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男同性恋患者暴露前药物预防可预防HIV感染

 Title: Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

Author: Grant RM, Lama JR, Anderson PL et al
N Engl J Med. 2010, 363(27):2587-2599.  
PMID: 21091279
Background
Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition.
Methods
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.
Results
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).
Conclusions
Oral FTC–TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect.


题目:男同性恋患者暴露前药物预防可预防HIV感染
作者:Grant RM, Lama JR, Anderson PL et al
N Engl J Med(新英格兰医学杂志). 2010, 363(27):2587-2599.  
PMID: 21091279
背景
暴露前抗逆转录病毒药物预防是预防人免疫缺陷病毒(HIV)感染的一种理想方法。
方法
2499位HIV血清阳性男性或与双性恋男性,每天服用随机指定的联合口服抗逆转录病毒药-恩曲他滨与替诺福韦酯(FTC–TDF)或安慰剂。所有受试者实施HIV检测、提供风险降低咨询、发放避孕套,并对性传播感染进行管理。
结果
跟踪研究受试者的人年数为3324(中位数为1.2年,最高值为2.8年)。受试者中有10人征集时已感染HIV,随访期间100人感染HIV(其中FTC-TDF组36人,安慰剂组64人)。表明HIV发病率降低44%(95%置信区间,15/63,P = 0.005) FTC-TDF组中,43位血清反应阴性受试者中有22位检测到研究药物,占51%;34位HIV感染受试者中也有3人检测到,占9% (P<0.001)。与服用安慰剂组受试者相比,FTC-TDF组受试者前4周呕吐颇为频繁。两组出现严重不良事件的几率相似(P = 0.57)。
结论
受试者口服FTC-TDF可预防HIV感染。测得血液药物浓度与预防效果高度相关。

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