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Clinical Effectiveness of Pharmacy-Led versus Conventionally Delivered Antiviral Treatment for Hepatitis C in Patients Receiving Opioid Substitution Therapy: A Pragmatic Cluster Randomised Trial
37 Pages Posted: 2 Mar 2020
More...Abstract
Background: Highly-effective direct acting antiviral drugs (DAAs) provide the opportunity to eliminate Hepatitis C (HCV) infection. This study examined whether a community pharmacy pathway increased treatment uptake, treatment completion and cure rates for people receiving opioid substitution therapy (OST), compared to conventional care.
Methods: This cluster randomised trial was performed in 55 community pharmacies with patients receiving OST. Pharmacists either referred patients with evidence of HCV antibodies to conventional care (27 pharmacies) or assessed them in the pharmacy (28 pharmacies). All pharmacies were trained to offer dried blood spot testing (DBST). In the pharmacy arm, infection with HCV genotype 1 or 3 was confirmed, assessment bloods were taken, and DAAs were prescribed by a pharmacist. In the comparison arm, the patient received care outside the pharmacy. Once prescribed, medication in both arms was delivered as daily modified directly observed therapy alongside OST. The primary outcome was number of patients achieving sustained virologic response 12 weeks (SVR12) after treatment completion compared to total number of people receiving OST treatment at participating pharmacies.
Findings: More OST users in the pharmacy arm versus the conventional care arm agreed to DBST (245 vs 145, OR 2∙292, 0∙968-5∙427, p=0∙059); more patients diagnosed with HCV, initiated (112 vs 61, OR 1∙889, 1∙276-2∙789, p=0∙0015) and completed treatment (108 vs 58, OR 1∙928, 1∙321-2∙813, p=0∙0007); more patients achieved the primary endpoint SVR12 in the pharmacy arm compared to the conventional arm (98 vs 43, OR 2∙375, 1∙555-3∙628, p< 0∙0001).
Interpretation: Utilising pharmacists to deliver an HCV pathway, made testing and treatment more accessible for patients, whilst ensuring improved reach and maintaining high treatment success rates. Use of this pathway could form a key part on an integrated approach to HCV elimination.
Trial Registration: Trial registration: NCT02706223.
Funding Statement: Partnership between the Scottish Government, Gilead Sciences Inc. and Bristol Myers-Squib.
Declaration of Interests: Dr Radley: Honorariums from Gilead and Abbvie; Research Grants from Gilead and Roche. Prof Donnan: Research grants from Novo Nordisk, GSK, Shire pharmaceuticals, Gilead and Bristol Myers Squibb. Member of the New Drugs Committee of the Scottish Medicines Consortium. Dr Barclay: Speakers fees from Abbvie, Gilead, and advisory board fees from Abbvie, BMS, Gilead, MSD. Professor Dillon: Research Grants, and Honorariums from Abbvie, Bristol Myers Squibb, Gilead, Janssen, Merck Roche Sharp & Dohme and Roche. All other authors declare no competing interests.
Ethics Approval Statement: Ethics approval granted by East of Scotland Research Ethics Committee 2 (15/ES/0086), sponsor, research & development and Caldecott approvals by University of Dundee, NHS Tayside, NHS Grampian and NHS Greater Glasgow and Clyde.
Keywords: Hepatitis C; clinical pathways; community pharmacy; Randomised controlled trial; direct-acting antivirals
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