Conditions: HCV Infection
Keywords: Hepatitis C HCV Cirrhosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 155
Healthy volunteers: no

Brief summary:
This study is to determine the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) with and without ribavirin (RBV), and to evaluate the safety and tolerability of each regimen as assessed by review of the accumulated safety data. Approximately 150 participants with genotype 1 HCV infection, who have previously received treatment for HCV, and who have a diagnosis for cirrhosis will be enrolled. Participants will be randomized to 1 of 2 groups.

Group 1: SOF/LDV FDC tablet plus placebo to match RBV for 24 weeks

Group 2: Delayed treatment group: placebo to match SOF/LDV FDC plus placebo to match RBV for 12 weeks, followed by SOF/LDV FDC once daily plus RBV in a divided daily dose for 12 weeks

Randomization will 1:1 to the two groups and will be stratified by HCV genotype (1a, 1b; mixed or other genotype 1 results will be stratified as genotype 1a), and prior HCV therapy treatment response (never achieved HCV RNA \< the lower limit of quantitation (LLOQ), or achieved HCV RNA \< LLOQ).

Detailed description:

Arms:
arm 1: LDV/SOF FDC tablet plus placebo to match RBV for 24 weeks arm 2: Placebo to match SOF/LDV FDC plus placebo to match RBV for 12 weeks, followed by LDV/SOF FDC plus RBV for 12 weeks.

Interventions: intervention 1: LDV/SOF intervention 2: RBV intervention 3: Placebo to match LDV/SOF intervention 4: Placebo to match RBV
Intervention descriptions: intervention 1: LDV/SOF (90/400 mg) FDC tablet administered orally once daily intervention 2: RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) intervention 3: Placebo to match LDV/SOF administered orally once daily intervention 4: Placebo to match RBV administered orally in a divided daily dose

Protocol document: