A Study Describing the Care Cascade and Effectiveness and Safety of Glecaprevir/Pibrentasvir in Adult Participants With Hepatitis C Virus in French Addiction Centers

Study Overview
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Brief Summary
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Hepatitis C Virus is liver disease and is a leading cause of death and morbidity with around 71 million people affected worldwide. Widespread availability of highly effective direct-acting antivirals (DAAs) have dramatically changed the treatment landscape of HCV with a cure rate of over 95%. In May 2019, French Health Authorities expanded prescription abilities to all physicians treating adult treatment-naive patients with HCV without cirrhosis of the liver. This study will assess the treatment uptake and barriers to treatment by non-HCV specialist in France in community-based addiction centers. Beyond these evaluations, data on health resource utilization in addiction centers, level of knowledge of both patients and providers on HCV infection and treatment, care cascade, effectiveness and safety of Glecaprevir/Pibrentasvir among patients treated in addiction centers and evolution of addiction behavior after treatment are of specific interest. Glecaprevir/Pibrentasvir is a drug approved to treat HCV. About 400 Adult participants with a confirmed positive HCV ribonucleic acid (RNA) test will be enrolled in the study at approximately 30 addiction centers in France. All participants will attend an inclusion visit. Participants who are not prescribed Glecaprevir/Pibrentasvir at the inclusion visit will have no further follow-up in the study. Participants who are prescribed Glecaprevir/Pibrentasvir will take three tablets once daily. The duration of the study is approximately 12 months. All study visits will occur during routine clinical practice but there may be a higher burden for participants prescribed Glecaprevir/Pibrentasvir. These participants will be asked to complete questionnaires after each visit.

Official Title
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New Care Pathways to Achieve HCV Elimination in the Community: Real-world Outcomes From HCV Infected Patients Treated in Addiction Centers in France

Conditions
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Hepatitis C Virus (HCV)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Followed in an addiction center. Confirmed positive for HCV ribonucleic acid (RNA). Exclusion Criteria: -None.

Ages Eligible for Study
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Minimum Age: 18 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 with Hepatitis C Virus With or Without Treatment<br>This study includes 3 populations for analysis: Target Population (TP): Defined as all participants enrolled in the study regardless of whether treated for HCV or not. Core Population (CP): Defined as all participants of the TP who have been prescribed glecaprevir/pibrentasvir (G/P) and started treatment. Safety Population (SP): Defined as all participants who received at least one dose of G/P. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with and without Hepatitis C Virus (HCV) treatment prescribed at end of the inclusion visit. | Percentage of participants with and without HCV treatment prescribed at end of the inclusion visit. Criteria for treatment choice and reasons for treatment refusal will be described. | Inclusion visit (Week 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Care Resources and Utilization | HCRU in the addiction centers will be described on the basis of declarative questionnaires completed at time of the study implementation (yearly number of people followed, health resources, staffing, formation of center team, capabilities regarding HCV screening, specialized consultations in hepatology, and liver fibrosis tests). | Inclusion visit (Week 0) | 
| Level of HCV infection knowledge | The level of knowledge of both patients and providers on HCV infection will be described on the basis of declarative questionnaires. For patients, analysis will be performed in the TP population and according to patient subgroups (with and without HCV treatment). | Inclusion visit (Week 0) | 
| Determinants associated with initiation of HCV treatment | Criteria for treatment choice or no treatment uptake assessed by physician, patient, and disease characteristics. | Inclusion visit (Week 0) | 
| Data and disease characteristics from patients with and without HCV treatment | Data and disease characteristics from patients with and without HCV treatment. | Inclusion visit (Week 0) | 
| Number of participants with HCV Antibodies (HCV Ab) | Number of participants with HCV Antibodies (HCV Ab). | Inclusion visit (Week 0) | 
| Number of participants with HCV RNA | Number of participants with HCV RNA. | Inclusion visit (Week 0) | 
| Time from HCV Ab to HCV RNA | Time from HCV Ab to HCV RNA. | Inclusion visit (Week 0) | 
| Time from HCV RNA to end of treatment | Time from HCV RNA to end of treatment. | Approximately 12 months | 
| Number of participants who completed treatment | Number of participants who completed treatment. | Approximately 12 months | 
| Percentage of participants achieving SVR12 | SVR12 defined as HCV RNA under the lower limit of quantification (LLOQ) 12 weeks after the last dose of treatment with a sensitive polymerase chain reaction (PCR) test. | Approximately 12 months | 
| Percentage of cured participants willing to share their experience with other substance abuse patients. | Percentage of cured participants willing to share their experience with other substance abuse patients at the SVR12 visit and up to 6 months after the SVR12 visit. | Approximately 12 months | 
| Number of participants achieving sustained viral response at 12 weeks (SVR12) | Number of participants achieving sustained viral response at 12 weeks (SVR12). | Approximately 12 months | 
| Time to SVR12 | Time to SVR12 | Approximately 12 months | 
| Number of people in charge of patient follow-up | Number of people in charge of patient follow-up including physicians, nurses, social workers. | Approximately 12 months | 
| Percentage of participants with treatment adherence | Defined as the percentage of participants who have taken the target dose according to participant reporting. | Approximately 12 months | 
| Patient Reported Quality of Life | Anxiety and depression questionnaires and global assessment using visual analog scale. | Approximately 12 months | 
| Number of participants with addictive behaviors | Addictive behaviors of participants (alcohol and drug consumption) will be assessed by participant-completed questionnaires. | Approximately 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C Virus, HCV, glecaprevir/pibrentasvir, Maviret