From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).
N Engl J Med. 2019 Jul 18;381(3):219-229. doi: 10.1056/NEJMoa1809866.
Universal antiretroviral therapy (ART) with annual population testing and a multidisease, patient-centered strategy could reduce new human immunodeficiency virus (HIV) infections and improve community health.
We randomly assigned 32 rural communities in Uganda and Kenya to baseline HIV and multidisease testing and national guideline-restricted ART (control group) or to baseline testing plus annual testing, eligibility for universal ART, and patient-centered care (intervention group). The primary end point was the cumulative incidence of HIV infection at 3 years. Secondary end points included viral suppression, death, tuberculosis, hypertension control, and the change in the annual incidence of HIV infection (which was evaluated in the intervention group only).
A total of 150,395 persons were included in the analyses. Population-level viral suppression among 15,399 HIV-infected persons was 42% at baseline and was higher in the intervention group than in the control group at 3 years (79% vs. 68%; relative prevalence, 1.15; 95% confidence interval [CI], 1.11 to 1.20). The annual incidence of HIV infection in the intervention group decreased by 32% over 3 years (from 0.43 to 0.31 cases per 100 person-years; relative rate, 0.68; 95% CI, 0.56 to 0.84). However, the 3-year cumulative incidence (704 incident HIV infections) did not differ significantly between the intervention group and the control group (0.77% and 0.81%, respectively; relative risk, 0.95; 95% CI, 0.77 to 1.17). Among HIV-infected persons, the risk of death by year 3 was 3% in the intervention group and 4% in the control group (0.99 vs. 1.29 deaths per 100 person-years; relative risk, 0.77; 95% CI, 0.64 to 0.93). The risk of HIV-associated tuberculosis or death by year 3 among HIV-infected persons was 4% in the intervention group and 5% in the control group (1.19 vs. 1.50 events per 100 person-years; relative risk, 0.79; 95% CI, 0.67 to 0.94). At 3 years, 47% of adults with hypertension in the intervention group and 37% in the control group had hypertension control (relative prevalence, 1.26; 95% CI, 1.15 to 1.39).
Universal HIV treatment did not result in a significantly lower incidence of HIV infection than standard care, probably owing to the availability of comprehensive baseline HIV testing and the rapid expansion of ART eligibility in the control group. (Funded by the National Institutes of Health and others; SEARCH ClinicalTrials.gov number, NCT01864603.).
采用全民抗逆转录病毒疗法（ART），每年进行人群检测，并采取多疾病、以患者为中心的策略，可能会降低新的人类免疫缺陷病毒（HIV）感染率，改善社区健康状况。
我们将乌干达和肯尼亚的 32 个农村社区随机分配至基线 HIV 和多疾病检测及国家指南限制的 ART（对照组）或基线检测+年度检测、普遍 ART 资格和以患者为中心的护理（干预组）。主要终点是 3 年时 HIV 感染的累积发病率。次要终点包括病毒抑制、死亡、结核病、高血压控制以及 HIV 感染的年度发病率变化（仅在干预组中进行评估）。
共有 150395 人纳入分析。在 15399 名 HIV 感染者中，人群水平的病毒抑制率在基线时为 42%，干预组在 3 年时高于对照组（79%比 68%；相对流行率，1.15；95%置信区间[CI]，1.11 至 1.20）。干预组 3 年内 HIV 感染的年度发病率下降了 32%（从 0.43 降至 0.31 例/100人年；相对发生率，0.68；95%CI，0.56 至 0.84）。然而，干预组和对照组 3 年时的累积发病率（分别为 704 例新发 HIV 感染）无显著差异（分别为 0.77%和 0.81%；相对风险，0.95；95%CI，0.77 至 1.17）。在 HIV 感染者中，干预组第 3 年的死亡风险为 3%，对照组为 4%（每 100 人年分别有 0.99 和 1.29 例死亡；相对风险，0.77；95%CI，0.64 至 0.93）。在 HIV 感染者中，第 3 年 HIV 相关结核病或死亡的风险在干预组为 4%，对照组为 5%（每 100 人年分别有 1.19 和 1.50 例事件；相对风险，0.79；95%CI，0.67 至 0.94）。在第 3 年，干预组中有 47%的高血压成年患者和对照组中有 37%的高血压成年患者得到了血压控制（相对流行率，1.26；95%CI，1.15 至 1.39）。
全民 HIV 治疗并未导致 HIV 感染发病率显著低于标准护理，这可能是由于对照组中全面的基线 HIV 检测和 ART 资格的迅速扩大。（由美国国立卫生研究院等资助；SEARCH 临床试验注册编号，NCT01864603。）
