Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study



Status:Completed
Conditions:Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/18/2018
Start Date:December 1, 2014
End Date:September 15, 2016

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An Open Label Study to Evaluate The Efficacy And Safety Of Sofosbuvir/GS-5816 Fixed Dose Combination With Ribavirin For 24 Weeks In Chronic HCV Infected Subjects Who Participated In A Prior Gilead Sponsored HCV Treatment Study

The primary objective of this study is to evaluate the efficacy, safety and tolerability of
treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks
in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead
sponsored study and did not achieve sustained virologic response (SVR).


Key Inclusion Criteria:

- Willing and able to provide written informed consent

- HCV genotype determined by the Central Laboratory

- HCV RNA > LLOQ at screening

- Participated and completed a Gilead sponsored HCV treatment study of direct acting
antiviral (DAA) containing regimens.

- Male and female of childbearing potential must agree to use protocol specified
method(s) of contraception

Key Exclusion Criteria:

- Current or prior history: 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

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

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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Wellington, FL
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