The Effectiveness of ABT-450/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Ireland

NCT02582671 | Completed Results

• 1 other identifier: P15-702
• Study Type: observational
• Target: 101
• Locations: 0 countries
• Sites: N/A

Brief Summary

The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions. This observational study was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to the local label, under real world conditions in Ireland in a clinical practice patient population.

Conditions

Chronic Hepatitis C

Keywords

Real World Effectiveness; Observational Study; Sustained Virologic Response; Chronic Hepatitis C; Chronic Hepatitis C genotype 1; Ombitasvir/paritaprevir/ritonavir ± dasabuvir

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

  SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria: * evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN * an HCV RNA value ≥50 IU/mL at the last measurement post-baseline * HCV RNA \<50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure

  12 weeks after the last actual dose of study drug

Secondary Outcomes (7)

• Percentage of Participants With Virologic Response at End of Treatment (EOT)

  Up to 24 weeks

• Percentage of Participants With Relapse

  From the end of treatment through the end of study (maximum of 48 weeks post-treatment)

• Percentage of Participants With Viral Breakthrough

  Up to 24 weeks

• Percentage of Participants With On-treatment Virologic Failure

  Up to 24 weeks

• Percentage of Participants Meeting Relapse Criteria

  Up to 12 weeks after the last actual dose of study drug

Study Arms (1)

Participants with HCV genotype 1

Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks

Drug: Ombitasvir/paritaprevir/ritonavir; Drug: Dasabuvir; Drug: Ribavirin

Interventions

Ombitasvir/paritaprevir/ritonavir DRUG

Co-formulated tablet

Also known as: Ombitasvir also known as ABT-267, Paritaprevir also known as ABT-450

Participants with HCV genotype 1

Dasabuvir DRUG

Tablet

Also known as: ABT-333

Participants with HCV genotype 1

Ribavirin DRUG

Tablet

Participants with HCV genotype 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with chronic hepatitis C virus infection, genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin

You may qualify if:

• Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label
• If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
• Participants must not have participated or intended to participate in a concurrent interventional therapeutic trial

You may not qualify if:

• \- None

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.

  PMID: 30739368 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

ombitasvir; paritaprevir; dasabuvir; Ribavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 21, 2015
• Study Start: November 5, 2015
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: May 6, 2019
• Results First Posted: May 6, 2019

Record last verified: 2019-04