Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6

Study Overview
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Brief Summary
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This multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6.

Official Title
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Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6

Conditions
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Hepatitis C Virus (HCV)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic hepatitis C virus infection and administering glecaprevir plus pibrentasvir. Exclusion Criteria: Patients previously treated with glecaprevir plus pibrentasvir.

Ages Eligible for Study
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Minimum Age: 0 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 |
| --- | --- |
| HCV Genotypes 1, 2, 3, 4, 5, or 6 participants<br>Participants receiving combination therapy with the glecaprevir plus pibrentasvir (GLE/PIB) regimen according to 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 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level < the lower limit of quantification (LLOQ) 12 weeks after the last dose of Glecaprevir plus Pibrentasvir. | 12 weeks after last dose of drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Post-treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA >= LLOQ between the end of treatment and 12 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 24 weeks after last dose of drug | 
| Percentage of Participants with On-treatment Virologic Failure | On-treatment virologic failure was defined as HCV RNA levels reach < LLOQ during treatment then increase to >= LLOQ during treatment, or confirmed increase of > 1 log10 IU/mL above the lowest value post-baseline HCV RNA during treatment. | Up to 12 weeks after first dose | 
| Percentage of Participants Achieving SVR4 | SVR4 defined as defined as the HCV RNA level < LLOQ 4 weeks after the last dose of Glecaprevir plus Pibrentasvir. | 4 weeks after last dose | 
| Percentage of Participants Achieving SVR8 | SVR8 defined as defined as the HCV RNA level < LLOQ 8 weeks after the last dose of Glecaprevir plus Pibrentasvir. | 8 weeks after last dose of drug | 
| Percentage of Participants Achieving SVR24 | SVR24 defined as the HCV RNA level < LLOQ 24 weeks after the last dose of Glecaprevir plus Pibrentasvir. | 24 weeks after last dose of drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genotype, sustained virologic response, chronic hepatitis C virus (HCV), glecaprevir, pibrentasvir, chronic hepatitis C virus genotype 1, chronic hepatitis C virus genotype 2, chronic hepatitis C virus genotype 3, chronic hepatitis C virus genotype 4, chronic hepatitis C virus genotype 5, chronic hepatitis C virus genotype 6