Conditions: Hepatitis C
Keywords: HCV genotype 2 (GT-2) HCV genotype 3 (GT-3)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 527
Healthy volunteers: no

Brief summary:
This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.

Detailed description:

Arms:
arm 1: Participants were randomized to receive sofosbuvir+RBV for 12 weeks. arm 2: Participants were randomized to receive PEG+RBV for 24 weeks.

Interventions: intervention 1: Sofosbuvir intervention 2: PEG intervention 3: RBV
Intervention descriptions: intervention 1: Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily intervention 2: Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection intervention 3: Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose

* Dose of sofosbuvir+RBV group based on baseline weight: \< 75kg = 1000 mg and ≥ 75 kg = 1200 mg
* Dose of PEG+RBV group: 800 mg

Protocol document: