Conditions: Chronic Hepatitis C
Keywords: HCV genotype 2 (GT-2) HCV genotype 3 (GT-3) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy Interferon intolerant Interferon ineligible GS-7977 Ribavirin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 278
Healthy volunteers: no

Brief summary:
This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.

Detailed description:
Participants who were randomized to the placebo arm and completed all scheduled study procedures were eligible to receive active SOF+RBV in open-label Study GS-US-334-0109.

Participants who do not achieve sustained virologic response (SVR) were eligible for enrollment in the Sequence Registry Study GS-US-248-0123. The purpose of the Sequence Registry Study is to monitor the persistence of resistant mutations for up to 3 years.

Participants who achieved SVR were eligible for enrollment in the SVR Registry Study GS-US-248-0122. The purpose of the SVR Registry Study is to evaluate durability of SVR for up to 3 years after treatment.

Arms:
arm 1: Participants were randomized to receive SOF+RBV for 12 weeks. arm 2: Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks.

Interventions: intervention 1: SOF intervention 2: RBV intervention 3: Placebo to match SOF intervention 4: Placebo to match RBV
Intervention descriptions: intervention 1: Sofosbuvir (SOF) 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) was administered as a tablet orally according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg). intervention 3: Placebo to match SOF was administered orally once daily. intervention 4: Placebo to match RBV was administered orally twice daily.

Protocol document: