N/A
Completed N=51
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C
Source: ClinicalTrials.gov NCT02817594 ↗Enrolled (actual)
51
Serious AEs
4.0%
Results posted
May 2019
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) — 89.6 percentage of participants
Summary
The interferon-free combination regimen of paritaprevir/r - 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 local label, under real world conditions in the Netherlands in a clinical practice patient population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) |
89.6 | — |
| SECONDARY Percentage of Participants Achieving Virological Response at End of Treatment |
95.8 | — |
| SECONDARY Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment |
91.5 | — |
| SECONDARY Percentage of Participants With Relapse |
6.8 | — |
| SECONDARY Percentage of Participants With Breakthrough |
0.0 | — |
| SECONDARY Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment |
0; 3; 1; 1 | — |
| SECONDARY Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA |
1; 41; 2; 2; 1; 1 | — |
| SECONDARY Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin |
1; 11; 0; 0; 2 | — |
| SECONDARY Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days |
96.0 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies |
32; 2; 0 | — |
| SECONDARY Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score |
0.000; 0.000; 0.000 | — |
| SECONDARY Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score |
0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism |
0.0; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Treatment-naïve or -experienced adult male or female participants with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with the current local label.
- If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
- Participants must voluntarily sign and date informed consent prior to inclusion into the study
Exclusion Criteria
- Patients participating or intending to participate in a concurrent interventional therapeutic trial.
- Unable to complete the questionnaires due to cognitive impairment or lack of any kind of cognitive competence, as to be judged by the healthcare professional who is treating the patient.
- Unable to complete the questionnaires due to language incompetence.
- Unable to voluntarily sign and date the informed consent.
Data sourced from ClinicalTrials.gov (NCT02817594). 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.