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Long-term protection from HIV infection with oral HIV pre-exposure prophylaxis in gay and bisexual men: findings from the expanded and extended EPIC-NSW prospective implementation study
The Lancet HIV ( IF 16.1 ) Pub Date : 2021-07-01 , DOI: 10.1016/s2352-3018(21)00074-6
Andrew E Grulich 1 , Fengyi Jin 1 , Benjamin R Bavinton 1 , Barbara Yeung 1 , Mohamed A Hammoud 1 , Janaki Amin 2 , Gesalit Cabrera 1 , Shawn Clackett 3 , Erin Ogilvie 1 , Stefanie Vaccher 1 , Tobias Vickers 1 , Anna McNulty 4 , David J Smith 5 , Nila J Dharan 1 , Christine Selvey 6 , Cherie Power 6 , Karen Price 7 , Iryna Zablotska 8 , David A Baker 9 , Mark Bloch 10 , Katherine Brown 11 , Christopher J Carmody 12 , Andrew Carr 13 , Daniel Chanisheff 14 , Nicholas Doong 15 , Robert Finlayson 16 , David A Lewis 17 , Josephine Lusk 18 , Sarah Martin 19 , Catriona Ooi 20 , Phillip Read 21 , Nathan Ryder 22 , Don Smith 23 , Clara Tuck Meng Soo 24 , David J Templeton 25 , Emmanuel Vlahakis 26 , Rebecca Guy 1 ,
Affiliation  

Background

Daily pre-exposure prophylaxis (PrEP) is effective in preventing HIV, but few long-term data are available on effectiveness and adherence in real-world settings. Here, we report trends in HIV incidence over 3 years in individuals at high risk who were prescribed PrEP in New South Wales (NSW), as well as adherence before the transition to subsidised PrEP.

Methods

Expanded PrEP Implementation in Communities–New South Wales (EPIC-NSW) was a pragmatic, prospective, single-arm, implementation study of daily, oral PrEP in 31 sites (sexual health clinics, general practices, and a hospital) in NSW, Australia. Eligible participants were HIV-negative adults (aged ≥18 years) who were at high risk of HIV infection as defined in local PrEP guidelines. Participants were prescribed coformulated (once-daily, oral tablet) tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) as HIV PrEP and were followed up with HIV testing, sexually transmitted infection testing, and PrEP dispensing. Originally planned for 3700 participants followed for 1 year, the study was expanded so that all eligible participants in the state could obtain PrEP and extended until publicly subsidised PrEP became available in Australia. The primary outcome was new HIV infection among all participants who were dispensed PrEP at least once and had at least one follow-up HIV test result. Adherence was estimated by medication possession ratio (MPR), defined as the proportion of PrEP pills dispensed in 90 days, assuming daily dosing. This study is registered with ClinicalTrials.gov, NCT02870790.

Findings

Between March 1, 2016, and April 30, 2018, we enrolled 9709 participants. 9596 participants were dispensed PrEP, of whom 9448 (98·3%) were gay or bisexual men. Participants were followed up until March 31, 2019, with at least one follow-up HIV test available in 9520 (99·2%) participants. Mean MPR declined from 0·93 to 0·64 from the first to the ninth quarter. There were 30 HIV seroconversions over 18 628 person-years, an incidence of 1·61 per 1000 person-years (95% CI 1·13–2·30). Being younger, living in a postcode with fewer gay men, reporting more risk behaviours at baseline, and having an MPR of less than 0·6 were each univariately associated with increased HIV incidence. In the final year of follow-up, when PrEP was mostly purchased rather than provided free by the study, HIV incidence remained low at 2·24 per 1000 person-years (1·46–3·44).

Interpretation

HIV incidence remained low over up to 3 years of follow-up, including during a transition from study-provided to publicly subsidised PrEP. In a setting of affordable PrEP and associated health-care services, very low HIV incidence of 1 to 2 per 1000 person-years can be maintained in gay and bisexual men who were previously at high risk.

Funding

New South Wales Ministry of Health, Australian Capital Territory Health Directorate, Gilead Sciences.



中文翻译:

男同性恋和双性恋男性通过口服 HIV 暴露前预防长期预防 HIV 感染:扩展和扩展的 EPIC-NSW 前瞻性实施研究的结果

背景

每日暴露前预防 (PrEP) 可有效预防 HIV,但关于现实环境中的有效性和依从性的长期数据很少。在这里,我们报告了在新南威尔士州 (NSW) 接受 PrEP 的高危人群 3 年内 HIV 发病率的趋势,以及在过渡到有补贴的 PrEP 之前的依从性。

方法

新南威尔士社区扩大 PrEP 实施 (EPIC-NSW) 是一项务实、前瞻性、单臂、每日口服 PrEP 实施研究,在澳大利亚新南威尔士州的 31 个地点(性健康诊所、全科诊所和医院)进行. 符合条件的参与者是 HIV 阴性成人(年龄≥18 岁),他们处于当地 PrEP 指南中定义的 HIV 感染高危人群。参与者服用复合制剂(每日一次,口服片剂)富马酸替诺福韦二吡呋酯(300 毫克)和恩曲他滨(200 毫克)作为 HIV PrEP,并进行了 HIV 检测、性传播感染检测和 PrEP 分配进行随访。最初计划对 3700 名参与者进行为期 1 年的随访,该研究扩大到该州所有符合条件的参与者都可以获得 PrEP,并延长到公共补贴的 PrEP 在澳大利亚可用。主要结果是所有参与者中新的 HIV 感染,这些参与者至少接受了一次 PrEP,并且至少有一次 HIV 后续检测结果。依从性是通过药物拥有率 (MPR) 来估计的,MPR 定义为假设每天给药的 90 天内分发的 PrEP 药丸的比例。本研究已在 ClinicalTrials.gov 注册,NCT02870790。

调查结果

2016 年 3 月 1 日至 2018 年 4 月 30 日期间,我们招募了 9709 名参与者。9596 名参与者接受了 PrEP,其中 9448 (98·3%) 是男同性恋或双性恋男性。参与者被随访至 2019 年 3 月 31 日,在 9520 (99·2%) 名参与者中至少进行了一次 HIV 随访。从第一季度到第九季度,平均 MPR 从 0·93 下降到 0·64。在 18 628 人年期间有 30 次 HIV 血清转换,发病率为每 1000 人年 1·61(95% CI 1·13-2·30)。年轻、生活在男同性恋者较少的邮政编码、基线时报告更多的危险行为以及 MPR 低于 0·6 均与 HIV 发病率增加呈单变量相关。在随访的最后一年,当 PrEP 主要是购买而不是由研究免费提供时,HIV 发病率仍然很低,为每 1000 人年 2·24 (1·46–3·44)。

口译

在长达 3 年的随访期间,包括从研究提供的 PrEP 过渡到公共资助的 PrEP 期间,HIV 发病率仍然很低。在负担得起的 PrEP 和相关医疗保健服务的环境中,以前处于高风险的男同性恋和双性恋男性可以保持每 1000 人年 1 至 2 人的极低 HIV 发病率。

资金

新南威尔士州卫生部、澳大利亚首都地区卫生局、吉利德科学公司。

更新日期:2021-08-03
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