Reaching people receiving opioid agonist therapy at community pharmacies with hepatitis C virus: an international randomised controlled trial.


Journal

Alimentary pharmacology & therapeutics
ISSN: 1365-2036
Titre abrégé: Aliment Pharmacol Ther
Pays: England
ID NLM: 8707234

Informations de publication

Date de publication:
06 2022
Historique:
revised: 22 02 2022
received: 14 01 2022
accepted: 19 04 2022
pubmed: 11 5 2022
medline: 27 5 2022
entrez: 10 5 2022
Statut: ppublish

Résumé

Conventional healthcare models struggle to engage those at risk of hepatitis C virus (HCV) infection. This international study evaluated point-of-care (PoC) HCV RNA diagnostic outreach and direct-acting antiviral (DAA) treatment for individuals receiving opioid agonist therapy (OAT) in community pharmacies. We assessed the effectiveness of a roving nurse-led pathway offering PoC HCV RNA testing to OAT clients in community pharmacies relative to conventional care. Pharmacies in Scotland, Wales, and Australia were randomised to provide PoC HCV RNA testing or conventional referral. Pharmacists directed OAT clients to on-site nurses (intervention) or local clinics (control). Infected participants were treated with DAAs, alongside OAT. Primary outcome was the number of participants with sustained virologic response at 12 weeks (SVR) and analysed using mixed effects logistic regression in the intention-to-treat (ITT) population. Forty pharmacies were randomised. The ITT population contained 1410 OAT clients. In the conventional arm (n = 648), 62 (10%) agreed to testing, 17 (27%) were tested, 6 (35%) were positive and 5 (83%) initiated treatment. In the intervention arm (n = 762), 148 (19%) agreed to testing, 144 (97%) were tested, 23 (16%) were positive and 22 (96%) initiated treatment. SVR was obtained by 2 (40%; conventional) and 18 (82%; intervention). Intervention arm participants had higher odds of testing, OR 16.95 (7.07-40.64, p < 0.001); treatment, OR 4.29 (1.43-12.92, p = 0.010); and SVR, OR 8.64 (1.82-40.91, p = 0.007). Nurse-led PoC diagnosis in pharmacies made HCV care more accessible for OAT clients relative to conventional care. However, strategies to improve testing uptake are required. NCT03935906.

Sections du résumé

BACKGROUND
Conventional healthcare models struggle to engage those at risk of hepatitis C virus (HCV) infection. This international study evaluated point-of-care (PoC) HCV RNA diagnostic outreach and direct-acting antiviral (DAA) treatment for individuals receiving opioid agonist therapy (OAT) in community pharmacies.
AIMS
We assessed the effectiveness of a roving nurse-led pathway offering PoC HCV RNA testing to OAT clients in community pharmacies relative to conventional care.
METHODS
Pharmacies in Scotland, Wales, and Australia were randomised to provide PoC HCV RNA testing or conventional referral. Pharmacists directed OAT clients to on-site nurses (intervention) or local clinics (control). Infected participants were treated with DAAs, alongside OAT. Primary outcome was the number of participants with sustained virologic response at 12 weeks (SVR) and analysed using mixed effects logistic regression in the intention-to-treat (ITT) population.
RESULTS
Forty pharmacies were randomised. The ITT population contained 1410 OAT clients. In the conventional arm (n = 648), 62 (10%) agreed to testing, 17 (27%) were tested, 6 (35%) were positive and 5 (83%) initiated treatment. In the intervention arm (n = 762), 148 (19%) agreed to testing, 144 (97%) were tested, 23 (16%) were positive and 22 (96%) initiated treatment. SVR was obtained by 2 (40%; conventional) and 18 (82%; intervention). Intervention arm participants had higher odds of testing, OR 16.95 (7.07-40.64, p < 0.001); treatment, OR 4.29 (1.43-12.92, p = 0.010); and SVR, OR 8.64 (1.82-40.91, p = 0.007).
CONCLUSIONS
Nurse-led PoC diagnosis in pharmacies made HCV care more accessible for OAT clients relative to conventional care. However, strategies to improve testing uptake are required.
TRIAL REGISTRATION
NCT03935906.

Identifiants

pubmed: 35538396
doi: 10.1111/apt.16953
doi:

Substances chimiques

Analgesics, Opioid 0
Antiviral Agents 0
RNA 63231-63-0

Banques de données

ClinicalTrials.gov
['NCT03935906']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1512-1523

Informations de copyright

© 2022 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

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Auteurs

Christopher J Byrne (CJ)

Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.
Tayside Clinical Trials Unit, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.

Andrew Radley (A)

Directorate of Public Health, NHS Tayside, Kings Cross Hospital, Dundee, UK.

Sarah K Inglis (SK)

Tayside Clinical Trials Unit, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.

Lewis Beer (L)

Tayside Clinical Trials Unit, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.

Nicki Palmer (N)

Department of Microbiology and Infectious Diseases Cardiff, Public Health Wales, Cardiff, UK.

Minh Duc Pham (M)

Department of Infectious Diseases, The Alfred and Monash University, Melbourne, Victoria, Australia.
Disease Elimination Program, Burnet Institute, Melbourne, Victoria, Australia.

Kate Allardice (K)

Disease Elimination Program, Burnet Institute, Melbourne, Victoria, Australia.

Huan Wang (H)

Division of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, UK.

Emma Robinson (E)

Department of Gastroenterology, NHS Tayside, Ninewells Hospital and Medical School, Dundee, UK.

Monika Hermansson (M)

AbbVie Ltd, AbbVie House, Maidenhead, UK.

Dimitri Semizarov (D)

AbbVie Ltd, AbbVie House, Maidenhead, UK.

Brendan Healy (B)

Department of Microbiology and Infectious Diseases Cardiff, Public Health Wales, Cardiff, UK.

Joseph S Doyle (JS)

Department of Infectious Diseases, The Alfred and Monash University, Melbourne, Victoria, Australia.
Disease Elimination Program, Burnet Institute, Melbourne, Victoria, Australia.

John F Dillon (JF)

Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.
Department of Gastroenterology, NHS Tayside, Ninewells Hospital and Medical School, Dundee, UK.

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