NCT01858766

Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection

A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naive Subjects With Chronic HCV Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 379 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	SOF	400 mg tablet administered orally once daily
DRUG	VEL	Tablet administered orally once daily
DRUG	RBV	200 mg 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: 2013-04-01
• Primary completion: 2014-05-01
• Completion: 2014-08-01
• First posted: 2013-05-21
• Last updated: 2018-11-14
• Results posted: 2016-09-15

Locations

51 sites across 2 countries: United States, Puerto Rico