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

• Status: Completed
• Trial end date: 2017-07-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Ribavirin; Ritonavir; Sofosbuvir

Criteria

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