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

TY - JOUR

T1 - Reaching people receiving opioid agonist therapy at community pharmacies with hepatitis C virus

T2 - An international randomised controlled trial

AU - Byrne, Christopher J.

AU - Radley, Andrew

AU - Inglis, Sarah K.

AU - Beer, Lewis

AU - Palmer, Nicki

AU - Duc Pham, Minh

AU - Allardice, Kate

AU - Wang, Huan

AU - Robinson, Emma

AU - Hermansson, Monika

AU - Semizarov, Dimitri

AU - Healy, Brendan

AU - Doyle, Joseph S.

AU - Dillon, John F.

N1 - Funding Information: AbbVie LTD. Grant Number: 811527 © 2022 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

PY - 2022/6

Y1 - 2022/6

N2 - 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, OR 16.95 (7.07–40.64, p < 0.001); treatment, OR 4.29 (1.43–12.92, p = 0.010); and SVR, OR 8.64 (1.82–40.91, p = 0.007).Conclusions: Nurse-led PoC diagnosis in pharmacies made HCV care more accessible for OAT clients relative to conventional care. However, strategies to improve testing uptake are required. Trial registration: NCT03935906.

AB - 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, OR 16.95 (7.07–40.64, p < 0.001); treatment, OR 4.29 (1.43–12.92, p = 0.010); and SVR, OR 8.64 (1.82–40.91, p = 0.007).Conclusions: Nurse-led PoC diagnosis in pharmacies made HCV care more accessible for OAT clients relative to conventional care. However, strategies to improve testing uptake are required. Trial registration: NCT03935906.

UR - https://www.scopus.com/pages/publications/85129973387

U2 - 10.1111/apt.16953

DO - 10.1111/apt.16953

M3 - Article

C2 - 35538396

SN - 0269-2813

VL - 55

SP - 1512

EP - 1523

JO - Alimentary Pharmacology & Therapeutics

JF - Alimentary Pharmacology & Therapeutics

IS - 12

ER -