NCT02378935

Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection

A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Genotype 1 HCV Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	VOX	100 mg tablet(s) administered orally once daily with food
DRUG	SOF/VEL	400/100 mg FDC tablet administered orally once daily with food
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: 2015-02-17
• Primary completion: 2016-02-01
• Completion: 2016-04-12
• First posted: 2015-03-04
• Last updated: 2020-03-06
• Results posted: 2017-12-08

Locations

34 sites across 3 countries: United States, New Zealand, Puerto Rico

Regulatory

• FDA-regulated drug study