NCT02201953

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 558 (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 of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	SOF/VEL	400/100 mg FDC tablet administered orally once daily
DRUG	SOF	400 mg tablet administered orally once daily
DRUG	RBV	Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2014-07-28
• Last updated: 2018-11-16
• Results posted: 2016-10-26

Locations

76 sites across 9 countries: United States, Australia, Canada, France, Germany, Italy, New Zealand, Puerto Rico, United Kingdom