Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection (ASTRAL-3)

This study will evaluate the safety, tolerability, and efficacy of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed dose combination (FDC) for 12 weeks compared to treatment with SOF plus ribavirin (RBV) for 24 weeks in participants with chronic genotype 3 hepatitis C virus (HCV) infection.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection
Enrollment: 558
Study Start Date: July 2014
Estimated Study Completion Date: November 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental: SOF/VEL 12 Weeks
- Experimental: SOF+RBV 24 Weeks