Study of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

Study Overview
=================
Brief Summary
-----------------
The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC) viral infection has been shown to be safe and effective in randomized controlled clinical trials. This observational study is an effectiveness research examining the regimen of GLE/PIB, used according to local label, under real world conditions in a clinical practice patient population.

Official Title
-----------------
Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

Conditions
-----------------
Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants are treatment-naïve or treatment-experienced with pegylatedinterferon (pegIFN), or IFN, and/or ribavirin (RBV) and/or sofosbuvir (PRS) with confirmed chronic hepatitis C (CHC), genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral glecaprevir plus pibrentasvir (GLE/PIB) regimen according to standard of care, international guidelines and in line with the current local label. Participants may be enrolled up to 4 weeks after treatment initiation Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial. Exclusion Criteria: None.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 standard of care, international guidelines and in line with the current local label. | |

What is the study measuring?
-----------------
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 less than the lower limit of quantification 12 weeks after the last dose of Glecaprevir plus Pibrentasvir | 12 weeks (i.e. at least 70 days) after the last dose of Glecaprevir plus Pibrentasvir | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Taking Concomitant Medications | The percentage of participants taking concomitant medications from the decision to initiate treatment through 12 weeks after the last dose of glecaprevir plus pibrentasvir. | Up to approximately 28 weeks | 
| Percentage of Glecaprevir plus Pibrentasvir (GLE/PIB) Doses Taken out of that Prescribed | The percentage of GLE/PIB doses taken by participant in relation to the prescribed target dose (number of pills taken out of the number of pills that should have been taken). | Up to approximately 16 weeks | 
| Changes from Baseline in Estimated Glomerular Filtration Rate (eGFR) | Among participants with renal impairment, changes from baseline during treatment in estimated glomerular filtration rate (eGFR determined by Modification of Diet in Renal Disease [MDRD] equation). | Up to 16 weeks | 
| Number of Healthcare 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 an Health Care Provider (HCP) or designee in relation to their HCV infection during the study. | Up to approximately 28 weeks | 
| Percentage of Participants Using Each Treatment Regimen | Percentage of participants using each treatment regimen (intended treatment duration of 8, 12, or 16 weeks) | Up to 16 weeks | 
| Percentage of Participants with Co-morbidities | The percentage of participants with co-morbidities at baseline. | Baseline (Day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Hepatitis C, Sustained Virological Response, Chronic Hepatitis C genotype 1, Chronic Hepatitis C genotype 2, Chronic Hepatitis C genotype 3, Chronic Hepatitis C genotype 4, Chronic Hepatitis C genotype 5, Chronic Hepatitis C genotype 6