Reinfection and Risk Behaviors After Treatment of Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy : A Cohort Study.
Journal
Annals of internal medicine
ISSN: 1539-3704
Titre abrégé: Ann Intern Med
Pays: United States
ID NLM: 0372351
Informations de publication
Date de publication:
09 2022
09 2022
Historique:
pubmed:
9
8
2022
medline:
23
9
2022
entrez:
8
8
2022
Statut:
ppublish
Résumé
Hepatitis C virus (HCV) reinfection after successful treatment may reduce the benefits of cure among people who inject drugs. To evaluate the rate of HCV reinfection for 3 years after successful treatment among people receiving opioid agonist therapy (OAT). A 3-year, long-term, extension study of persons enrolled in the CO-STAR (Hepatitis C Patients on Opioid Substitution Therapy Antiviral Response) study (ClinicalTrials.gov: NCT02105688). 55 clinical trial sites in 13 countries. Aged 18 years and older with chronic HCV infection with genotypes 1, 4, or 6 receiving stable OAT. No treatments were administered. Serum samples were assessed for HCV reinfection. Urine drug screening was performed. Among 296 participants who received treatment, 286 were evaluable for reinfection and 199 were enrolled in the long-term extension study. The rate of HCV reinfection was 1.7 [95% CI, 0.8 to 3.0] per 100 person-years; 604 person-years of follow-up). A higher rate of reinfection was seen among people with recent injecting drug use (1.9 [95% CI, 0.5 to 4.8] per 100 person-years; 212 person-years). Ongoing drug use and injecting drug use were reported by 59% and 21% of participants, respectively, at the 6-month follow-up visit and remained stable during 3 years of follow-up. Participants were required to be 80% adherent to OAT at baseline and may represent a population with higher stability and lower risk for HCV reinfection. Rate of reinfection may be underestimated because all participants did not continue in the long-term extension study; whether participants who discontinued were at higher risk for reinfection is unknown. Reinfection with HCV was low but was highest in the first 24 weeks after treatment completion and among people with ongoing injecting drug use and needle-syringe sharing. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Sections du résumé
BACKGROUND
Hepatitis C virus (HCV) reinfection after successful treatment may reduce the benefits of cure among people who inject drugs.
OBJECTIVE
To evaluate the rate of HCV reinfection for 3 years after successful treatment among people receiving opioid agonist therapy (OAT).
DESIGN
A 3-year, long-term, extension study of persons enrolled in the CO-STAR (Hepatitis C Patients on Opioid Substitution Therapy Antiviral Response) study (ClinicalTrials.gov: NCT02105688).
SETTING
55 clinical trial sites in 13 countries.
PATIENTS
Aged 18 years and older with chronic HCV infection with genotypes 1, 4, or 6 receiving stable OAT.
INTERVENTION
No treatments were administered.
MEASUREMENTS
Serum samples were assessed for HCV reinfection. Urine drug screening was performed.
RESULTS
Among 296 participants who received treatment, 286 were evaluable for reinfection and 199 were enrolled in the long-term extension study. The rate of HCV reinfection was 1.7 [95% CI, 0.8 to 3.0] per 100 person-years; 604 person-years of follow-up). A higher rate of reinfection was seen among people with recent injecting drug use (1.9 [95% CI, 0.5 to 4.8] per 100 person-years; 212 person-years). Ongoing drug use and injecting drug use were reported by 59% and 21% of participants, respectively, at the 6-month follow-up visit and remained stable during 3 years of follow-up.
LIMITATIONS
Participants were required to be 80% adherent to OAT at baseline and may represent a population with higher stability and lower risk for HCV reinfection. Rate of reinfection may be underestimated because all participants did not continue in the long-term extension study; whether participants who discontinued were at higher risk for reinfection is unknown.
CONCLUSION
Reinfection with HCV was low but was highest in the first 24 weeks after treatment completion and among people with ongoing injecting drug use and needle-syringe sharing.
PRIMARY FUNDING SOURCE
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Substances chimiques
Analgesics, Opioid
0
Banques de données
ClinicalTrials.gov
['NCT02105688']
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM