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 |
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.
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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