Conditions: Chronic Hepatitis C Virus (HCV) Infection
Keywords: Chronic Hepatitis C Hepatitis C Hepatitis C Virus Hepatitis C Genotype 1b Interferon-Free
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 36
Healthy volunteers: no

Brief summary:
This was a multicenter study evaluating the efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12 weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV treatment-experienced, cirrhotic HCV genotype 1b-infected adults.

Detailed description:
The primary objective of this study was to assess the safety and efficacy (the percentage of participants achieving a 12-week sustained virologic response (SVR12), \[HCV ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks following treatment\]) of co-formulated ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/r) and dasabuvir co-administered with RBV for 12 weeks in HCV genotype 1b-infected adult participants with compensated cirrhosis. The secondary objectives of this study were to assess the number and percentage of participants with virologic failure during treatment and the percentage of participants with relapse post-treatment.

Arms:
arm 1: Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks

Interventions: intervention 1: Ombitasvir/Paritaprevir/Ritonavir intervention 2: Dasabuvir intervention 3: Ribavirin (RBV)
Intervention descriptions: intervention 1: Tablet; paritaprevir co-formulated with ritonavir and ombitasvir intervention 2: Tablet intervention 3: Tablet

Protocol document: