Prevention of HIV-1 Infection with Early Antiretroviral Therapy
Prevention of HIV-1 Infection with Early Antiretroviral Therapy
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DOI：
10.1056/nejmoa1105243
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发表时间：
2011-08-11
影响因子：
158.5
通讯作者：
Fleming, Thomas R.
中科院分区：
文献类型：
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作者：
Cohen, Myron S.;Chen, Ying Q.;Fleming, Thomas R.
BackgroundAntiretroviral疗法，减少病毒复制可以限制传播的人类免疫缺陷病毒1型（HIV-1）在serodiscordant couples.MethodsIn九个国家，我们招募了1763对夫妇，其中一个合作伙伴是HIV-1阳性，另一个是HIV-1阴性; 54%的受试者来自非洲，50%的感染的合作伙伴是男性。将CD 4计数在350至550个细胞/立方毫米之间的HIV-1感染受试者以1：1的比例随机分配，立即（早期治疗）或在CD 4计数下降或HIV-1相关症状发作后（延迟治疗）接受抗逆转录病毒治疗。一级预防终点是HIV-1阴性伴侣中的HIV-1传播。主要临床终点是最早发生肺结核、严重细菌感染、世界卫生组织4期事件或死亡。结果截至2011年2月21日，共观察到39例HIV-1传播（发生率，1.2/100人-年; 95%置信区间[CI]，0.9 - 1.7）;其中，28例与受感染的伴侣有病毒学联系（发病率，0.9/100人-年，95%CI，0.6 - 1.3）。在28个连锁传播中，只有1个发生在早期治疗组（风险比，0.04; 95%CI，0.01 - 0.27; P
BackgroundAntiretroviral therapy that reduces viral replication could limit the transmission of human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples.MethodsIn nine countries, we enrolled 1763 couples in which one partner was HIV-1-positive and the other was HIV-1-negative; 54% of the subjects were from Africa, and 50% of infected partners were men. HIV-1-infected subjects with CD4 counts between 350 and 550 cells per cubic millimeter were randomly assigned in a 1: 1 ratio to receive antiretroviral therapy either immediately (early therapy) or after a decline in the CD4 count or the onset of HIV-1-related symptoms (delayed therapy). The primary prevention end point was linked HIV-1 transmission in HIV-1-negative partners. The primary clinical end point was the earliest occurrence of pulmonary tuberculosis, severe bacterial infection, a World Health Organization stage 4 event, or death.ResultsAs of February 21, 2011, a total of 39 HIV-1 transmissions were observed (incidence rate, 1.2 per 100 person-years; 95% confidence interval [CI], 0.9 to 1.7); of these, 28 were virologically linked to the infected partner (incidence rate, 0.9 per 100 person-years, 95% CI, 0.6 to 1.3). Of the 28 linked transmissions, only 1 occurred in the early-therapy group (hazard ratio, 0.04; 95% CI, 0.01 to 0.27; P