N/A
Completed N=394
Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C
Source: ClinicalTrials.gov NCT02640547 ↗Enrolled (actual)
394
Serious AEs
3.6%
Results posted
Oct 2018
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) — 96.8; 100.0; 96.6; 95.0 percentage of participants
Summary
This study seeks to provide evidence of the effectiveness and obtain patient reported outcomes (PRO) and work productivity data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), +/- dasabuvir (DSV), +/- ribavirin (RBV) in chronic hepatitis C virus infected patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) |
96.8; 100.0; 96.6; 95.0 | — |
| SECONDARY Percentage of Participants Achieving Virological Response at End of Treatment |
95.5; 100.0; 95.1; 100.0 | — |
| SECONDARY Percentage of Participants With Relapse |
0.6; 0.0; 0.6; 0.0 | — |
| SECONDARY Percentage of Participants With Breakthrough |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With a Rapid Virological Response at Week 4 |
3.7; 0.0; 4.0; 5.0 | — |
| SECONDARY Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24) |
96.3; 100.0; 96.0; 95.0 | — |
| SECONDARY Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment (SVR12) |
97.6; 100.0; 97.4; 95.0 | — |
| SECONDARY Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment |
0.5; 0.0; 0.6; 0.0; 1.6; 0.0 | — |
| SECONDARY Assigned Treatment Regimen |
0; 0; 0; 8; 0; 0 | — |
| SECONDARY Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA |
18; 227; 141; 0; 0; 1 | — |
| SECONDARY Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV |
14; 105; 1; 8; 0; 19 | — |
| SECONDARY Number of Participants With Comorbidities |
224; 10; 214; 16; 15; 2 | — |
| SECONDARY Number of Participants Who Received Concomitant Medications |
10; 103; 64 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies |
8; 19; 42; 3; 3; 8 | — |
| SECONDARY Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score |
0.06; 0.04; 0.04; 0.07; 0.05; 0.04 | — |
| SECONDARY Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score |
4.10; 7.41; 5.13; 7.93; 9.11; 7.01 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism |
-5.0; 0.0; 0.0; -5.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) |
-5.0; 0.0; 0.0; -5.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Treatment-naïve or -experienced adult male or female patients 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).
- Patients must voluntarily sign and date a patient authorization to use and/or disclose his/her anonymized health data prior to inclusion into the study.
- Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial
Exclusion Criteria
-None
Data sourced from ClinicalTrials.gov (NCT02640547). 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.