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

NCT04366973 | Completed

• 1 other identifier: P20-127
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 30

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.

Conditions

Hepatitis C Virus (HCV)

Keywords

Hepatitis C Virus; HCV; glecaprevir/pibrentasvir; Maviret

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Health Care Resources and Utilization

  Inclusion visit (Week 0)

• Level of HCV infection knowledge

  Inclusion visit (Week 0)

• Determinants associated with initiation of HCV treatment

  Inclusion visit (Week 0)

• Data and disease characteristics from patients with and without HCV treatment

  Inclusion visit (Week 0)

• Number of participants with HCV Antibodies (HCV Ab)

  Inclusion visit (Week 0)

Study Arms (1)

Participants with Hepatitis C Virus With or Without Treatment

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants treated with glecaprevir/pibrentasvir for confirmed positive Hepatitis C Virus.

You may qualify if:

• Followed in an addiction center.
• Confirmed positive for HCV ribonucleic acid (RNA).

You may not qualify if:

• None.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (30)

Centre de soin d'accompagnement et de prevention en addictologie- CHU Archet 2 /ID# 218682

Nice, Alpes-Maritimes, 06200, France

Location

Centre de Soins d'Accompagnement et de Prevention en Addictologie-Tempo Oppelia /ID# 218701

Valence, Drome, 26000, France

Location

CSAPA Bagnols sur ceze /ID# 233397

Bagnols-sur-Cèze, Gard, 30200, France

Location

Centre de soin d'accompagnement et de prevention en addictologie- L'ENVOL /ID# 218680

Nîmes, Gard, 30900, France

Location

CEID Bordeaux /ID# 221517

Bordeaux, Gironde, 33000, France

Location

Centre de Soins d'Accompagnement et de Prevention en Addictologie- Arc en ciel /ID# 218700

Montpellier, Herault, 34000, France

Location

Centre de soin d'accompagnement et prevention en addictologie-UTTD Montpellier /ID# 218683

Montpellier, Herault, 34090, France

Location

Csapa Doaur Nevez de Ploermel /Id# 240583

Ploërmel, Morbihan, 56800, France

Location

Centres de Soin d'Accompagnement et de Prevention en Addictologie-Les WADS CMSEA /ID# 218671

Metz, Moselle, 57000, France

Location

Centre de Soins Accompagnement et de Prevention en Addictologie-Boris Vian /ID# 221284

Lille, Nord, 59800, France

Location

Association Tremplin 17 - Saintes /ID# 218708

Saintes, Nouvelle-Aquitaine, 17100, France

Location

Centre de soins d'accompagnement et de prevention en addictologie-ANPAA 82 /ID# 218675

Montauban, Occitanie, 82000, France

Location

Centre Hospitalier Le Vinatier - Service universitaire d'addictologie de Lyon /ID# 218695

Bron, Rhone, 69500, France

Location

Centre de Soins Accompagnement et de Prevention en Addictologie-Antibes /ID# 221277

Antibes, 06600, France

Location

Centres de Soin d'Accompagnement et de Prevention en Addictologie -Bayonne /ID# 218673

Bayonne, 64109, France

Location

CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 221278

Clermont-Ferrand, 63000, France

Location

Centre de Soins Accompagnement et de Prevention en Addictologie - AGORA /ID# 223793

Cognac, 16010, France

Location

Centre de Soins Accompagnement et de Prevention en Addictologie - ARGILE /ID# 223792

Colmar, 68000, France

Location

Centre de Soins d'Accompagnement et de Prevention en Addictologie-ANPAA 21 /ID# 222909

Fontaine-lès-Dijon, 21121, France

Location

Centre de Soins Accompagnement et de Prevention en Addictologie-CICAT /ID# 221281

Le Coudray, 28630, France

Location

Centre Bobillot - Limoges /ID# 221922

Limoges, 87000, France

Location

Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Sémaphore /ID# 222954

Marseille, 13001, France

Location

Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Cap /ID# 222776

Mulhouse, 68200, France

Location

Clinique Jules Verne /ID# 241666

Nantes, 44300, France

Location

Centre de Soins d'Accompagnement et de Prevention en Addictologie- Malaussena /ID# 218703

Nice, 06000, France

Location

Centre de Soins d'Accompagnement et de Prevention en Addictologie-Nova Dona /ID# 221516

Paris, 75014, France

Location

CSAPA CAARUD Aurore EGO /ID# 225050

Paris, 75018, France

Location

CEID Bearn addictions /ID# 221279

Pau, 64000, France

Location

Centre de soin d'accompagnement et de prevention en addictologie -ITHAQUE /ID# 218678

Strasbourg, 67000, France

Location

Centre de soin d'accompagnement et de prevention en addictologie-Paul Guiraud /ID# 218710

Bagneux, Île-de-France Region, 92220, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 29, 2020
• Study Start: May 26, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

FR (30)