Study of Oral Glecaprevir/Pibrentasvir Tablets in Participants Aged 12 Years or Older With Chronic Hepatitis C to Assess Sustained Virological Response

Study Overview
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Brief Summary
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Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver), liver cancer or the need for liver transplant. This study will evaluate how effective glecaprevir/pibrentasvir (GLE/PIB) is in participants with chronic HCV infection. Effectiveness will be assessed as the achievement of sustained virologic response. GLE/PIB is an approved drug for the treatment of HCV. Participants 12 years or older with chronic HCV infection will be enrolled. This is a prospective (conducted in future) study in therapy of direct-acting antiviral (DAA) treatment-experienced participants with chronic hepatitis C genotype 1. Around 67 participants will be enrolled at multiple sites in Russian Federation. Participants will receive oral GLE/PIB tablets as prescribed by the physician in accordance with local clinical practice, international guidelines and/or label. Prescription is independent from this study and is decided before providing opportunity to the participate in the study. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 12 weeks.

Official Title
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Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in DAA Treatment-Experienced Patients With Chronic Hepatitis C Genotype 1 in Russian Federation (CHOICE)

Conditions
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Hepatitis C Virus (HCV)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Direct-acting antiviral treatment-experienced participants with confirmed chronic hepatitis C (CHC) genotype 1, receiving combination therapy with the all oral glecaprevir/pibrentasvir (GLE/PIB) regimens according to standard of care, international guidelines and in line with the current local label. Participants can enroll up to 4 weeks after starting treatment Exclusion Criteria: - Participating or intending to participate in a concurrent interventional therapeutic trial.

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 |
| --- | --- |
| Participants treated with Glecaprevir/Pibrentasvir<br>Participants will receive glecaprevir/pibrentasvir (GLE/PIB) as prescribed by physician in accordance with local clinical practice. | |

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 (SVR) at Week 12 (SVR12) | SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < 50 IU/ml or lower limit of quantification/detection (LLoQ/D) available at the site at Week 12 after the last actual dose. | Week 12 after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving SVR12 | SVR12 is defined as HCV RNA < LLoQ/D 12 weeks after the last actual dose of GLE/PIB with a sensitive polymerase chain reaction (PCR) available in the clinical site in the settings of the Russian Federation in subgroups of interest. | Week 12 after the end of treatment | 
| Number of Participants With Co-morbidities and Taking Concomitant Medication | Number of participants with co-morbidities and taking concomitant medication of interest report will be calculated. | Up to Week 12 after the end of treatment | 
| Health Care Resource Utilization (HCRU) | HCRU will be total number of visits/touchpoints (face to face or phone call) with a Health Care Provider (HCP) or designee in relation to their HCV infection during the study as recorded overall and by subpopulations of interest. | Up to Week 12 after the end of treatment | 
| Percent of Glecaprevir/Pibrentasvir Dose Taken by Participant Report in Relation to the Prescribed Target Dose | Number of pills taken out of the number that should have been taken will be calculated. | Up to Week 12 after the end of treatment | 
| Number of Participants With Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient 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 overall and in subgroups of interest. 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. | Up to Week 12 after the end of treatment | 
| Percentage of Participants Who Experienced Post-Baseline Shifts in Clinical Laboratory Values | Percentage of participants who experience post-baseline shifts during treatment in clinical laboratory values will be summarized overall and in subgroups of interest. | Up to Week 12 after the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GLE/PIB, Hepatitis C Virus (HCV), Chronic Hepatitis C Infection, Glecaprevir/pibrentasvir, CHOICE, Chronic Hepatitis C Genotype 1