An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs

Study Overview
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Brief Summary
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Post-marketing surveillance study to evaluate the real world safety and effectiveness of Maviret (Glecaprevir/Pibrentasvir) administered under a normal, routine treatment practice by Korean patients with Chronic Hepatitis C Genotypes 1 to 6

Detailed Description
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Patients with type C hepatitis genotypes 1-6 who had been prescribed Maviret (glecaprevir/pibrentasvir) in accordance with approved local label. The sample size for this study is due to a requirement by local authorities.

Official Title
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Post-marketing Surveillance to Assess the Safety and Effectiveness of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs

Conditions
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Hepatitis C

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with chronic C hepatitis genotypes 1 to 6. Participants prescribed Maviret in accordance with approved local label. Exclusion Criteria: - Patients with contraindications to the approved local labels for Maviret.

Ages Eligible for Study
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Minimum Age: 12 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 |
| --- | --- |
| Hepatitis C<br>Participants with Hepatitis C Genotypes 1 to 6 receiving Maviret (glecaprevir/pibrentasvir) for 8, 12, or 16 weeks. | |

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 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after end of treatment. | 12 weeks after the last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ persistently during treatment period. | Up to 30 weeks | 
| Percentage of Participants With Post-treatment Relapse | Post-treatment relapse defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the end of treatment among participants who complete treatment and with HCV RNA levels < LLOQ at the end of treatment. | Up to 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, Chronic Hepatitis C, Genotypes, Genotypes 1 to 6, Maviret, Glecaprevir, Pibrentasvir