Phase 3 Study of Sofosbuvir and Ribavirin

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2011
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.
Epistemonikos ID: 61c3209e286d7c1f551ecf2e3c992627b7bbc6db
First added on: May 10, 2024