Chair, Anthony Martinez, MD, AAHIVS, FAASLD, prepared useful Practice Aids pertaining to HCV infection for this CME/MOC/NCPD/CPE activity titled “Sharing the Cure: Best Practices for Primary Care Providers to Improve HCV Prevention, Care, and Treatment.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/NCPD/CPE information, and to apply for credit, please visit us at https://bit.ly/3KQ6D3z. CME/MOC/NCPD/CPE credit will be available until April 20, 2023.
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Sharing the Cure: Best Practices for Primary Care Providers to Improve HCV Prevention, Care, and Treatment
1. Simplified HCV Treatment Algorithm for
Treatment-Naïve Adults Without Cirrhosis1
Full abbreviations, accreditation, and disclosure information available at
PeerView.com/ABJ40
•
Adults with chronic hepatitis C (any genotype) who
do not have cirrhosis and have not previously received
hepatitis C treatment
Patients who have any of the following characteristics
• Prior hepatitis C treatment
• Cirrhosis
• HIV or HBsAg positive
• Current pregnancy
• Known or suspected hepatocellular carcinoma
• Prior liver transplantation
Who is eligible for
simplified treatment?
Calculate FIB-4 score
Medication reconciliation
• Record current medications, including over-the-counter drugs and herbal/dietary supplements
Potential drug–drug interaction assessment
•
Drug–drug interactions can be assessed using the AASLD/IDSA guidance or the University of Liverpool drug interaction checker
Education
• Educate the patient about proper administration of medications, adherence, and prevention of reinfection
Pretreatment laboratory testing
•
Within 6 months of initiating
treatment
– CBC
–
Hepatic function panel
(ie, albumin, total and direct
bilirubin, ALT, AST)
– eGFR
•
Any time prior to starting antiviral
therapy
–
Quantitative HCV RNA (HCV
viral load)
–
HIV antigen/antibody test
–
Hepatitis B surface antigen
•
Before initiating antiviral therapy
–
Serum pregnancy testing and
counseling about pregnancy
risks of HCV medication
should be offered to women
of childbearing age
Who is NOT eligible for
simplified treatment?
Pretreatment Assessment
Cirrhosis assessment
• Liver biopsy not required; cirrhosis defined as FIB-4 score 3.25 or any of the following findings
– Transient elastography indicating cirrhosis (eg, FibroScan stiffness 12.5 kPa)
–
Noninvasive serologic tests above proprietary cutoffs indicating cirrhosis (eg, FibroSure, Enhanced Liver Fibrosis Test, etc)
– Clinical evidence of cirrhosis (eg, liver nodularity and/or splenomegaly on imaging, platelet count 150,000/mm3
, etc)
– Prior liver biopsy showing cirrhosis
2. Simplified HCV Treatment Algorithm for
Treatment-Naïve Adults Without Cirrhosis1
Full abbreviations, accreditation, and disclosure information available at
PeerView.com/ABJ40
1. https://www.hcvguidelines.org/.
• Glecaprevir (300 mg)/pibrentasvir (120 mg)
– Taken with food for a duration of 8 weeks
• Sofosbuvir (400 mg)/velpatasvir (100 mg)
– For a duration of 12 weeks
Recommended Regimens
•
Inform patients taking diabetes medication of the potential for symptomatic hypoglycemia; monitoring for hypoglycemia
is recommended
•
Inform patients taking warfarin of the potential for changes in their anticoagulation status; monitoring INR for
subtherapeutic anticoagulation is recommended
•
No laboratory monitoring is required for other patients
•
An in-person or telehealth/phone visit may be scheduled, if needed, for patient support, assessment of symptoms, and/or
new medications
On-Treatment Monitoring
•
Assessment of qualitative HCV
RNA and a hepatic function
panel are recommended
12 weeks or later following
completion of therapy
to confirm HCV RNA is
undetectable (virologic cure)
and transaminase normalization
•
Assessment for other causes of
liver disease is recommended
for patients with elevated
transaminase levels after
achieving SVR
•
No liver-related follow-up is
recommended for noncirrhotic
patients who achieve SVR
•
Patients with ongoing risk for
HCV infection (eg, intravenous
drug use or MSM engaging in
unprotected sex) should be
counseled about risk reduction
and tested for HCV RNA annually
and whenever they develop
elevated ALT, AST, or bilirubin
•
Advise patients to avoid excess
alcohol use
•
Patients in whom initial HCV
treatment fails to achieve cure
(SVR) should be evaluated by a
specialist, in accordance with
AASLD/IDSA guidance
•
Until retreatment occurs,
assessment for disease
progression every 6 to
12 months with a hepatic
function panel, CBC, and INR
is recommended
•
Advise patients to avoid excess
alcohol use
Post-Treatment Assessment
of Cure (SVR)
Follow-Up After Achieving
Virologic Cure (SVR)
Follow-Up for Patients Who Do
NOT Achieve a Virologic Cure
3. Simplified HCV Treatment Algorithm
for Treatment-Naïve Adults
With Compensated Cirrhosis1
Full abbreviations, accreditation, and disclosure information available at
PeerView.com/ABJ40
Who is eligible for
simplified treatment?
Calculate FIB-4 score
Ultrasound of the liver
• Conducted within the prior 6 months • Evaluate to exclude HCC and subclinical ascites
Medication reconciliation
• Record current medications, including over-the-counter drugs and herbal/dietary supplements
Potential drug–drug interaction assessment
• Drug–drug interactions can be assessed using the AASLD/IDSA guidance or the University of Liverpool drug interaction checker
Education
• Educate the patient about proper administration of medications, adherence, and prevention of reinfection
Pretreatment laboratory testing
•
Within 3 months of initiating
treatment
–
CBC
– INR
–
Hepatic function panel
(ie, albumin, total and direct
bilirubin, ALT, AST)
– eGFR
•
Any time prior to starting antiviral
therapy
–
Quantitative HCV RNA (HCV viral
load)
– HIV antigen/antibody test
– Hepatitis B surface antigen
–
HCV genotype (if treating with
sofosbuvir/velpatasvir)
•
Before initiating antiviral therapy
–
Serum pregnancy testing and
counseling about pregnancy
risks of HCV medication should
be offered to women of
childbearing age
Who is NOT eligible for
simplified treatment?
Calculate CTP score
•
Patients with a CTP score ≥7 (ie, CTB B or C) have decompensated cirrhosis and this simplified treatment approach is not recommended
Pretreatment Assessment
•
Adults with chronic hepatitis C (any genotype) who
have compensated cirrhosis (Child-Pugh A) and have not
previously received HCV treatment
•
Liver biopsy not required; cirrhosis presumed if patient has
FIB-4 score 3.25 or any of the following findings from a
previously performed test
–
Transient elastography indicating cirrhosis (eg, FibroScan
stiffness 12.5 kPa)
–
Noninvasive serologic tests above proprietary cutoffs
indicating cirrhosis (eg, FibroSure, Enhanced Liver Fibrosis
Test, etc)
–
Clinical evidence of cirrhosis (eg, liver nodularity and/or
splenomegaly on imaging, platelet count 150,000/mm3
, etc)
– Prior liver biopsy showing cirrhosis
Patients who have any of the following characteristics
• C
urrent or prior episode of decompressed cirrhosis,
defined as Child-Turcotte Pugh (CTP) score ≥7 (ascites,
hepatic encephalopathy, total bilirubin 2.0 mg/dL,
albumin ≤3.5 g/dL, or INR ≥1.7)
• Prior hepatitis C treatment
•
End-stage renal disease (ie, eGFR 30 mL/min/m2
)
• HIV or HBsAg positive
• Current pregnancy
• Known or suspected hepatocellular carcinoma
•
Prior liver transplantation
4. Simplified HCV Treatment Algorithm
for Treatment-Naïve Adults
With Compensated Cirrhosis1
Full abbreviations, accreditation, and disclosure information available at
PeerView.com/ABJ40
a
Patients with genotype 3 require baseline NS5A resistance-associated substitution (RAS) testing. Those without Y93H can be treated with 12 weeks of sofosbuvir/velpatasvir.
1. https://www.hcvguidelines.org.
Genotype 1-6
• Glecaprevir (300 mg)/pibrentasvir (120 mg)
– Taken with food for a duration of 8 weeks
Genotype 1, 2, 4, 5, or 6
• Sofosbuvir (400 mg)/velpatasvir (100 mg)
– For a duration of 12 weeks
Recommended Regimensa
•
Providers may order blood tests to monitor for liver injury during treatment because hepatic decompensation
(eg, jaundice, etc) occurs rarely among patients with cirrhosis receiving HCV antiviral treatment
•
Patients should see a specialist if they develop worsening liver blood tests (eg, bilirubin, AST, ALT, etc); jaundice, ascites, or
encephalopathy; or new liver-related symptoms
•
Inform patients taking diabetes medication of the potential for symptomatic hypoglycemia; monitoring for hypoglycemia
is recommended
•
Inform patients taking warfarin of the potential for changes in their anticoagulation status; monitoring INR for
subtherapeutic anticoagulation is recommended
•
An in-person or telehealth/phone visit may be scheduled, if needed, for patient support, assessment of symptoms, and/or
new medications
On-Treatment Monitoring
•
Assessment of qualitative HCV RNA
and a hepatic function panel are
recommended 12 weeks or later
following completion of therapy to
confirm HCV RNA is undetectable
(virologic cure) and transaminase
normalization
•
Assessment for other causes of liver
disease is recommended for patients
with elevated transaminase levels
after achieving SVR
•
Ultrasound surveillance for HCC (with
or without alpha-fetoprotein testing)
every 6 months is recommended for
patients with cirrhosis in accordance
with AASLD guidance
•
Upper endoscopic surveillance for
esophageal varices is recommended
in accordance with AASLD guidance
on portal hypertensive bleeding
in cirrhosis
•
Patients with ongoing risk for HCV
infection (eg, IV drug use or MSM
engaging in unprotected sex) should
be counseled about risk reduction
and tested for HCV RNA annually and
whenever they develop elevated
ALT, AST, or bilirubin
•
Patients should abstain from alcohol
to avoid progression of liver disease
•
Patients in whom initial HCV
treatment fails to achieve cure (SVR)
should be evaluated for retreatment
by a specialist, in accordance with
AASLD/IDSA guidance
•
Ultrasound surveillance for HCC
(with or without alpha-fetoprotein
testing) every 6 months is
recommended for patients with
cirrhosis, in accordance with
AASLD guidance
•
Assessment for disease progression
every 6 to 12 months with a hepatic
function panel, CBC, creatinine, and
INR is recommended
•
Patients should abstain from
alcohol to avoid progression of
liver disease
Post-Treatment Assessment
of Cure (SVR)
Follow-Up After Achieving
Virologic Cure (SVR)
Follow-Up for Patients Who Do
NOT Achieve a Virologic Cure
5. Screening and Diagnosis
of Hepatitis C Infection
Full abbreviations, accreditation, and disclosure information available at
PeerView.com/ABJ40
Persons with HIV
Persons who have ever injected drugs or shared
needles, syringes, or other drug preparation
equipment, including those who injected once
or a few times many years ago
Persons with selected medical conditions,
including persons who have ever received
maintenance hemodialysis and persons with
persistently abnormal ALT levels
Prior recipients of transfusions or organ
transplants, including persons who
•
Received clotting factor concentrates
produced before 1987
•
Received a transfusion of blood or blood
components before July 1992
• Received an organ transplant before July 1992
•
Were notified that they received blood
from a donor who later tested positive for
HCV infection
Healthcare, emergency medical, and public
safety personnel after needle sticks, sharps, or
mucosal exposures to HCV-positive blood
Children born to mothers with HCV infection
Hepatitis C testing regardless of age or setting
prevalence among persons with recognized
conditions or exposures
Routine periodic testing
for persons with
ongoing risk factors
CDC Recommendations for Hepatitis C Screening Among Adults1
Hepatitis C screening at least once in
a lifetime for all adults aged
≥18 years, except in settings where
the prevalence of HCV infection
(HCV RNA-positivity) is 0.1%a
Hepatitis C screening
among all adults
Hepatitis C screening for all
pregnant women during each
pregnancy, except in settings where
the prevalence of HCV infection
(HCV RNA-positivity) is 0.1%a
Hepatitis C screening
amongpregnantwomen
in every pregnancy
Hepatitis C testing for any person
who requests it, regardless of age
or setting prevalence or disclosure
of risk because many persons might
be reluctant to disclose
stigmatizing risks
Any person who
requests
hepatitis C testing
6. Screening and Diagnosis
of Hepatitis C Infection
Full abbreviations, accreditation, and disclosure information available at
PeerView.com/ABJ40
a
For persons who might have been exposed to HCV within the past 6 months, testing for HCV RNA or follow-up testing for HCV antibody is recommended. For persons who are immunocompromised,
testing for HCV RNA can be considered. b
To differentiate past, resolved HCV infection from biologic false positivity for HCV antibody, testing with another HCV antibody assay can be considered.
Repeat HCV RNA testing if the person tested is suspected to have had HCV exposure within the past 6 months or has clinical evidence of HCV disease, or if there is concern regarding the handling or
storage of the test specimen.
1. Schillie S et al. MMWR Recomm Rep. 2020;69:1-17. 2. Centers for Disease Control and Prevention (CDC). MMWR Morb Mortal Wkly Rep. 2013;62:362-365.
HCV
antibody
Not detected Detected
Nonreactive Reactive
No current
HCV infection
Current HCV
infection
No HCV antibody
detected
HCV RNA
Additional
testing
as appropriate
Link to care
HCV Testing Sequence for Identifying Current HCV Infection1
STOP