A Study of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation

Study Overview
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Brief Summary
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The objective of this study is to assess the effectiveness of the glecaprevir/pibrentasvir (GLE/PIB) regimen in adolescent participants aged 12 to <18 years of age with chronic hepatitis C (CHC) in clinical practice in the Russian Federation. The study also plans to assess effectiveness of GLE/PIB in subpopulations of interest like co-infected hepatitis C virus (HCV)/human immunodeficiency virus (HIV) adolescents, in various HCV genotype/subgenotype, cirrhotic and non-cirrhotic participants, treatment-experienced (prior treatment with pegylated interferon (pegIFN) or IFN, and/or Ribavirin (RBV) and/or sofosbuvir [PRS]) and treatment-naïve, adolescents who use drugs (PWUD) and non-drug users.

Official Title
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Real World EviDEnce of the EffecTIveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents 12 to <18 Years of Age With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation (DETI-2)

Conditions
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Hepatitis C Virus (HCV)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of chronic hepatitis C (CHC) with genotypes 1, 2, 3, 4, 5 or 6 with or without compensated cirrhosis Treatment naive or treatment experienced participants Receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines with the current local label Participant and his/her legal representative voluntarily signs and dates an informed consent form Must not be participating or intending to participant in a concurrent interventional therapeutic trial 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 |
| --- | --- |
| Participants Treated with GLE/PIB<br>Participants treated with all oral glecaprevir/pibrentasvir (GLE/PIB) and the decision to treat with GLE/PIB is made before the decision to offer an opportunity to join this study. Prescription of the treatment regimen is at the discretion of the physician and in accordance with local clinical practice and label. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Percentage of Participants Achieving Sustained Viral Response 12 (SVR12) | Defined as HCV RNA <50 IU/mL or <lower limit of qualification/detection (LLoQ/D) at the site 12 weeks after the last actual dose of GLE/PIB. | At Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Sustained Viral Response 12 (SVR12) With a Sensitive Polymerase Chain Reaction (PCR) Available in the Clinical Site | Defined as HCV RNA <50 IU/mL or <lower limit of qualification/detection (LLoQ/D) at the stie 12 weeks after the last actual dose of GLE/PIB. | At Week 12 | 
| Number of Participants With Co-morbidities | Number and percentage of participants with co-morbidities will be analyzed. | At Baseline Visit (Week 0) | 
| Number of Participants Taking Concomitant Medications | Number and percentage of participants taking concomitant medications will be analyzed. | Up to approximately 28 weeks | 
| Percentage of GLE/PIB Dose Taken by Participants in Relation to the Prescribed Target Dose | Percentage of GLE/PIB pills taken out of the number that was prescribed. | Up to approximately 16 weeks | 
| Number of Participants with Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. | Up to approximately 28 weeks | 
| Average Number of Visits/Touch Points as Part of Health Care Resource Utilization (HCRU) | Health Care Resource Utilization (HCRU) for a participant will be the total number of visits/touchpoints (face to face or phone call ) with a health care provider or designee in relation to their HCV infection during the study as recorded on an electronic case report form (eCRF). | Up to approximately 28 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 (C), Maviret