Clinical trial NCT02669940: Observational, Multi-Center Study of the Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation
Official title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation - An Observational, Multi-Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Genotype 1
Keywords: Ombitasvir
Dasabuvir
Paritaprevir
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-02-01
Enrollment: 158
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: Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label.

Brief summary: This study seeks to assess the effectiveness, patient reported outcomes, work productivity and healthcare resource utilization of the interferon-free regimen of paritaprevir /ritonavir (r) - ombitasvir, ± dasabuvir ± ribavirin (RBV) in participants with chronic hepatitis C in a real life setting across clinical practice populations.


Eligibility criteria: Inclusion Criteria:

Patients are eligible for observation in this cohort if the following applies:

* Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label
* If RBV is co-administered with paritaprevir/r - ombitasvir with or without dasabuvir, 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 informed consent prior to inclusion into the study

Exclusion Criteria:

* Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)
timeFrame: 12 weeks after the last actual dose of study drug
Secondary outcomes:
measure: Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse
timeFrame: 12 weeks after last actual dose of study drug
measure: SVR12 Non-Response: Percentage of Participants With Breakthrough
timeFrame: 12 weeks after the last actual dose of study drug
measure: SVR12 Non-Response: Percentage of Participants With Failure to Suppress
timeFrame: 12 weeks after the last actual dose of study drug
measure: SVR12 Non-Response: Percentage of Participants With Relapse
timeFrame: 12 weeks after last actual dose of study drug
measure: SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure
timeFrame: 12 weeks after last actual dose of study drug
measure: SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data
timeFrame: 12 weeks after last actual dose of study drug
measure: Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)
timeFrame: 24 weeks after last actual dose of study drug
measure: Percentage of Participants Achieving Virological Response at End of Treatment
timeFrame: From baseline until end of treatment (12 or 24 weeks after actual first dose)
Other outcomes:
measure: Percentage of Participants Achieving SVR12: Additional Analysis
timeFrame: 12 weeks after the last actual dose of study drug
measure: Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis
timeFrame: 12 weeks after last actual dose of study drug
measure: SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis
timeFrame: 12 weeks after the last actual dose of study drug
measure: SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis
timeFrame: 12 weeks after the last actual dose of study drug
measure: SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis
timeFrame: 12 weeks after last actual dose of study drug
measure: Percentage of Participants Achieving SVR24: Additional Analysis
timeFrame: 24 weeks after last actual dose of study drug
measure: Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis
timeFrame: From baseline until end of treatment (12 or 24 weeks after actual first dose)
Locations:
Study officials:
affiliation: AbbVie
name: Andrey Strugovschikov, MD
role: STUDY_DIRECTOR
References: