Conditions: Hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 257
Healthy volunteers: no

Brief summary:
This is a study comparing grazoprevir (MK-5172) plus elbasvir (MK-8742) treatment with sofosbuvir (SOF) plus Pegylated Interferon plus Ribavirin (RBV) \[PR\] treatment in treatment-naïve and prior PR treatment failure participants with chronic Hepatitis C Virus (HCV) genotype (GT)1, GT4, or GT6 infection. The primary objectives are to compare efficacy (assessed by the percentage of participants achieving sustained virologic response 12 weeks after ending study treatment \[SVR12\]) and safety between the grazoprevir plus elbasvir treatment arm and the SOF plus PR treatment arm. The primary hypothesis is that the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir treatment arm is non-inferior to that in the SOF plus PR treatment arm.

Detailed description:

Arms:
arm 1: Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up. arm 2: Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.

Interventions: intervention 1: Sofosbuvir intervention 2: PegIntron intervention 3: Ribavirin intervention 4: Grazoprevir/Elbasvir (100 mg/50 mg) FDC
Intervention descriptions: intervention 1: 400 mg tablets, taken orally (PO) every day (QD) for 12 weeks. intervention 2: PegIntron administered subcutaneously every week (QW) at 1.5 mcg/kg for 12 weeks. intervention 3: Capsule and/or tablet administered PO twice daily (BID) based on weight (1000 - 1200 mg) for 12 weeks. intervention 4: Grazoprevir/Elbasvir (100 mg/50 mg) FDC, taken PO QD for 12 weeks.

Protocol document: