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