Conditions: Chronic HCV Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 687
Healthy volunteers: no

Brief summary:
The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C virus (HCV) infection.

Detailed description:

Arms:
arm 1: Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks. arm 2: Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks. arm 3: Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks. arm 4: Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.

Interventions: intervention 1: Sofosbuvir intervention 2: RBV intervention 3: PEG
Intervention descriptions: intervention 1: Sofosbuvir 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) intervention 3: Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week

Protocol document: