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。