Antiretroviral Preexposure Prophylaxis for Heterosexual HIV Transmission in Botswana
Antiretroviral Preexposure Prophylaxis for Heterosexual HIV Transmission in Botswana
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DOI：
10.1056/nejmoa1110711
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发表时间：
2012-08-02
影响因子：
158.5
通讯作者：
Brooks, John T.
中科院分区：
文献类型：
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作者：
Thigpen, Michael C.;Kebaabetswe, Poloko M.;Brooks, John T.
暴露前使用抗逆转录病毒药物预防可以减少男男性行为者中人类免疫缺陷病毒(HIV)的传播；然而，在异性恋中的效果尚不确定。方法我们随机分配HIV血清阴性的男性和女性接受富马酸替诺福韦和恩曲他滨(TDF-FTC)或匹配的安慰剂，每天一次。每月安排研究访问，参与者接受一整套预防服务，包括艾滋病毒检测、坚持服药咨询、性传播感染管理、不良事件监测和降低风险的个性化咨询；每半年在一组参与者中进行骨密度测试。结果总共1219名男性和女性(45.7%女性)接受了随机分组，并接受了1563人年(中位数为1.1年；最长为3.7年)的跟踪调查。由于保留率低和后勤限制，我们提前结束了这项研究，并通过有序的研究结束而不是扩大登记人数来跟踪登记的参与者。TDF-FTC组恶心发生率明显高于TDF-FTC组(18.5%vs.7.1%，P
BackgroundPreexposure prophylaxis with antiretroviral agents has been shown to reduce the transmission of human immunodeficiency virus (HIV) among men who have sex with men; however, the efficacy among heterosexuals is uncertain.MethodsWe randomly assigned HIV-seronegative men and women to receive either tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or matching placebo once daily. Monthly study visits were scheduled, and participants received a comprehensive package of prevention services, including HIV testing, counseling on adherence to medication, management of sexually transmitted infections, monitoring for adverse events, and individualized counseling on risk reduction; bone mineral density testing was performed semiannually in a subgroup of participants.ResultsA total of 1219 men and women underwent randomization (45.7% women) and were followed for 1563 person-years (median, 1.1 years; maximum, 3.7 years). Because of low retention and logistic limitations, we concluded the study early and followed enrolled participants through an orderly study closure rather than expanding enrollment. The TDF-FTC group had higher rates of nausea (18.5% vs. 7.1%, P