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

Phase 2

Completed

• Conditions: Chronic Hepatitis C Infection
• Interventions: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: Sofosbuvir; Drug: Ribavirin

• Registration Number: NCT02356562
• Lead Sponsor: AbbVie

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.

Study Timeline

• Study First Submitted: 2015-02-02
• Study First Submitted QC: 2015-02-02
• Study Start: 2015-02-03
• Study First Posted: 2015-02-05
• Primary Completion: 2016-10-28
• Study Completion: 2017-07-07
• Status Verified: 2017-10
• Results First Submitted: 2017-10-19
• Results First Submitted QC: 2017-10-19
• Last Update Submitted: 2017-11-22
• Results First Posted: 2017-11-24
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3-DAA with or without SOF and RBV	ombitasvir/paritaprevir/ritonavir and dasabuvir	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
3-DAA with or without SOF and RBV	Ribavirin	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
3-DAA with or without SOF and RBV	Sofosbuvir	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

Primary Outcome Measures

Name	Time	Method
Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment	12 weeks after the last dose of active drug	SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment	12 weeks after the last dose of active drug	SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug
Percentage of Participants With On-treatment Virologic Failure	Up to week 24	On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after \< LLOQ during treatment, confirmed increase of \> 1 log (subscript)10(subscript) IU/mL above the lowest post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.
Percentage of Participants With Post-Treatment Relapse	Within 12 weeks after the last actual dose of active study drug	Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA \< LLOQ at the end of treatment.