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Hepatitisweb study
Hepatitisweb study
Sofosbuvir in HCV-HIV Coinfection & HCV GT 1,2,3PHOTON-1 Trial
Phase 3
Sulkowski MS, et al. JAMA. 2014;312:353-61.
Treatment Naïve and Treatment Experienced HIV Coinfection
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Hepatitisweb studySource: Sulkowski MS, et al. JAMA. 2014;312:353-61.
Sofosbuvir and Ribavirin for HCV-HIV CoinfectionPHOTON-1 Trial: Study Features
PHOTON-1 Trial: Features Design: Open-label, nonrandomized, uncontrolled, phase 3 trial using
sofosbuvir + ribavirin in HCV-HIV coinfection and HCV GT 1, 2, or 3 Setting: 34 treatment centers in United States and Puerto Rico Entry Criteria
- HIV coinfection; HCV Genotype 1, 2, or 3- Treatment naïve (GT 1,2,3) or treatment experienced (GT 2,3)- On antiretroviral therapy with HIV RNA ≤ 50 copies/ml and CD4 ≥ 200 or not on antiretroviral therapy and CD4 ≥ 500- Compensated cirrhosis permitted (<20% total patients)
Patient Characteristics- N = 223 HCV-HIV coinfected patients- On ARV Rx: GT1 (98%); GT 2/3 naive (90%); GT 2/3 experienced (95%)
Primary End-Points- Efficacy (SVR12), safety, and impact on HIV
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Hepatitisweb studySource: Sulkowski MS, et al. JAMA. 2014;312:353-61.
Sofosbuvir and Ribavirin for HCV-HIV CoinfectionPHOTON-1 Trial: Participants
Treatment Naive Treatment Experienced
GT 1(n=114)
GT 2 or 3(n=68)
GT 2 or 3(n=41)
Age, mean (range) 48 (25-70) 49 (24-71) 54 (34-68)
Male, % 82% 81% 90%
Black, % 32% 12% 17%
IL28B CC genotype, % 27% 37% 49%
Cirrhosis, % 4% 10% 24%
On ART§, % 98% 90% 95%
CD4 count, cells/mm3, median 581 562 579
§Tenofovir-emtricitabine plus [efavirenz, r-atazanavir, r-darunavir, raltegravir, rilpivirine, or other]
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Hepatitisweb studySource: Sulkowski MS, et al. JAMA. 2014;312:353-61.
Sofosbuvir and Ribavirin for HCV-HIV CoinfectionPHOTON-1 Trial: Treatment Arms
Sofosbuvir + RBV(n = 114)
Sofosbuvir + RBV(n = 68)
GT 1 Naïve
Sofosbuvir + RBV(n = 41)
GT 2,3 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
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Hepatitisweb study
Sofosbuvir and Ribavirin for HCV-HIV CoinfectionPHOTON-1 Trial: Results
PHOTON-1: SVR 12 with Sofosbuvir + RBV x 12-24 weeks
Source: Sulkowski MS, et al. JAMA. 2014;312:353-61.
Genotype 1 Genotype 2 Genotype 3 Genotype 2 Genotype 30
20
40
60
80
100
76
88
67
92 94
Patie
nts
(%) w
ith S
VR 1
2
24-week Rx
87/114 23/26 28/42 22/24 16/17
Treatment Naive Treatment Experienced
24-week Rx 12-week Rx
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Hepatitisweb studySource: Sulkowski MS, et al. JAMA. 2014;312:353-61.
Sofosbuvir and Ribavirin for HCV-HIV CoinfectionPHOTON-1 Trial: Conclusions
Conclusions and Relevance: “In this open-label, nonrandomized, uncontrolled study, patients with HIV who were coinfected with HCV genotype 1, 2, or 3 who received the oral, interferon-free combination of sofosbuvir and ribavirin for 12 or 24 weeks had high rates of SVR12. Further studies of this oral regimen in diverse populations of coinfected patients are warranted.”
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Hepatitisweb study
Hepatitisweb study
This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects.
Hepatitis C Onlinewww.hepatitisc.uw.edu
Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/
Funded by a grant from the Centers for Disease Control and Prevention.