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 Type
OBSERVATIONAL
Enrollment
95
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
CSAPA Bagnols sur ceze /ID# 233397
Bagnols-sur-Cèze, Gard, France
Centre de soin d'accompagnement et de prevention en addictologie- L'ENVOL /ID# 218680
Nîmes, Gard, France
CEID Bordeaux /ID# 221517
Bordeaux, Gironde, France
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.
Time frame: Inclusion visit (Week 0)
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Inclusion visit (Week 0)
Number of participants with HCV Antibodies (HCV Ab)
Number of participants with HCV Antibodies (HCV Ab).
Time frame: Inclusion visit (Week 0)
Number of participants with HCV RNA
Number of participants with HCV RNA.
Time frame: Inclusion visit (Week 0)
Time from HCV Ab to HCV RNA
Time from HCV Ab to HCV RNA.
Time frame: Inclusion visit (Week 0)
Time from HCV RNA to end of treatment
Time from HCV RNA to end of treatment.
Time frame: Approximately 12 months
Number of participants who completed treatment
Number of participants who completed treatment.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Approximately 12 months
Time to SVR12
Time to SVR12
Time frame: 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.
Time frame: 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.
Time frame: Approximately 12 months
Patient Reported Quality of Life
Anxiety and depression questionnaires and global assessment using visual analog scale.
Time frame: Approximately 12 months
Number of participants with addictive behaviors
Addictive behaviors of participants (alcohol and drug consumption) will be assessed by participant-completed questionnaires.
Time frame: Approximately 12 months
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Centre de Soins d'Accompagnement et de Prevention en Addictologie- Arc en ciel /ID# 218700
Montpellier, Herault, France
Centre de soin d'accompagnement et prevention en addictologie-UTTD Montpellier /ID# 218683
Montpellier, Herault, France
Csapa Doaur Nevez de Ploermel /Id# 240583
Ploërmel, Morbihan, France
Centres de Soin d'Accompagnement et de Prevention en Addictologie-Les WADS CMSEA /ID# 218671
Metz, Moselle, France
Association Tremplin 17 - Saintes /ID# 218708
Saintes, New Aquitaine, France
...and 20 more locations