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.