A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection

AbbVie

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C Infection

Treatments: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: Ribavirin; Drug: Sofosbuvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02356562

M14-224

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of previous direct acting antiviral (DAA) therapy failure; Part 2 only: history of previous direct acting antiviral (DAA) therapy failure and received at least 8 weeks of SOF/ledipasvir; participant must be treatment naïve to all other anti-HCV therapies
• HCV genotype 1 infection
• Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control

Exclusion criteria

• Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody
• Discontinuation of the prior DAA treatment for reasons other than virologic failure
• Confirmed presence of hepatocellular carcinoma
• Abnormal lab tests

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

3-DAA with or without SOF and RBV

Experimental group

Description:

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

Treatment:

Drug: Sofosbuvir

Drug: Ribavirin

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir