Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic 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:July 2014
End Date:September 2015

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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with
chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.


Inclusion Criteria:

- Willing and able to provide written informed consent

- HCV RNA ≥ 10^4 IU/mL at screening

- HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central
laboratory

- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

- Classification as treatment naive or treatment experienced

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

Exclusion Criteria:

- Current or prior history of clinically-significant illness (other than HCV) or any
other major medical disorder that may interfere with treatment, assessment, or
compliance with the protocol; individuals currently under evaluation for a potentially
clinically-significant illness (other than HCV) are also excluded.

- Screening ECG with clinically significant abnormalities

- Laboratory results outside of acceptable ranges at Screening

- Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A
inhibitor

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