Conditions: Chronic Hepatitis C Infection Compensated Cirrhosis
Keywords: Cirrhosis Hepatitis C Child Pugh A Compensated Cirrhosis Hepatitis C Genotype 1 Cirrhotic Chronic Hepatitis C Hepatitis C Virus ombitasvir paritaprevir dasabuvir Interferon-Free Viekira Pak
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 381
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.

Detailed description:
During the treatment period of the study, participants received treatment with ABT-450/ritonavir/ABT-267 and ABT-333 coadministered with RBV for either 12 or 24 weeks. Upon completing the treatment period or premature discontinuation of the treatment period, participants entered a 48-week post-treatment period.

Arms:
arm 1: ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks arm 2: ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks

Interventions: intervention 1: ABT-450/r/ABT-267, ABT-333 intervention 2: Ribavirin (RBV)
Intervention descriptions: intervention 1: Tablet; ABT-450 coformulated with ritonavir and ABT-267; ABT-333 tablet intervention 2: Capsule

Protocol document: