Conditions: Chronic HCV Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 117
Healthy volunteers: no

Brief summary:
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 hepatitis C virus (HCV) infection.

Detailed description:

Arms:
arm 1: Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks. arm 2: Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks.

Interventions: intervention 1: Sofosbuvir intervention 2: RBV
Intervention descriptions: intervention 1: 400 mg tablet administered orally once daily intervention 2: 200 mg 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)

Protocol document: