普遍检测和治疗对艾滋病毒发病率的影响 - HPTN 071（PopART）。
Effect of Universal Testing and Treatment on HIV Incidence - HPTN 071 (PopART).
机构信息
From the London School of Hygiene and Tropical Medicine (R.J.H., S. Floyd, K. Sabapathy, A.S., B.K., D.M., V.B., J.R.H., H.A.), Imperial College London (K.H., S. Fidler), and the National Institute for Health Research Imperial Biomedical Research Centre (S. Fidler), London, and the University of Oxford, Oxford (C.F.) - all in the United Kingdom; the Fred Hutchinson Cancer Research Center, Seattle (D.D., T.S., E.W., L.E.); the Desmond Tutu Tuberculosis Center, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa (N. Mandla, B.Y., A.J., R.D., N. Makola, G.H., P.B., N.B.); Zambart, Lusaka, Zambia (J.B., M.P., A.S., B.K., M.S., V.B., K. Shanaube, H.A.); Johns Hopkins University School of Medicine, Baltimore (S.H.E., E.P.-M.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda (D.N.B.) - both in Maryland; FHI 360, Durham, NC (A.M., S.G., N.D.S.); the Yale School of Public Health, New Haven, CT (S.H.V.); and ICAP at Columbia University, New York (W.E.-S.).
出版信息
N Engl J Med. 2019 Jul 18;381(3):207-218. doi: 10.1056/NEJMoa1814556.
BACKGROUND
A universal testing and treatment strategy is a potential approach to reduce the incidence of human immunodeficiency virus (HIV) infection, yet previous trial results are inconsistent.
METHODS
In the HPTN 071 (PopART) community-randomized trial conducted from 2013 through 2018, we randomly assigned 21 communities in Zambia and South Africa (total population, approximately 1 million) to group A (combination prevention intervention with universal antiretroviral therapy [ART]), group B (the prevention intervention with ART provided according to local guidelines [universal since 2016]), or group C (standard care). The prevention intervention included home-based HIV testing delivered by community workers, who also supported linkage to HIV care and ART adherence. The primary outcome, HIV incidence between months 12 and 36, was measured in a population cohort of approximately 2000 randomly sampled adults (18 to 44 years of age) per community. Viral suppression (<400 copies of HIV RNA per milliliter) was assessed in all HIV-positive participants at 24 months.
RESULTS
The population cohort included 48,301 participants. Baseline HIV prevalence was 21% or 22% in each group. Between months 12 and 36, a total of 553 new HIV infections were observed during 39,702 person-years (1.4 per 100 person-years; women, 1.7; men, 0.8). The adjusted rate ratio for group A as compared with group C was 0.93 (95% confidence interval [CI], 0.74 to 1.18; P = 0.51) and for group B as compared with group C was 0.70 (95% CI, 0.55 to 0.88; P = 0.006). The percentage of HIV-positive participants with viral suppression at 24 months was 71.9% in group A, 67.5% in group B, and 60.2% in group C. The estimated percentage of HIV-positive adults in the community who were receiving ART at 36 months was 81% in group A and 80% in group B.
CONCLUSIONS
A combination prevention intervention with ART provided according to local guidelines resulted in a 30% lower incidence of HIV infection than standard care. The lack of effect with universal ART was unanticipated and not consistent with the data on viral suppression. In this trial setting, universal testing and treatment reduced the population-level incidence of HIV infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 071 [PopArt] ClinicalTrials.gov number, NCT01900977.).
背景
普遍检测和治疗策略是降低人类免疫缺陷病毒（HIV）感染发生率的一种潜在方法，但之前的试验结果并不一致。
方法
在 2013 年至 2018 年进行的 HPTN 071（PopART）社区随机试验中，我们将赞比亚和南非的 21 个社区（总人口约 100 万）随机分为 A 组（包含普遍抗逆转录病毒疗法[ART]的组合预防干预）、B 组（根据当地指南提供的 ART 预防干预[自 2016 年以来即为普遍做法]）或 C 组（标准护理）。预防干预包括由社区工作人员提供的家庭 HIV 检测，他们还支持艾滋病毒护理和 ART 依从性的联系。主要结局是每个社区约 2000 名随机抽样成年人（18 至 44 岁）在 12 至 36 个月期间的 HIV 发病率。所有 HIV 阳性参与者在 24 个月时评估病毒抑制情况（<400 拷贝/ml 的 HIV RNA）。
结果
人群队列包括 48301 名参与者。每组的基线 HIV 流行率为 21%或 22%。在 12 至 36 个月期间，39702 人年中观察到 553 例新的 HIV 感染（每 100 人年 1.4 例；女性为 1.7 例，男性为 0.8 例）。与 C 组相比，A 组的调整后率比值为 0.93（95%置信区间[CI]，0.74 至 1.18；P=0.51），B 组为 0.70（95%CI，0.55 至 0.88；P=0.006）。A 组 24 个月时 HIV 阳性参与者的病毒抑制率为 71.9%，B 组为 67.5%，C 组为 60.2%。在 36 个月时，估计社区中接受 ART 的 HIV 阳性成年人的比例在 A 组为 81%，在 B 组为 80%。
结论
根据当地指南提供的包含 ART 的组合预防干预可使 HIV 感染发病率降低 30%。普遍 ART 的效果不佳是出乎意料的，与病毒抑制数据不一致。在本试验设置中，普遍检测和治疗降低了人群 HIV 感染的发生率。（由美国国立过敏和传染病研究所等资助；HPTN 071[PopArt]临床试验.gov 编号，NCT01900977。）
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