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

Completed

• Conditions: Genotype 1; Chronic Hepatitis C

• Registration Number: NCT02669940
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-02-01
• Study Start: 2016-04-15
• Primary Completion: 2017-07-04
• Study Completion: 2017-07-04
• Status Verified: 2018-07
• Results First Submitted: 2018-07-02
• Results First Submitted QC: 2018-10-18
• Last Update Submitted: 2018-10-18
• Results First Posted: 2018-11-14
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)	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 Outcome Measures

Name	Time	Method
SVR12 Non-Response: Percentage of Participants With Breakthrough	12 weeks after the last actual dose of study drug	Breakthrough is defined as at least 1 documented HCV RNA \<50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment.
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	SVR24 is defined as HCV RNA levels \< 50 IU/mL 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
SVR12 Non-Response: Percentage of Participants With Relapse	12 weeks after last actual dose of study drug	Relapse is defined as HCV RNA \<50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.
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	Breakthrough is defined as at least 1 documented HCV RNA \<50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL. Relapse is defined as HCV RNA \< 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.
SVR12 Non-Response: Percentage of Participants With Failure to Suppress	12 weeks after the last actual dose of study drug	Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.
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	On-treatment virologic failure included virological breakthrough and failure to suppress. Virological breakthrough was defined as at least one documented HCV RNA \< 50 IU/mL or undetectable/negative followed by HCV RNA ≥ 50 IU/mL during treatment. Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.
Percentage of Participants Achieving Virological Response at End of Treatment	From baseline until end of treatment (12 or 24 weeks after actual first dose)	Virologic response is defined as HCV RNA \< 50 IU/mL.