Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy (POLARIS-1)

This study will evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic HCV infection who have previously received treatment with direct-acting antiviral therapy.

Subjects randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.


Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection
Enrollment: 416
Actual Study Start Date: November 2015
Study Completion Date: June 21, 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental: SOF/VEL/VOX (Primary Study)
- Experimental: Placebo (Primary Study)
- Experimental: SOF/VEL/VOX (Deferred Treatment Substudy)


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