N/A
Completed N=101
The Effectiveness of ABT-450/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Ireland
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT02582671 ↗
Enrolled (actual)
101
Serious AEs
1.0%
Results posted
May 2019
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 97.0; 98.0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
97.0; 98.0 | — |
| SECONDARY Percentage of Participants With Virologic Response at End of Treatment (EOT) |
97.0 | — |
| SECONDARY Percentage of Participants With Relapse |
— | — |
| SECONDARY Percentage of Participants With Viral Breakthrough |
— | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
— | — |
| SECONDARY Percentage of Participants Meeting Relapse Criteria |
— | — |
| SECONDARY Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria |
2.0 | — |
| SECONDARY Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria |
1.0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 had to voluntarily sign and date an informed consent form prior to inclusion into the study
- Participants must not have participated or intended to participate in a concurrent interventional therapeutic trial
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02582671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.