Clinical Impact of Data From the CROI 2015,Seattle

February 23-26, 2015
Seattle, Washington
HIV/AIDS Seattle Update
CCO Independent Conference Coverage
of the 2015 Conference on Retroviruses and Opportunistic Infections*
*CCO is an independent medical education company that
provides state-of-the-art medical information to healthcare
professionals through conference coverage and other
educational programs.
This program is supported by an educational grant from
This program is supported by educational grants from
Gilead Sciences, Merck, and ViiV.

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2015 Conference on Retroviruses and Opportunistic Infections
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Faculty
Joseph J. Eron, Jr., MD
Professor of Medicine and Epidemiology
University of North Carolina School of
Medicine
Director, AIDS Clinical Trials Unit
University of North Carolina
Chapel Hill, North Carolina
Joel E. Gallant, MD, MPH
Medical Director of Specialty Services
Southwest CARE Center
Santa Fe, New Mexico
Adjunct Professor of Medicine
Division of Infectious Diseases
Johns Hopkins University School of Medicine
Baltimore, Maryland
Kathleen E. Squires, MD
W. Paul and Ida H. Havens Professor of
Infectious Diseases
Director, Division of Infectious Diseases
Sidney Kimmel Medical College of Thomas
Jefferson University
Philadelphia, Pennsylvania

Disclosures
Joseph J. Eron, Jr., MD, has disclosed that he has received consulting
fees from AbbVie, Bristol-Myers Squibb, Gilead Sciences,
GlaxoSmithKline/ViiV, Merck, Tibotec/Janssen, and Tobira; and has
received funds for research support from GlaxoSmithKline/ViiV.
Joel E. Gallant, MD, has disclosed that he has received consulting fees
from Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck, and ViiV
and funds for research support from AbbVie, Bristol-Myers Squibb,
Gilead Sciences, GlaxoSmithKline/ViiV, Janssen, Merck, and Sangamo
Biosciences.
Kathleen E. Squires, MD, has disclosed that she has received funds for
research support paid to Thomas Jefferson University from Gilead
Sciences and has served on advisory boards for Bristol-Myers Squibb,
Gilead Sciences, Janssen, Merck, and ViiV.

PROUD: Immediate vs Deferred PrEP in
High-Risk MSM in “Real World” Trial
 Randomized, open-label trial of daily
oral TDF/FTC PrEP in HIV- MSM in 13
clinics in London
– Immediate (n = 267) vs
– Deferred for 12 mos (n = 256)
 Primary endpoint: HIV infection in first
12 mos
 86% reduction in risk seen over 60 wks
with immediate PrEP (90% CI: 58% to
96%, P = .0002)
– Rate difference: 7.6 (90% CI: 4.1-11.2)
– Number needed to treat to prevent 1
infection: 13 (90% CI: 9-25)
 2 of 3 infected persons in immediate
group seroconverting at study entry or
shortly after first dose of PrEP
 M184V/I observed in 3/6 patients who
seroconverted
– No K65R observed
 High rate of STIs seen in both groups
 DMSB interrupted trial; recommended
that all participants be offered PrEP
HIV Incidence
Group Infected, n
Incidence/100
PY (90% CI)
Immediate 3 1.3 (0.4-3.0)
Deferred 19 8.9 (6.0-12.7)
McCormack S, et al. CROI 2015. Abstract 22LB.
Reproduced with permission.

0.20
0.16
0.12
0.08
0.04
0.00
0 2 4 6 8 10 12 14 16 18 20 22 24 26
Mos
ANRS Ipergay: On-Demand Oral PrEP in
High-Risk MSM
 Randomized double-blind trial of event-
driven oral TDF/FTC* (n = 199) vs
placebo (n = 201) (both with prevention
services) in France
– 2 tablets taken 2-24 hrs before sex
– 1 tablet 24 hrs after sex
– 1 tablet 48 hrs after first event-driven
dose
 Primary endpoint: HIV seroconversion
 86% reduction in risk seen in PrEP arm
(95% CI: 40% to 99%, P = .002)
– Number needed to treat for 1 yr to
prevent 1 infection: 18
– Median of 16 pills taken per mo in each
arm
 In pts with infection, no TFV found in
serum in last 2 visits
 4 cases of acute HCV infection noted
among lab abnormalities
 DSMB stopped trial early and
recommended all participants start
PrEP
Molina JM, et al. CROI 2015. Abstract 23LB.
*On-demand PrEP strategy not FDA approved.
2 infections;
incidence 0.94/100 PY
14 infections;
incidence 6.6/100 PY
201
199
141
140
74
82
55
58
41
43
Pts at Risk, n
Placebo
TDF/FTC
Placebo
TDF/FTC
P = .002
ProbabilityofHIV
Infection
Kaplan-Meier Estimate of Time to
HIV Infection

Oral PrEP + ART as Prevention in High-
Risk Serodiscordant Couples
 Partners Demonstration Project in Africa
– Oral daily TDF/FTC PrEP for HIV-
uninfected partner in serodiscordant
couple continued 6 mos beyond
initiation of ART for infected partner
– High-risk couples defined as younger
age, fewer children, uncircumcised HIV-
negative male, cohabitating, unprotected
sex in past mo, high HIV-1 RNA in HIV-
positive partner
 Interim analysis
– > 95% of HIV-negative partners using
PrEP
– 80% of HIV-positive partners have
initiated ART; of these, > 90% with
suppression
 96% reduction in expected infections
‒ IRR, expected vs observed: 0.04 (95%
CI: 0.01-0.19; P < .0001)
 In pts with seroconversion, no TFV
detectable in plasma at time of
seroconversion
– HIV-positive partner in 1 couple not on ART
(high CD4+ count)
– Other couple dissolved and HIV-negative
partner in new relationship
Baeten J, et al. CROI 2015. Abstract 24. Reproduced with permission.
HIV Incidence, Actual vs Expected
Group Infected, n
Incidence/100 PY
(95% CI)
Expected 39.7 5.2 (3.7-6.9)
Actual 2 0.2 (0-0.9)

Medical Cost Savings Associated With HIV
Prevention in the United States
 Cost modeling analysis of the Medical Expenditure Panel
Survey
 Investigators used Cost-Effectiveness of Preventing AIDS
Complications Model to project discounted lifetime medical
costs, assuming HIV infection at 35 yrs of age
 The medical cost savings of averting 1 HIV infection was
found to be $229,800
 Cost savings are higher if taking secondary infections into
account and lower if infection is delayed vs totally averted
Schackmann R, et al. CROI 2015. Abstract 1104.

PROMISE: Randomized Trial of PMTCT
Strategies: Antepartum Component
 Multinational trial in HIV-positive pregnant women in India and Africa
 Primary endpoint: HIV infection in infant
– MTCT through neonatal 14 days of age significantly lower in triple ART arms
– Difference: -1.28% (95% CI, -2.11% to -0.44%)
Fowler MG, et al. CROI 2015. Abstract 31LB.
ZDV + sdNVP + TDF/FTC tail
TDF/FTC + LPV/RTV*
ZDV/3TC + LPV/RTV
HIV-positive pregnant women
Gestational age ≥ 14 wks
No triple ART in current
pregnancy
Did not meet country
eligibility for ART
CD4+ ≥ 350 or country
threshold for ART
CrCl > 60
No active TB
(N = 3529)
MTCT, % (infections/births)
1.8 (25/1326)
0.56 (9/1710)†
*In Version 2 of the protocol, only
HBV-positive women in TDF/FTC arm.
†
Combined triple ARV arms.
Primary Endpoint ResultsAntepartum component
14 days postdelivery

PROMISE: Less MTCT but Adverse Events
Greater in Triple ART Arms
 Higher moderate, but not severe, adverse pregnancy outcome with triple ARV
– Severe outcomes less in ZDV/3TC arm vs TDF/FTC arm
– Lower risk of infant death with ZDV/3TC vs TDF/FTC: 0.6% (2/346) vs 4.4%
(15/341), P = .001
– Primarily among deaths in infants < 34 wks of gestational age
Fowler MG, et al. CROI 2015. Abstract 31LB. Reproduced with permission.
ZDV (Arm A)
ZDV/3TC + LPV/RTV (Arm B)
TDF/FTC + LPV/RTV (Arm C)
40
30
20
10
0
Moderate Adverse Outcomes Severe Adverse Outcomes
27
38
35
20
17
9
20
9
7
4
19
13
6
3 3210
B vs C
P = .02 B vs C
P = .04
A vs C
P = .004
A vs C
P = .04
%WithEvent
Any < 37 Wk
Gest. Age
Any < 34 Wk
Gest. Age
< 2500 g
Birth Wt
< 1500 g
Birth Wt

Studies 104/111: Tenofovir Alafenamide
Fumarate vs TDF in Treatment-Naive Pts
 Parallel, randomized, double-blind, active-controlled phase III studies
 Primary endpoint: HIV-1 RNA at Wk 48
TAF/FTC/EVG/COBI*
single-tablet regimen
(n = 866)
TDF/FTC/EVG/COBI†
single-tablet regimen
(n = 867)
Treatment-naive
HIV-infected pts with
HIV-1 RNA ≥ 1000 copies/mL,
eGFR ≥ 50 mL/min
(N = 1733)
Stratified by HIV-1 RNA,
CD4+ cell count,
geographic region
Wk 48
Primary endpoint Wk 144
*10/200/150/150 mg once daily.
†
300/200/150/150 mg once daily.
Wohl DA, et al. CROI 2015. Abstract 113LB.

Virologic
Success*
Virologic
Failure
No Data
Studies 104/111: TAF Noninferior to TDF at
Week 48
 TAF also noninferior to TDF at Wk 48 in
each study (104 and 111)
 Results similar across all baseline
virologic and demographic subgroups
 7 pts in TAF arm and 5 pts in TDF arm
with NRTI resistance at VF
– 1 in TAF arm and 2 in TDF arm with
combined M184V/I + K65R
 5 pts in TAF arm and 3 pts in TDF arm
with INSTI resistance at VF
 0.9% in TAF arm and 1.5% in TDF arm
discontinued due to AE
 CD4+ increases greater in TAF arm:
211 vs 181 (P = .024)
Pts(%)
92
90
Δ +2.0%
(95% CI: -0.7% to +4.7)
TAF/FTC/EVG/COBI
(n = 866)
TDF/FTC/EVG/COBI
(n = 867)
0
20
40
60
80
100
4 4 4 6
n =
*HIV-1 RNA < 50 c/mL as defined by FDA Snapshot algorithm

Discontinued for AE, death, or missing data.
800 784
Wohl DA, et al. CROI 2015. Abstract 113LB. Reproduced with permission.

Renal Markers With TAF and TDF at Wk 48
 Smaller decreases in eGFR with TAF[1]
 Smaller changes in proteinuria with TAF[1]
 In separate single-arm trial of
virologically suppressed pts with eGFR
30-69 mL/min switched to open-label
TAF/FTC/EVG/COBI[2]
– 65% on TDF at BL
 At Wk 48 after switch:
– 92% maintained virologic suppression
– No change in eGFR
– Reduction in proteinuria and markers of
renal tubular function
– Improvement in hip and spine BMD
1. Sax P, et al. CROI 2015. Abstract 143. Reproduced with permission. 2. Pozniak A, et al. CROI 2015. Abstract 795.
P < .00120
10
0
-10
-20
0 12 24 36 48
Time (Wks)
-6.6
-11.2
MeanΔFromBLineGFR,
mL/min(Cockcroft-Gault)
TAF/FTC/EVG/COBI (n = 866)
TDF/FTC/EVG/COBI (n = 867)
Median % Change From BL in Urine
Protein:Creatinine Ratio
Marker
TAF
(n = 866)
TDF
(n =
867)
P
Value
Protein -3 +20 < .001
Albumin -5 +7 < .001
Retinol-binding
protein
+9 +51 < .001
β2-microglobulin -32 +24 < .001

Studies 104/111: Significantly Smaller
Decline in Hip and Spine BMD With TAF
 Significantly smaller decline in hip and spine BMD with TAF
 Higher lipid levels with TAF, but TC:HDL-C ratio same as TDF[1]
0 24 48 0 24 48
-8
-6
-4
-2
0
2
Wk Wk
-8
-6
-4
-2
0
2
= 845
= 850
797
816
784
773
836
848
789
815
780
767
-1.30
-2.86
-0.66
-2.95
P < .001
P < .001
Mean%Change
FromBL
Sax P, et al. CROI 2015. Abstract 143. Reproduced with permission.
n
n
TAF/FTC/EVG/COBI (n = 866)
TDF/FTC/EVG/COBI (n = 867)
Change in Spine BMD Change in Hip BMD

LATTE: Cabotegravir (GSK1265744) + RPV
as Maintenance ART: Wk 96 Results
 Cabotegravir, DTG analogue with long half-life, oral or injectable formulations
 Randomized, dose-ranging phase IIb study of oral formulation
 Primary endpoint: HIV-1 RNA < 50 c/mL at Wk 48
CAB 10 mg QD + RPV 25 mg QD
CAB 30 mg QD + RPV 25 mg QD
*Pts with HIV-1 RNA < 50 c/mL at Wk 24 continued to maintenance phase.

TDF/FTC or ABC/3TC.
ART-naive pts,
HIV-1 RNA
≥ 1000 c/mL
(N = 243) CAB 60 mg QD + RPV 25 mg QD
EFV 600 mg QD + 2 NRTIs QD
(n = 62)
Margolis D, et al. CROI 2015. Abstract 554LB.
CAB 10 mg QD + 2 NRTIs
(n = 60)
(n = 60)
(n = 61)
Wk 48
primary analysis
Stratified by HIV-1 RNA
(≤ vs > 100,000 c/mL) and NRTI Wk 24
Induction Phase* Maintenance Phase
Wk 96

LATTE: Virologic Success Through
Maintenance Wk 96
 6 pts in CAB arms with PDVF at Wk 96; 4 additional pts since Wk 48
– 3 pts in CAB 10-mg arm with treatment-emergent NNRTI resistance; 1 of these with both
NNRTI + INSTI RAMs but decreased ARV exposure in PK analysis
Margolis D, et al. CROI 2015. Abstract 554LB. Reproduced with permission.
HIV-1RNA<50c/mLby
SnapshotAlgorithm(%)
100
80
60
40
20
0
BL 4 12 24 28 36 48 72 96
Induction Phase Maintenance Phase
CAB 10 mg (n = 60)
CAB 30 mg (n = 60)*
CAB 60 mg (n = 61)
EFV 600 mg (n = 62)
68%
63%
84%
75%
Wks*CAB 30 mg selected for future development

BMS-955176: Investigational Second-
Generation Maturation Inhibitor
 BMS-955176 binds tightly and
reversibly to HIV-1 Gag with greater
potency and coverage of Gag
polymorphs than first-generation
maturation inhibitors
– Low-dose with half-life supportive of
once-daily dosing
– Low serum binding
– No significant safety issues in early
clinical studies
 Antiviral activity measured over 10
days in placebo-controlled study
– HIV-infected treatment-naive and
experienced pts with HIV-1 RNA
≥ 5000 and CD4+ count ≥ 200
 All doses ≥ 10 mg associated with HIV-
1 RNA declines over dosing period
– Median change in HIV-1 RNA from BL to
Day 11: 1.4 log10 c/mL
 No serious AEs; no discontinuations
due to AEs over study period
Hwang C, et al. CROI 2015. Abstract 114LB. Reproduced with permission.
1 2 3 4 5 6 7 8 91011 13 25
Dosing period
Study Days
1
0
-1
-1.8
BMS-955176: Median Δ in HIV-1 RNA Over Time
Placebo
5 mg
10 mg
20 mg
40 mg
80 mg
120 mg
MedianΔinHIV-1RNA
FromBL(log10c/mL)

NA-ACCORD: Recent Abacavir Use and
Risk of MI
 Retrospective analysis of pts in 7
clinical cohorts with recent ABC use
from 1/1/1995 to 12/31/2010
 “Recent” ABC initiation: prescribed
within previous 6 mos
 ABC initiators (n = 1948) vs non-ABC
initiators (n = 14,785):
– “Full” study population: all ART users
excluding persons on ABC at study entry
– “Restricted” population: ART-naive
persons who initiated ART in the cohort
 Endpoint of incident MIs: presence of
clinical diagnosis or elevation of cardiac
enzymes
– All MIs independently adjudicated
Palella F, et al. CROI 2015. Abstract 749LB.
0.00 2.001.00 4.003.00
Full Study
Restricted
Study
D:A:D
Replication
1.95
1.33
 Recent ABC use significant in restricted
population and D:A:D replication
 Association diminished after adjusting
for additional CVD risk factors in
multivariate analysis
 Significant factors
– Both: age 60+ yrs, HTN, eGFR < 30,
AIDS
– Full: smoking, DM
Adjusted HRs for MI in Those With Recent ABC Use

A5260: Changes in Limb and Trunk Fat
With INSTI vs PI/RTV First-line Regimens
 Metabolic substudy of A5257,
comparison of first-line TDF/FTC +
– RAL (n = 106)
– ATV/RTV (n = 109)
– DRV/RTV (n = 113)
 Endpoints: change from BL to Wk 96
in peripheral fat, central adiposity,
lean mass
– ATV/RTV vs DRV/RTV
– Combined PIs vs RAL
 Trend toward greater % change in
lean mass in ATV/RTV vs DRV/RTV
– Combined PIs similar to RAL
 Similar changes in limb and trunk fat
(SAT and VAT) among regimens
 Greater gains in VAT and SAT in BL VL
stratum HIV-1 RNA ≥ 100,000 c/mL vs
< 100,000 c/mL, regardless of regimen
McComsey G, et al. CROI 2015. Abstract 140. Reproduced with permission.
ATV/RTV 31%
RAL 33%
DRV/RTV 29%
N
ATV/RTV 108 97
RAL 105 95
DRV/RTV 112 94
Wk 96BL
50
40
30
20
10
0
VAT Change
Mean%ChangeFrom
Baseline
ATV/RTV vs DRV/RTV (P = .54)
PI/RTV vs RAL (P = .72)

Randomized Trial of Statin Therapy and
Coronary Plaque Progression
 Randomized 12-mo trial in HIV+ pts
on stable ART with LDL-C < 130
and ≥ 1 coronary plaque
– Atorvastatin 20 mg (↑ to 40 mg at
3 mos) (n = 19) vs
– Placebo (n = 21)
 Statin therapy reduced progression
of coronary plaques
– Reduced overall plaque volume,
including lipid-laden plaques
– Reduced high-risk morphology
plaques
 Statin therapy safe and well
tolerated
Lo J, et al. CROI 2015. Abstract 136. Reproduced with permission.
Plaque Progression in Proximal Left
Anterior Descending Coronary Artery
With Atorvastatin or Placebo
BL
12 mos
PlaceboAtorvastatin

D:A:D: ARV Exposure and Risk of CKD
 Retrospective analysis of pts with BL
eGFR > 90/mL/min (N = 23,560)
– Evaluated cumulative exposure to TDF,
ABC, ATV/RTV, LPV/RTV, other PIs
and risk of CKD
– 210 pts developed CKD
 Multivariate analysis: exposure to TDF,
ATV/RTV, and LPV/RTV significantly
associated with CKD development
– Risk ↑ greatly over 5 yrs
 Association with TDF or LPV/RTV and
CKD remains when excluding those
who stopped drugs during or before
study entry
 When TDF exposure censored, CKD
risk per yr of ATV/RTV or LPV/RTV
exposure increased substantially
 CKD risk ↓ with time after stopping TDF
CKD Risk by Yrs of ARV Exposure, IRR (95%
CI)
Drug 1 Yr 2 Yrs 5 Yrs
TDF
1.12
(1.06-
1.18)
1.25
(1.12-1.39)
1.74
(1.33-2.27)
ATV/
RTV
1.27
(1.18-
1.36)
1.61
(1.40-1.84)
3.27
(2.32-4.61)
LPV/
RTV
1.16
(1.10-
1.22)
1.35
(1.21-1.50)
2.11
(1.62-2.75)Mocroft A, et al. CROI 2015. Abstract 142. Reproduced with permission.
Relationship Between Increasing
Exposure to ARVS and CKD
1.80
1.60
1.40
1.20
1.00
0.00
ATV/RTV LPV/RTVTDF
Univariate
Multivariate
On treatment
TDF censored

ION-4: LDV/SOF for 12 Wks in GT1/4
HCV/HIV-Coinfected Pts
 Phase III open-label study in HIV
virologically suppressed HIV/HCV
coinfected pts (N = 335)
– 20% with compensated cirrhosis
– n = 8 with HCV GT4
 ART regimens
– TDF/FTC/EFV (n = 160)
– TDF/FTC + RAL (n = 146)
– TDF/FTC/RPV (n = 29)
 HCV treatment experienced, 55%
– Previous HCV PI therapy: 29%
– n = 13 previously failed SOF + RBV
 Very high rate of SVR12
– No difference in SVR rates based on
HCV treatment experience or cirrhosis
status
SVR12(%)
96
0
20
40
60
80
95 97 96 94
Overall No Yes
n/N =
321/
335
142/
150
100
179/
185
258/
268
63/
67
No Yes
Naggie S, et al. CROI 2015. Abstract 152LB. Reproduced with permission.
SVR Rates According to BL Characteristics
CirrhosisPrevious
HCV Tx

ION-4: LDV/SOF Effective Across All Pt
Demographic and Disease Subgroups
 10 relapses all in black pts
 No pt with HIV virologic rebound
 No discontinuation of therapy due
to adverse events
 4 pts experienced increase in
creatinine > 0.4 mg/dL
– 2 completed treatment without
change in ART
– 1 pt changed TDF to new NRTI
– TDF dose reduced in 1 pt
Naggie S, et al. CROI 2015. Abstract 152LB. Reproduced with permission.
Black
Nonblack
1a
1b
4
< 800,000
≥ 800,000
< 30
≥ 30
CC
CT
TT
TDF/FTC/EFV
TDF/FTC + RAL
TDF/FTC/RPV
< 350
≥ 350
HCV Genotype
Baseline HCV
RNA (IU/mL)
Baseline BMI
(kg/m2
)
Race
IL28B
ARV Regimen
Baseline CD4
(cells/mm³)
Overall
60 70 80 90 100
SVR12, % (95% CI)
Statistically
significant in
multivariate
analysis

ION-4: Resistance Analysis and LDV/SOF
Drug–Drug Interactions With bPIs
 Deep sequencing at BL
identified 67 (20%) pts with
NS5A RAVs[1]
– 63 (94%) of these pts achieved
SVR12
 RAVs in NS5A found in 10/12
pts with virologic failure
 No S282T mutation in NS5B
found in any pt at BL or
virologic failure
 In drug–drug interaction studies
with LDV/SOF and boosted PIs
and TFV[2]
– LDV/SOF increases ATV, RTV,
and TFV exposure
– ATV/RTV + TDF/FTC
increases LDV
– DRV/RTV + TDF/FTC
decreases SOF
 Staggered administration did
not mitigate interactions but
interactions not deemed
clinically relevant
1. Naggie S, et al. CROI 2015. Abstract 152LB. 2. German P, et al. CROI 2015. Abstract 82.

ALLY-2: SOF + DCV in GT1-6 HCV/HIV-
Coinfected Pts
 Phase III open-label study
– Non GT1 < 20% in each cohort; compensated cirrhosis < 50% overall; HIV-1 RNA < 50 c/mL
and CD4+ ≥ 100 in pts on ART; CD4 ≥ 350 in pts not on ART
– ART allowed: PI/RTV, NRTIs, NNRTIs, INSTIs, MVC, ENF
 Primary endpoint: SVR12 in GT1 naive pts treated for 12 wks
Wyles DL, et al. CROI 2015. Abstract 151LB.
Treatment-naive pts
(N = 151)
SOF 400 mg QD +
DCV 30/60/90* mg QD
(n = 101)
SOF 400 mg QD +
DCV 30/60/90* mg QD
(n = 52)
Treatment-experienced pts
(N = 52)
Wk 12
Pts followed
to Wk 36
SOF 400 mg QD +
DCV 30/60/90* mg QD
(n = 50)
Wk 8
*Standard dose of 60 mg adjusted for ART: 30 mg with RTV; 90 mg with NNRTIs except RPV.

 High SVR12 rates with 12 wks SOF +
DCV
– Large decline in SVR rate with
shortening to 8 wks
12-Wk 12-Wk8-Wk 12-Wk 12-Wk8-Wk
ALLY-2: Virologic Outcomes With SOF +
DCV in HIV/HCV-Coinfected Pts
 In 12-wk groups analyzed by GT, 100%
with SVR12 except GT1a
– GT1a naive: 96%; exp’d: 97%
 Similar SVR12 rates in pts with or
without baseline NS5A RAVs
 12 pts with relapse, 10 in 8-wk arm
– 1 in 8-wk arm had emergent NS5A
RAVs
 No NS5B RAVs at BL or time of failure
 No discontinuation of therapy due to
AEs
 10 pts with HIV-1 RNA > 50 at EOT
– 8 with repeat testing; 7 with suppression
without change in ART; 1 with HIV-1
RNA of 59; 2 LTFU
 2 with HIV VF = HIV-1 RNA ≥ 400 c/mL
SVR12,%
96
0
20
40
60
80
98
76
97 98
n/N =
80/
83
43/
44
100
31/
41
98/
101
51/
52
76
38/
50
Wyles DL, et al. CROI 2015. Abstract 151LB.
Naive Exp’d Naive Exp’d
GT1 Overall

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