Clinical trial NCT02356562: 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
Official title: An Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With or Without Sofosbuvir (SOF) and Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C
Interferon-Free
Treatment Experienced
Chronic Hepatitis C
Hepatitis C Virus
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-02-05
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment
timeFrame: 12 weeks after the last dose of active drug
Secondary outcomes:
measure: Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment
timeFrame: 12 weeks after the last dose of active drug
measure: Percentage of Participants With On-treatment Virologic Failure
timeFrame: Up to week 24
measure: Percentage of Participants With Post-Treatment Relapse
timeFrame: Within 12 weeks after the last actual dose of active study drug
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Eric Cohen, MD
role: STUDY_DIRECTOR
References:
citation: King JR, Dutta S, Cohen D, Podsadecki TJ, Ding B, Awni WM, Menon RM. Drug-Drug Interactions between Sofosbuvir and Ombitasvir-Paritaprevir-Ritonavir with or without Dasabuvir. Antimicrob Agents Chemother. 2015 Nov 23;60(2):855-61. doi: 10.1128/AAC.01913-15. Print 2016 Feb.