Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection



Status:Completed
Conditions:Infectious Disease, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/17/2018
Start Date:September 2014
End Date:September 2015

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A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks
compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants
with chronic genotype 2 hepatitis C virus (HCV) infection.


Inclusion Criteria:

- Willing and able to provide written informed consent

- HCV RNA ≥ 10^4 IU/mL

- HCV genotype 2

- Chronic HCV infection (≥ 6 months)

- Females of childbearing potential must have a negative serum pregnancy test

- Males and females of childbearing potential who engage in heterosexual intercourse
must agree to use protocol specified method(s) of contraception

- Must be of generally good health, with the exception of chronic HCV infection, as
determined by the investigator.

Exclusion Criteria:

- Current or prior history of clinically-significant illness (other than HCV that may
interfere with treatment, assessment or compliance with the protocol;

- Screening electrocardiogram (ECG) with clinically significant abnormalities

- Laboratory results outside of acceptable ranges at Screening

- Pregnant or nursing female or male with pregnant female partner

- Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease,
alfa-1 antitrypsin deficiency, cholangitis)

- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
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