NCT02607800

Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy

A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subjects With Chronic HCV Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 943 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic hepatitis C virus (HCV) infection.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	SOF/VEL/VOX	400/100/100 mg tablet administered orally once daily with food
DRUG	SOF/VEL	400/100 mg tablet administered orally once daily with or without food

Timeline

• Start date: 2015-11-16
• Primary completion: 2016-10-10
• Completion: 2017-01-11
• First posted: 2015-11-18
• Last updated: 2019-03-05
• Results posted: 2017-11-08

Locations

93 sites across 8 countries: United States, Australia, Canada, France, Germany, New Zealand, Puerto Rico, United Kingdom

Regulatory

• FDA-regulated drug study