N/A
Completed N=735
The Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in France
Source: ClinicalTrials.gov NCT02618928 ↗Enrolled (actual)
735
Serious AEs
2.8%
Results posted
Jun 2019
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) — 90.7 percentage of participants
Summary
This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) in participants with chronic hepatitis C (CHC) virus in clinical practices across France.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) |
90.7 | — |
| SECONDARY Percentage of Participants Achieving Virological Response at End of Treatment |
94.4 | — |
| SECONDARY Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment |
95.5 | — |
| SECONDARY Percentage of Participants With Relapse |
1.2 | — |
| SECONDARY Percentage of Participants With Breakthrough |
0.5 | — |
| SECONDARY Percentage of Participants With Rapid Virological Response at Week 4 (RVR4) |
49.0 | — |
| SECONDARY Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24) |
94.8 | — |
| SECONDARY Number of Participants in Each Non-response Category 12 Weeks Post-treatment |
11; 7; 2; 14; 3; 30 | — |
| SECONDARY Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category |
38; 623; 19; 15; 15; 10 | — |
| SECONDARY Percentage of Participants With Adherence to Ribavirin by Adherence Category |
22; 219; 20; 15; 10; 6 | — |
| SECONDARY Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days |
98.5 | — |
| SECONDARY Number of Participants Who Received Concomitant Medications |
351; 60; 58; 46; 45; 40 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies |
163; 20; 1 | — |
| SECONDARY Change From Baseline in Fatigue Impact Scale Total Score |
-6.78; -18.27; -16.75 | — |
| SECONDARY Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score |
0.044; 0.088; 0.087 | — |
| SECONDARY Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score |
6.8; 10.6; 10.4 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism |
5.2; 0.4; -1.5 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism |
-1.2; -5.5; -7.4 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) |
1.3; -4.9; -8.7 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment |
1.6; -7.2; -9.5 | — |
| SECONDARY Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ) |
-0.100; -0.099; 0.119; 0.135 | — |
| SECONDARY Change From Baseline in Patient Activation Measure 13 (PAM-13) |
0.44 | — |
| SECONDARY Number of Participants With Outpatient Consultations Due to Liver Disease by Category |
515; 80; 94; 5 | — |
| SECONDARY Number of Participants With Hospitalizations Due to Liver Disease by Category |
685; 9 | — |
| SECONDARY Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c) |
-7.07 | — |
Eligibility Criteria
Inclusion Criteria
- Treatment-naïve or -experienced participants with confirmed CHC, genotype 1 or 4
- Participants receiving or who will receive the interferon-free ABBVIE REGIMEN ± RBV according to product label
- RBV prescribed in line with the current local label
Exclusion Criteria
- Participant is not participating or intending to participate in a concurrent interventional therapeutic trial
Data sourced from ClinicalTrials.gov (NCT02618928). 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.