Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)

Study Overview
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Brief Summary
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The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) +/- Ribavirin (RBV) in chronic hepatitis C virus (HCV) infected participants in Austria.

Official Title
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Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Austria (REAL)

Conditions
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Chronic Hepatitis C

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype (GT)1 or GT4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label If RBV is co-administered with the ABBVIE REGIMEN, 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 a patient authorization to use and disclose his/her anonymized health data prior to inclusion into the study Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial Exclusion Criteria: none

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 |
| --- | --- |
| Chronic infection of HCV GT1 or GT4<br>Participants with confirmed chronic hepatitis C genotype (GT) 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) ± Ribavirin (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 study drug. | 12 Weeks after the last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Virological Response at End of Treatment (EoTR) | The percentage of participants with virological response (HCV RNA <50 IU/mL) at end of treatment (EoT, defined as last intake of ABBVIE REGIMEN or ribavirin [RBV]). | Up to 24 weeks of treatment | 
| Percentage of Participants With On-treatment Virologic Failure (Breakthrough) | The percentage of participants with on-treatment virologic failure (breakthrough [defined as at least one documented HCV RNA <50 IU/mL followed by HCV RNA >= 50 IU/mL during treatment]). | Up to approximately 24 weeks | 
| Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up) | SVR12 is defined as HCV RNA levels < 50 IU/mL 12 weeks after the last actual dose of study drug in the Core Population Sufficient Follow-up (CPSFU). | 12 weeks after last dose of study drug | 
| Percentage of Participants With Post-treatment Relapse | The percentage of participants with relapse (defined as HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL) | Up to 12 weeks after last dose of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paritaprevir, Dasabuvir, Ombitasvir, Chronic Hepatitis C, HCV