Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

This study will evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.


Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
Enrollment: 333
Study Start Date: December 2015
Study Completion Date: January 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental: SOF/VEL/VOX
- Experimental: SOF/VEL


Related journal:
- Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection.