Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C Interferon-Free Treatment Experienced Chronic Hepatitis C Hepatitis C Virus
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 29
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 sofosbuvir (SOF) and ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus infection. This study will contain 2 parts.

Part 1: Approximately 20 participants and at least 10 of the 20 participants previously treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without RBV, and experienced treatment failure.

Part 2: Approximately 10 participants and all participants previously treated with SOF/ledipasvir and experienced treatment failure.

Detailed description:
Efficacy, safety, and demographic analyses were performed separately for the 2 study parts using the intent-to-treat (ITT) population, which consists of all enrolled participants who received at least one dose of study drug.

Arms:
arm 1: 3-DAA (ombitasvir/paritaprevir/ritonavir once daily \[QD\] and dasabuvir twice daily \[BID\]) with and without sofosbuvir (SOF) QD and with or without ribavirin (RBV) BID for 12 or 24 weeks

Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir and dasabuvir intervention 2: Sofosbuvir intervention 3: Ribavirin
Intervention descriptions: intervention 1: tablet, ombitasvir coformulated with paritaprevir and ritonavir; tablet, dasabuvir intervention 2: tablet intervention 3: tablet

Protocol document: