Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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 or 3 hepatitis C virus (HCV) infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Body mass index (BMI) ≥ 18 kg/m^2

• HCV RNA ≥ 10000 IU/mL at screening

• Prior treatment failure to a regimen including interferon with or without RBV

• HCV genotype 1 or 3

• Chronic HCV infection

• Cirrhosis determination

• Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

• Current or prior history of clinically significant illness other than HCV

• Screening ECG with clinically significant abnormalities

• Prior exposure to HCV specific direct acting antiviral agent

• Pregnant or nursing female or male with pregnant female partner

• Chronic liver disease of non-HCV etiology

• Hepatitis B

• Active drug abuse

• Use of any prohibited concomitant medications