Reaching people receiving opioid agonist therapy at community pharmacies with hepatitis C virus: an international randomised controlled trial

Abstract

Background: Conventional healthcare models struggle to engage those at risk of hepatitis C virus (HCV) infection. This international study evaluated point-of-care (PoC) HCV RNA diagnostic outreach and direct-acting antiviral (DAA) treatment for individuals receiving opioid agonist therapy (OAT) in community pharmacies. Aims:We assessed the effectiveness of a roving nurse-led pathway offering PoC HCV RNA testing to OAT clients in community pharmacies relative to conventional care. Methods: Pharmacies in Scotland, Wales, and Australia were randomised to provide PoC HCV RNA testing or conventional referral. Pharmacists directed OAT clients to on-site nurses (intervention) or local clinics (control). Infected participants were treated with DAAs, alongside OAT. Primary outcome was the number of participants with sustained virologic response at 12 weeks (SVR) and analysed using mixed effects logistic regression in the intention-to-treat (ITT) population.Results: Forty pharmacies were randomised. The ITT population contained 1410 OAT clients. In the conventional arm (n = 648), 62 (10%) agreed to testing, 17 (27%) were tested, 6 (35%) were positive and 5 (83%) initiated treatment. In the intervention arm (n = 762), 148 (19%) agreed to testing, 144 (97%) were tested, 23 (16%) were positive and 22 (96%) initiated treatment. SVR was obtained by 2 (40%; conventional) and 18 (82%; intervention). Intervention arm participants had higher odds of testing,

Decentralisation of hepatitis C virus care into community settings: A key approach on the path to elimination

“…11 An international randomised trial of nurse-led point-of-care RNA diagnosis and DAA treatmentnurses facilitated DAAs according to an algorithm in UK sites, with MDT support if required-for OAT clients also reported positive preliminary results. 12 These reports align with a recent systematic review which found that decentralisation and integration of HCV care into community sites delivered comparable care to specialistled care irrespective of patient population. 13 Through enhanced diagnostic and treatment activity engagement delivered with wider community members of the care teams delivering HCV care i.e.…”

“…A randomised trial in Scotland which compared pharmacist‐led dried blood spot test diagnosis and pharmacist DAA prescribing for OAT clients—with MDT support sought under guidance of a decision matrix—led to higher rates of diagnosis and cure than conventional hospital care 11 . An international randomised trial of nurse‐led point‐of‐care RNA diagnosis and DAA treatment—nurses facilitated DAAs according to an algorithm in UK sites, with MDT support if required—for OAT clients also reported positive preliminary results 12 . These reports align with a recent systematic review which found that decentralisation and integration of HCV care into community sites delivered comparable care to specialist‐led care irrespective of patient population 13 .…”

Viral hepatitis testing and treatment in community pharmacies: a systematic review and meta-analysis

“…Two studies assessed testing uptake at pharmacies compared with other settings among people on OAT. 24 , 25 One found participants had higher odds of testing (OR 16.95, 95% CI 7.07–40.64, p < 0.001), when tested in the pharmacy by an in-reach nurse compared with being counselled by the pharmacist then referred to standard care outside the pharmacy. 24 The other found a higher odds of DBS testing (OR 2.25, 95% CI 1.48–3.41, p < 0.001) in pharmacies compared with other settings.…”

“… 24 , 25 One found participants had higher odds of testing (OR 16.95, 95% CI 7.07–40.64, p < 0.001), when tested in the pharmacy by an in-reach nurse compared with being counselled by the pharmacist then referred to standard care outside the pharmacy. 24 The other found a higher odds of DBS testing (OR 2.25, 95% CI 1.48–3.41, p < 0.001) in pharmacies compared with other settings. 25 In the other two comparative studies, all participants were tested at the pharmacy.…”

Laying the foundations for hepatitis C elimination: evaluating the development and contribution of community care pathways to diagnostic efforts

“…Within pharmacies, initial research indicated opioid agonist therapy (OAT) clients preferred to access HCV care in their community pharmacy, which led to feasibility studies of DBS testing in this setting – an effective approach – and subsequent trials which demonstrated pharmacist-led HCV testing and treatment resulted in OAT clients being twice as likely to agree to a test, 88% more likely to initiate treatment, and twice as likely to achieve a cure [ 12 , 13 , 15 , 16 , 24 ]. This pathway was later developed further by offering point-of-care RNA testing, which was also shown to be effective, and pharmacies now form a core stream within the pathway portfolio in Tayside [ 25 , 26 ]. Drug treatment and prison pathways were collaboratively developed through partnerships formed in the MCN, which involved training both non-specialist healthcare, and non-healthcare, staff to test and refer for HCV using DBS sampling, and concurrent to the evidence generating processes undertaken within other pathways.…”