Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to
receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated
interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to
an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA
level (< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a
2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA < lower
limit of detection [15 IU/mL] from Weeks 4 through 12) received an additional 12 weeks of
PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV.
Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400
mg plus PEG+RBV for 12 weeks.