Conditions: Hepatitis C
Keywords: 7977 GS-7977 PSI-7977 Sofosbuvir (SOF) Pegylated Interferon (Peg-IFN) Ribavirin (RBV)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 601
Healthy volunteers: no

Brief summary:
This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.

Detailed description:

Arms:
arm 1: SOF+RBV for 16 weeks arm 2: SOF+RBV for 24 weeks arm 3: SOF+RBV+Peg-IFN for 12 weeks arm 4: Participants from the SOF+RBV arms (16 weeks or 24 weeks) who experienced virologic failure on treatment, or during the posttreatment period at or before Posttreatment Week 24 may be eligible to enroll into the Retreatment Substudy to receive SOF+RBV+Peg-IFN for 12 weeks.

Interventions: intervention 1: SOF intervention 2: RBV intervention 3: Peg-IFN
Intervention descriptions: intervention 1: 400 mg tablet administered orally once daily intervention 2: 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: 180 µg administered via subcutaneous injection once weekly

Protocol document: