IRB-14-6328[INDEP.IRB: CHESAPEAKE IRB]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 [Protocol:GS-US-337-1118]
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.
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