Conditions: Hepatitis C Virus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 237
Healthy volunteers: no

Brief summary:
This study will evaluate the safety and efficacy of combination treatment with grazoprevir (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained viral response 12 weeks after the end of all study treatment (SVR12) will be \>45%.

Detailed description:

Arms:
arm 1: Participants receive grazoprevir 100 mg tablet, orally, once per day (QD) + elbasvir 50 mg tablet, orally, QD, for 12 weeks. arm 2: Participants receive placebos to both grazoprevir and elbasvir for 12 weeks, and after a 4-week break, grazoprevir 100 mg tablet, orally, QD + elbasvir 50 mg tablet, orally, QD for 12 weeks. arm 3: Participants receive grazoprevir 100 mg tablet, orally, QD + elbasvir 50 mg tablet, orally, QD for 12 weeks with intensive PK testing.

Interventions: intervention 1: Grazoprevir intervention 2: Elbasvir intervention 3: Placebo to Grazoprevir intervention 4: Placebo to Elbasvir
Intervention descriptions: intervention 1: Grazoprevir 100 mg tablet intervention 2: Elbasvir 50 mg tablet intervention 3: Placebo tablet matched to grazoprevir intervention 4: Placebo tablet matched to elbasvir

Protocol document: