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:
The research team acknowledge the contributions of all community pharmacists who participated, as well as the contributions of Eilidh Fergus (NHS Tayside), Linda Johnston (University of Dundee), Shirley Cleary (University of Dundee), Nicki Palmer (Public Health Wales), Kerry Rockey (Public Health Wales), Kate Allardice (Burnet Institute) and Kico Chan (Burnet Institute), for their key role in the successful delivery of the study under challenging circumstances. Declaration of personal interests: CJB, SKI, NP, MDP, KA, HW and ER have nothing to disclose. AR reports he has received research grants from Gilead, Bristol Myers Squibb, Abbvie and Roche and has received honorariums from Gilead and personal fees from Abbvie. LB reports grants from NIHR during the conduct of the study. DS and MH are employees of AbbVie and may hold stock in AbbVie. BH reports personal fees and other from Abbvie, personal fees and other from Gilead, outside the submitted work. JSD reports grants and personal fees from AbbVie, grants and personal fees from Gilead Sciences, and grants Bristol Myers Squibb, outside the submitted work. JFD reports grants and personal fees from Abbvie; grants and personal fees from Gilead, grants and personal fees from MSD outside the submitted work. AUTHORSHIP Guarantor of the article: Christopher J Byrne.
Funding Information:
CJB, SKI, NP, MDP, KA, HW and ER have nothing to disclose. AR reports he has received research grants from Gilead, Bristol Myers Squibb, Abbvie and Roche and has received honorariums from Gilead and personal fees from Abbvie. LB reports grants from NIHR during the conduct of the study. DS and MH are employees of AbbVie and may hold stock in AbbVie. BH reports personal fees and other from Abbvie, personal fees and other from Gilead, outside the submitted work. JSD reports grants and personal fees from AbbVie, grants and personal fees from Gilead Sciences, and grants Bristol Myers Squibb, outside the submitted work. JFD reports grants and personal fees from Abbvie; grants and personal fees from Gilead, grants and personal fees from MSD outside the submitted work. Declaration of personal interests:
Publisher Copyright:
© 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 - http://www.scopus.com/inward/record.url?scp=85129973387&partnerID=8YFLogxK
U2 - 10.1111/apt.16953
DO - 10.1111/apt.16953
M3 - Article
C2 - 35538396
AN - SCOPUS:85129973387
SN - 0269-2813
VL - 55
SP - 1512
EP - 1523
JO - Alimentary Pharmacology & Therapeutics
JF - Alimentary Pharmacology & Therapeutics
IS - 12
ER -
