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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C Virus (HCV)

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• France
  • Antibes, France, 06600
    • Centre de Soins Accompagnement et de Prevention en Addictologie-Antibes /ID# 221277
  • Bayonne, France, 64109
    • Centres de Soin d'Accompagnement et de Prevention en Addictologie -Bayonne /ID# 218673
  • Clermont Ferrand, France, 63000
    • CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 221278
  • Cognac, France, 16010
    • Centre de Soins Accompagnement et de Prevention en Addictologie - AGORA /ID# 223793
  • Colmar, France, 68000
    • Centre de Soins Accompagnement et de Prevention en Addictologie - ARGILE /ID# 223792
  • Fontaine-lès-Dijon, France, 21121
    • Centre de Soins d'Accompagnement et de Prevention en Addictologie-ANPAA 21 /ID# 222909
  • Le Coudray, France, 28630
    • Centre de Soins Accompagnement et de Prevention en Addictologie-CICAT /ID# 221281
  • Limoges, France, 87000
    • Centre Bobillot - Limoges /ID# 221922
  • Marseille, France, 13001
    • Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Sémaphore /ID# 222954
  • Mulhouse, France, 68200
    • Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Cap /ID# 222776
  • Nantes, France, 44300
    • Clinique Jules Verne /ID# 241666
  • Nice, France, 06000
    • Centre de Soins d'Accompagnement et de Prevention en Addictologie- Malaussena /ID# 218703
  • Paris, France, 75014
    • Centre de Soins d'Accompagnement et de Prevention en Addictologie-Nova Dona /ID# 221516
  • Paris, France, 75018
    • CSAPA CAARUD Aurore EGO /ID# 225050
  • Pau, France, 64000
    • CEID Bearn addictions /ID# 221279
  • Strasbourg, France, 67000
    • Centre de soin d'accompagnement et de prevention en addictologie -ITHAQUE /ID# 218678
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06200
      • Centre de soin d'accompagnement et de prevention en addictologie- CHU Archet 2 /ID# 218682
  • Drome
    • Valence, Drome, France, 26000
      • Centre de Soins d'Accompagnement et de Prevention en Addictologie-Tempo Oppelia /ID# 218701
  • Gard
    • Bagnols Sur Ceze, Gard, France, 30200
      • CSAPA Bagnols sur ceze /ID# 233397
    • Nimes, Gard, France, 30900
      • Centre de soin d'accompagnement et de prevention en addictologie- L'ENVOL /ID# 218680
  • Gironde
    • Bordeaux, Gironde, France, 33000
      • CEID Bordeaux /ID# 221517
  • Herault
    • Montpellier, Herault, France, 34000
      • Centre de Soins d'Accompagnement et de Prevention en Addictologie- Arc en ciel /ID# 218700
    • Montpellier, Herault, France, 34090
      • Centre de soin d'accompagnement et prevention en addictologie-UTTD Montpellier /ID# 218683
  • Ile-de-France
    • Bagneux, Ile-de-France, France, 92220
      • Centre de soin d'accompagnement et de prevention en addictologie-Paul Guiraud /ID# 218710
  • Morbihan
    • Ploermel, Morbihan, France, 56800
      • Csapa Doaur Nevez de Ploermel /Id# 240583
  • Moselle
    • Metz, Moselle, France, 57000
      • Centres de Soin d'Accompagnement et de Prevention en Addictologie-Les WADS CMSEA /ID# 218671
  • Nord
    • Lille, Nord, France, 59800
      • Centre de Soins Accompagnement et de Prevention en Addictologie-Boris Vian /ID# 221284
  • Nouvelle-Aquitaine
    • Saintes, Nouvelle-Aquitaine, France, 17100
      • Association Tremplin 17 - Saintes /ID# 218708
  • Occitanie
    • Montauban, Occitanie, France, 82000
      • Centre de soins d'accompagnement et de prevention en addictologie-ANPAA 82 /ID# 218675
  • Rhone
    • Bron, Rhone, France, 69500
      • Centre Hospitalier Le Vinatier - Service universitaire d'addictologie de Lyon /ID# 218695

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-None.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: HCV; Hepatitis C Virus; Maviret; glecaprevir/pibrentasvir
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: P20-127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No