N/A
Completed N=244
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary
Source: ClinicalTrials.gov NCT02636608 ↗Enrolled (actual)
244
Serious AEs
2.9%
Results posted
Jul 2019
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) — 94.5 percentage of participants
Summary
The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO), work productivity and safety data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin in chronic hepatitis C virus infected participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) |
94.5 | — |
| SECONDARY Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24) |
96.6 | — |
| SECONDARY Percentage of Participants Achieving Virological Response at End of Treatment |
97.1 | — |
| SECONDARY Percentage of Participants With Relapse |
1.3 | — |
| SECONDARY Number of Participants With Breakthrough |
— | — |
| SECONDARY Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment |
2; 3; 3; 2; 3 | — |
| SECONDARY Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category |
3.4; 93.7; 0.8; 0.8; 1.3 | — |
| SECONDARY Percentage of Participants With Adherence to Ribavirin by Adherence Category |
1.0; 78.1; 5.7; 6.7; 8.6 | — |
| SECONDARY Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days |
93.1 | — |
| SECONDARY Number of Participants Who Received Concomitant Medications |
169; 78; 53; 42; 42; 34 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies |
29; 6; 0 | — |
| SECONDARY Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score |
5.70; 2.77; 9.18; 5.98; 10.5; 6.07 | — |
| SECONDARY Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score |
0.02; 0.02; 0.03; 0.04; 0.04; 0.04 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism |
-2.1; -1.7; 1.0 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism |
0.6; -5.7; -7.3 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) |
-2.3; -8.1; -7.3 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment |
-0.5; -6.7; -8.5 | — |
| SECONDARY Change From Baseline in Patient Activation Measure 13 (PAM-13) |
0.85; 0.22 | — |
| SECONDARY Number of Participants Who Participated in the AbbVie Patient Support Program (PSP) |
179 | — |
| SECONDARY Utilization of the AbbVie Patient Support Program (PSP) Components |
141; 134; 128; 58; 65; 54 | — |
| SECONDARY Satisfaction With the AbbVie Patient Support Program (PSP) Components |
95; 33; 6; 0; 50; 42 | — |
Eligibility Criteria
Inclusion Criteria
- Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C (CHC), genotype 1 and 4, receiving combination therapy with the interferon-free paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin (PTV/r+OBV±DSV±RBV) according to standard of care and in line with the current local label.
- If RBV is co-administered with the PTV/r+OBV±DSV±RBV, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
- Patients must voluntarily sign and date Subject Information Form and Informed Consent Form prior to inclusion into the study.
- Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.
- Patient has been started on PTV/r+OBV±DSV±RBV therapy no more than one (1) month prior to the study enrollment.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02636608). 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.