Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/21/2018
Start Date:July 2014
End Date:November 2015

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An Open-Label, Multicenter Study To Evaluate The Efficacy And Safety Of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin For 12 or 24 Weeks In Chronic Genotype 1 HCV Infected Subjects Who Participated In A Prior Gilead-Sponsored HCV Treatment Study

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin
(RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have
participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve
sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification
(LLOQ) 24 weeks after last dose of study drug (SVR24).


Key Inclusion Criteria:

- Willing and able to provide written informed consent

- Infection with HCV genotype 1

- HCV RNA > LLOQ at screening

- Participation in a prior Gilead-sponsored study

- Screening laboratory values within defined thresholds

- Use of two effective contraception methods if female of childbearing potential or
sexually active male

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

- Must be able to comply with the dosing instructions for study drug administration and
able to complete the study schedule of assessments

Key Exclusion Criteria:

- Pregnant or nursing female or male with pregnant female partner

- Co-infection with HIV or hepatitis B virus (HBV)

- Current or prior history of clinical hepatic decompensation (Groups 1 and 2 only)

- Hepatocellular carcinoma (HCC)

- History of clinically significant illness or any other medical disorder that may
interfere with subject treatment, assessment or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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38
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