Conditions: Hepatitis C
Keywords: Chronic Hepatitis C infection Genotype 1 HCV GT1 GT 1
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 64
Healthy volunteers: no

Brief summary:
Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day 0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study which continued for 48 weeks. Participants were evaluated for sustained virologic response (SVR) for an additional 24 weeks following completion of study treatment.

Detailed description:

Arms:
arm 1: Participants received sofosbuvir 100 mg (1 x 100 mg tablet) and placebo to match sofosbuvir (3 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) arm 2: Participants received sofosbuvir 200 mg (2 x 100 mg tablets) and placebo to match sofosbuvir (2 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) arm 3: Participants received sofosbuvir 400 mg (4 x 100 mg tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) arm 4: Participants received placebo to match sofosbuvir (4 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)

Interventions: intervention 1: Sofosbuvir intervention 2: Placebo intervention 3: PEG intervention 4: RBV
Intervention descriptions: intervention 1: Sofosbuvir tablet(s) administered orally once daily intervention 2: Placebo to match sofosbuvir administered orally once daily intervention 3: Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection. intervention 4: Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).

Protocol document: