Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis



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

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A Phase 2, Randomized, Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection and Cirrhosis

This study is to evaluate the antiviral efficacy, safety, and tolerability of combination
therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV)
± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1
hepatitis C virus (HCV) infection and cirrhosis.


Inclusion Criteria:

- Age ≥ 18 years, with chronic HCV genotype 1 infection

- Documentation as treatment-experienced having received pegylated interferon (Peg-IFN)
+ RBV ≥ 4 weeks of duration without an additional agent in the regimen without
achieving sustained viral response (SVR)

- Presence of compensated cirrhosis

- Screening laboratory values within defined thresholds

- Must use specific contraceptive methods if female of childbearing potential or
sexually active male

- Not pregnant or a nursing female

Exclusion Criteria:

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

- Current or prior history of clinical hepatic decompensation

- 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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