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

TY - JOUR

T1 - DOT-C

T2 - A cluster randomised feasibility trial evaluating directly observed anti-HCV therapy in a population receiving opioid substitute therapy from community pharmacy

AU - Radley, Andrew

AU - Tait, Jan

AU - Dillon, John F.

N1 - This study was supported in part through a grant from Gilead Sciences Ltd.

PY - 2017/9

Y1 - 2017/9

N2 - 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.

AB - 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.

KW - Hepatitis C

KW - Directly acting antiviral drugs

KW - Clinical pathways

KW - Community pharmacy

KW - Feasibility trial

UR - https://www.scopus.com/pages/publications/85020863951

U2 - 10.1016/j.drugpo.2017.05.042

DO - 10.1016/j.drugpo.2017.05.042

M3 - Article

C2 - 28647161

SN - 0955-3959

VL - 47

SP - 126

EP - 136

JO - International Journal of Drug Policy

JF - International Journal of Drug Policy

ER -