在社区药房接受阿片类激动剂治疗的人群中预防丙型肝炎病毒感染：一项国际随机对照试验。

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

机构信息

Division of Molecular and Clinical Medicine, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.

Tayside Clinical Trials Unit, School of Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.

出版信息

Aliment Pharmacol Ther. 2022 Jun;55(12):1512-1523. doi: 10.1111/apt.16953. Epub 2022 May 10.

DOI:10.1111/apt.16953

PMID:35538396

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, 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.

摘要

背景

传统的医疗模式难以接触到有感染丙型肝炎病毒 (HCV) 风险的人群。这项国际研究评估了在社区药房中，对接受阿片类药物激动剂治疗 (OAT) 的个体进行即时护理 (PoC) HCV RNA 诊断外展和直接作用抗病毒药物 (DAA) 治疗的效果。

目的

我们评估了巡回护士主导的途径为社区药房中的 OAT 客户提供 PoC HCV RNA 检测的效果，与常规护理相比。

方法

苏格兰、威尔士和澳大利亚的药房被随机分配提供 PoC HCV RNA 检测或常规转诊。药剂师将 OAT 客户引导至现场护士（干预组）或当地诊所（对照组）。感染参与者接受 DAA 治疗，同时接受 OAT。主要结局是在 12 周时具有持续病毒学应答 (SVR) 的参与者数量，并在意向治疗 (ITT) 人群中使用混合效应逻辑回归进行分析。

结果

40 家药房被随机分配。ITT 人群包含 1410 名 OAT 客户。在常规组（n=648）中，有 62 人（10%）同意接受检测，17 人（27%）接受了检测，6 人（35%）呈阳性，5 人（83%）开始接受治疗。在干预组（n=762）中，有 148 人（19%）同意接受检测，144 人（97%）接受了检测，23 人（16%）呈阳性，22 人（96%）开始接受治疗。2 人（40%；常规组）和 18 人（82%；干预组）获得 SVR。干预组参与者的检测、治疗和 SVR 几率更高，OR 值分别为 16.95（7.07-40.64，p<0.001）、4.29（1.43-12.92，p=0.010）和 8.64（1.82-40.91，p=0.007）。