N/A
Completed N=472
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Germany (LIFE-C)
Source: ClinicalTrials.gov NCT02615145 ↗Enrolled (actual)
472
Serious AEs
2.8%
Results posted
Oct 2019
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR12) — 88.1; 88.4; 77.9; 93.9 percentage of participants
Summary
The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.
This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Germany in a clinical practice patient population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR12) |
88.1; 88.4; 77.9; 93.9; 85.1 | — |
| SECONDARY Percentage of Participants With Virological Response at End of Treatment (EoTR) |
93.4; 94.8; 89.0; 97.8; 80.9 | — |
| SECONDARY Number of Participants With On-Treatment Virological Failure or Relapse |
6; 3; 3; 0; 3; 5 | — |
| SECONDARY Percentage of Participants With Rapid Virological Response at Week 4 (RVR4) |
57.0; 57.2; 62.1; 54.7; 55.3 | — |
| SECONDARY Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24) |
95.0; 95.4; 92.8; 96.5; 91.9 | — |
| SECONDARY Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48) |
92.7; 93.2; 89.0; 95.1; 88.0 | — |
| SECONDARY Change From Baseline in PRISM Over Time |
5.41; 7.05; 5.31; 10.2; 10.1; 10.3 | 0.1110 |
| SECONDARY Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection |
70.0; 69.3; 71.0; 68.3; 76.6 | — |
| SECONDARY Percentage of Participants Taking ≥ 1 Co-Medication |
59.1; 64.4; 54.1; 66.0 | — |
| SECONDARY Mean Duration of of ABBVIE REGIMEN and RBV Taken |
83; 84; 83; 84; 81; 84 | — |
| SECONDARY Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken |
98.7; 98.6; 97.7; 99.1; 99.8; 95.4 | — |
| SECONDARY Change From Baseline in FACIT-F Scale Over Time |
4.17; 6.45; 4.49; 12.5; 9.92; 10.2 | 0.5751 |
| SECONDARY Change From Baseline to EoT in PAM-13 Questionnaire |
1.91; 0.01; -0.74 | 0.3869 |
| SECONDARY Change From Baseline Over Time in WPAI: Total Work Productivity Impairment |
5.5; 5.0; 4.4; 7.5; -4.3; -4.2 | — |
| SECONDARY Change From Baseline Over Time in WPAI: Total Activity Impairment |
-2.1; 7.0; -3.0; -2.8; -11.9; -7.7 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies |
124; 16; 65; 43; 13; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Treatment-naïve or -experienced 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 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 pseudonymized 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
- Adolescents; people not treated according to label
Data sourced from ClinicalTrials.gov (NCT02615145). 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.