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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Hepatitis C, Genotype 1

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants With Chronic Hepatitis C Genotype 1<br>Participants 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks after the last actual dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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 | 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. | 12 weeks after 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) | SVR24 is defined as HCV RNA levels < 50 IU/mL 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV. | 24 weeks after last actual dose of study drug | 
| Percentage of Participants Achieving Virological Response at End of Treatment | Virologic response is defined as HCV RNA < 50 IU/mL. | From baseline until end of treatment (12 or 24 weeks after actual first dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ombitasvir, Dasabuvir, Paritaprevir