Clinical trial NCT02615145: 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)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
Dasabuvir
Ombitasvir+Paritaprevir+Ritonavir
Observational Study
Quality of life
Work-ability
Fibrosis
Cirrhosis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-11-26
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Hepatitis C (CHC)

Brief 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.


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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR12)
timeFrame: 12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks)
Secondary outcomes:
measure: Percentage of Participants With Virological Response at End of Treatment (EoTR)
timeFrame: EoT, (treatment period was 12 weeks or 24 weeks)
measure: Number of Participants With On-Treatment Virological Failure or Relapse
timeFrame: Up to post-treatment Week 12 (treatment period was 12 or 24 weeks)
measure: Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)
timeFrame: Week 4
measure: Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)
timeFrame: 24 Weeks After EoT (treatment period was 12 or 24 weeks)
measure: Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)
timeFrame: 48 Weeks After EoT (treatment period was 12 or 24 weeks)
measure: Change From Baseline in PRISM Over Time
timeFrame: Baseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks)
measure: Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection
timeFrame: up to post-treatment Week 48 (treatment period was 12 or 24 weeks)
measure: Percentage of Participants Taking ≥ 1 Co-Medication
timeFrame: up to post-treatment Week 48 (treatment period was 12 or 24 weeks)
measure: Mean Duration of of ABBVIE REGIMEN and RBV Taken
timeFrame: Up to Week 12 or Week 24
measure: Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken
timeFrame: Up to Week 12 or Week 24
measure: Change From Baseline in FACIT-F Scale Over Time
timeFrame: Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT
measure: Change From Baseline to EoT in PAM-13 Questionnaire
timeFrame: Baseline, EoT (treatment period was 12 or 24 weeks)
measure: Change From Baseline Over Time in WPAI: Total Work Productivity Impairment
timeFrame: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT
measure: Change From Baseline Over Time in WPAI: Total Activity Impairment
timeFrame: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies
timeFrame: up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.