Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose
combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or
treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection.
A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment,
approximately 60 having had prior treatment with a regimen containing pegylated interferon
(PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus
treatment-experienced and by HCV genotype (1a versus 1b).
Phase:
Phase 2
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Ledipasvir Ledipasvir, sofosbuvir drug combination Ribavirin Sofosbuvir