Overview

Phase 3 Study of Sofosbuvir and Ribavirin

Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Ribavirin
Sofosbuvir