N/A
Completed N=158
Observational, Multi-Center Study of the Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation
Chronic Hepatitis C · Genotype 1
Source: ClinicalTrials.gov NCT02669940 ↗
Enrolled (actual)
158
Serious AEs
1.3%
Results posted
Nov 2018
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) — 22.2; 16.1; 18.6; 23.3 percentage of participants
Summary
This study seeks to assess the effectiveness, patient reported outcomes, work productivity and healthcare resource utilization of the interferon-free regimen of paritaprevir /ritonavir (r) - ombitasvir, ± dasabuvir ± ribavirin (RBV) in participants with chronic hepatitis C in a real life setting across clinical practice populations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) |
22.2; 16.1; 18.6; 23.3; 17.0; 19.6 | — |
| SECONDARY Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse |
73.0; 78.5; 76.3; 76.7; 83.0; 80.4 | — |
| SECONDARY SVR12 Non-Response: Percentage of Participants With Breakthrough |
1.6; 3.2; 2.6; 1.7; 3.4; 2.7 | — |
| SECONDARY SVR12 Non-Response: Percentage of Participants With Failure to Suppress |
61.9; 54.8; 57.7; 65.0; 58.0; 60.8 | — |
| SECONDARY SVR12 Non-Response: Percentage of Participants With Relapse |
9.5; 20.4; 16.0; 10.0; 21.6; 16.9 | — |
| SECONDARY SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data |
4.8; 5.4; 5.1 | — |
| SECONDARY Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) |
20.6; 14.0; 16.7; 20.0; 13.6; 16.2 | — |
| SECONDARY Percentage of Participants Achieving Virological Response at End of Treatment |
31.7; 30.1; 30.8; 31.7; 30.7; 31.1 | — |
Eligibility Criteria
Inclusion Criteria
Patients are eligible for observation in this cohort if the following applies:
- Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label
- If RBV is co-administered with paritaprevir/r - ombitasvir with or without dasabuvir, 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 informed consent prior to inclusion into the study
Exclusion Criteria
- Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial
Data sourced from ClinicalTrials.gov (NCT02669940). 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.