NCT01497366

Phase 3 Study of Sofosbuvir and Ribavirin

A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients With Chronic Genotype 2 or 3 HCV Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 527 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Sofosbuvir	Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
DRUG	PEG	Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
DRUG	RBV	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

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-01-01
• Completion: 2013-04-01
• First posted: 2011-12-22
• Last updated: 2014-04-02
• Results posted: 2014-04-02

Locations

97 sites across 8 countries: United States, Australia, Canada, Italy, Netherlands, New Zealand, Puerto Rico, Sweden