N/A
Completed N=40
Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study
Source: ClinicalTrials.gov NCT02798315 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) — 100 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 Kuwait 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) |
100 | — |
| SECONDARY Percentage of Participants With Virological Response at End of Treatment (EoT) |
100 | — |
| SECONDARY Percentage of Participants With Relapse at EoT |
— | — |
| SECONDARY Percentage of Participants With Breakthrough. |
— | — |
| SECONDARY Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse |
0; 0 | — |
| SECONDARY Percentage of Participants Meeting the SVR Non-response Categories of Premature Study Drug Discontinuation or Missing SVR12 Data and/or None of the Above Criteria |
0; 0 | — |
| SECONDARY Adherence to ABBVIE Regimen: Percentage of the Direct-acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA |
38; 1 | — |
| SECONDARY Adherence to RBV: Percentage of RBV Dose Taken in Relation to the Target Dose of RBV |
32; 1 | — |
| SECONDARY Adherence: Percentage of Planned Duration of RBV Taken by Participant |
101.0 | — |
| SECONDARY Change From Baseline in the PAM-13 Questionnaire |
7.60 | — |
| SECONDARY Patient Support Program (PSP) Questionnaire: Utilization of PSP Components |
28; 24; 6; 3; 6; 2 | — |
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).
- Participant must not be participating or intending to participate in a concurrent interventional therapeutic trial.
Exclusion Criteria
- Participant must not be participating or attending in a concurrent interventional therapeutic trial.
Data sourced from ClinicalTrials.gov (NCT02798315). 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.