Reaching people receiving opioid agonist therapy attending community pharmacies with HCV: An international cluster randomised controlled trial.


Author: Christopher Byrne Andrew Radley Sarah Inglis Lewis Beer Nicki Palmer Minh Duc Pham Kate Allardice Huan Wang Monika Hermansson Dimitri Semizarov Brendan Healy Joseph Doyle John Dillon

Theme: Clinical Research Year: 2021

Background: Direct acting antivirals (DAA) can facilitate elimination of hepatitis c virus (HCV). However, conventional healthcare models struggle to engage those at risk. This study evaluated point-of-care (POC) HCV RNA diagnosis and DAA treatment for Opioid Agonist Therapy (OAT) clients in community pharmacies against conventional care. Methods: Pharmacies in Scotland, Wales, and Australia were randomized to conventional or intervention pathways. In the conventional pathway, pharmacists discussed HCV with OAT clients and directed them to local testing sites. In the intervention pathway, clients were directed to nurses for POC RNA testing in the pharmacy using Genedrive Diagnostics’ platform. HCV-positive participants received DAAs alongside OAT and follow-up for Sustained Virologic Response (SVR); via local sites in the conventional arm, and within pharmacies in the intervention arm. The study ran from October 2019–January 2021. Mixed effects logistic regression was performed using Stata IC 16. Results: Forty pharmacies were randomized evenly to each arm. The intention-to-treat (ITT) population contained 1,410 OAT clients. In the conventional arm (n=648), 62 (10%) agreed to testing, 17 (27%) were tested, 6 (35%) were RNA positive, and 5 (83%) initiated treatment. In the intervention arm (n=762), 148 (19%) agreed to testing, 144 (97%) were tested, 23 (16%) were RNA positive, and 22 (96%) initiated treatment. SVR was obtained by 2 (40%; conventional) and 18 (82%; intervention) participants. Statistical analysis indicated that participants in the intervention arm had higher odds of being tested, OR 16.95 (7.07–40.64), p =

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