Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C
1 other identifier
observational
216
0 countries
N/A
Brief Summary
The interferon-free combination regimen of paritaprevir/ritonavir/ombitasvir 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 is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to the local label, under real-world conditions in Greece in a clinical practice patient population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2016
CompletedFirst Posted
Study publicly available on registry
April 1, 2016
CompletedStudy Start
First participant enrolled
April 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedResults Posted
Study results publicly available
March 15, 2019
CompletedMarch 15, 2019
October 1, 2018
1.6 years
March 24, 2016
October 22, 2018
October 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma 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
Up to 24 weeks
Percentage of Participants With Viral Breakthrough
Up to 24 weeks
Percentage of Participants With On-treatment Virologic Failure
12 weeks after the last actual dose of study drug
Percentage of Participants Meeting Relapse Criteria
12 weeks after the last actual dose of study drug
- +2 more secondary outcomes
Study Arms (1)
Participants with HCV genotype 1 or 4
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
Interventions
Co-formulated tablet
Eligibility Criteria
Participants with chronic hepatitis C virus infection, genotype 1 or 4, 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 or 4, 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)
- Participant must not have participated or intended to participate in a concurrent interventional therapeutic trial
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
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: 30739368DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY CHAIR
Georgios Mitas, MS
AbbVie Pharmaceuticals S.A. (Greece)
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
March 24, 2016
First Posted
April 1, 2016
Study Start
April 5, 2016
Primary Completion
October 31, 2017
Study Completion
October 31, 2017
Last Updated
March 15, 2019
Results First Posted
March 15, 2019
Record last verified: 2018-10