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

AbbVie29 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C Infection

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment

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.

Time frame: 12 weeks after the last dose of active drug

Secondary Outcomes

Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment

SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug

Time frame: 12 weeks after the last dose of active drug

Percentage of Participants With On-treatment Virologic Failure

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.

Time frame: Up to week 24

Percentage of Participants With Post-Treatment Relapse

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.

Time frame: Within 12 weeks after the last actual dose of active study drug