLD and any institution,
and institutions irrevocably consent to the personal and subject
matter jurisdiction, and venue, of such court.
Continuing Medical Education and Disclosures
8A
Statement on Disclosure
AASLD is committed to ensuring balance, independence objectivity and scientific rigor in its sponsored and jointly sponsored
educational activities. Individuals in a position to control the content of an AASLD-sponsored activity (program planners, course
directors, speakers, etc.) are expected to disclose all relevant financial relationships during the past 12 months.
When an unlabeled use of a commercial product or an investigational use not yet approved for any purpose is discussed during
an educational activity, the speaker shall disclose to the audience that the product is not labeled for the use under discussion or
that the product is still investigational.
All disclosure information is provided to the activity participant prior to the start of the educational activity. In addition, disclosure
slides will be the first side in each oral presentation viewed by participants. AASLD will identify and resolve all conflicts of interest
prior to program implementation.
Invited speakers, course directors, moderators, program planners, abstract reviewers and staff have provided the following
disclosures:
2014 Committee, Abstract Reviewer and Staff Disclosures
Afdhal, Nezam H., MD
(Abstract Reviewer)
Consulting: Abbott, Pharmasett, Gilead, Springbank,
GlaxoSmithKline, Idenix, Merck, Vertex
Grants/Research Support: Merck, Vertex, Idenix, GlaxoSmithKline,
Springbank, Gilead, Pharmasett, Abbott
Adhami, Talal, MD
(Program Evaluation Committee)
Speaking and Teaching: Gilead
Ahmad, Jawad, MD
(Abstract Reviewer)
Nothing to disclose
Alberti, Alfredo, MD
(Abstract Reviewer)
Grants/Research Support: Merck, Gilead
Advisory Board: Merck, Roche, Gilead
Speaking and Teaching: Novartis, Bristol-Myers Squibb
Al-Osaimi, Abdullah, MD
(Abstract Reviewer)
Nothing to disclose
Alvarez, Fernando, MD
(Abstract Reviewer)
Nothing to disclose
Angeli, Paolo, MD, PhD
(Abstract Reviewer)
Advisory Board: Sequana Medical
Aranda-Michel, Jaime, MD
(Abstract Reviewer)
Nothing to disclose
Arteel, Gavin E., PhD
(Basic Research Committee, Abstract Reviewer)
Grants/Research Support: NIH
Asrani, Sumeet, MD
(Abstract Reviewer)
Nothing to disclose
Aytaman, Ayse, MD
(Abstract Reviewer)
Nothing to disclose
Bajaj, Jasmohan S., MD
(Clinical Research Committee, Abstract Reviewer)
Grants/Research Support: Salix, Otsuka, Grifols
Advisory Board: American College of Gastroenterology, Grifols,
Salix, Merz, Otsuka, Ocera
Bambha, Kiran, MD
(Abstract Reviewer)
Nothing to disclose
Bass, Nathan M., MD, PhD
(Abstract Reviewer)
Nothing to disclose
Beaven, Simon, MD
(Abstract Reviewer)
Nothing to disclose
Beavers, Kimberly, MD
(Program Evaluation Committee)
Nothing to disclose
Befeler, Alex, MD
(Program Evaluation Committee, Abstract Reviewer)
Advisory Board: Gilead
Stock: Amgen, Gilead
Bergasa, Nora V., MD
(Abstract Reviewer)
Nothing to disclose
Beier, Juliane Ingeborg, PhD
(Education Committee)
Nothing to disclose
Berzigotti, Annalisa, MD, PhD
(Education Committee)
Nothing to disclose
8A
Continuing Medical Education and Disclosures (continued)
9A
Bhamba, Kiran, MD
(Clinical Research Committee)
Nothing to disclose
Biggins, Scott W., MD
(Abstract Reviewer)
Nothing to disclose
Boelsterli, Urs A., PhD
(Abstract Reviewer)
Nothing to disclose
Bologna, Gregory
(Staff)
Nothing to disclose
Bosch, Jaime, MD
(Abstract Reviewer)
Consulting: Falk, Gilead Science, Norgine, ONO-USA, Intercept
Pharma, Exalenz, Almirall, Conatus
Grants/Research Support: Gore
Bowlus, Christopher L., MD
(Education Committee)
Advisory Board: Lumena
Grants/Research Support: Gilead, Lumena, Intercept
Brady, Carla W., MD
(Program Evaluation Committee, Scientific Program Committee)
Nothing to disclose
Brenner, David A., MD
(Abstract Reviewer)
Nothing to disclose
Brigstock, David R., PhD
(Basic Research Committee)
Intellectual Property Rights: FibroGen, Inc.
Brosgart, Carol, MD
(Abstract Reviewer)
Nothing to disclose
Brown, Kimberly Ann, MD
(Abstract Reviewer)
Advisory Board: CLDF, Merck, Salix, Gilead, Vertex, Novartis,
Genentech, Janssen, Salix
Grants/Research Support: CLDF, Gilead, Exalenz, CDC, Bristol-
Myers Squibb, Bayer-Onyx, Ikaria, Hyperion, Merck
Speaking and Teaching: Salix, Merck, Genentech, Gilead, CLDF,
Vertex
Consulting: Salix, Blue Cross Transplant Centers
Browning, Jeffrey D., MD
(Basic Research Committee)
Nothing to disclose
Bruce, Heidi
(Staff)
Nothing to disclose
Brunt, Elizabeth M., MD
(Abstract Reviewer)
Consulting: Synageva
Speaking and Teaching: Geneva Foundation, Independent
Contractor: Kadmon, Rottapharm
Buck, Martina, PhD
(Basic Research Committee)
Grants/Research Support: NIH
Speaking and Teaching: Conatus, Gilead
Caravan, Peter, PhD
(Abstract Reviewer)
Stock: Factor IA, LLC, Collagen Medical
Consulting: Biogen Idec
Carithers, Robert L., MD
(Abstract Reviewer)
Nothing to disclose
Carr, Rotonya M., MD
(Basic Research Committee)
Nothing to disclose
Chalasani, Naga P., MD
(Abstract Reviewer)
Grants/Research Support: Galectin, Cumberland, Gilead,
Intercept, Lilly
Consulting: Salix, AbbVie, Lilly, Boehringer Ingelheim, Aegerion
Chavin, Kenneth D., MD, PhD
(Scientific Program Committee, Surgery and Liver Transplantation
Committee)
Grants/Research Support: Novartis
Scientific Consultant: Bridge to Life
Chojkier, Mario, MD
(Abstract Reviewer)
Nothing to disclose
Chung, Raymond T., MD
(Governing Board, Basic Research Committee, Abstract Reviewer)
Scientific Consultant: AbbVie
Grants/Research Support: Gilead, Mass Biologics, Transzyme,
Vertex
Cohen, Stanley M., MD
(Training and Workforce Committee)
Nothing to disclose
Colquhoun, Steven D., MD
(Abstract Reviewer)
Nothing to disclose
Corbett, Ruth J., MSN, APRN
(Training and Workforce Committee, Abstract Reviewer)
Nothing to disclose
Corey, Kathleen E., MD
(Clinical Research Committee)
Nothing to disclose
Cotler, Scott, MD
(Clinical Research Committee, Abstract Reviewer)
Nothing to disclose
Crawford, James, MD, PhD
(Abstract Reviewer)
Nothing to disclose
Continuing Medical Education and Disclosures (continued)
10A
Currie, Sue, EdD, MA
(Hepatology Associates Committee)
Employee, Officer, Director: Health Interactions
Cusi, Kenneth, MD, PhD
(Abstract Reviewer)
Nothing to disclose
Czaja, Mark J., MD
(Scientific Program Committee, Basic Research Committee,
Abstract Reviewer)
Consulting: Oncozyme Pharma, Inc.
Grants/Research Support: Oncozyme Pharma, Inc.
Daniel, James F., MD
(Program Evaluation Committee)
Nothing to disclose
Davis, Gary L., MD
(Governing Board, Program Evaluation Committee, Scientific
Program Committee, Abstract Reviewer)
Nothing to disclose
Dawson, Paul, MD
(Abstract Reviewer)
Consulting: GlaxoSmithKline, Isis Pharmaceuticals, Lumena
Pharmaceuticals
Stock: XenoPort, Inc.
Deal, Julie
(Staff)
Stock: Bristol-Myers Squibb
Delgado-Borrego, Aymin, MD
(Program Evaluation Committee)
Nothing to disclose
DeLeve, Laurie D., MD, PhD
(Abstract Reviewer)
Advisory Board: Pfizer, Takeda, Bristol-Myers Squibb
Di Bisceglie, Adrian M., MD, FACP
(Governing Board, Scientific Program Committee)
Advisory Board: Gilead, Data Safety Monitoring Board, Bayer,
Novartis
Grants/Research Support: AbbVie, Bristol-Myers Squibb, Gilead,
Janssen, Transgene, Vertex, Alpha-1 Foundation
Royalties: Section Editor on Hepatitis C, UpToDate
Diaz, Susan M., PA-C, MPAS
(Surgery and Liver Transplantation Committee)
Nothing to disclose
Dickson, Rolland C., MD
(Education Committee, Abstract Reviewer)
Advisory Board: Bristol-Myers Squibb, Cowen and Associates
Grants/Research Support: Gilead, Roche, Tibotec, Vertex
Scientific Consultant: Biotest
Speaking and Teaching: Gilead
Diehl, Anna Mae, MD
(Abstract Reviewer)
Consulting: Roche
Grants/Research Support: Gilead, Genfit
Dieterich, Douglas, MD
(Abstract Reviewer)
Consulting: Gilead, Bristol-Myers Squibb
Advisory Board: Merck, Idenix, Janssen
Dolganiuc, Angela, MD
(Abstract Reviewer)
Nothing to disclose
Doo, Edward, MD
(Abstract Reviewer)
Nothing to disclose
Echard, Steven
(Staff)
Nothing to disclose
Eggers, Carol A., MSN, FNP
(Program Evaluation Committee)
Nothing to disclose
Eghtesad, Bijan, MD
(Surgery and Liver Transplantation Committee)
Nothing to disclose
Ekong, Udeme D., MD
(Abstract Reviewer)
Nothing to disclose
El-Serag, Hashem B., MD
(Abstract Reviewer)
Nothing to disclose
Emerick, Karan M., MD
(Abstract Reviewer)
Nothing to disclose
Emond, Jean C., MD
(Abstract Reviewer)
Nothing to disclose
Fallon, Michael B., MD
(Abstract Reviewer)
Grants/Research Support: Bayer-Onyx, Eaisi, Gilead, Grifolis
Feld, Jordan J., MD
(Abstract Reviewer)
Advisory Board: Idenix, Merck, Janssen, Gilead, AbbVie, Merck,
Theravance, Bristol-Myers Squibb
Grants/Research Support: AbbVie, Boehringer Ingelheim, Janssen,
Gilead, Merck
Feldstein, Ariel E., MD
(Abstract Reviewer)
Nothing to disclose
Feng, Sandy, MD, PhD
(Abstract Reviewer)
Nothing to disclose
Fenkel, Jonathan M., MD
(Abstract Reviewer)
Consulting: Gilead, Janssen
Continuing Medical Education and Disclosures (continued)
11A
Fiel, Maria Isabel, MD
(Education Committee)
Leadership: HEPATOLOGY
Speaking and Teaching: Richmond University Hospital
Grants/Research Support: P20 Mini Center, RO1 Detection of liver
fibrosis, HCC in non-cirrhotic liver
Expert Testimony: Fowler White Burnett, Kopff, Nardelli & Dopf,
Bailly and McMillan McCormick Fitzpatrick
Firpi, Roberto J., MD
(Education Committee, Abstract Reviewer)
Advisory Board: Gilead, Vertex
Grants/Research Support: Bayer, Boehringer, Bristol-Myers Squibb,
Gilead, Idenix, Novartis, Salix
Fitz, J. Gregory, MD
(Governing Board)
Nothing to disclose
Fix, Oren K., MD
(Training and Workforce Committee, Abstract Reviewer)
Nothing to disclose
Forde, Kimberly A., MD
(Clinical Research Committee)
Nothing to disclose
Foster, Temitope Y., MD
(Program Evaluation Committee)
Nothing to disclose
Friedman, Joshua, MD, PhD
(Abstract Reviewer)
Employment: Janssen Research & Development
Fuchs, Michael, MD, PhD
(Training and Workforce Committee)
Nothing to disclose
Fung, John J., MD
(Abstract Reviewer)
Advisory Board: Astellas, Novartis
Consulting: Vital Therapies
Grants/Research Support: Sanofi
Gao, Bin, MD, PhD
(Abstract Reviewer)
Nothing to disclose
Gardenier, Donald, DNP, FNP-BC
(Hepatology Associates Committee)
Scientific Consultant: BV, Elsevier
Leadership in Related Society: American Association of Nurse
Practitioners
Gaspard, Gabrielle M., MPH
(Basic Research Committee)
Nothing to disclose
Gautam, Manjushree, MD
(Abstract Reviewer)
Nothing to disclose
George, Jacob, MD, PhD
(Clinical Research Committee, Abstract Reviewer)
Advisory Board: Roche, Bristol-Myers Squibb, MSD, Gilead,
Janssen
Gerbes, Alexander L., MD
(Abstract Reviewer)
Nothing to disclose
Gershwin, M. Eric, MD
(Abstract Reviewer)
Nothing to disclose
Ghany, Marc G., MD
(Scientific Program Committee, Clinical Research Committee)
Expert Testimony: Clinical Care Options
Gilles, HoChong, FNP
(Education Committee, Hepatology Associates Committee)
Speaking and Teaching: Bayer
Gish, Robert, MD
(Abstract Reviewer)
Consulting: Arrowhead
Advisory Board: Gilead, Bristol-Myers Squibb, Genentech,
Arrowhead
Stock: Arrowhead
Goacher, Elizabeth K., PA-C, MHS
(Clinical Research Committee)
Speaking and Teaching: Merck, Vertex
Gonzalez, Stevan, MD
(Abstract Reviewer)
Speaking and Teaching: Gilead, Salix
Gonzalez-Peralta, Regino P., MD
(Abstract Reviewer)
Consulting: Roche, Boehringer Ingelheim, Vertex
Grants/Research Support: Bristol-Myers Squibb, Roche, Merck
Gordon, Fredric D., MD
(Abstract Reviewer)
Nothing to disclose
Gordon, Stuart C., MD
(Abstract Reviewer)
Consulting: Bristol-Myers Squibb, Gilead, CVS Caremark, Merck
Grants/Research Support: Exalenz, Roche/Genentech, Vertex,
Gilead, Bristol-Myers Squibb, Abbott, Intercept
Advisory Board: Tibotec
Grace, Norman D., MD
(Abstract Reviewer)
Nothing to disclose
Green, Richard, MD
(Abstract Reviewer)
Nothing to disclose
Guo, Grace, MD
(Abstract Reviewer)
Nothing to disclose
Continuing Medical Education and Disclosures (continued)
12A
Gupta, Sanjeev, MD
(Abstract Reviewer)
Nothing to disclose
Hagedorn, Curt H., MD
(Abstract Reviewer)
Nothing to disclose
Harrison, Stephen, MD
(Education Committee, Abstract Reviewer)
Advisory Board: Galectin, Genfit
Speaking and Teaching: Gilead
Hassanein, Tarek, MD
(Abstract Reviewer)
Grants/Research Support: AbbVie, Boehringer Ingelheim, Bristol-
Myers Squibb, Eiasi, Gilead, Janssen, Idenix, Ikaria, Merck, Roche,
Ocera, Salix, Sundise, TaiGen, Takeda, Vital Therapies
Speaking and Teaching: Baxter, Bristol-Myers Squibb, Gilead,
Salix
Advisory Board: AbbVie, Bristol-Myers Squibb
Heimbach, Julie, MD
(Abstract Reviewer)
Nothing to disclose
Henderson, Neil C., MBChB, PhD
(Abstract Reviewer)
Nothing to disclose
Horne, Patrick, MSN, ARNP
(Education Committee, Hepatology Associates Committee)
Advisory Board: Gilead
Grants/Research Support: Bayer
Horslen, Simon, MD
(Abstract Reviewer)
Nothing to disclose
Howell, Charles D., MD
(Education Committee)
Grants/Research Support: Boehringer Ingelheim, Bristol-Myers
Squibb, Gilead
Leadership in a Related Society: National Medical Association
Hepatitis C Task Force
Ioannou, George, MD
(Clinical Research Committee)
Nothing to disclose
Jalan, Rajiv, MD, PhD
(Abstract Reviewer)
Consulting: Ocera, Conatus
Grants/Research Support: Grifols, Gambro
Janssen, Harry L.A., MD, PhD
(Program Evaluation Committee, Abstract Reviewer)
Consulting: Santaris, Roche, Novartis, Medtronic, Merck, Gilead,
Debio, Abbott, Bristol-Myers Squibb
Grants/Research Support: Anadys, Bristol-Myers Squibb, Gilead,
Innogenetics, Kirin, Merck, Medtronic, Novartis, Roche, Santaris
Jeong, Won-ll, DVM, PhD
(Abstract Reviewer)
Nothing to disclose
Jonas, Maureen M., MD
(Abstract Reviewer)
Consulting: Eisai
Grants/Research Support: Bristol-Myers Squibb, Roche, Merck
Advisory Board: Gilead
Kaestner, Klaus H., PhD
(Abstract Reviewer)
Nothing to disclose
Kamath, Patrick S., MD
(Abstract Reviewer)
Advisory Board: Sequana Medical
Kaplowitz, Neil, MD
(Abstract Reviewer)
Consulting: GlaxoSmithKline, JNJ, Merck, Novartis, Hepregen,
Takeda, Otsuka, Pfizer, Geron, Daiichi-Sanyo
Independent Contractor: Acetaminophen Litigation
Karpen, Saul J., MD, PhD
(Scientific Program Committee, Abstract Reviewer)
Nothing to disclose
Keaveny, Andrew, MD
(Education Committee)
Expert Testimony: UpToDate, Inc.
Kim, Arthur Y., MD
(Abstract Reviewer)
Grants/Research Support: Gilead, Bristol-Myers Squibb
Consulting: AbbVie, Gilead
Kisseleva, Tatiana, MD, PhD
(Abstract Reviewer)
Nothing to disclose
Klett, Janeil
(Staff)
Stock: Merck, Pfizer
Klintmalm, Goran, MD, PhD
(Abstract Reviewer)
Grants/Research Support: Astellas, Novartis, Opson, Quark
Advisory Board: Novartis
Kneteman, Norman M., MD
(Abstract Reviewer)
Nothing to disclose
Knisely, Alexander S., MD
(Abstract Reviewer)
Nothing to disclose
Kohli, Rohit, MD
(Clinical Research Committee, Abstract Reviewer)
Grants/Research Support: Synageva Biopharma, Johnson and
Johnson
Independent Contractor: Lumena Pharmaceuticals, Galectin
Therapeutics
Korenblat, Kevin M., MD
(Abstract Reviewer)
Grants/Research Support: Merck
Advisory Board: Vertex
Continuing Medical Education and Disclosures (continued)
13A
Koteish, Ayman A., MD
(Program Evaluation Committee)
Nothing to disclose
Kowdley, Kris V., MD
(Abstract Reviewer)
Advisory Board: Janssen, Ikaria, Boehringer Ingelheim, Vertex,
AbbVie, Gilead, Merck, Novartis, Trio Health
Grants/Research Support: AbbVie, Beckman, Boehringer
Ingelheim, Bristol-Myers Squibb, Gilead, Ikaria, Janssen, Merck,
Mochida
Kulkarni, Sanjay, MD
(Surgery and Liver Transplantation Committee)
Grants/Research Support: Alexion
Lai, Ching Lung, MD
(Abstract Reviewer)
Nothing to disclose
Larson, Anne M., MD
(Abstract Reviewer)
Speaking and Teaching: Gilead, Genentech, Salix
Lau, George, MD
(Abstract Reviewer)
Consulting: Novartis, Roche
Lauer, Georg M., MD
(Basic Research Committee, Abstract Reviewer)
Nothing to disclose
Laurin, Jacqueline, MD
(Education Committee)
Nothing to disclose
Leise, Michael, MD
(Abstract Reviewer)
Nothing to disclose
Leonis, Mike A., MD, PhD
(Training and Workforce Committee)
Grants/Research Support: NIH
Leadership in Related Society: NASPGHAN Research Committee
member
Levitsky, Josh, MD
(Training and Workforce Committee, Abstract Reviewer)
Consulting: Transplant Genomics, Inc.
Grants/Research Support: Novartis
Speaking and Teaching: Gilead, Salix
Levy, Cynthia, MD
(Clinical Research Committee, Abstract Reviewer)
Consulting: Lumena, Gilead, Evidera
Liangpunsakul, Suthat, MD
(Abstract Reviewer)
Nothing to disclose
Liddle, Christopher, MD, PhD
(Abstract Reviewer)
Nothing to disclose
Lidofsky, Steven D., MD
(Abstract Reviewer)
Nothing to disclose
Lim, Joseph K., MD
(Abstract Reviewer)
Grants/Research Support: Achillion, Abbott, Boehringer Ingelheim,
Bristol-Myers Squibb, Genentech, Gilead, Janssen/Tibotec, Vertex
Consulting: Merck, Vertex, Gilead, Bristol-Myers Squibb,
Boehringer Ingelheim
Lindor, Keith, MD
(Governing Board, Hepatology Associates Committee, Scientific
Program Committee)
Advisory Board: Intercept, Lumena
Ling, Simon C., MBChB, MRCP
(Abstract Reviewer)
Grants/Research Support: Bristol-Myers Squibb
Lippello, Anita, CRNP, NP-C, DNP
(Hepatology Associates Committee)
Nothing to disclose
Little, Ester C., MD
(Education Committee)
Nothing to disclose
Liu, Chen, MD, PhD
(Abstract Reviewer)
Nothing to disclose
Llovet, Josep M., MD
(Abstract Reviewer)
Grants/Research Support: Beohringer Ingelheim, Bayer, Bristol-
Myers Squibb
Consulting: GlaxoSmithKline, Bayer, Bristol-Myers Squibb, Imclone,
Biocompatibles, Novartis
Advisory Board: Nanostring, Blueprint Medicines
Lok, Anna S. F., MD
(Governing Board, Education Committee, Abstract Reviewer)
Advisory Board: Gilead, Immune Targeting System, MedImmune,
Arrowhead, Bayer, GlaxoSmithKline, Janssen, Novartis, ISIS,
Tekmira
Grants/Research Support: Abbott, Bristol-Myers Squibb, Gilead,
Merck, Roche, Boehringer Ingelheim
Loomba, Rohit, MD
(Program Evaluation Committee, Abstract Reviewer)
Advisory Board: American Liver Foundation
Grants/Research Support: Daiichi Sankyo, Inc., Merck
Scientific Consultant: Gilead, J and J Inc., Merck
Loomes, Kathleen M., MD
(Training and Workforce Committee)
Grants/Research Support: NIH
Lu, Shelly, MD
(Abstract Reviewer)
Nothing to disclose
Magee, John, MD
(Surgery and Liver Transplantation Committee, Abstract Reviewer)
Grants/Research Support: Novartis
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study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149
study and results of HepQuant tests with HCV antivirals PDF pg 1149

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study and results of HepQuant tests with HCV antivirals PDF pg 1149

  • 1. Official Journal of the American Association for the Study of Liver Diseases HEPATOLOGY VOLUME 60, NUMBER 1 (SUPPL) — OCTOBER 2014 HEPATOLOGYOctober2014—Pages1–1266VOLUME60,NUMBER1(SUPPL)
  • 2. Take advantage of your free subscription—after the meeting, and all year long.* Visit liverlearning.aasld.org *Your LiverLearning® subscription is free with your registration through November 30, 2015. Content from The Liver Meeting® will be available in this online library in December— but don’t stop there. LiverLearning® includes more than 6,000 presentations and educational offerings searchable by topic, type, date, speaker, and more. Content from other AASLD meetings will be added throughout the year. FIND OUT MORE AT THE PAVILION Visit the AASLD Pavilion Just outside registration FREE with yourregistration Access content from The LiverMeeting 2014® and other AASLD meetings through LiverLearning® .
  • 3. Over 9 years of prescribing experience in the US More than 9 million prescriptions filled worldwide1 All individuals depicted are models and not actual patients. Over 99 years of prescribing experience in the US Important Safety Information WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY • Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted. • Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE (entecavir) is used to treat chronic HBV infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART). • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, alone or in combination with antiretrovirals. Please see Brief Summary of Full Prescribing Information, Including Boxed WARNINGS, following the next pages. Indication BARACLUDE (entecavir) is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. The following points should be considered when initiating BARACLUDE: • This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection and compensated liver disease. • Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease. • Virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy. (continued on the following pages)
  • 4. BARACLUDE® (entecavir) is a recommended first-line option in CHB guidelines in the US and around the world2-8 BAR reco in C US a American Association for the Study of Liver Diseases (AASLD) US Algorithm European Association for the Study of the Liver (EASL) Japanese Ministry of Health, Labour and Welfare Study Group Guideline for CHB The Korean Association for the Study of the Liver Chinese Medical Association Asian Pacific Association for the Study of the Liver For nucleoside-naïve chronic hepatitis B (CHB) adults with evidence of active virus and either evidence of persistent elevations in ALT or AST or histologically active disease Warnings and Precautions • Before initiating BARACLUDE (entecavir) therapy, HIV antibody testing should be offered to all patients. BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use. • Lactic acidosis with BARACLUDE use has been reported, often in association with hepatic decompensation, other serious medical conditions, or drug exposures. Patients with decompensated liver disease may be at higher risk for lactic acidosis. BARACLUDE should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. Adverse Reactions • In clinical trials in patients with compensated liver disease, the most common (≥3%) adverse reactions of any severitywithatleast a possible relation to study drug for BARACLUDE- treated subjects were headache, fatigue, dizziness, and nausea. In these trials, the most common adverse reactions of moderate to severe intensity (grades 2-4) were diarrhea, dyspepsia, nausea, vomiting, fatigue, headache, dizziness, somnolence, and insomnia. • In the decompensated liver disease trial, the most common adverse reactions of any severity among patients treated with BARACLUDE, regardless of causality, included: peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%). In this trial, 18% (18/102) of BARACLUDE patients and 20% (18/89) of adefovir patients died during the first 48 weeks of therapy. The majority of those deaths were due to liver related causes. Drug Interactions BARACLUDE is primarily eliminated by the kidneys, therefore coadministration of BARACLUDE with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Patients should be monitored closely when receiving BARACLUDE with other renally-eliminated drugs. Pregnancy and Nursing Mothers • There are no adequate and well-controlled studies of BARACLUDE in pregnant women. BARACLUDE should be used during pregnancy only if clearly needed and after careful consideration of the risks and benefits. • There are no studies on the effect of BARACLUDE on transmission of HBV from mother to infant. Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV. • It is not known whether BARACLUDE is excreted into human milk; however, many drugs are excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants from BARACLUDE, risks and benefits should be considered when deciding whether to discontinue breast- feeding or discontinue BARACLUDE in nursing women. Pediatric Use • Safety and effectiveness of BARACLUDE in pediatric patients below the age of 16 years have not been established. Renal Impairment • Dosage adjustment of BARACLUDE is recommended for patients with a creatinine clearance <50 mL/min, including those on Please see Brief Summary of Full Prescribing Information, including Boxed WARNINGS, following the next pages. Important Safety Information about BARACLUDE® (entecavir) TABLETS: (continued from previous page) (continued on the following page) APASL
  • 5. BARACLUDE (entecavir) is also recommended as a first-line therapy in the publication: The Management of Chronic Hepatitis B in Asian Americans9 BARACLUDE is a registered trademark of Bristol-Myers Squibb Company. ©2014 Bristol-Myers Squibb Company, Princeton, NJ 08543 USA 686US14BR01544-02-01 07/14 For nucleoside-naïve chronic hepatitis B (CHB) adults with evidence of active virus and either evidence of persistent elevations in ALT or AST or histologically active disease REFERENCES: 1. IMS Health Custom Analysis (February 13, 2013), LifeLINK, MIDAS. 2. Lok ASF, McMahon BJ. AASLD Guidelines. Chronic hepatitis B: update 2009. Hepatology. 2009;50(3):1–36. 3. Keeffe EB, Dieterich DT, Han SHB, et al. A treatment algorithm for the management of chronic hepatitis B virus infection in the United States: 2008 update. Clin Gastroenterol Hepatol. 2008;6(12):1315– 1341. 4. European Association for the Study of the Liver. EASL clinical practice guidelines: management of chronic hepatitis B. J Hepatol. 2012;57:167–185. 5. Liaw YF, Leung N, Kao JH, et al; for the chronic hepatitis B guideline working party of the Asian-Pacific Association for the Study of Liver. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2008 update. Hepatol Int. 2008;2(3):263–283. 6. Chinese Society of Hepatology, Chinese Medical Association and Chinese Society of Infectious Diseases, Chinese Medical Association. Guideline on prevention and treatment of chronic hepatitis B in China (2005). Chin Med J. 2007;120(24):2159–2173. 7. Lee KS, Kim DJ. The Korean Association for the Study of Liver (KASL) Guidelines. Chronic hepatitis B treatment. Korean J Hepatol. 2007;13(4):447–488. 8. Kumada H, Okanoue T, Onji M, et al. Guidelines for the treatment of chronic hepatitis and cirrhosis due to hepatitis B virus infection for the fiscal year 2008 in Japan. Hepatol Res. 2010;40(1):1-7. 9. Tong MJ, Pan CQ, Hann HW, et al. The management of chronic hepatitis B in Asian Americans. Dig Dis Sci. 2011;56(11):3143–3162. hemodialysis or continuous ambulatory peritoneal dialysis. Liver Transplant Recipients • Renal function must be carefully monitored both before and during treatment with BARACLUDE (entecavir) in a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus. Dosage and Administration BARACLUDE should be administered on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal). The recommended dose of BARACLUDE: • in nucleoside-naïve adult s and adolescents (16+ yrs) with compensated liver disease is 0.5 mg once daily • in adults and adolescents (16+ yrs) with compensated liver disease, and refractory to lamivudine or with known lamivudine or telbivudine resistance mutations (rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L) is 1 mg once daily • in adults with decompensated liver disease is 1 mg once daily The optimal duration of treatment with BARACLUDE for patients with chronic HBV infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown. Additional Information BARACLUDE is not a cure for HBV. Patients should be advised that treatment with BARACLUDE has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination. Please see following pages for Brief Summary of Full Prescribing Information, including Boxed WARNINGS. Important Safety Information (continued) Renal Impairment (continued) Approved and available for CHB in over 50 countries and regions worldwide
  • 6. BARACLUDE® (entecavir)BARACLUDE® (entecavir) tablets, for oral use BARACLUDE® (entecavir) oral solution Brief Summary of Prescribing Information. For complete prescribing information consult official package insert. WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions]. Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE (entecavir) is used to treat chronic hepatitis B virus (HBV) infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) [see Warnings and Precautions]. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors alone or in combination with antiretrovirals [see Warnings and Precautions]. CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS: Severe Acute Exacerbations of Hepatitis B - Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir [see Adverse Reactions]. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted. Patients Co-infected with HIV and HBV - BARACLUDE has not been evaluated in HIV/HBV co-infected patients who were not simultaneously receiving effective HIV treatment. Limited clinical experience suggests there is a potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors if BARACLUDE is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated [see Microbiology (12.4) in full Prescribing Information]. Therefore, therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving HAART. Before initiating BARACLUDE therapy, HIV antibody testing should be offered to all patients. BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use. Lactic Acidosis and Severe Hepatomegaly with Steatosis - Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors, including BARACLUDE, alone or in combination with antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside inhibitor exposure may be risk factors. Particular caution should be exercised when administering nucleoside analogue inhibitors to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Lactic acidosis with BARACLUDE use has been reported, often in association with hepatic decompensation, other serious medical conditions, or drug exposures. Patients with decompensated liver disease may be at higher risk for lactic acidosis. Treatment with BARACLUDE should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations). ADVERSE REACTIONS: The following adverse reactions are discussed in other sections of the labeling: • Exacerbations of hepatitis after discontinuation of treatment [see Boxed Warning, Warnings and Precautions]. • Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning, Warnings and Precautions]. Clinical Trial Experience in Adults - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Compensated Liver Disease - Assessment of adverse reactions is based on four studies (AI463014, AI463022, AI463026, and AI463027) in which 1720 subjects with chronic hepatitis B virus infection and compensated liver disease received double-blind treatment with BARACLUDE 0.5 mg/day (n=679), BARACLUDE 1 mg/day (n=183), or lamivudine (n=858) for up to 2 years. Median duration of therapy was 69 weeks for BARACLUDE-treated subjects and 63 weeks for lamivudine-treated subjects in Studies AI463022 and AI463027 and 73 weeks for BARACLUDE-treated subjects and 51 weeks for lamivudine-treated subjects in Studies AI463026 and AI463014. The safety profiles of BARACLUDE and lamivudine were comparable in these studies. The most common adverse reactions of any severity (≥3%) with at least a possible relation to study drug for BARACLUDE-treated subjects were headache, fatigue, dizziness, and nausea. The most common adverse reactions among lamivudine-treated subjects were headache, fatigue, and dizziness. One percent of BARACLUDE-treated subjects in these four studies compared with 4% of lamivudine-treated subjects discontinued for adverse events or abnormal laboratory test results. Clinical adverse reactions of moderate-severe intensity and considered at least possibly related to treatment occurring during therapy in four clinical studies in which BARACLUDE was compared with lamivudine are presented in Table 1. Table 1: Clinical Adverse Reactionsa of Moderate-Severe Intensity (Grades 2-4) Reported in Four Entecavir Clinical Trials Through 2 Years Nucleoside-Inhibitor-Naïveb Lamivudine-Refractoryc Body System/ Adverse Reaction BARACLUDE 0.5 mg n=679 LVD 100 mg n=668 BARACLUDE 1 mg n=183 LVD 100 mg n=190 Any Grade 2-4 adverse reactiona Gastrointestinal Diarrhea Dyspepsia Nausea Vomiting General Fatigue Nervous System Headache Dizziness Somnolence Psychiatric Insomnia 15% <1% <1% <1% <1% 1% 2% <1% <1% <1% 18% 0 <1% <1% <1% 1% 2% <1% <1% <1% 22% 1% 1% <1% <1% 3% 4% 0 0 0 23% 0 0 2% 0 3% 1% 1% 0 <1% a Includes events of possible, probable, certain, or unknown relationship to treatment regimen. b Studies AI463022 and AI463027. c Includes Study AI463026 and the BARACLUDE 1 mg and lamivudine treatment arms of Study AI463014, a Phase 2 multinational, randomized, double-blind study of three doses of BARACLUDE (0.1, 0.5, and 1 mg) once daily versus continued lamivudine 100 mg once daily for up to 52 weeks in subjects who experienced recurrent viremia on lamivudine therapy. LVD = Lamivudine. Laboratory Abnormalities - Frequencies of selected treatment-emergent laboratory abnormalities reportedduringtherapyinfourclinicaltrialsofBARACLUDEcomparedwithlamivudinearelistedinTable2. Table 2: Selected Treatment-Emergenta Laboratory Abnormalities Reported in Four Entecavir Clinical Trials Through 2 Years Nucleoside-Inhibitor-Naïveb Lamivudine-Refractoryc Test BARACLUDE 0.5 mg n=679 LVD 100 mg n=668 BARACLUDE 1 mg n=183 LVD 100 mg n=190 Any Grade 3-4 laboratory abnormalityd ALT >10 x ULN and >2 x baseline ALT >5 x ULN Albumin <2.5 g/dL Total bilirubin >2.5 x ULN Lipase ≥2.1 x ULN Creatinine >3 x ULN Confirmed creatinine increase ≥0.5 mg/dL Hyperglycemia, fasting >250 mg/dL Glycosuriae Hematuriaf Platelets <50,000/mm3 35% 2% 11% <1% 2% 7% 0 1% 2% 4% 9% <1% 36% 4% 16% <1% 2% 6% 0 1% 1% 3% 10% <1% 37% 2% 12% 0 3% 7% 0 2% 3% 4% 9% <1% 45% 11% 24% 2% 2% 7% 0 1% 1% 6% 6% <1% a On-treatment value worsened from baseline to Grade 3 or Grade 4 for all parameters except albumin (any on-treatment value <2.5 g/dL), confirmed creatinine increase ≥0.5 mg/dL, and ALT >10 x ULN and >2 x baseline. b Studies AI463022 and AI463027. c Includes Study AI463026 and the BARACLUDE 1 mg and lamivudine treatment arms of Study AI463014, a Phase 2 multinational, randomized, double-blind study of three doses of BARACLUDE (0.1, 0.5, and 1 mg) once daily versus continued lamivudine 100 mg once daily for up to 52 weeks in subjects who experienced recurrent viremia on lamivudine therapy. d Includes hematology, routine chemistries, renal and liver function tests, pancreatic enzymes, and urinalysis. e Grade 3 = 3+, large, ≥500 mg/dL; Grade 4 = 4+, marked, severe. f Grade 3 = 3+, large; Grade 4 = ≥4+, marked, severe, many. LVD = Lamivudine, ULN = upper limit of normal. Among BARACLUDE-treated subjects in these studies, on-treatment ALT elevations greater than 10 times the upper limit of normal (ULN) and greater than 2 times baseline generally resolved with continued treatment. A majority of these exacerbations were associated with a ≥2 log10 /mL reduction in viral load that preceded or coincided with the ALT elevation. Periodic monitoring of hepatic function is recommended during treatment. Exacerbations of Hepatitis after Discontinuation of Treatment - An exacerbation of hepatitis or ALT flare was defined as ALT >10 x ULN and >2 x the subject’s reference level (minimum of the baseline or last measurement at end of dosing). For all subjects who discontinued treatment (regardless of reason), the proportion of subjects who experienced post-treatment ALT flares was as follows: 2% (4/174) in the BARACLUDE-treated group and 9% (13/147) in the lamivudine-treated group in nucleoside-inhibitor-naïve, HBeAg-positive subjects in study AI463022; 8% (24/302) in the BARACLUDE-treated group and 11% (30/270) in the lamivudine-treated group in nucleoside-inhibitor-naïve HBeAg-negative subjects in study AI463027; 12% (6/52) in the BARACLUDE-treated group and 0% (0/16) in the lamivudine-treated group among lamivudine-refractory subjects in study AI463026. The median time to off-treatment exacerbation was 23 weeks for BARACLUDE-treated subjects and 10 weeks for lamivudine-treated subjects. In these studies, a subset of subjects was allowed to discontinue treatment at or after 52 weeks if they achieved a protocol-defined response to therapy. If BARACLUDE is discontinued without regard to treatment response, the rate of post-treatment flares could be higher. [See Warnings and Precautions.] Decompensated Liver Disease - Study AI463048 was a randomized, open-label study of BARACLUDE 1 mg once daily versus adefovir dipivoxil 10 mg once daily given for up to 48 weeks in adult subjects with chronic HBV infection and evidence of hepatic decompensation, defined as a Child-Turcotte-Pugh (CTP) score of 7 or higher [see Clinical Studies (14.1) in full Prescribing Information]. Among the 102 subjects receiving BARACLUDE, the most common treatment-emergent adverse events of any severity, regardless of causality, occurring through Week 48 were peripheral
  • 7. edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%). Clinical adverse reactions not listed in Table 1 that were observed through Week 48 include blood bicarbonate decreased (2%) and renal failure (<1%). Eighteen of 102 (18%) subjects treated with BARACLUDE and 18/89 (20%) subjects treated with adefovir dipivoxil died during the first 48 weeks of therapy. The majority of deaths (11 in the BARACLUDE group and 16 in the adefovir dipivoxil group) were due to liver-related causes such as hepatic failure, hepatic encephalopathy, hepatorenal syndrome, and upper gastrointestinal hemorrhage. The rate of hepatocellular carcinoma (HCC) through Week 48 was 6% (6/102) for subjects treated with BARACLUDE and 8% (7/89) for subjects treated with adefovir dipivoxil. Five percent of subjects in either treatment arm discontinued therapy due to an adverse event through Week 48. No subject in either treatment arm experienced an on-treatment hepatic flare (ALT >2 x baseline and >10 x ULN) through Week 48. Eleven of 102 (11%) subjects treated with BARACLUDE and 11/89 (13%) subjects treated with adefovir dipivoxil had a confirmed increase in serum creatinine of 0.5 mg/dL through Week 48. HIV/HBV Co-infected - The safety profile of BARACLUDE 1 mg (n=51) in HIV/HBV co-infected subjects enrolled in Study AI463038 was similar to that of placebo (n=17) through 24 weeks of blinded treatment and similar to that seen in non-HIV infected subjects [see Warnings and Precautions]. Liver Transplant Recipients - Among 65 subjects receiving BARACLUDE in an open-label, post-liver transplant trial [see Use in Specific Populations], the frequency and nature of adverse events were consistent with those expected in patients who have received a liver transplant and the known safety profile of BARACLUDE. Clinical Trial Experience in Pediatric Subjects - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of BARACLUDE in pediatric subjects 2 to less than 18 years of age is based on two ongoing clinical trials in subjects with chronic HBV infection (one Phase 2 pharmacokinetic trial [AI463028] and one Phase 3 trial [AI463189]). These trials provide experience in 168 HBeAg-positive subjects treated with BARACLUDE for a median duration of 72 weeks. The adverse reactions observed in pediatric subjects who received treatment with BARACLUDE were consistent with those observed in clinical trials of BARACLUDE in adults. Adverse drug reactions reported in greater than 1% of pediatric subjects included abdominal pain, rash events, poor palatability (“product taste abnormal”), nausea, diarrhea, and vomiting. Postmarketing Experience - The following adverse reactions have been reported during postmarketing use of BARACLUDE. Because these reactions were reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or establish a causal relationship to BARACLUDE exposure. Immune system disorders: Anaphylactoid reaction. Metabolism and nutrition disorders: Lactic acidosis. Hepatobiliary disorders: Increased transaminases. Skin and subcutaneous tissue disorders: Alopecia, rash. DRUG INTERACTIONS: Since entecavir is primarily eliminated by the kidneys [see Clinical Pharmacology (12.3) in full Prescribing Information], coadministration of BARACLUDE with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Coadministration of entecavir with lamivudine, adefovir dipivoxil, or tenofovir disoproxil fumarate did not result in significant drug interactions. The effects of coadministration of BARACLUDE with other drugs that are renally eliminated or are known to affect renal function have not been evaluated, and patients should be monitored closely for adverse events when BARACLUDE is coadministered with such drugs. USE IN SPECIFIC POPULATIONS: Pregnancy - Pregnancy Category C. There are no adequate and well- controlled studies of BARACLUDE in pregnant women. Because animal reproduction studies are not always predictive of human response, BARACLUDE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Antiretroviral Pregnancy Registry: To monitor fetal outcomes of pregnant women exposed to BARACLUDE, an Antiretroviral Pregnancy Registry has been established. Healthcare providers are encouraged to register patients by calling 1-800-258-4263. Animal Data - Animal reproduction studies with entecavir in rats and rabbits revealed no evidence of teratogenicity. Developmental toxicity studies were performed in rats and rabbits. There were no signs of embryofetal or maternal toxicity when pregnant animals received oral entecavir at approximately 28 (rat) and 212 (rabbit) times the human exposure achieved at the highest recommended human dose of 1 mg/day. In rats, maternal toxicity, embryofetal toxicity (resorptions), lower fetal body weights, tail and vertebral malformations, reduced ossification (vertebrae, sternebrae, and phalanges), and extra lumbar vertebrae and ribs were observed at exposures 3100 times those in humans. In rabbits, embryofetal toxicity (resorptions), reduced ossification (hyoid), and an increased incidence of 13th rib were observed at exposures 883 times those in humans. In a peri-postnatal study, no adverse effects on offspring occurred when rats received oral entecavir at exposures greater than 94 times those in humans. Labor and Delivery - There are no studies in pregnant women and no data on the effect of BARACLUDE on transmission of HBV from mother to infant. Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV. Nursing Mothers - It is not known whether BARACLUDE is excreted into human milk; however, entecavir is excreted into the milk of rats. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from BARACLUDE, a decision should be made to discontinue nursing or to discontinue BARACLUDE taking into consideration the importance of continued hepatitis B therapy to the mother and the known benefits of breastfeeding. Pediatric Use - BARACLUDE was evaluated in two clinical trials of pediatric subjects 2 years of age and older with HBeAg-positive chronic HBV infection and compensated liver disease. The exposure of BARACLUDE in nucleoside-inhibitor-treatment-naïve and lamivudine-experienced pediatric subjects 2 years of age and older with HBeAg-positive chronic HBV infection and compensated liver disease receiving 0.015 mg/kg (up to 0.5 mg once daily) or 0.03 mg/kg (up to 1 mg once daily), respectively, was evaluated in Study AI463028. Safety and efficacy of the selected dose in treatment-naïve pediatric subjects were confirmed in Study AI463189, a randomized, placebo-controlled treatment trial [see Adverse Reactions and Indications and Usage (1), Dosage and Administration (2.3), Clinical Pharmacology (12.3), and Clinical Studies (14.2) in full Prescribing Information]. There are limited data available on the use of BARACLUDE in lamivudine-experienced pediatric patients; BARACLUDE should be used in these patients only if the potential benefit justifies the potential risk to the child. Since some pediatric patients may require long-term or even lifetime management of chronic active hepatitis B, consideration should be given to the impact of BARACLUDE on future treatment options [see Microbiology (12.4) in full Prescribing Information]. The efficacy and safety of BARACLUDE have not been established in patients less than 2 years of age. Use of BARACLUDE in this age group has not been evaluated because treatment of HBV in this age group is rarely required. BARACLUDE® (entecavir) BARACLUDE® (entecavir) Geriatric Use - Clinical studies of BARACLUDE did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Entecavir is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.4) in full Prescribing Information]. Racial/Ethnic Groups - There are no significant racial differences in entecavir pharmacokinetics. The safety and efficacy of BARACLUDE 0.5 mg once daily were assessed in a single-arm, open-label trial of HBeAg-positive or -negative, nucleoside-inhibitor-naïve, Black/African American (n=40) and Hispanic (n=6) subjects with chronic HBV infection. In this trial, 76% of subjects were male, the mean age was 42 years, 57% were HBeAg-positive, the mean baseline HBV DNA was 7.0 log10 IU/mL, and the mean baseline ALT was 162 U/L. At Week 48 of treatment, 32 of 46 (70%) subjects had HBV DNA <50 IU/mL (approximately 300 copies/mL), 31 of 46 (67%) subjects had ALT normalization (≤1 × ULN), and 12 of 26 (46%) HBeAg-positive subjects had HBe seroconversion. Safety data were similar to those observed in the larger controlled clinical trials. Because of low enrollment, safety and efficacy have not been established in the US Hispanic population. Renal Impairment - Dosage adjustment of BARACLUDE is recommended for patients with creatinine clearance less than 50 mL/min, including patients on hemodialysis or CAPD [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) in full Prescribing Information]. Liver Transplant Recipients - The safety and efficacy of BARACLUDE were assessed in a single-arm, open-label trial in 65 subjects who received a liver transplant for complications of chronic HBV infection. Eligible subjects who had HBV DNA less than 172 IU/mL (approximately 1000 copies/mL) at the time of transplant were treated with BARACLUDE 1 mg once daily in addition to usual post-transplantation management, including hepatitis B immune globulin. The trial population was 82% male, 39% Caucasian, and 37% Asian, with a mean age of 49 years; 89% of subjects had HBeAg-negative disease at the time of transplant. Four of the 65 subjects received 4 weeks or less of BARACLUDE (2 deaths, 1 retransplantation, and 1 protocol violation) and were not considered evaluable. Of the 61 subjects who received more than 4 weeks of BARACLUDE, 60 received hepatitis B immune globulin post-transplant. Fifty-three subjects (82% of all 65 subjects treated) completed the trial and had HBV DNA measurements at or after 72 weeks treatment post-transplant. All 53 subjects had HBV DNA <50 IU/mL (approximately 300 copies/mL). Eight evaluable subjects did not have HBV DNA data available at 72 weeks, including 3 subjects who died prior to study completion. No subjects had HBV DNA values ≥50 IU/mL while receiving BARACLUDE (plus hepatitis B immune globulin). All 61 evaluable subjects lost HBsAg post-transplant; 2 of these subjects experienced recurrence of measurable HBsAg without recurrence of HBV viremia. This trial was not designed to determine whether addition of BARACLUDE to hepatitis B immune globulin decreased the proportion of subjects with measurable HBV DNA post-transplant compared to hepatitis B immune globulin alone. If BARACLUDE treatment is determined to be necessary for a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus, renal function must be carefully monitored both before and during treatment with BARACLUDE [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) in full Prescribing Information]. OVERDOSAGE: There is limited experience of entecavir overdosage reported in patients. Healthy subjects who received single entecavir doses up to 40 mg or multiple doses up to 20 mg/day for up to 14 days had no increase in or unexpected adverse events. If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Following a single 1 mg dose of entecavir, a 4-hour hemodialysis session removed approximately 13% of the entecavir dose. NONCLINICAL TOXICOLOGY: Carcinogenesis, Mutagenesis, Impairment of Fertility. Carcinogenesis - Long-term oral carcinogenicity studies of entecavir in mice and rats were carried out at exposures up to approximately 42 times (mice) and 35 times (rats) those observed in humans at the highest recommended dose of 1 mg/day. In mouse and rat studies, entecavir was positive for carcinogenic findings. In mice, lung adenomas were increased in males and females at exposures 3 and 40 times those in humans. Lung carcinomas in both male and female mice were increased at exposures 40 times those in humans. Combined lung adenomas and carcinomas were increased in male mice at exposures 3 times and in female mice at exposures 40 times those in humans. Tumor development was preceded by pneumocyte proliferation in the lung, which was not observed in rats, dogs, or monkeys administered entecavir, supporting the conclusion that lung tumors in mice may be a species-specific event. Hepatocellular carcinomas were increased in males and combined liver adenomas and carcinomas were also increased at exposures 42 times those in humans. Vascular tumors in female mice (hemangiomas of ovaries and uterus and hemangiosarcomas of spleen) were increased at exposures 40 times those in humans. In rats, hepatocellular adenomas were increased in females at exposures 24 times those in humans; combined adenomas and carcinomas were also increased in females at exposures 24 times those in humans. Brain gliomas were induced in both males and females at exposures 35 and 24 times those in humans. Skin fibromas were induced in females at exposures 4 times those in humans. It is not known how predictive the results of rodent carcinogenicity studies may be for humans. Mutagenesis - Entecavir was clastogenic to human lymphocyte cultures. Entecavir was not mutagenic in the Ames bacterial reverse mutation assay using S. typhimurium and E. coli strains in the presence or absence of metabolic activation, a mammalian-cell gene mutation assay, and a transformation assay with Syrian hamster embryo cells. Entecavir was also negative in an oral micronucleus study and an oral DNA repair study in rats. Impairment of Fertility - In reproductive toxicology studies, in which animals were administered entecavir at up to 30 mg/kg for up to 4 weeks, no evidence of impaired fertility was seen in male or female rats at systemic exposures greater than 90 times those achieved in humans at the highest recommended dose of 1 mg/day. In rodent and dog toxicology studies, seminiferous tubular degeneration was observed at exposures 35 times or greater than those achieved in humans. No testicular changes were evident in monkeys. 1323583 Rev May 2014 686US14BR01514-02-01
  • 8. OFFIC IAL JOURNAL OF THE AMERI CAN A SSOCIATION F OR THE STUDY OF LI VER DISEASES Editor Michael H. Nathanson, New Haven, CT SENIOR ASSOCIATE EDITORS James L. Boyer, New Haven, CT Roberto J. Groszmann, New Haven, CT ASSOCIATE EDITORS Frank A. Anania, Atlanta, GA Jorge A. Bezerra, Cincinnati, OH Guadalupe Garcia-Tsao, New Haven, CT Stephen A. Harrison, Fort Sam Houston, TX Donald M. Jensen, Chicago, IL Brett Lindenbach, New Haven, CT Jacquelyn Maher, San Francisco, CA Wajahat Mehal, New Haven, CT Lola M. Reid, Chapel Hill, NC Mario Strazzabosco, New Haven, CT Norah Terrault, San Francisco, CA Snorri S. Thorgeirsson, Bethesda, MD Michael Trauner, Vienna, Austria CONSULTING BIOSTATISTICIAN James Dziura, New Haven, CT HEPATOLOGY ELSEWHERE Yasuko Iwakiri, New Haven, CT Tamar H. Taddei, New Haven, CT EDITORS EMERITUS Irwin M. Arias, Boston, MA, Founding Editor Steven Schenker, San Antonio, TX Paul D. Berk, New York, NY D. Montgomery Bissell, San Francisco, CA Andres T. Blei, Chicago, IL Keith D. Lindor, Rochester, MN CLINICAL OBSERVATIONS IN HEPATOLOGY Victor J. Navarro, Philadelphia, PA Simona Jakab, New Haven, CT HEPATOLOGY HIGHLIGHTS Jean-Franc¸ois Dufour, Bern, Switzerland PRODUCTION STAFF Ann Haran, Managing Editor Kareytis Martinez, Editorial Assistant Tazeen Shirazi, Editorial Assistant Dana Lombardi, Editorial Assistant Kara Cheatham, Editorial Assistant EDITORIAL BOARD Manal Abdelmalek, Durham, NC Juan Abraldes, Alberta, Canada Gianfranco Alpini, Temple, TX Raul Andrade, Ma´laga, Spain Mario Angelico, Rome, Italy Paul Angulo, Lexington, KY Meena Bansal, New York, NY Ulrich Beuers, Amsterdam, Netherlands Jordi Bruix, Barcelona, Spain Elizabeth Brunt, St. Louis, MO John Bucuvalas, Cincinatti, OH Michael Charlton, Rochester, MN John Chiang, Rootstown, OH David Cohen, Boston, MA Kenneth Cusi, San Antonio, TX Mark Czaja, New York, NY Gennaro D’Amico, Palermo, Italy Gary Davis, Dallas, TX Anna Mae Diehl, Durham, NC Alvaro Domenico, Rome, Italy Jean Dubuisson, Lille, France Ronald Oude Elferink, Amsterdam, Netherlands Jeff Esko, Manchester, United Kingdom Michael Fallon, Houston, TX Jordan Feld, Toronto, Canada Ariel Feldstein, Cleveland, OH Andrew Feranchak, Dallas, TX Peter Ferenci, Vienna, Austria Jose Fernandez-Checa, Barcelona, Spain Peter Fickert, Graz, Austria Stuart Forbes, Edinburgh, United Kingdom Michael Fried, Chapel Hill, NC Mark Furth, Winston-Salem, NC Bin Gao, Bethesda, MD Juan Carlos Garcia-Paga´n, Barcelona, Spain Eugenio Gaudio, Rome, Italy Eric Gershwin, Sacramento, CA Jim D Gorham, Lebanon, NH Arash Grakoui, Atlanta, GA Ivo Graziadei, Innsbruck, Austria Kenichi Ikejima, Tokyo, Japan Ira Jacobson, New York, NY Dhanpat Jain, New Haven, CT Harmut Jaeschke, Kansas City, KS Peter Jansen, Netherlands Harry Janssen, Rotterdam, Netherlands Cynthia Ju, Denver, CO Patrick Kamath, Rochester, MN Neil Kaplowitz, Los Angeles, CA Tom Karlsen, Oslo, Norway Saul Karpen, Atlanta, GA W. Ray Kim, Rochester, MN Curtis Klaassen, Kansas City, KS Percy Knolle, Bonn, Germany Sanjay Kulkarni, New Haven, CT William Lee, Dallas, TX Stanley Lemon, Chapel Hill, NC Massimo Levrero, Rome, Italy Joseph Lim, New Haven, CT Maribel Lucena, Ma´laga, Spain Derek Mann, Newcastle Upon Tyne, United Kingdom M. Michele Manos, Oakland, CA Fabio Marra, Florence, Italy Jane McKeating, Birmingham, United Kingdom Brian McMahon, Anchorage, Alaska Philip Meuleman, Ghent, Belgium Pram Mistry, New Haven, CT Atsushi Miyajima, Tokyo, Japan Satdarshan Monga (Paul) Singh, Pittsburgh, PA Richard Moreau, Beaujon, France Masaki Mori, Osaka, Japan Antonio Moschetta, Bari, Italy Andrew Muir, Durham, NC Kevin Mullen, Cleveland, OH Laura Nagy, Cleveland, OH David Nelson, Bethesda, MD James Neuberger, Birmingham, United Kingdom Young-Nyun Park, Yonsei, Korea Markus Peck-Radosavljevic, Vienna, Austria Robert Perrillo, Dallas, TX Massimo Pinzani, Florence, Italy Jeffrey Pollak, New Haven, CT Fred Poordad, Los Angeles, CA Elizabeth Powell, Brisbane, Australia Nancy Reau, Chicago, IL K. Rajender Reddy, Philadelphia, PA Mary Rinella, Chicago, IL Cristina Ripoll, Halle an der Saale, Germany Lewis R. Roberts, Rochester, MN Sammy Saab, Los Angeles, CA Francesco Salerno, Milan, Italy Peter Schirmacher, Heidelberg, Germany Robert Schwabe, New York, NY Gamel Shiha, Almansoura, Egypt Ben Shneider, Pittsburgh, PA Ron Sokol, Aurora, CO Bruno Stieger, Zurich, Switzerland Fred Suchy, Denver, CO Mark Sulkowski, Baltimore, MD Gyongyi Szabo, Worchester, MA Puneeta Tandon, Edmonton, Canada Neil Theise, New York, NY Zhigang Tian, Hefei, China Dawn Torres, Baltimore, MD Augusto Villanueva, Barcelona, Spain Miriam Vos, Atlanta, GA Fu-Sheng Wang, Beijing, China Yunfang Wang, Beijing, China Xin Wei Wang, Bethesda, MD Rebecca Wells, Philadelphia, PA Brian West, New Haven, CT Reiner Wiest, Regensberg, Germany Florence Wong, Toronto, Canada Hushan Yang, Philadelphia, PA Min You, San Francisco, CA Nizar Zein, Cleveland, OH Jessica Zucman-Rossi, Paris, France American Association for the Study of Liver Diseases—Governing Board 2014 President Adrian M. Di Bisceglie, St. Louis, MO President-Elect Gyongi Szabo, Worcester, MA Secretary Gary L. Davis, Simpsonville, SC Past President J. Gregory Fitz, Dallas, TX Councilors Keith D. Lindor, Tempe, AZ Anna S.F. Lok, Ann Arbor, MI Ronald J. Sokol, Aurora, CO Councilors-at-Large Raymond T. Chung, Boston, MA Susan Orloff, Portland, OR K. Rajender Reddy, Philadelphia, PA Publications Committee Chair Theo Heller, Bethesda, MD Treasurer W. Ray Kim, Stanford, CA AASLD National Headquarters: 1001 North Fairfax Street, Suite 400, Alexandria, VA 22314. Phone: 703-299-9766; Fax: 703-299-9622; E-mail: AASLD@AASLD.org. Chief Executive Officer, Steven Echard Editorial Office: 1001 North Fairfax Street, Suite 400, Alexandria, VA 22314. Phone: 703-299-9766; Fax: 703-299-9676; E-mail: hepatology@aasld.org HEPATOLOGY (Print ISSN 0270-9139; Online ISSN 1527-3350 at Wiley Online Library (wileyonlinelibrary.com)) is published monthly in two indexed volumes through Wiley Subscription Services, a Wiley Company, 111 River St., Hoboken, NJ 07030. Subscription rates for Volumes 59-60, 2014. Institution (includes Liver Transplantation, Volume 20, 2014) Print only: in U.S., $2,440. For all other prices please consult the journal’s website at onlinelibrary.wiley.com/journal/10.1002/(ISSN)1527-3352. Prices subject to change without notice. Periodicals postage paid at Hoboken, NJ, and at additional mailing offices. Delivery Terms and Legal Title: Where the subscription price includes print issues and delivery is to the recipient’s address, delivery terms are Delivered at Place (DAP); the recipient is responsible for paying any import duty or taxes. Title to all issues transfers FOB our shipping point, freight prepaid. We will endeavor to fulfill claims for missing or damaged copies within six months of publication, within our reasonable discretion and subject to availability. POSTMASTER: Send all address changes to HEPATOLOGY, John Wiley & Sons Inc., c/o The Sheridan Press, PO Box 465, Hanover, PA 17331. Copyright VC 2014 by the American Association for the Study of Liver Diseases. All rights reserved. Printed in the United States of America by Cadmus Communications, a Cenveo company. Printed on acid-free paper effective with Volume 11, Number 2, 1990.
  • 9. 2015 Research and Career Development Awards We understand the phenomenal return on investment that research can provide. Several young investigators began their careers in biomedical research thanks to funding from our program, demonstrating the importance of these awards not only to investigators and practitioners, but to the very endeavor of medical and hepatobiliary research itself. Application Deadline: DECEMBER 4, 2014 *NP/PA Clinical Hepatology Fellowship Application Deadline: FEBRUARY 5, 2015 Recipient Notification: MAY 2015 Award Start Date: JULY 1, 2015 Research Awards Pinnacle Research Award in Liver Disease $300,000—3 year award NEW IN 2015 Clinical and Translational Research Awards in Liver Diseases $150,000—2 year award Career Development Award in Liver Transplantation $90,000—2 year award Career Development Awards NP/PA Clinical Hepatology Fellowship* $78,000—1 year award AASLD/LIFER Clinical and Translational Research Fellowship $75,000—1 year award Advanced/Transplant Hepatology Fellowship $60,000—1 year award Awards applications are available at WWW.AASLD.ORG/AWARDS
  • 10. iiA The overall goal of The Liver Meeting® is to provide a forum for the exchange of ground breaking research and clinical information in diseases of the liver and biliary tract and in liver transplantation. Target Audience Groups include clinical hepatologists, gastroenterologists, other health care providers (midlevel providers, internists, pediatricians, family practitioners), and trainees (students, residents, and specialty fellows). The target audience also encompasses scientists studying the development, physiology, pathology, translational medicine, and clinical trials related to the liver and biliary tract and liver transplantation. AASLD takes responsibility for the content, quality, and scientific integrity of this live activity. Learning Objectives Upon participation in this live educational activity, learners will be able to: • Incorporate new scientific evidence into clinical care protocols and improve the outcome of adults and children with acute and chronic diseases of the liver and biliary tract. • Establish new collaborations, implement new clinical trials, develop comparative effectiveness projects, and complete investigative efforts that will improve the outcome of adults and children with acute and chronic diseases of the liver and biliary tract. • Implement effective care plans to improve the long-term outcome of the transplanted patient. Continuing Medical Education (CME) Accreditation Statement The American Association for the Study of Liver Diseases (AASLD) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Credit Designation Statement AASLD designates these live activities for AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Maximum Credits Available Annual Meeting (State-of-the-Art Lectures; President’s Choice; General Hepatology Update; Advances for Practitioners; Plenaries and Parallel Sessions; Global Forum; MOC Session; Value-Based Medicine in Hepatology; and Emerging Trends) . . . . . . . . . . . . . . . . . . 20.5 CME Credits Postgraduate Course. . . . . . . . . . . . . . . . 12.0 CME Credits Basic Research Workshop . . . . . . . . . . . . . 4.0 CME Credits Hepatology Associates Course . . . . . . . . . . 5.5 CME Credits AASLD/ILTS Transplant Course* . . . . . . . . . 6.5 CME Credits AASLD/NASPGHAN   Pediatric Symposium**. . . . . . . . . . . . . . 3.0 CME Credits AASLD/ASGE Endoscopy Course** . . . . . . . 7.0 CME Credits Transplant Surgery Workshop . . . . . . . . . . 3.5 CME Credits *This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through the joint providership of the American Association for the Study of Liver Diseases (AASLD), and the International Liver Transplantation Society (ILTS). AASLD is accredited by the ACCME to provide continuing medical education for physicians. **Co-sponsored activity: The American Association for the Study of Liver Diseases (AASLD) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Please note: As an accredited provider, AASLD ensures the content of all CME activities and related materials will promote improvements or quality in health care, and not a specific proprietary business interest of a commercial interest. As such, some sessions or ticketed activities may not offer CME credits. Continuing Education (CE) The Institute for Advancement of Human Behavior (IAHB) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. These activities are co-provided by IAHB and AASLD. Maximum 20 contact hours. The following ticketed activities will award nurse continuing education contact hours: • AASLD/ILTS Transplant Course – 5 contact hours • Postgraduate Course – 10 contact hours • Hepatology Associates Course – 5 contact hours Faculty Disclosure It is the policy of AASLD to ensure balance, independence, objectivity, and scientific rigor in all its individually or jointly sponsored educational programs. All faculty/authors participating in any AASLD sponsored programs, as well as planners and committee members are expected to disclose any real or apparent conflict(s) of interest that may have a direct bearing on the subject matter of the continuing medical education program. When an unlabeled use of a commercial product, or an investigational use not yet approved for any purpose is discussed during an educational activity, the speaker shall disclose to the audience that the product is not labeled for the use under discussion or that the product is still investigational. All disclosure information is provided to the activity participant prior to the start of the educational activity. In addition, disclosure slides will be the first slide in each oral presentation viewed by participants. AASLD will identify and resolve all conflicts of interest prior to program implementation. Accreditation and Continuing Education Information
  • 11. iiiA Accreditation and Continuing Education Information Disclaimer Statement Statements, opinions, and results of studies presented at The Liver Meeting® are solely those of the authors and do not reflect the policy or position of AASLD. AASLD does not provide any warranty to the accuracy or reliability of information presented either verbally or in writing by presenters. No responsibility is assumed by AASLD for any injury and/or damage to persons or property resulting from any use of such information. Use of AASLD Scientific Program Content Information presented during the 65th Annual Meeting is the property of AASLD and the presenter. Information may not be recorded, photographed, copied, photocopied, transferred to electronic format, reproduced, or distributed without the written permission of AASLD and the presenter. Any use of the program content, which includes, but is not limited to oral presentations, audiovisual materials used by speakers, and program handouts, without the written consent of AASLD is prohibited. Claiming CME/CE Credit and Certificates of Attendance The CME/CE evaluations are electronic and can be completed using the following options: • Upon download, use the meeting app to evaluate the sessions in real-time • Using your personal device, link to the CME and/or CE evaluation on The Liver Meeting® website • Visit Tech Connect to access the evaluation from any available kiosk CME and CE credit will be awarded upon completion of the electronic evaluation. You will have the ability to download and/or print a certificate for your records once you have completed the CME and/or CE evaluations. Certificates of Attendance are also available. Certificates may be downloaded and/or printed upon completion of The Liver Meeting® evaluation. Outcomes Follow-up Survey A follow-up survey will be sent to all attendees within three months of the conclusion of the meeting to assess the new skills and competencies learned as a result of participating in this live activity.
  • 12. ivA Future Meetings 2015 Digestive Disease Week® (DDW) May 16 – 19 Walter E. Washington Convention Center Washington, DC Clinical Hepatology: State-of-the-Art Management June 27 – 28 The Westin Chicago River North Chicago, Illinois Emerging Trends Conference AASLD Industry Colloquium: Novel Targets and Therapies in Liver Disease Spring 2015 Location TBD The Liver Meeting® November 13 – 17 Moscone West Convention Center San Francisco, California Postgraduate Course Managing Liver Disease - From the Clinic to the Community November 14 Moscone West Convention Center San Francisco, California
  • 13. vA THE AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES 65th ANNUAL MEETING AND POSTGRADUATE COURSE N O V E M B E R 7 – N O V E M B E R 1 1   •   B O S T O N , M A The Liver Meeting® 2O14 Table of Contents Meeting-at-a-Glance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2A General Meeting Information . . . . . . . . . . . . . . . . . . . . . . . 5A Limited License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7A Disclosure Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8A Oral Sessions Friday, November 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32A Saturday, November 8 . . . . . . . . . . . . . . . . . . . . . . . . . . 39A Sunday, November 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . 43A Monday, November 10 . . . . . . . . . . . . . . . . . . . . . . . . . . 65A Tuesday, November 11 . . . . . . . . . . . . . . . . . . . . . . . . . . 85A Poster Sessions Saturday, November 8 . . . . . . . . . . . . . . . . . . . . . . . . . . 92A Sunday, November 9 . . . . . . . . . . . . . . . . . . . . . . . . . . 119A Monday, November 10 . . . . . . . . . . . . . . . . . . . . . . . . . 146A Tuesday, November 11 . . . . . . . . . . . . . . . . . . . . . . . . . 169A Abstracts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197A Author Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1206A Category Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1256A The Scientific Program Committee has created an exciting and diverse scientific program that highlights new technology, current clinical issues and hot topics facing the hepatology community. Members include: Adrian M. Di Bisceglie, MD, FACP, Co-Chair Gary L. Davis, MD, Co-Chair Carla W. Brady, MD Kenneth D. Chavin, MD, PhD Mark J. Czaja, MD Marc G. Ghany, MD Saul J. Karpen, MD, PhD Keith D. Lindor, MD Gyongyi Szabo, MD, PhD Rebecca T. Wells, MD
  • 14. NP/PA Clinical Hepatology Fellowship Program $ 78,000, One Year* Pursue a full year of training in clinical hepatology—apply for the NP/PA Clinical Hepatology Fellowship. If you are new to the field or interested in a shift in focus to clinical hepatology—the NP/PA Clinical Hepatology Fellowship provides $78,000* for one year of clinical training for those committed to the field of hepatology and better treatment for patients with liver disease. The application is available at www.aasld.org/awards Application Deadline: FEBRUARY 5, 2015 Award Start Date: JULY 1, 2015 *Salary and benefit support only—AASLD provides equal opportunity for all research and fellowship award applicants without regard to race, color, creed, religion, gender, sexual orientation, national origin, age, marital status, mental or physical disability, pregnancy, military or veteran status, or any other basis prohibited by state or federal law.
  • 15. Earn CME and prepare for your internal medicine, gastroenterology, or transplant hepatology exam with board-style practice questions from Clinical Liver Disease (CLD). Each question set helps you identify areas for further review and links to free online resources—articles, videos, webinars, and podcasts—that can help you update your knowledge on a variety of hepatology topics. Nurses and physician assistants will also benefit from the review questions and from the full spectrum of clinical education available through CLD. Visit cldlearning.com/questions to start today. CLD is an online learning resource of the American Association for the Study of Liver Diseases. Free Board Review Questions
  • 16. YOU CAN ALSO DOWNLOAD THESE PRACTICE GUIDELINE TOPICS FOR LIVER DISEASE ■■ Acute Liver Failure ■■ Alcoholic Liver Disease ■■ Ascites due to Cirrhosis ■■ Autoimmune Hepatitis ■■ Gastroesophageal Varices and Variceal Hemorrhage in Cirrhosis ■■ Hemochromatosis ■■ Hepatitis B, Chronic ■■ Hepatocellular Carcinoma ■■ Liver Biopsy ■■ Long-Term Management of Adult Patients After Liver Transplantation ■■ Long-Term Management of Pediatric Patients After Liver Transplantation ■■ Non-alcoholic Fatty Liver Disease ■■ Primary Biliary Cirrhosis ■■ Primary Sclerosing Cholangitis ■■ TIPS in Management of Portal Hypertension ■■ Vascular Disorders of the Liver ■■ Wilson Disease NEW Practice Guidelines in 2014 Available at www.aasld.org ■■ Hepatic Encephalopathy in Chronic Liver Disease ■■ Evaluation for Liver Transplantation in Adults ■■ Evaluation of the Pediatric Patient for Liver Transplantation These evidence-based guidelines are developed and updated regularly by a committee of experts and include recommendations of preferred approaches to the diagnostic, therapeutic, and preventative aspects of care. FIND OUT MORE AT THE PAVILION Visit the AASLD Pavilion Just outside registration
  • 17. 2A Meeting-at-a-Glance The majority of events during The Liver Meeting® will take place in the Hynes Convention Center. Those events not taking place at the convention center will be noted. Sessions marked with an asterisk * require a ticket for entrance. Day/Time Activity Location Page Friday, November 7 7:55 am – 3:00 pm AASLD/ASGE Endoscopy Course * Room 302 32A 8:00 am – 2:45 pm AASLD/ ILTS Transplant Course * Ballroom B/C 33A 10:00 am – Noon Career Development Workshop * Room 311 34A Noon – 3:00 pm AASLD/NASPGHAN Pediatric Symposium * Room 312 35A 12:30 – 2:45 pm Competency Training Workshop Room 309 36A 12:30 – 3:30 pm Clinical Research Workshop * Room 304/306 37A 3:30 – 7:30 pm Postgraduate Course * Auditorium 38A Saturday, November 8 8:00 am – 5:00 pm Postgraduate Course * Auditorium 39A 9:00 am – Noon SIG Program: Outreach in Liver Transplant Room 302 40A 12:20 – 1:40 pm Meet-the-Professor Luncheons * Check your Ticket 41A 2:00 – 7:30 pm Poster Session I Hall C • Ascites, Renal Dysfunction and Hepatorenal Syndrome 92A • Behavioral, Quality of Life, and Practice Issues 93A • Cholangiocyte Biology 93A • Cholestasis and Autoimmune Liver Disease 94A • Donor Factors and Allocation 97A • Encephalopathy and Other Complications 98A • Experimental Cholestasis 101A • Fibrosis: Clinical and Translational 101A • Hemochromatosis, Wilson Disease, a-1 Antitrypsin Deficiency 104A • Imaging in Cancer 104A • Imaging in Fibrosis 105A • Immunosuppression 106A • Infections and Acute on Chronic Liver Failure 110A • Inflammation and Immunobiology: Animal Models 112A • Innate Immunity and Adaptive 113A • Living Donor and Split Transplant 114A • Mechanisms of Injury 115A • Metabolic and Genetic Diseases 115A • Viral and Autoimmune Hepatitis 116A • Viral Hepatitis and Liver Transplant 116A 3:30 – 7:00 pm Transplant Surgery Workshop * Room 302 42A 5:15 – 6:15 pm AASLD Business Meeting (Members Only) Auditorium 42A 5:00 – 7:30 pm Exhibits Open Hall D 41A 5:00 – 7:30 pm Opening Reception Hall C/D 41A Sunday, November 9 6:45 – 7:45 am Early Morning Workshops * Check your ticket 43A 8:00 – 9:30 am Transplant Plenary I Auditorium 44A 8:00 am – Noon Basic Research Workshop * Ballroom A 45A 8:00 am – 1:30 pm Hepatology Associates Course * Room 304/306 46A 8:00 am – 5:30 pm Poster Session II Hall C • Acute Liver Failure 119A • Basic Fibrosis 121A • Clinical Steatohepatitis 123A • Experimental Hepatocarcinogenesis 129A • Hepatitis C: Approved Therapeutic Agents 132A • Hepatotoxicity: Drug Metabolism 138A • Hepatotoxicity: Mechanisms 139A • Imaging of Steatohepatitis 140A • Steatohepatitis 140A • Transport, Bilirubin, Cholesterol, Lipids and Bile Salts 145A
  • 18. 3A Sunday, November 9 9:30 – 10:00 am Thomas E. Starzl Transplant Surgery State-of-the-Art Lecture Auditorium 47A 9:30 am – 3:00 pm Exhibits Open Hall D 44A 10:00 – 10:30 am Coffee Break Hall D 47A 10:00 – 11:30 am Emerging Trends Symposium Room 312 48A 10:30 am – Noon Transplant Plenary II Auditorium 49A Noon – 12:30 pm Hans Popper Basic Science State-of-the-Art Lecture Auditorium 50A 1:00 – 3:00 pm Value-based Medicine in Hepatology Room 302 50A 1:15 – 2:45 pm Maintenance of Certification (MOC) Update Room 210 51A 1:30 – 2:00 pm Snack Break Hall D 51A 2:00 – 2:30 pm Ethics and Humanities State-of-the-Art Lecture Auditorium 52A 2:45 – 3:00 pm Distinguished Clinician Educator / Mentor Award Auditorium 52A 3:00 – 4:30 pm General Hepatology Update Ballroom A/B/C 52A 3:00 – 4:30 pm Parallel Sessions 1. Advances in Fibrosis Imaging Room 309 53A 2. Antivirals, Acute Liver Failure in Liver Transplantation Room 312 53A 3. Basic Mechanisms of Liver Fibrosis Sheraton, Republic Ballroom 54A 4. Cholestatic and Autoimmune Liver Disease Room 302 54A 5. Experimental Hepatocarcinogenesis Sheraton, Back Bay Ballroom C 55A 6. Hepatitis C: Currently Approved Drugs Auditorium 55A 7. Mechanisms of Hepatotoxicity Room 210 56A 8. Novel Approaches in Diagnosis and Treatment in NAFLD and NASH Room 304/306 56A 9. Tissue Damage in Liver Disease and Inflammatory and Viral Room 311 57A 4:45 – 6:15 pm Parallel Sessions 10. HBV Diagnosis, Epidemiology, Prevention and Natural History Room 312 57A 11. Hepatitis C: Health Economics and Cost-effectiveness Room 304/306 58A 12. Hepatitis C: New Agents – Part 1 Auditorium 58A 13. Machine Perfusion and Cellular Therapy Room 309 59A 14. Outcomes in Cirrhosis Ballroom A/B/C 59A 15. Steatohepatitis: Experimental Room 311 60A 4:45 – 6:45 pm SIG Program: Pharmacogenomic Approaches in DILI Research Room 210 61A 4:45 – 7:00 pm SIG Program: Primary Liver Carcinomas with Intermediate/Stem Cell Features: Microscopic to Genomic Evidence and Back Sheraton, Back Bay Ballroom C 62A 4:45 – 7:00 pm SIG Program: Controversies in the Management of PSC in Children and Adults Room 302 63A 4:45 – 7:45 pm SIG Program: The Cell Biology of Hepatic Disease Sheraton, Republic Ballroom 64A Monday, November 10 6:45 – 7:45 am Early Morning Workshops * Check your ticket 65A 8:00 – 9:30 am Basic Plenary Auditorium 66A 8:00 am – 5:30 pm Poster Session III Hall C • Alcohol: Clinical and Basic Mechanisms 146A • Basic Hepatobiliary Neoplasia 148A • Biliary Atresia and Cholestasis 150A • Cellular and Molecular Biology 150A • Cellular Immunobiology 152A • Clinical Hepatobiliary Neoplasia 153A • Cost-effectiveness 160A • HCV: Diagnostics, Epidemiology, and Natural History 160A • Health Care Delivery 166A • Pediatric Liver Disease – Basic Science 168A • Pediatric Liver Transplantation 168A 9:30 – 10:00 am Distinguished Service and Achievement Awards Auditorium 66A 9:30 am – 3:00 pm Exhibits Open Hall D 66A 10:00 – 10:30 am Hyman J. Zimmerman Hepatotoxicity State-of-the-Art Lecture Auditorium 67A 10:30 – 11:00 am Coffee Break Hall D 67A 11:00 am – 12:30 pm Clinical Plenary Auditorium 68A 11:00 am – 12:30 pm Advances for Practitioners Ballroom A/B/C 69A 11:45 am – 1:15 pm Professional Development Workshop * Sheraton, Republic Ballroom 70A Meeting-at-a-Glance (continued) Day/Time Activity Location Page
  • 19. 4A Meeting-at-a-Glance (continued) Day/Time Activity Location Page Monday, November 10 1:30 – 2:00 pm Snack Break Hall D 70A 2:00 – 4:00 pm Global Forum Room 304/306 71A 2:15 – 2:45 pm President’s Choice Auditorium 72A 2:45 – 4:30 pm Late-breaking Abstract Session Auditorium 72A 3:00 – 4:30 pm Parallel Sessions 16. Access, Delivery, and Cost of Care Room 210 73A 17. Allocation, MELD, and Liver Transplantation Room 312 73A 18. Basic Hepatobiliary Neoplasia Room 310 74A 19. Cholestatic Liver Disease Room 302 74A 20. Mechanisms and Mortality in Alcoholic Liver Disease Room 313 75A 21. Molecular and Cellular Biology Room 309 75A 22. Pediatric Liver Diseases: Models, Modifiers, Mechanisms, and Markers Room 311 76A 23. Pharmacologic Therapies for Cirrhosis Complications Ballroom A/B/C 76A 4:45 – 6:15 pm HCV Symposium: #What’s Trending in Hepatitis C? Auditorium 77A 4:45 – 6:15 pm Parallel Sessions 24. Clinical Hepatobiliary Neoplasia Room 302 78A 25. Hepatitis C: Diagnosis, Epidemiology and Natural History Room 312 78A 26. Living Donor and Split Liver Transplantation, Hepatobiliary Surgery Room 210 79A 27. Pediatric Liver Diseases: Clinical and Translational Studies Room 311 79A 28. The Good and Bad of Innate Immunity in Liver Disease Room 309 80A 4:45 – 6:50 pm SIG Program: Non-invasive Methods to Stratify Risk in Patients with Compensated Cirrhosis Ballroom A/B/C 81A 4:45 – 6:55 pm SIG Program: Immunity and Lipids as New Drivers in Inflammation and Fibrosis of Non-Alcoholic Steatohepatitis Sheraton, Back Bay Ballroom C 82A 4:45 – 7:25 pm SIG Program: Renal Dysfunction in Cirrhosis: Should We Change the Way we Manage These Patients? Sheraton, Republic Ballroom 83A 4:45 – 7:50 pm SIG Program: The Next Generation of HBV Therapy: From Discovery to Cure Room 304/306 84A Tuesday, November 11 6:45 – 7:45 am Early Morning Workshops * Check your ticket 85A 8:00 – 9:30 am Hepatitis Plenary Auditorium 86A 8:00 am – Noon Poster Session IV Hall C • HBV: Diagnostics, Epidemiology, and Natural History 169A • HBV: Virology and Pathogenesis 174A • HCV: Health Economics and Cost-effectiveness 177A • HCV: Virology, Pathogenesis and Immunology 178A • Hepatitis B Therapy 182A • Hepatitis C: New Agents (Not Approved) 187A • Hepatitis C: Preclinical Development 191A • Portal Hypertension: Experimental 192A • Stem Cell Biology 194A • Varices and Bleeding 194A 9:45 – 10:30 am Hepatitis Debrief Auditorium 86A 10:30 – 11:00 am Leon Schiff State-of-the-Art Lecture Auditorium 87A 11:15 am – 12:45 pm Parallel Sessions 29. Biliary Biology and Pathobiology: Mechanisms and Treatments Room 210 88A 30. Correlates of Complications in Cirrhosis Room 302 88A 31. Emerging Trends in NASH Room 304/306 89A 32. HBV Basic Virology Room 311 89A 33. HCV Pathogenesis: Is the Battle Over? Room 312 90A 34. Hepatitis B: Outcomes of Approved Therapy Ballroom A/B/C 90A 35. Hepatitis C: New Agents – Part 2 Auditorium 91A *Indicates a ticket is required for entrance.
  • 20. 5A Abstracts Abstract information and text selected for presentation at The Liver Meeting® are available in many formats: • USB drive distributed at registration* • Online Itinerary Planner* • LiverLearning® • ePosters* • October supplement to Hepatology (members and sub- scribers) – in order to minimize waste, additional copies of this supplement will not be available at the meeting. • Meeting app* *The Abstracts on USB Flash-drive is supported by AbbVie *The online Itinerary Planner is supported by Bristol-Myers Squibb *ePosters are supported by Merck * Meeting app supported by Bayer HealthCare and Onyx Pharmaceuticals Abstract Embargo Accepted abstracts are made available to the public on the AASLD website and are published in the October supplement of Hepatology. Information contained in those abstracts may not be released until the abstracts appear on the AASLD website. Academic institutions, private organizations, and companies with products whose values may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an abstract on the AASLD website. How- ever, information beyond that contained in the abstract, e.g., discussion of the abstract done as part of a scientific presenta- tion or presentation of additional or new information that will be available at the time of the meeting is embargoed from release to the general public until the first day of The Liver Meeting®. Information released prior to this day is a violation of the AASLD Abstract Embargo Policy and the abstract is subject to with- drawal from The Liver Meeting® program. Authors are responsi- ble for notifying financial and other sponsors about this policy. AASLD may allow for exceptions, on a case-by-case basis, to the Abstract Embargo Policy for compelled disclosures man- dated by federal securities laws. However, AASLD requires the company President, General Counsel, or other appropriate offi- cial of a company seeking such an exception to attest in writing to the specific facts in support of the request, including exactly how the securities laws are implicated, with statutory citation(s). General statements of the need to comply with the law will not be considered sufficient. Requests for an exception must be sent to the AASLD CEO. AASLD requires a minimum of five (5) days from receipt of the request to evaluate the request. In granting an exception, AASLD requires the company to state in their public disclosure that the complete and final results will be presented at The Liver Meeting®. AASLD will also require the inclusion of unreleased and unique data in such a presentation at The Liver Meeting®. Public release of a journal article relevant to the abstract will be considered an exception to the Embargo Policy if at the time of the abstract submission deadline, the decision concerning the manuscript had not been revealed to the authors. ADA Compliance The Hynes Convention Center and all participating hotels at The Liver Meeting® are fully accessible to the physically chal- lenged. Anyone who has a need for special assistance should notify the appropriate hotel or the Hynes Convention Center and indicate the type of assistance needed. AASLD cannot ensure the availability of appropriate assistance without prior notice. Exhibit Hall • Hall D The Exhibit Hall, an informative and important component of The Liver Meeting®, provides you with a valuable opportunity to meet with representatives from various organizations that are committed to the field of hepatology. A complete listing of exhibitors and their product descriptions can be found on our website at www.thelivermeeting.org/exhibitors Exhibit Hours Saturday, November 8 5:00 – 7:30 pm Sunday, November 9 9:30 am – 3:00 pm Monday, November 10 9:30 am – 3:00 pm Posters • Hall C The Poster Sessions are an important event during The Liver Meeting®. Approximately 470 posters will be displayed daily. The top 10% of posters accepted are designated in the pro- gram as a “Presidential Poster of Distinction”. Posters should be set-up and viewed during the following times: Poster Session I Saturday, November 8 Set-up: 8:00 am – 2:00 pm Viewing Time: 2:00 – 7:30 pm Presentation Time: 5:30 – 7:00 pm* *Posters must be displayed until 7:30 pm Dismantle Time: 7:30 – 8:00 pm General Information
  • 21. 6A Poster Session II Sunday, November 9 Set-up: 6:30 – 8:00 am Viewing Time: 8:00 am – 5:30 pm Presentation Time: 12:30 – 2:00 pm* *Posters must be displayed until 5:30 pm Dismantle Time: 5:30 – 6:00 pm Poster Session III Monday, November 10 Set-up: 6:30 – 8:00 am Viewing Time: 8:00 am – 5:30 pm Presentation Time: 12:30 – 2:00 pm* *Posters must be displayed until 5:30 pm Dismantle Time: 5:30 – 6:00 pm Poster Session IV Tuesday, November 11 Set-up: 6:30 – 8:00 am Viewing Time: 8:00 am – Noon Presentation Time: 10:30 am – Noon* *Posters must be displayed until Noon Dismantle Time: Noon – 12:30 pm Posters must be dismantled immediately following the viewing time. Posters left on the boards will be removed and discarded. Note: No CME will be provided for Poster Sessions. ePosters • AASLD Pavilion ePosters are an interactive technologically advanced viewing system that brings posters to virtual life for all of The Liver Meet- ing® attendees and archived in LiverLearning®. ePosters will be available from the first day of the meeting in the AASLD Pavilion. ePosters are supported by Merck Press Room • Room 208 Friday, November 7 1:00 pm – 5:00 pm Saturday, November 8 8:00 am – 6:00 pm Sunday, November 9 8:00 am – 5:00 pm Monday, November 10 8:00 am – 5:00 pm Tuesday, November 11 8:00 am – Noon The official press contact for The Liver Meeting® is: Ann Haran AASLD 1001 N. Fairfax Street, Suite 400 Alexandria, VA 22314-2720 Telephone: 703-299-9766 Fax: 703-299-9676 Email: aharan@aasld.org Website: www.thelivermeeting.org/press Registration Hours • Hall A Thursday, November 6 2:00 – 8:00 pm Friday, November 7 6:30 am – 7:30 pm Saturday, November 8 6:30 am – 7:30 pm Sunday, November 9 6:30 am – 6:00 pm Monday, November 10 6:30 am – 6:00 pm Tuesday, November 11 6:30 am – 12:30 pm Speaker Ready Room • Room 207 Presenters should check-in 24 hours in advance, or no later than 2 hours prior to your session. If you are a speaker/presenter, review the presenter tab at www.thelivermeeting.org prior to the meeting for presentation tips, instructions, and guidelines. Friday, November 7 6:30 am – 7:30 pm Saturday, November 8 6:30 am – 7:30 pm Sunday, November 9 6:30 am – 6:00 pm Monday, November 10 6:30 am – 6:00 pm Tuesday, November 11 6:30 am – 12:30 pm General Information (continued) When citing an abstract, please use the following format: Desai RJ, Schnitzler MA, Di Bisceglie AM. Estimated impact of screening and anitviral treatment on prevention of HBV reactivation associated with cancer chemotherapy [Abstract]. Hepatology 2014, 60(4Suppl.1):[Page]A.
  • 22. 7A Limited License for Use The Liver Meeting® is protected by copyright, trademark, and/ or other applicable laws. Any use of The Liver Meeting®, including recordings and the development of derivative works, is prohibited. The name, logo and acronym of the American Association for the Study of Liver Diseases and The Liver Meet- ing® are the exclusive property of and are trademarked by AASLD. They may not be used in any way, for any purpose, or at any time (including but not limited to announcements, invitations, emails, Web publications, etc.) without the express written permission of AASLD. Without limiting the foregoing, Information presented during The Liver Meeting® is the property of AASLD and the presenter. Information may not be recorded, photographed, copied, photocopied, transferred to electronic format, reproduced, or distributed without the written permission of AASLD and the presenter. Any use of the program content which includes, but is not limited to, oral presentations, audiovisual materials used by speakers, and program handouts, without the written consent of AASLD is prohibited. Notwithstanding the above, AASLD grants a non-exclusive, non-transferable, royalty-free license to nonprofit, §501(c) (3), AAMC-accredited educational institutions to conduct a “Best of AASLD” conference or similar event (“Event”) of up to eight (8) hours in length that features highlights from AASLD sessions at the most recent occurrence of The Liver Meeting® and to utilize the name of AASLD in connection with the same. No Event may be held, nor may the name of AASLD be utilized, except pursuant to this Limited License or as otherwise authorized by AASLD in writing. When using the term “AASLD” or “The Liver Meeting®”, you must attribute AASLD’s trademark as follows: The Liver Meet- ing® and AASLD are registered trademarks of the American Association for the Study of Liver Diseases. You may not use the AASLD trademark(s): • In, as, or as part of your own trademarks • To identify products or services that do not belong to AASLD • In a manner likely to cause confusion, including colors and fonts • In a manner that implies inaccurately that AASLD sponsors or endorses, or is otherwise connected with your own activities, products and services The content of an Event shall be of the highest quality and shall accurately reflect material and information presented at the AASLD sessions. No Event shall include any statements or other communication that maligns or disparages AASLD or any AASLD session, presenter, or representative. All Event announcements, brochures, descriptions, and mate- rials, whether in print or electronic form, shall clearly identify the content as being derived from AASLD sessions by including the following statement: “All content is derived from presenta- tions and similar offerings made at The Liver Meeting® 2014 and is presented with permission of the American Association for the Study of Liver Diseases.” As between AASLD and any institution, AASLD is the owner of all AASLD programming and AASLD does not relinquish any such ownership rights by virtue of this Limited License. AASLD disclaims all warranties, express and implied, as to any information or materials presented in connection with any AASLD session or meeting, including as to intellectual property ownership. AASLD shall not be liable for any direct, indirect, punitive, consequential, or other damages in any way arising or resulting from the Event or the use of information or materi- als from AASLD sessions by any institution. Should any claim or suit be brought against AASLD arising from an Event, the institution shall indemnify and hold AASLD harmless for any damages, liability, and costs, including attorney fees, suffered or incurred by AASLD in defense and satisfaction thereof. This Limited License does not create a partnership, joint ven- ture, or similar relationship between AASLD and any institution. This Limited License is non-transferable, including by sale or sublicense. This Limited License shall terminate automatically upon violation of any of its terms. In addition, AASLD may terminate, or mod- ify the terms of, this Limited License in its discretion, generally or with respect to any particular institution. This Limited License shall be construed in accordance with the laws of the Commonwealth of Virginia, without regard to conflicts principles, and, as applicable, federal copyright and trademark laws. A court of competent jurisdiction in or for Alexandria, Virginia shall be the exclusive forum for the resolution of any dispute between AASLD and any institution, and institutions irrevocably consent to the personal and subject matter jurisdiction, and venue, of such court.
  • 23. Continuing Medical Education and Disclosures 8A Statement on Disclosure AASLD is committed to ensuring balance, independence objectivity and scientific rigor in its sponsored and jointly sponsored educational activities. Individuals in a position to control the content of an AASLD-sponsored activity (program planners, course directors, speakers, etc.) are expected to disclose all relevant financial relationships during the past 12 months. When an unlabeled use of a commercial product or an investigational use not yet approved for any purpose is discussed during an educational activity, the speaker shall disclose to the audience that the product is not labeled for the use under discussion or that the product is still investigational. All disclosure information is provided to the activity participant prior to the start of the educational activity. In addition, disclosure slides will be the first side in each oral presentation viewed by participants. AASLD will identify and resolve all conflicts of interest prior to program implementation. Invited speakers, course directors, moderators, program planners, abstract reviewers and staff have provided the following disclosures: 2014 Committee, Abstract Reviewer and Staff Disclosures Afdhal, Nezam H., MD (Abstract Reviewer) Consulting: Abbott, Pharmasett, Gilead, Springbank, GlaxoSmithKline, Idenix, Merck, Vertex Grants/Research Support: Merck, Vertex, Idenix, GlaxoSmithKline, Springbank, Gilead, Pharmasett, Abbott Adhami, Talal, MD (Program Evaluation Committee) Speaking and Teaching: Gilead Ahmad, Jawad, MD (Abstract Reviewer) Nothing to disclose Alberti, Alfredo, MD (Abstract Reviewer) Grants/Research Support: Merck, Gilead Advisory Board: Merck, Roche, Gilead Speaking and Teaching: Novartis, Bristol-Myers Squibb Al-Osaimi, Abdullah, MD (Abstract Reviewer) Nothing to disclose Alvarez, Fernando, MD (Abstract Reviewer) Nothing to disclose Angeli, Paolo, MD, PhD (Abstract Reviewer) Advisory Board: Sequana Medical Aranda-Michel, Jaime, MD (Abstract Reviewer) Nothing to disclose Arteel, Gavin E., PhD (Basic Research Committee, Abstract Reviewer) Grants/Research Support: NIH Asrani, Sumeet, MD (Abstract Reviewer) Nothing to disclose Aytaman, Ayse, MD (Abstract Reviewer) Nothing to disclose Bajaj, Jasmohan S., MD (Clinical Research Committee, Abstract Reviewer) Grants/Research Support: Salix, Otsuka, Grifols Advisory Board: American College of Gastroenterology, Grifols, Salix, Merz, Otsuka, Ocera Bambha, Kiran, MD (Abstract Reviewer) Nothing to disclose Bass, Nathan M., MD, PhD (Abstract Reviewer) Nothing to disclose Beaven, Simon, MD (Abstract Reviewer) Nothing to disclose Beavers, Kimberly, MD (Program Evaluation Committee) Nothing to disclose Befeler, Alex, MD (Program Evaluation Committee, Abstract Reviewer) Advisory Board: Gilead Stock: Amgen, Gilead Bergasa, Nora V., MD (Abstract Reviewer) Nothing to disclose Beier, Juliane Ingeborg, PhD (Education Committee) Nothing to disclose Berzigotti, Annalisa, MD, PhD (Education Committee) Nothing to disclose 8A
  • 24. Continuing Medical Education and Disclosures (continued) 9A Bhamba, Kiran, MD (Clinical Research Committee) Nothing to disclose Biggins, Scott W., MD (Abstract Reviewer) Nothing to disclose Boelsterli, Urs A., PhD (Abstract Reviewer) Nothing to disclose Bologna, Gregory (Staff) Nothing to disclose Bosch, Jaime, MD (Abstract Reviewer) Consulting: Falk, Gilead Science, Norgine, ONO-USA, Intercept Pharma, Exalenz, Almirall, Conatus Grants/Research Support: Gore Bowlus, Christopher L., MD (Education Committee) Advisory Board: Lumena Grants/Research Support: Gilead, Lumena, Intercept Brady, Carla W., MD (Program Evaluation Committee, Scientific Program Committee) Nothing to disclose Brenner, David A., MD (Abstract Reviewer) Nothing to disclose Brigstock, David R., PhD (Basic Research Committee) Intellectual Property Rights: FibroGen, Inc. Brosgart, Carol, MD (Abstract Reviewer) Nothing to disclose Brown, Kimberly Ann, MD (Abstract Reviewer) Advisory Board: CLDF, Merck, Salix, Gilead, Vertex, Novartis, Genentech, Janssen, Salix Grants/Research Support: CLDF, Gilead, Exalenz, CDC, Bristol- Myers Squibb, Bayer-Onyx, Ikaria, Hyperion, Merck Speaking and Teaching: Salix, Merck, Genentech, Gilead, CLDF, Vertex Consulting: Salix, Blue Cross Transplant Centers Browning, Jeffrey D., MD (Basic Research Committee) Nothing to disclose Bruce, Heidi (Staff) Nothing to disclose Brunt, Elizabeth M., MD (Abstract Reviewer) Consulting: Synageva Speaking and Teaching: Geneva Foundation, Independent Contractor: Kadmon, Rottapharm Buck, Martina, PhD (Basic Research Committee) Grants/Research Support: NIH Speaking and Teaching: Conatus, Gilead Caravan, Peter, PhD (Abstract Reviewer) Stock: Factor IA, LLC, Collagen Medical Consulting: Biogen Idec Carithers, Robert L., MD (Abstract Reviewer) Nothing to disclose Carr, Rotonya M., MD (Basic Research Committee) Nothing to disclose Chalasani, Naga P., MD (Abstract Reviewer) Grants/Research Support: Galectin, Cumberland, Gilead, Intercept, Lilly Consulting: Salix, AbbVie, Lilly, Boehringer Ingelheim, Aegerion Chavin, Kenneth D., MD, PhD (Scientific Program Committee, Surgery and Liver Transplantation Committee) Grants/Research Support: Novartis Scientific Consultant: Bridge to Life Chojkier, Mario, MD (Abstract Reviewer) Nothing to disclose Chung, Raymond T., MD (Governing Board, Basic Research Committee, Abstract Reviewer) Scientific Consultant: AbbVie Grants/Research Support: Gilead, Mass Biologics, Transzyme, Vertex Cohen, Stanley M., MD (Training and Workforce Committee) Nothing to disclose Colquhoun, Steven D., MD (Abstract Reviewer) Nothing to disclose Corbett, Ruth J., MSN, APRN (Training and Workforce Committee, Abstract Reviewer) Nothing to disclose Corey, Kathleen E., MD (Clinical Research Committee) Nothing to disclose Cotler, Scott, MD (Clinical Research Committee, Abstract Reviewer) Nothing to disclose Crawford, James, MD, PhD (Abstract Reviewer) Nothing to disclose
  • 25. Continuing Medical Education and Disclosures (continued) 10A Currie, Sue, EdD, MA (Hepatology Associates Committee) Employee, Officer, Director: Health Interactions Cusi, Kenneth, MD, PhD (Abstract Reviewer) Nothing to disclose Czaja, Mark J., MD (Scientific Program Committee, Basic Research Committee, Abstract Reviewer) Consulting: Oncozyme Pharma, Inc. Grants/Research Support: Oncozyme Pharma, Inc. Daniel, James F., MD (Program Evaluation Committee) Nothing to disclose Davis, Gary L., MD (Governing Board, Program Evaluation Committee, Scientific Program Committee, Abstract Reviewer) Nothing to disclose Dawson, Paul, MD (Abstract Reviewer) Consulting: GlaxoSmithKline, Isis Pharmaceuticals, Lumena Pharmaceuticals Stock: XenoPort, Inc. Deal, Julie (Staff) Stock: Bristol-Myers Squibb Delgado-Borrego, Aymin, MD (Program Evaluation Committee) Nothing to disclose DeLeve, Laurie D., MD, PhD (Abstract Reviewer) Advisory Board: Pfizer, Takeda, Bristol-Myers Squibb Di Bisceglie, Adrian M., MD, FACP (Governing Board, Scientific Program Committee) Advisory Board: Gilead, Data Safety Monitoring Board, Bayer, Novartis Grants/Research Support: AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Transgene, Vertex, Alpha-1 Foundation Royalties: Section Editor on Hepatitis C, UpToDate Diaz, Susan M., PA-C, MPAS (Surgery and Liver Transplantation Committee) Nothing to disclose Dickson, Rolland C., MD (Education Committee, Abstract Reviewer) Advisory Board: Bristol-Myers Squibb, Cowen and Associates Grants/Research Support: Gilead, Roche, Tibotec, Vertex Scientific Consultant: Biotest Speaking and Teaching: Gilead Diehl, Anna Mae, MD (Abstract Reviewer) Consulting: Roche Grants/Research Support: Gilead, Genfit Dieterich, Douglas, MD (Abstract Reviewer) Consulting: Gilead, Bristol-Myers Squibb Advisory Board: Merck, Idenix, Janssen Dolganiuc, Angela, MD (Abstract Reviewer) Nothing to disclose Doo, Edward, MD (Abstract Reviewer) Nothing to disclose Echard, Steven (Staff) Nothing to disclose Eggers, Carol A., MSN, FNP (Program Evaluation Committee) Nothing to disclose Eghtesad, Bijan, MD (Surgery and Liver Transplantation Committee) Nothing to disclose Ekong, Udeme D., MD (Abstract Reviewer) Nothing to disclose El-Serag, Hashem B., MD (Abstract Reviewer) Nothing to disclose Emerick, Karan M., MD (Abstract Reviewer) Nothing to disclose Emond, Jean C., MD (Abstract Reviewer) Nothing to disclose Fallon, Michael B., MD (Abstract Reviewer) Grants/Research Support: Bayer-Onyx, Eaisi, Gilead, Grifolis Feld, Jordan J., MD (Abstract Reviewer) Advisory Board: Idenix, Merck, Janssen, Gilead, AbbVie, Merck, Theravance, Bristol-Myers Squibb Grants/Research Support: AbbVie, Boehringer Ingelheim, Janssen, Gilead, Merck Feldstein, Ariel E., MD (Abstract Reviewer) Nothing to disclose Feng, Sandy, MD, PhD (Abstract Reviewer) Nothing to disclose Fenkel, Jonathan M., MD (Abstract Reviewer) Consulting: Gilead, Janssen
  • 26. Continuing Medical Education and Disclosures (continued) 11A Fiel, Maria Isabel, MD (Education Committee) Leadership: HEPATOLOGY Speaking and Teaching: Richmond University Hospital Grants/Research Support: P20 Mini Center, RO1 Detection of liver fibrosis, HCC in non-cirrhotic liver Expert Testimony: Fowler White Burnett, Kopff, Nardelli & Dopf, Bailly and McMillan McCormick Fitzpatrick Firpi, Roberto J., MD (Education Committee, Abstract Reviewer) Advisory Board: Gilead, Vertex Grants/Research Support: Bayer, Boehringer, Bristol-Myers Squibb, Gilead, Idenix, Novartis, Salix Fitz, J. Gregory, MD (Governing Board) Nothing to disclose Fix, Oren K., MD (Training and Workforce Committee, Abstract Reviewer) Nothing to disclose Forde, Kimberly A., MD (Clinical Research Committee) Nothing to disclose Foster, Temitope Y., MD (Program Evaluation Committee) Nothing to disclose Friedman, Joshua, MD, PhD (Abstract Reviewer) Employment: Janssen Research & Development Fuchs, Michael, MD, PhD (Training and Workforce Committee) Nothing to disclose Fung, John J., MD (Abstract Reviewer) Advisory Board: Astellas, Novartis Consulting: Vital Therapies Grants/Research Support: Sanofi Gao, Bin, MD, PhD (Abstract Reviewer) Nothing to disclose Gardenier, Donald, DNP, FNP-BC (Hepatology Associates Committee) Scientific Consultant: BV, Elsevier Leadership in Related Society: American Association of Nurse Practitioners Gaspard, Gabrielle M., MPH (Basic Research Committee) Nothing to disclose Gautam, Manjushree, MD (Abstract Reviewer) Nothing to disclose George, Jacob, MD, PhD (Clinical Research Committee, Abstract Reviewer) Advisory Board: Roche, Bristol-Myers Squibb, MSD, Gilead, Janssen Gerbes, Alexander L., MD (Abstract Reviewer) Nothing to disclose Gershwin, M. Eric, MD (Abstract Reviewer) Nothing to disclose Ghany, Marc G., MD (Scientific Program Committee, Clinical Research Committee) Expert Testimony: Clinical Care Options Gilles, HoChong, FNP (Education Committee, Hepatology Associates Committee) Speaking and Teaching: Bayer Gish, Robert, MD (Abstract Reviewer) Consulting: Arrowhead Advisory Board: Gilead, Bristol-Myers Squibb, Genentech, Arrowhead Stock: Arrowhead Goacher, Elizabeth K., PA-C, MHS (Clinical Research Committee) Speaking and Teaching: Merck, Vertex Gonzalez, Stevan, MD (Abstract Reviewer) Speaking and Teaching: Gilead, Salix Gonzalez-Peralta, Regino P., MD (Abstract Reviewer) Consulting: Roche, Boehringer Ingelheim, Vertex Grants/Research Support: Bristol-Myers Squibb, Roche, Merck Gordon, Fredric D., MD (Abstract Reviewer) Nothing to disclose Gordon, Stuart C., MD (Abstract Reviewer) Consulting: Bristol-Myers Squibb, Gilead, CVS Caremark, Merck Grants/Research Support: Exalenz, Roche/Genentech, Vertex, Gilead, Bristol-Myers Squibb, Abbott, Intercept Advisory Board: Tibotec Grace, Norman D., MD (Abstract Reviewer) Nothing to disclose Green, Richard, MD (Abstract Reviewer) Nothing to disclose Guo, Grace, MD (Abstract Reviewer) Nothing to disclose
  • 27. Continuing Medical Education and Disclosures (continued) 12A Gupta, Sanjeev, MD (Abstract Reviewer) Nothing to disclose Hagedorn, Curt H., MD (Abstract Reviewer) Nothing to disclose Harrison, Stephen, MD (Education Committee, Abstract Reviewer) Advisory Board: Galectin, Genfit Speaking and Teaching: Gilead Hassanein, Tarek, MD (Abstract Reviewer) Grants/Research Support: AbbVie, Boehringer Ingelheim, Bristol- Myers Squibb, Eiasi, Gilead, Janssen, Idenix, Ikaria, Merck, Roche, Ocera, Salix, Sundise, TaiGen, Takeda, Vital Therapies Speaking and Teaching: Baxter, Bristol-Myers Squibb, Gilead, Salix Advisory Board: AbbVie, Bristol-Myers Squibb Heimbach, Julie, MD (Abstract Reviewer) Nothing to disclose Henderson, Neil C., MBChB, PhD (Abstract Reviewer) Nothing to disclose Horne, Patrick, MSN, ARNP (Education Committee, Hepatology Associates Committee) Advisory Board: Gilead Grants/Research Support: Bayer Horslen, Simon, MD (Abstract Reviewer) Nothing to disclose Howell, Charles D., MD (Education Committee) Grants/Research Support: Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Leadership in a Related Society: National Medical Association Hepatitis C Task Force Ioannou, George, MD (Clinical Research Committee) Nothing to disclose Jalan, Rajiv, MD, PhD (Abstract Reviewer) Consulting: Ocera, Conatus Grants/Research Support: Grifols, Gambro Janssen, Harry L.A., MD, PhD (Program Evaluation Committee, Abstract Reviewer) Consulting: Santaris, Roche, Novartis, Medtronic, Merck, Gilead, Debio, Abbott, Bristol-Myers Squibb Grants/Research Support: Anadys, Bristol-Myers Squibb, Gilead, Innogenetics, Kirin, Merck, Medtronic, Novartis, Roche, Santaris Jeong, Won-ll, DVM, PhD (Abstract Reviewer) Nothing to disclose Jonas, Maureen M., MD (Abstract Reviewer) Consulting: Eisai Grants/Research Support: Bristol-Myers Squibb, Roche, Merck Advisory Board: Gilead Kaestner, Klaus H., PhD (Abstract Reviewer) Nothing to disclose Kamath, Patrick S., MD (Abstract Reviewer) Advisory Board: Sequana Medical Kaplowitz, Neil, MD (Abstract Reviewer) Consulting: GlaxoSmithKline, JNJ, Merck, Novartis, Hepregen, Takeda, Otsuka, Pfizer, Geron, Daiichi-Sanyo Independent Contractor: Acetaminophen Litigation Karpen, Saul J., MD, PhD (Scientific Program Committee, Abstract Reviewer) Nothing to disclose Keaveny, Andrew, MD (Education Committee) Expert Testimony: UpToDate, Inc. Kim, Arthur Y., MD (Abstract Reviewer) Grants/Research Support: Gilead, Bristol-Myers Squibb Consulting: AbbVie, Gilead Kisseleva, Tatiana, MD, PhD (Abstract Reviewer) Nothing to disclose Klett, Janeil (Staff) Stock: Merck, Pfizer Klintmalm, Goran, MD, PhD (Abstract Reviewer) Grants/Research Support: Astellas, Novartis, Opson, Quark Advisory Board: Novartis Kneteman, Norman M., MD (Abstract Reviewer) Nothing to disclose Knisely, Alexander S., MD (Abstract Reviewer) Nothing to disclose Kohli, Rohit, MD (Clinical Research Committee, Abstract Reviewer) Grants/Research Support: Synageva Biopharma, Johnson and Johnson Independent Contractor: Lumena Pharmaceuticals, Galectin Therapeutics Korenblat, Kevin M., MD (Abstract Reviewer) Grants/Research Support: Merck Advisory Board: Vertex
  • 28. Continuing Medical Education and Disclosures (continued) 13A Koteish, Ayman A., MD (Program Evaluation Committee) Nothing to disclose Kowdley, Kris V., MD (Abstract Reviewer) Advisory Board: Janssen, Ikaria, Boehringer Ingelheim, Vertex, AbbVie, Gilead, Merck, Novartis, Trio Health Grants/Research Support: AbbVie, Beckman, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Ikaria, Janssen, Merck, Mochida Kulkarni, Sanjay, MD (Surgery and Liver Transplantation Committee) Grants/Research Support: Alexion Lai, Ching Lung, MD (Abstract Reviewer) Nothing to disclose Larson, Anne M., MD (Abstract Reviewer) Speaking and Teaching: Gilead, Genentech, Salix Lau, George, MD (Abstract Reviewer) Consulting: Novartis, Roche Lauer, Georg M., MD (Basic Research Committee, Abstract Reviewer) Nothing to disclose Laurin, Jacqueline, MD (Education Committee) Nothing to disclose Leise, Michael, MD (Abstract Reviewer) Nothing to disclose Leonis, Mike A., MD, PhD (Training and Workforce Committee) Grants/Research Support: NIH Leadership in Related Society: NASPGHAN Research Committee member Levitsky, Josh, MD (Training and Workforce Committee, Abstract Reviewer) Consulting: Transplant Genomics, Inc. Grants/Research Support: Novartis Speaking and Teaching: Gilead, Salix Levy, Cynthia, MD (Clinical Research Committee, Abstract Reviewer) Consulting: Lumena, Gilead, Evidera Liangpunsakul, Suthat, MD (Abstract Reviewer) Nothing to disclose Liddle, Christopher, MD, PhD (Abstract Reviewer) Nothing to disclose Lidofsky, Steven D., MD (Abstract Reviewer) Nothing to disclose Lim, Joseph K., MD (Abstract Reviewer) Grants/Research Support: Achillion, Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Gilead, Janssen/Tibotec, Vertex Consulting: Merck, Vertex, Gilead, Bristol-Myers Squibb, Boehringer Ingelheim Lindor, Keith, MD (Governing Board, Hepatology Associates Committee, Scientific Program Committee) Advisory Board: Intercept, Lumena Ling, Simon C., MBChB, MRCP (Abstract Reviewer) Grants/Research Support: Bristol-Myers Squibb Lippello, Anita, CRNP, NP-C, DNP (Hepatology Associates Committee) Nothing to disclose Little, Ester C., MD (Education Committee) Nothing to disclose Liu, Chen, MD, PhD (Abstract Reviewer) Nothing to disclose Llovet, Josep M., MD (Abstract Reviewer) Grants/Research Support: Beohringer Ingelheim, Bayer, Bristol- Myers Squibb Consulting: GlaxoSmithKline, Bayer, Bristol-Myers Squibb, Imclone, Biocompatibles, Novartis Advisory Board: Nanostring, Blueprint Medicines Lok, Anna S. F., MD (Governing Board, Education Committee, Abstract Reviewer) Advisory Board: Gilead, Immune Targeting System, MedImmune, Arrowhead, Bayer, GlaxoSmithKline, Janssen, Novartis, ISIS, Tekmira Grants/Research Support: Abbott, Bristol-Myers Squibb, Gilead, Merck, Roche, Boehringer Ingelheim Loomba, Rohit, MD (Program Evaluation Committee, Abstract Reviewer) Advisory Board: American Liver Foundation Grants/Research Support: Daiichi Sankyo, Inc., Merck Scientific Consultant: Gilead, J and J Inc., Merck Loomes, Kathleen M., MD (Training and Workforce Committee) Grants/Research Support: NIH Lu, Shelly, MD (Abstract Reviewer) Nothing to disclose Magee, John, MD (Surgery and Liver Transplantation Committee, Abstract Reviewer) Grants/Research Support: Novartis