A Study Describing the Care Cascade and Effectiveness and Safety of Glecaprevir/Pibrentasvir in Adult Participants With Hepatitis C Virus in French Addiction Centers
- Conditions
- Hepatitis C Virus (HCV)
- Registration Number
- NCT04366973
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- Followed in an addiction center.
- Confirmed positive for HCV ribonucleic acid (RNA).
-None.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants with and without Hepatitis C Virus (HCV) treatment prescribed at end of the inclusion visit. Inclusion visit (Week 0) 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.
- Secondary Outcome Measures
Name Time Method Number of participants with HCV Antibodies (HCV Ab) Inclusion visit (Week 0) Number of participants with HCV Antibodies (HCV Ab).
Time from HCV RNA to end of treatment Approximately 12 months Time from HCV RNA to end of treatment.
Health Care Resources and Utilization Inclusion visit (Week 0) 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).
Level of HCV infection knowledge Inclusion visit (Week 0) 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).
Determinants associated with initiation of HCV treatment Inclusion visit (Week 0) Criteria for treatment choice or no treatment uptake assessed by physician, patient, and disease characteristics.
Number of participants achieving sustained viral response at 12 weeks (SVR12) Approximately 12 months Number of participants achieving sustained viral response at 12 weeks (SVR12).
Percentage of cured participants willing to share their experience with other substance abuse patients. Approximately 12 months 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.
Data and disease characteristics from patients with and without HCV treatment Inclusion visit (Week 0) Data and disease characteristics from patients with and without HCV treatment.
Number of participants who completed treatment Approximately 12 months Number of participants who completed treatment.
Number of people in charge of patient follow-up Approximately 12 months Number of people in charge of patient follow-up including physicians, nurses, social workers.
Number of participants with HCV RNA Inclusion visit (Week 0) Number of participants with HCV RNA.
Time from HCV Ab to HCV RNA Inclusion visit (Week 0) Time from HCV Ab to HCV RNA.
Percentage of participants achieving SVR12 Approximately 12 months 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.
Time to SVR12 Approximately 12 months Time to SVR12
Percentage of participants with treatment adherence Approximately 12 months Defined as the percentage of participants who have taken the target dose according to participant reporting.
Number of participants with addictive behaviors Approximately 12 months Addictive behaviors of participants (alcohol and drug consumption) will be assessed by participant-completed questionnaires.
Patient Reported Quality of Life Approximately 12 months Anxiety and depression questionnaires and global assessment using visual analog scale.
Trial Locations
- Locations (30)
Association Tremplin 17 - Saintes /ID# 218708
🇫🇷Saintes, Nouvelle-Aquitaine, France
Centre de soin d'accompagnement et de prevention en addictologie-Paul Guiraud /ID# 218710
🇫🇷Bagneux, Ile-de-France, France
CEID Bearn addictions /ID# 221279
🇫🇷Pau, France
Centre de Soins d'Accompagnement et de Prevention en Addictologie- Arc en ciel /ID# 218700
🇫🇷Montpellier, Herault, France
Csapa Doaur Nevez de Ploermel /Id# 240583
🇫🇷Ploermel, Morbihan, France
CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 221278
🇫🇷Clermont Ferrand, France
Centre Bobillot - Limoges /ID# 221922
🇫🇷Limoges, France
Centre de soin d'accompagnement et de prevention en addictologie- L'ENVOL /ID# 218680
🇫🇷Nimes, Gard, France
Centre de soin d'accompagnement et de prevention en addictologie- CHU Archet 2 /ID# 218682
🇫🇷Nice, Alpes-Maritimes, France
Centre de Soins d'Accompagnement et de Prevention en Addictologie-Tempo Oppelia /ID# 218701
🇫🇷Valence, Drome, France
Centres de Soin d'Accompagnement et de Prevention en Addictologie-Les WADS CMSEA /ID# 218671
🇫🇷Metz, Moselle, France
CSAPA Bagnols sur ceze /ID# 233397
🇫🇷Bagnols Sur Ceze, Gard, France
Centre de soin d'accompagnement et prevention en addictologie-UTTD Montpellier /ID# 218683
🇫🇷Montpellier, Herault, France
Centre de Soins Accompagnement et de Prevention en Addictologie-Boris Vian /ID# 221284
🇫🇷Lille, Nord, France
Centre Hospitalier Le Vinatier - Service universitaire d'addictologie de Lyon /ID# 218695
🇫🇷Bron, Rhone, France
Centre de Soins Accompagnement et de Prevention en Addictologie-Antibes /ID# 221277
🇫🇷Antibes, France
Centre de Soins d'Accompagnement et de Prevention en Addictologie-Nova Dona /ID# 221516
🇫🇷Paris, France
Centres de Soin d'Accompagnement et de Prevention en Addictologie -Bayonne /ID# 218673
🇫🇷Bayonne, France
Centre de Soins Accompagnement et de Prevention en Addictologie - AGORA /ID# 223793
🇫🇷Cognac, France
Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Sémaphore /ID# 222954
🇫🇷Marseille, France
Clinique Jules Verne /ID# 241666
🇫🇷Nantes, France
CSAPA CAARUD Aurore EGO /ID# 225050
🇫🇷Paris, France
Centre de Soins Accompagnement et de Prevention en Addictologie - ARGILE /ID# 223792
🇫🇷Colmar, France
Centre de Soins d'Accompagnement et de Prevention en Addictologie-ANPAA 21 /ID# 222909
🇫🇷Fontaine-lès-Dijon, France
Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Cap /ID# 222776
🇫🇷Mulhouse, France
Centre de Soins Accompagnement et de Prevention en Addictologie-CICAT /ID# 221281
🇫🇷Le Coudray, France
Centre de Soins d'Accompagnement et de Prevention en Addictologie- Malaussena /ID# 218703
🇫🇷Nice, France
Centre de soin d'accompagnement et de prevention en addictologie -ITHAQUE /ID# 218678
🇫🇷Strasbourg, France
CEID Bordeaux /ID# 221517
🇫🇷Bordeaux, Gironde, France
Centre de soins d'accompagnement et de prevention en addictologie-ANPAA 82 /ID# 218675
🇫🇷Montauban, Occitanie, France