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

• Published in: The International journal of drug policy Vol. 47; pp. 126 - 136
• Main Authors: Radley, Andrew, Tait, Jan, Dillon, John F.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01-09-2017; Elsevier Science Ltd
• Subjects: Adult; Aged; Analgesics, Opioid - therapeutic use; Antiviral Agents - therapeutic use; Antiviral drugs; Blood tests; Clinical pathways; Clinical trials; Community pharmacists; Community pharmacy; Community Pharmacy Services - statistics & numerical data; Consumption; Directly acting antiviral drugs; Drug policy; Drug therapy; Evaluation; Feasibility; Feasibility Studies; Feasibility trial; Female; Genotypes; Hepatitis; Hepatitis C; Hepatitis C - blood; Hepatitis C - complications; Hepatitis C - drug therapy; Hepatitis C Antibodies - blood; Humans; Infections; Interferon; Interferon-alpha - therapeutic use; Male; Medical treatment; Middle Aged; Narcotics; Opiate Substitution Treatment - utilization; Opioids; Patients; Pharmacies; Pharmacists; Pharmacy; Ribavirin - therapeutic use; Substance Abuse, Intravenous - blood; Substance Abuse, Intravenous - complications; Substance Abuse, Intravenous - drug therapy; Uptake; Young Adult; Clinical pathways; Directly acting antiviral drugs; Hepatitis C; Feasibility trial; Community pharmacy
• ISSN: 0955-3959; 1873-4758
• DOI: 10.1016/j.drugpo.2017.05.042

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).
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.
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.
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.