DOT-C: A cluster randomised feasibility trial evaluating directly observed anti-HCV therapy in a population receiving opioid substitute therapy from community pharmacy.

ABSTRACT

BACKGROUND: Direct-acting antiviral therapy (DAAs) for hepatitis C infection (HCV) have a much smaller burden of treatment than interferon-based regimes, require less monitoring and are very effective. New pathways are required to increase access to treatment amongst people prescribed opioid substitution therapy (OST). METHODS: An exploratory cluster randomised controlled trial with mixed methods evaluation was undertaken to compare the uptake of dried blood spot testing (DBST) and treatment of people with genotype 1 HCV infection in a conventional service pathway versus a pharmacist-led pathway in a population receiving OST. RESULTS: Pharmacies randomised to the conventional pathway obtained 58 DBST from 244 patients (24%)15 new reactive tests and 33 new negative tests were identified. Within the pharmacist-led pathway, 94 DBST were obtained from 262 patients (36%) 26 new reactive tests and 54 new negative tests were identified. Participants in the pharmacist-led pathway were more likely to take a DBST (p<0.003). Of participants referred for treatment through the conventional pathway, 4 patients from 15 with new reactive tests (27%) attended clinic for assessment. In the pharmacist-led treatment pathway, 20 patients from 26 with new reactive tests (77%) attended for assessment blood tests. Participants in the pharmacist-led pathway were more likely to proceed through the assessment for treatment (p<0.002). One participant completed treatment through the conventional pathway and three patients completed treatment through the pharmacist-led pathway. The process evaluation identified key themes important to service user completers and staff participants. CONCLUSION: The study provides evidence that testing and treatment for HCV in a pharmacist led-pathway is a feasible treatment pathway for people who receive supervised OST consumption through community pharmacies. This feasibility trial therefore provides sufficient confirmation to justify proceeding to a full trial.