Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C HCV Chronic Hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 332
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.

Detailed description:

Arms:
arm 1: Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks. arm 2: Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks. arm 3: Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks, then were rerandomized to receive sofosbuvir only or sofosbuvir+RBV for 12 additional weeks.

Interventions: intervention 1: Sofosbuvir intervention 2: RBV intervention 3: PEG
Intervention descriptions: intervention 1: Sofosbuvir (SOF) administered as a 400 mg tablet 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) 180 μg administered once weekly by subcutaneous injection

Protocol document: