Conditions: Chronic Hepatitis C Cirrhosis Hepatitis C Virus
Keywords: Chronic Hepatitis C Interferon-Free Hepatitis C Genotype 1 Hepatitis C Virus Hepatitis C Cirrhosis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 99
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.

Detailed description:

Arms:
arm 1: 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.

Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir and dasabuvir intervention 2: Ribavirin
Intervention descriptions: intervention 1: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet intervention 2: Tablet

Protocol document: