Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection



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

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A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection

This study is to evaluate the safety, tolerability, and antiviral efficacy of
ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV)
administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1
hepatitis C virus (HCV) infection.


Inclusion Criteria:

- Age > 18, with chronic genotype 1 HCV infection

- HCV treatment-experienced, including patients who have previously failed a
nonstructural protein (NS)3/4A protease inhibitor plus pegylated interferon (PEG)/RBV
regimen

- HCV RNA > 10,000 IU/mL at screening

- Cirrhosis determination; a liver biopsy may be required

- Screening laboratory values within defined thresholds

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

Exclusion Criteria:

- Pregnant or nursing female or male with pregnant female partner

- Coinfection with HIV or hepatitis B virus

- Current or prior history of clinical hepatic decompensation

- Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin
cancers)

- Chronic use of systemic immunosuppressive agents

- History of clinically significant illness or any other medical disorder that may
interfere with subject treatment, assessment or compliance with the protocol
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53
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Charlotte, North Carolina 28207
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Springfield, Massachusetts 01199
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Statesville, North Carolina 28677
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