Hepati tis web study Hepati tis web study Sofosbuvir + Ribavirin in HCV-HIV Coinfection: HCV GT 1,2,3,4 PHOTON-2 Trial Phase 3 Molina JM, et al. IAC. 2014; Abstract MOAB0105LB. Treatment Naïve and Treatment Experienced HIV Coinfection
Hepatitisweb study
Hepatitisweb study
Sofosbuvir + Ribavirin in HCV-HIV Coinfection: HCV GT 1,2,3,4
PHOTON-2 Trial
Phase 3
Molina JM, et al. IAC. 2014; Abstract MOAB0105LB.
Treatment Naïve and Treatment Experienced HIV Coinfection
Hepatitisweb studySource: Molina JM, et al. IAC. 2014; Abstract MOAB0105LB.
Sofosbuvir plus Ribavirin for HCV-HIV CoinfectionPHOTON-2 Trial: Study Features
PHOTON-2 Trial: Features
Design: Open-label, nonrandomized, uncontrolled, phase 3 trial using sofosbuvir + ribavirin in HCV-HIV coinfection and HCV GT 1, 2, 3, or 4
Entry Criteria - HIV coinfection; HCV Genotype 1, 2, 3, or 4- Treatment naïve GT 1, 3, 4: 24 weeks- Treatment naïve GT 2: 12 weeks- Treatment experienced GT 2,3: 24 weeks - On antiretroviral therapy with HIV RNA ≤ 50 copies/ml and CD4 >200 or not on antiretroviral therapy and CD4 > 500- Compensated cirrhosis permitted (up to 20% of subjects); no platelet cutoff
Patient Characteristics- N = 274 HCV-HIV coinfected patients- GT1 (n=112); GT2 (n=25); GT3 (n=106); GT4 (n=31)
Primary End-Points- Efficacy (SVR12), safety, and impact on HIV
Hepatitisweb studySource: Molina JM, et al. IAC. 2014; Abstract MOAB0105LB.
Sofosbuvir plus Ribavirin for HCV-HIV CoinfectionPHOTON-2 Trial: Overall Demographics
PHOTON-2: HCV-HIV Coinfection (n = 274)
Age, mean (range) 47 (18-73)
Male, % 81%
Mean BMI (range) 24 (17-44)
HCV Treatment Naive 29 (13%)
HCV Genotype
1 112 (41%)
2 25 (9%)
3 106 (39%)
4 31 (11%)
Cirrhosis, % 54 (20%)
On ART, % 265 (97%)
Mean CD4 count, cells/mm3 588
Hepatitisweb studySource: Molina JM, et al. IAC. 2014; Abstract MOAB0105LB.
Sofosbuvir plus Ribavirin for HCV-HIV CoinfectionPHOTON-2 Trial: Treatment Arms
Sofosbuvir + RBV(n = 200)
Sofosbuvir + RBV(n = 19)
GT 1,3,4 Naïve
Sofosbuvir + RBV(n = 55)
GT 2 Naïve
GT 2,3 Experienced
Drug DosingSofosbuvir: 400 mg once dailyRibavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg
0 24 36Week 12
SVR12
SVR12
SVR12
Hepatitisweb study
Sofosbuvir plus Ribavirin for HCV-HIV CoinfectionPHOTON-2 Trial: Results
PHOTON-2: SVR 12 with Sofosbuvir + RBV x 12-24 weeks
Source: Molina JM, et al. IAC. 2014; Abstract MOAB0105LB.
GT 1 GT 2 GT 3 GT 4 GT 2 GT 30
20
40
60
80
100
8589 91
84 83 86
Pat
ien
ts (
%)
wit
h S
VR
12
95/112 17/19 26/31 5/6 42/49
Treatment Naive Treatment Experienced
All received 24-week Rx except 12 week Rx with GT-2 Treatment Naive
52/57
Hepatitisweb study
Sofosbuvir plus Ribavirin for HCV-HIV CoinfectionPHOTON-2 Trial: Results
PHOTON-2: SVR 12 with Sofosbuvir + RBV, by Genotype
Source: Molina JM, et al. IAC. 2014; Abstract MOAB0105LB.
GT 1 GT 2 GT 3 GT 40
20
40
60
80
100
85 88 8984
Pat
ien
ts w
ith
SV
R 1
2 (%
)
95/112 22/25 94/106 26/31
Hepatitisweb study
Hepatitisweb study
This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects.
Hepatitis C Online
www.hepatitisc.uw.edu
Hepatitis Web Study
http://depts.washington.edu/hepstudy/
Funded by a grant from the Centers for Disease Control and Prevention.