Conditions: Chronic Hepatitis C
Keywords: HCV genotype 2 (GT-2) HCV genotype 3 (GT-3) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy GS-7977 Ribavirin Open Label
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 534
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

Detailed description:

Arms:
arm 1: SOF+RBV for 12 weeks arm 2: SOF+RBV for 24 weeks arm 3: SOF+RBV+Peg-IFN for 12 weeks

Interventions: intervention 1: SOF intervention 2: RBV intervention 3: Peg-IFN
Intervention descriptions: intervention 1: SOF 400 mg tablet administered orally once daily intervention 2: RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) intervention 3: Peg-IFN 180 μg administered once weekly by subcutaneous injection

Protocol document: