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

AbbVie0 sites158 target enrollmentApril 15, 2016

ConditionsChronic Hepatitis C Genotype 1

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Hepatitis C
Sponsor: AbbVie
Enrollment: 158
Primary Endpoint: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 15, 2016

End Date

July 4, 2017

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)

Time Frame: 12 weeks after the last actual dose of study drug

SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels \< 50 IU/mL 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.

Secondary Outcomes

SVR12 Non-Response: Percentage of Participants With Breakthrough(12 weeks after the last actual dose of study drug)
SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data(12 weeks after last actual dose of study drug)
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)(24 weeks after last actual dose of study drug)
SVR12 Non-Response: Percentage of Participants With Relapse(12 weeks after last actual dose of study drug)
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse(12 weeks after last actual dose of study drug)
SVR12 Non-Response: Percentage of Participants With Failure to Suppress(12 weeks after the last actual dose of study drug)
SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure(12 weeks after last actual dose of study drug)
Percentage of Participants Achieving Virological Response at End of Treatment(From baseline until end of treatment (12 or 24 weeks after actual first dose))