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

NCT02356562 | Completed Phase 2 Results FDA Drug

• 1 other identifier: M14-224
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Hepatitis C Infection

Keywords

Hepatitis C; Interferon-Free; Treatment Experienced; Chronic Hepatitis C; Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks after the last dose of active drug

Secondary Outcomes (3)

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

  12 weeks after the last dose of active drug

• Percentage of Participants With On-treatment Virologic Failure

  Up to week 24

• Percentage of Participants With Post-Treatment Relapse

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

Study Arms (1)

3-DAA with or without SOF and RBV

EXPERIMENTAL

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

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

Interventions

ombitasvir/paritaprevir/ritonavir and dasabuvir DRUG

tablet, ombitasvir coformulated with paritaprevir and ritonavir; tablet, dasabuvir

Also known as: ABT-450/r/ABT-267, Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333

3-DAA with or without SOF and RBV

Sofosbuvir DRUG

tablet

Also known as: Sovaldi

3-DAA with or without SOF and RBV

Ribavirin DRUG

tablet

Also known as: RBV

3-DAA with or without SOF and RBV

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• 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.

  PMID: 26596948 DERIVED

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Interventions

ombitasvir; dasabuvir; Viekira Pak; paritaprevir; Sofosbuvir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Eric Cohen, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 5, 2015
• Study Start: February 3, 2015
• Primary Completion: October 28, 2016
• Study Completion: July 7, 2017
• Last Updated: December 20, 2017
• Results First Posted: November 24, 2017

Record last verified: 2017-10