N/A
Completed N=60
Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir (r) - Ombitasvir, + Dasabuvir Without Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis in the Russian Federation
Source: ClinicalTrials.gov NCT03053180 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Mar 2019
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) — 98.3 percentage of participants
Summary
This prospective, multi-center, observational study is designed to assess the real world effectiveness of paritaprevir/r - ombitasvir with dasabuvir (3DAA [direct-acting antiviral agent] ABBVIE REGIMEN) without ribavirin (RBV) and to describe baseline characteristics of participants with chronic hepatitis C virus (HCV) genotype 1b (GT1b) infection and compensated liver cirrhosis in Russia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) |
98.3 | — |
| SECONDARY Percentage of Participants Achieving Virological Response at End of Treatment (EoT) |
100.0 | — |
| SECONDARY Percentage of Participants With Relapse |
0.0 | — |
| SECONDARY Percentage of Participants With Breakthrough |
0.0 | — |
| SECONDARY Percentage of Participants With Failure to Suppress |
0.0 | — |
| SECONDARY Percentage of Participants With Missing SVR12 Data |
1.7 | — |
Eligibility Criteria
Inclusion Criteria
- 3DAA ABBVIE REGIMEN will be prescribed by physicians according to the routine clinical practice
- Treatment-naïve or interferon (IFN)/ribavirin (RBV)-experienced participants with confirmed CHC Gt1b and compensated liver cirrhosis, receiving therapy with the interferon-free 3DAA ABBVIE REGIMEN initiated not earlier than 2 weeks before the enrollment or the initiation is planned not later than 2 weeks after the day of enrollment in accordance to standard of care and in line with the current local label
- Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial
Exclusion Criteria
- Co-administration ribavirin (RBV) with the 3DAA ABBVIE REGIMEN
- Participants with Child Pugh B and C cirrhosis
- Participants with a history of prior direct-acting antiviral agent (DAA) therapy
- Any other contraindications to the administration of 3DAA ABBVIE REGIMEN according to the label
Data sourced from ClinicalTrials.gov (NCT03053180). 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.