Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.
Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.
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DOI：
10.1056/nejmoa1011205
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发表时间：
2010-12-30
期刊：
影响因子：
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通讯作者：
iPrEx Study Team
中科院分区：
文献类型：
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作者：
Grant RM;Lama JR;Anderson PL;McMahan V;Liu AY;Vargas L;Goicochea P;Casapía M;Guanira-Carranza JV;Ramirez-Cardich ME;Montoya-Herrera O;Fernández T;Veloso VG;Buchbinder SP;Chariyalertsak S;Schechter M;Bekker LG;Mayer KH;Kallás EG;Amico KR;Mulligan K;Bushman LR;Hance RJ;Ganoza C;Defechereux P;Postle B;Wang F;McConnell JJ;Zheng JH;Lee J;Rooney JF;Jaffe HS;Martinez AI;Burns DN;Glidden DV;iPrEx Study Team
暴露前的抗逆转录病毒预防是预防人类免疫缺陷病毒（HIV）采集的一种有前途的方法。
我们随机分配了与男性发生性关系的2499名艾滋病毒性男性或跨性别女性，以结合两种口服抗逆转录病毒药物，Emtricerabine和Tenofovir disoproxil fumarate（FTC – TDF）或每天接受HIV测试，conderted和sancement confuction，condection和Antermant consection，condermection和Antermant。
该受试者在3324个人年中接受了3324个人年（最大2.8岁）小组，研究在43位血清胶质受试者中有22例（51％），在34个受试者中，有3个受试者（9％）（p <0.001）在FTC – TDF组中更频繁地报道了恶心。
口服FTC – TDF提供了对受试者的艾滋病毒感染的保护，可检测到的血液水平与预防效应密切相关（由国家卫生研究院和梅琳达·盖茨基金会资助；
Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition. We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC–TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC–TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P = 0.005). In the FTC–TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC–TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P = 0.57). Oral FTC–TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.)