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]

Trial ID:
IRB-14-6328
Paul Pockros
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.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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