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



Status:Completed
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/17/2018
Start Date:June 2013
End Date:August 2014

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A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects 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 or 3 hepatitis C virus (HCV)
infection.


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
We found this trial at
41
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