Conditions: Chronic Hepatitis C
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 218
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg in the treatment of chronic hepatitis C virus (HCV) in participants who are co-infected with human immunodeficiency virus (HIV). The primary hypothesis is that the percentage of participants who receive grazoprevir + elbasvir and achieve Sustained Virologic Response after 12 weeks of therapy (SVR12) will be greater than 70%.

Detailed description:

Arms:
arm 1: Participants receive a fixed-dose combination (FDC) of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and are followed-up for 24 weeks.

Interventions: intervention 1: Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tablets
Intervention descriptions: intervention 1: MK-5172A FDC tablet: MK-5172 (100 mg)/MK-8742 (50 mg)

Protocol document: