A Study of the Safety, Effectiveness and Clinical Use of Maviret in Adolescent Patients With Chronic Hepatitis C Virus

Study Overview
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Brief Summary
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This study will assess the safety and effectiveness of Maviret (Glecaprevir plus Pibrentasvir (GLE/PIB)) in adolescent participants diagnosed with chronic hepatitis C (CHC) in a real world setting across clinical practice in Japan.

Official Title
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Real World Evidence of the Safety and Clinical Practice Use of Maviret in Adolescents Patients Infected With Chronic Hepatitis C Virus (All Case Survey)

Conditions
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Hepatitis C Virus (HCV)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic Hepatitis C Virus (HCV) infection treated in daily practice with Maviret Enrolled after Maviret treatment begins Prior treatment with Maviret Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 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 |
| --- | --- |
| Maviret Participants<br>Participants receiving glecaprevir plus pibrentasvir (GLE/PIB, other names: Maviret) as routine standard of care for HCV. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Drug Reactions (ADRs) | Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out. | Up to approximately 36 weeks | 
| Percentage of Participants with Adverse Drug Reactions (ADRs) | Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out. | Up to approximately 36 weeks | 
| Number of Participants with Serious Adverse Events (SAEs) | A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgement, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent serious adverse events (TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. | Up to approximately 36 weeks | 
| Percentage of Participants with Serious Adverse Events (SAEs) | A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgement, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent serious adverse events (TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. | Up to approximately 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving Sustained Virologic Response 12 (SVR12) | Defined as HCV Ribonucleic acid (RNA) not detected 12 weeks after the last dose of study drug. | At Week 12 | 
| Percentage of participants achieving Sustained Virologic Response (SVR) | SVR defined as HCV Ribonucleic acid (RNA) < Lower limit of quantification (LLOQ). | At 4, 8, 12 and 24 weeks after last dose of Maviret (up to approximately 36 weeks) | 
| Percentage of Participants with On-Treatment Virologic Failure (Breakthrough) | On-treatment virologic failure (breakthrough) defined as at least 1 documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment or failure to suppress (each measured on-treatment HCV RNA value ≥ 50 IU/mL). | Up to approximately 36 weeks | 
| Percentage of Participants with After-Treatment Virologic Failure (Relapse) | After-treatment virologic failure (relapse) is defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 24 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. | Up to approximately 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C Virus (HCV), Chronic Hepatitis C (CHC), Maviret, Mavyret