Clinical trial NCT04366973: A Study Describing the Care Cascade and Effectiveness and Safety of Glecaprevir/Pibrentasvir in Adult Participants With Hepatitis C Virus in French Addiction Centers
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus (HCV)
Keywords: Hepatitis C Virus
HCV
glecaprevir/pibrentasvir
Maviret
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-04-29
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants treated with glecaprevir/pibrentasvir for confirmed positive Hepatitis C Virus.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-None.

Primary outcomes:
measure: Percentage of participants with and without Hepatitis C Virus (HCV) treatment prescribed at end of the inclusion visit.
timeFrame: Inclusion visit (Week 0)
Secondary outcomes:
measure: Health Care Resources and Utilization
timeFrame: Inclusion visit (Week 0)
measure: Level of HCV infection knowledge
timeFrame: Inclusion visit (Week 0)
measure: Determinants associated with initiation of HCV treatment
timeFrame: Inclusion visit (Week 0)
measure: Data and disease characteristics from patients with and without HCV treatment
timeFrame: Inclusion visit (Week 0)
measure: Number of participants with HCV Antibodies (HCV Ab)
timeFrame: Inclusion visit (Week 0)
measure: Number of participants with HCV RNA
timeFrame: Inclusion visit (Week 0)
measure: Time from HCV Ab to HCV RNA
timeFrame: Inclusion visit (Week 0)
measure: Time from HCV RNA to end of treatment
timeFrame: Approximately 12 months
measure: Number of participants who completed treatment
timeFrame: Approximately 12 months
measure: Percentage of participants achieving SVR12
timeFrame: Approximately 12 months
measure: Percentage of cured participants willing to share their experience with other substance abuse patients.
timeFrame: Approximately 12 months
measure: Number of participants achieving sustained viral response at 12 weeks (SVR12)
timeFrame: Approximately 12 months
measure: Time to SVR12
timeFrame: Approximately 12 months
measure: Number of people in charge of patient follow-up
timeFrame: Approximately 12 months
measure: Percentage of participants with treatment adherence
timeFrame: Approximately 12 months
measure: Patient Reported Quality of Life
timeFrame: Approximately 12 months
measure: Number of participants with addictive behaviors
timeFrame: Approximately 12 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre de soin d'accompagnement et de prevention en addictologie- CHU Archet 2 /ID# 218682
state: Alpes-Maritimes
city: Valence
country: France
facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie-Tempo Oppelia /ID# 218701
state: Drome
city: Bagnols Sur Ceze
country: France
facility: CSAPA Bagnols sur ceze /ID# 233397
state: Gard
city: Nimes
country: France
facility: Centre de soin d'accompagnement et de prevention en addictologie- L'ENVOL /ID# 218680
state: Gard
city: Bordeaux
country: France
facility: CEID Bordeaux /ID# 221517
state: Gironde
city: Montpellier
country: France
facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie- Arc en ciel /ID# 218700
state: Herault
city: Montpellier
country: France
facility: Centre de soin d'accompagnement et prevention en addictologie-UTTD Montpellier /ID# 218683
state: Herault
city: Bagneux
country: France
facility: Centre de soin d'accompagnement et de prevention en addictologie-Paul Guiraud /ID# 218710
state: Ile-de-France
city: Ploermel
country: France
facility: Csapa Doaur Nevez de Ploermel /Id# 240583
state: Morbihan
city: Metz
country: France
facility: Centres de Soin d'Accompagnement et de Prevention en Addictologie-Les WADS CMSEA /ID# 218671
state: Moselle
city: Lille
country: France
facility: Centre de Soins Accompagnement et de Prevention en Addictologie-Boris Vian /ID# 221284
state: Nord
city: Saintes
country: France
facility: Association Tremplin 17 - Saintes /ID# 218708
state: Nouvelle-Aquitaine
city: Montauban
country: France
facility: Centre de soins d'accompagnement et de prevention en addictologie-ANPAA 82 /ID# 218675
state: Occitanie
city: Bron
country: France
facility: Centre Hospitalier Le Vinatier - Service universitaire d'addictologie de Lyon /ID# 218695
state: Rhone
city: Antibes
country: France
facility: Centre de Soins Accompagnement et de Prevention en Addictologie-Antibes /ID# 221277
city: Bayonne
country: France
facility: Centres de Soin d'Accompagnement et de Prevention en Addictologie -Bayonne /ID# 218673
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 221278
city: Cognac
country: France
facility: Centre de Soins Accompagnement et de Prevention en Addictologie - AGORA /ID# 223793
city: Colmar
country: France
facility: Centre de Soins Accompagnement et de Prevention en Addictologie - ARGILE /ID# 223792
city: Fontaine-lès-Dijon
country: France
facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie-ANPAA 21 /ID# 222909
city: Le Coudray
country: France
facility: Centre de Soins Accompagnement et de Prevention en Addictologie-CICAT /ID# 221281
city: Limoges
country: France
facility: Centre Bobillot - Limoges /ID# 221922
city: Marseille
country: France
facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Sémaphore /ID# 222954
city: Mulhouse
country: France
facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Cap /ID# 222776
city: Nantes
country: France
facility: Clinique Jules Verne /ID# 241666
city: Nice
country: France
facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie- Malaussena /ID# 218703
city: Paris
country: France
facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie-Nova Dona /ID# 221516
city: Paris
country: France
facility: CSAPA CAARUD Aurore EGO /ID# 225050
city: Pau
country: France
facility: CEID Bearn addictions /ID# 221279
city: Strasbourg
country: France
facility: Centre de soin d'accompagnement et de prevention en addictologie -ITHAQUE /ID# 218678
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: