Phase 3 Treatment Naïve and Treatment Experienced HIV Coinfection

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Presentation transcript:

Phase 3 Treatment Naïve and Treatment Experienced HIV Coinfection Sofosbuvir + Ribavirin in HCV-HIV Coinfection: HCV GT 1,2,3,4 PHOTON-2 Trial Molina JM, et al. Lancet. 2015;385:1098-106.

Sofosbuvir plus Ribavirin for HCV-HIV Coinfection PHOTON-2 Trial: Study Features PHOTON-2 Trial: Features Design: Open-label, nonrandomized, uncontrolled, phase 3 trial using sofosbuvir + ribavirin for HCV GT 1, 2, 3, or 4 in persons coinfected with HIV Setting: 45 clinics in Europe Entry Criteria - HIV coinfection; HCV Genotype 1, 2, 3, or 4 - Age 18 or older - HCV treatment naïve (GT 1-4) or treatment experienced (GT 2 or 3) - On HIV ARV Rx with HIV RNA ≤ 50 copies/ml and CD4 >200 cells/mm3 - Not on HIV ARV Rx and CD4 > 500 cells/mm3 - ARV regimen allowed: tenofovir-emtricitabine plus either ritonavir boosted atazanavir or darunavir, efavirenz, rilpivirine, or raltegravir - Compensated cirrhosis permitted (up to 20% of subjects); no platelet cutoff Primary End-Points - Efficacy (SVR12), safety, and impact on HIV Source: Molina JM, et al. Lancet. 2015;385:1098-106.

Sofosbuvir plus Ribavirin for HCV-HIV Coinfection PHOTON-2 Trial: Treatment Arms 24 36 Week 12 GT 1,3,4 Naïve Sofosbuvir + RBV (n = 200) SVR12 GT 2 Naïve Sofosbuvir + RBV (n = 19) SVR12 GT 2,3 Experienced Sofosbuvir + RBV (n = 55) SVR12 Drug Dosing Sofosbuvir: 400 mg once daily Ribavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg Source: Molina JM, et al. Lancet. 2015;385:1098-106.

Sofosbuvir plus Ribavirin for HCV-HIV Coinfection PHOTON-2 Trial: Results PHOTON-2: SVR12 with Sofosbuvir + RBV x 12-24 weeks 95/112 17/19 52/57 26/31 5/6 42/49 Treatment Naive Treatment Experienced All received 24-week Rx except 12 week Rx with GT-2 Treatment Naive Source: Molina JM, et al. Lancet. 2015;385:1098-106.

PHOTON-2: SVR12 with Sofosbuvir + RBV, by Genotype Sofosbuvir plus Ribavirin for HCV-HIV Coinfection PHOTON-2 Trial: Results PHOTON-2: SVR12 with Sofosbuvir + RBV, by Genotype 95/112 22/25 94/106 26/31 Source: Molina JM, et al. Lancet. 2015;385:1098-106.

Sofosbuvir and Ribavirin for HCV-HIV Coinfection PHOTON-2 Trial: Interpretation Interpretation: “Sofosbuvir and ribavirin provided high rates of sustained virological response after 12 weeks of treatment in treatment-naive and treatment-experienced patients co-infected with HIV and HCV genotypes 1–4. The characteristics of this interferon-free combination regimen make sofosbuvir plus ribavirin a useful treatment option for this patient population.” Source: Molina JM, et al. Lancet. 2015;385:1098-106.

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.