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

AbbVie158 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

158

Conditions

Chronic Hepatitis C Genotype 1

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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)

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.

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

Secondary Outcomes

Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse

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.

Time frame: 12 weeks after last actual dose of study drug

SVR12 Non-Response: Percentage of Participants With Breakthrough

Breakthrough is defined as at least 1 documented HCV RNA \<50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment.

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

SVR12 Non-Response: Percentage of Participants With Failure to Suppress

Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.

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

SVR12 Non-Response: Percentage of Participants With Relapse

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.

Time frame: 12 weeks after last actual dose of study drug

SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure

Data from ClinicalTrials.gov

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