N/A
Completed N=216
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C
Source: ClinicalTrials.gov NCT02725866 ↗Enrolled (actual)
216
Serious AEs
3.2%
Results posted
Mar 2019
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 91.1; 95.6 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
91.1; 95.6 | — |
| SECONDARY Percentage of Participants With Virologic Response at End of Treatment (EoT) |
93.9 | — |
| SECONDARY Percentage of Participants With Relapse |
0.9 | — |
| SECONDARY Percentage of Participants With Viral Breakthrough |
0.0 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
0.5 | — |
| SECONDARY Percentage of Participants Meeting Relapse Criteria |
0.9 | — |
| SECONDARY Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria |
2.3 | — |
| 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 |
3.8 | — |
Eligibility Criteria
Inclusion Criteria
- 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)
- Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study
- Participant must not have participated or intended to participate in a concurrent interventional therapeutic trial
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02725866). 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.