Conditions: Chronic Hepatitis C Infection Compensated Cirrhosis
Keywords: Hepatitis C Chronic Hepatitis C Compensated Cirrhosis Cirrhotic Hepatitis C Genotype 1b Hepatitis C Virus Interferon-Free Child Pugh A Ribavirin-Free
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 60
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.

Detailed description:
This was a multicenter study evaluating the efficacy and safety of ombitasvir/ paritaprevir/ritonavir and dasabuvir administered for 12 weeks in HCV genotype 1b (GT1b)-infected, treatment-naïve and previous pegylated interferon (pegIFN)/ ribavirin (RBV) treatment-experienced adults with compensated cirrhosis. The duration of the study was up to 36 weeks (not including a screening period of up to 42 days) and consisted of a 12-week Treatment Period and a 24-week Post-Treatment Period for all participants who received study drugs.

Arms:
arm 1: Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks

Interventions: intervention 1: Ombitasvir/Paritaprevir/Ritonavir intervention 2: Dasabuvir
Intervention descriptions: intervention 1: Tablet; paritaprevir co-formulated with ritonavir and ombitasvir intervention 2: Tablet

Protocol document: