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

Hepatitis C Virus (HCV) Clinical Trial

— NeoVie  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366973
• Other study ID #: P20-127
• Status: Completed
• Start date: May 26, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus (HCV)

Locations

Country	Name	City	State
France	Centre de Soins Accompagnement et de Prevention en Addictologie-Antibes /ID# 221277	Antibes
France	Centre de soin d'accompagnement et de prevention en addictologie-Paul Guiraud /ID# 218710	Bagneux	Ile-de-France
France	CSAPA Bagnols sur ceze /ID# 233397	Bagnols Sur Ceze	Gard
France	Centres de Soin d'Accompagnement et de Prevention en Addictologie -Bayonne /ID# 218673	Bayonne
France	CEID Bordeaux /ID# 221517	Bordeaux	Gironde
France	Centre Hospitalier Le Vinatier - Service universitaire d'addictologie de Lyon /ID# 218695	Bron	Rhone
France	CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 221278	Clermont Ferrand
France	Centre de Soins Accompagnement et de Prevention en Addictologie - AGORA /ID# 223793	Cognac
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 Accompagnement et de Prevention en Addictologie-CICAT /ID# 221281	Le Coudray
France	Centre de Soins Accompagnement et de Prevention en Addictologie-Boris Vian /ID# 221284	Lille	Nord
France	Centre Bobillot - Limoges /ID# 221922	Limoges
France	Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Sémaphore /ID# 222954	Marseille
France	Centres de Soin d'Accompagnement et de Prevention en Addictologie-Les WADS CMSEA /ID# 218671	Metz	Moselle
France	Centre de soins d'accompagnement et de prevention en addictologie-ANPAA 82 /ID# 218675	Montauban	Occitanie
France	Centre de soin d'accompagnement et prevention en addictologie-UTTD Montpellier /ID# 218683	Montpellier	Herault
France	Centre de Soins d'Accompagnement et de Prevention en Addictologie- Arc en ciel /ID# 218700	Montpellier	Herault
France	Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Cap /ID# 222776	Mulhouse
France	Clinique Jules Verne /ID# 241666	Nantes
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- Malaussena /ID# 218703	Nice
France	Centre de soin d'accompagnement et de prevention en addictologie- L'ENVOL /ID# 218680	Nimes	Gard
France	Centre de Soins d'Accompagnement et de Prevention en Addictologie-Nova Dona /ID# 221516	Paris
France	CSAPA CAARUD Aurore EGO /ID# 225050	Paris
France	CEID Bearn addictions /ID# 221279	Pau
France	Csapa Doaur Nevez de Ploermel /Id# 240583	Ploermel	Morbihan
France	Association Tremplin 17 - Saintes /ID# 218708	Saintes	Nouvelle-Aquitaine
France	Centre de soin d'accompagnement et de prevention en addictologie -ITHAQUE /ID# 218678	Strasbourg
France	Centre de Soins d'Accompagnement et de Prevention en Addictologie-Tempo Oppelia /ID# 218701	Valence	Drome

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Number of participants with HCV Antibodies (HCV Ab)	Number of participants with HCV Antibodies (HCV Ab).	Inclusion visit (Week 0)
Secondary	Number of participants with HCV RNA	Number of participants with HCV RNA.	Inclusion visit (Week 0)
Secondary	Time from HCV Ab to HCV RNA	Time from HCV Ab to HCV RNA.	Inclusion visit (Week 0)
Secondary	Time from HCV RNA to end of treatment	Time from HCV RNA to end of treatment.	Approximately 12 months
Secondary	Number of participants who completed treatment	Number of participants who completed treatment.	Approximately 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to SVR12	Time to SVR12	Approximately 12 months
Secondary	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
Secondary	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
Secondary	Patient Reported Quality of Life	Anxiety and depression questionnaires and global assessment using visual analog scale.	Approximately 12 months
Secondary	Number of participants with addictive behaviors	Addictive behaviors of participants (alcohol and drug consumption) will be assessed by participant-completed questionnaires.	Approximately 12 months

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