Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults 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, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.

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

Details

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

Criteria

Inclusion Criteria:

• Chronic HCV infection

• Body mass index (BMI) ≥ 18 kg/m^2

• HCV RNA ≥ 10000 IU/mL at screening

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

• Must not have cirrhosis

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

• Prior treatment of HCV with interferon or ribavirin

• 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