Clinical trial NCT02798315: Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study
Official title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Kuwait
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: Paritaprevir/r - Ombitasvir, ± Dasabuvir
Sustained Virological Response
Chronic Hepatitis C genotype 4
Observational Study
Chronic Hepatitis C genotype 1
Chronic Hepatitis C
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-06-14
Enrollment: 40
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: Participants with CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV.

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 Kuwait in a clinical practice patient population.


Eligibility criteria: Inclusion Criteria:

* Treatment-naïve or -experienced adult male or female participants 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 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:

* Participant must not be participating or attending in a concurrent interventional therapeutic trial.

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks (i.e. at least 70 days) after the last dose of study drug
Secondary outcomes:
measure: Percentage of Participants With Virological Response at End of Treatment (EoT)
timeFrame: Up to EoT, maximum of 24 weeks
measure: Percentage of Participants With Relapse at EoT
timeFrame: Up to EoT, maximum of 24 weeks
measure: Percentage of Participants With Breakthrough.
timeFrame: Up to EoT, maximum of 24 weeks
measure: Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse
timeFrame: 12 weeks (i.e. at least 70 days) after the last dose of study drug
measure: Percentage of Participants Meeting the SVR Non-response Categories of Premature Study Drug Discontinuation or Missing SVR12 Data and/or None of the Above Criteria
timeFrame: 12 weeks (i.e. at least 70 days) after the last dose of study drug
measure: Adherence to ABBVIE Regimen: Percentage of the Direct-acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
timeFrame: Up to 48 weeks
measure: Adherence to RBV: Percentage of RBV Dose Taken in Relation to the Target Dose of RBV
timeFrame: Up to 48 weeks
measure: Adherence: Percentage of Planned Duration of RBV Taken by Participant
timeFrame: Up to 48 weeks
measure: Change From Baseline in the PAM-13 Questionnaire
timeFrame: Up to 48 weeks
measure: Patient Support Program (PSP) Questionnaire: Utilization of PSP Components
timeFrame: Up to EoT, maximum of 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Hany Salaheldine, MD
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.