N/A
Completed N=236
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT02803138 ↗
Enrolled (actual)
236
Serious AEs
2.5%
Results posted
Oct 2019
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 70.6 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 local label, under real world conditions in Israel 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) |
70.6 | — |
| SECONDARY Percentage of Participants With Virologic Response at End of Treatment (EoT) |
82.0 | — |
| SECONDARY Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Posttreatment |
95.8 | — |
| SECONDARY Percentage of Participants With Relapse |
0.0 | — |
| SECONDARY Percentage of Participants With Viral Breakthrough |
0.0 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
1.3 | — |
| SECONDARY Percentage of Participants Meeting Relapse Criteria |
— | — |
| SECONDARY Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria |
1.8 | — |
| 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 |
25.9 | — |
Eligibility 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
- Participants must not have participated or intended to participate in a concurrent interventional therapeutic trial
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02803138). 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.