Conditions: Chronic Hepatitis C Infection
Keywords: Chronic Hepatitis C Hepatitis C Treatment Naive Hepatitis C Genotype 1 Hepatitis C Treatment Experienced Hepatitis C Virus
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 222
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.

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.

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: