N/A
Completed N=65
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Colombia
Source: ClinicalTrials.gov NCT02851069 ↗Enrolled (actual)
65
Serious AEs
10.8%
Results posted
Sep 2019
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment — 87.7 percentage of participants
Summary
This is a prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV) receiving the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) with or without ribavirin (RBV). The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label.
This study focused on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods followed physicians' routine clinical practice using a 12-week treatment regimen (four visits plus two interim data collection windows) or a 24-week treatment regimen (four visits plus three interim data collection windows) and is based on the anticipated regular follow-up for patients undergoing treatment for chronic hepatitis C (CHC). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment |
87.7 | — |
| SECONDARY Percentage of Participants With Virologic Response at End of Treatment (EoT) |
95.4 | — |
| SECONDARY Number of Participants Meeting Premature Study Drug Discontinuation |
4; 61 | — |
| SECONDARY Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria |
12.3; 1.5; 1.5; 4.6; 4.6 | — |
| SECONDARY Percentage of Participants With Relapse |
1.5 | — |
| SECONDARY Percentage of Participants With Relapse at EoT |
1.8 | — |
| SECONDARY Percentage of Participants With Viral Breakthrough |
0.0 | — |
| SECONDARY Percentage of Participants Meeting On-treatment Virologic Failure |
1.5 | — |
| SECONDARY Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4) |
66.2 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT |
44.4 | — |
Eligibility Criteria
Inclusion Criteria
- Treatment-naïve or -experienced adult male or female participants with confirmed CHC, genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) ± ribavirin (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
- None
Data sourced from ClinicalTrials.gov (NCT02851069). 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.