This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir
fixed-dose combination (LDV/SOF 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.
- Trial ID:
- Paul Pockros
- 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.
- 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