Antiretroviral prophylaxis for HIV prevention in heterosexual men and women.
Antiretroviral prophylaxis for HIV prevention in heterosexual men and women.
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DOI：
10.1056/nejmoa1108524
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发表时间：
2012-08-02
期刊：
影响因子：
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通讯作者：
Partners PrEP Study Team
中科院分区：
文献类型：
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作者：
Baeten JM;Donnell D;Ndase P;Mugo NR;Campbell JD;Wangisi J;Tappero JW;Bukusi EA;Cohen CR;Katabira E;Ronald A;Tumwesigye E;Were E;Fife KH;Kiarie J;Farquhar C;John-Stewart G;Kakia A;Odoyo J;Mucunguzi A;Nakku-Joloba E;Twesigye R;Ngure K;Apaka C;Tamooh H;Gabona F;Mujugira A;Panteleeff D;Thomas KK;Kidoguchi L;Krows M;Revall J;Morrison S;Haugen H;Emmanuel-Ogier M;Ondrejcek L;Coombs RW;Frenkel L;Hendrix C;Bumpus NN;Bangsberg D;Haberer JE;Stevens WS;Lingappa JR;Celum C;Partners PrEP Study Team
抗逆转录病毒暴露前预防（PrEP）可降低男男性行为者感染人类免疫缺陷病毒1型（HIV-1）的发生率，是异性恋人群预防HIV-1的一种有前途的方法。我们在来自肯尼亚和乌干达的异性恋夫妇中进行了一项口服抗逆转录病毒PrEP的随机三臂试验，其中一名成员为HIV-1血清阴性，另一名为HIV-1血清阳性。血清阴性的伴侣被随机分配到每日一次的替诺福韦（TDF），恩曲他滨/替诺福韦（FTC/TDF）组合或匹配的安慰剂，并每月随访长达36个月。在登记时，HIV-1血清阳性伴侣没有资格根据国家指南接受抗逆转录病毒治疗。所有夫妇都接受了标准的HIV-1治疗和预防服务，包括个人和夫妇降低风险咨询和避孕套。4758对夫妇入组; 62%的HIV-1血清阴性伴侣为男性。对于HIV-1血清阳性受试者，中位CD 4计数为495个细胞/μL（四分位数间距375-662）。在82例随机化后HIV-1感染者中，17例属于TDF组（发生率为0.65/100人-年），在分配FTC/TDF的患者中有13例（发生率0.50/100人-年），52例在分配安慰剂的患者中（发病率1.99/100人-年），表明TDF的HIV-1发病率相对降低67（95% CI 44至81，p<0.001），FTC/TDF为75%（95% CI 55至87，p<0.001）。FTC/TDF和TDF的HIV-1保护作用无显著差异（p=0.23），两种研究药物均显著降低了男性和女性的HIV-1发病率。各研究组的严重医学事件发生率相似。口服TDF和FTC/TDF在异性恋男性和女性中对HIV-1感染提供了实质性的保护，TDF和FTC/TDF的疗效相当。（由比尔和梅林达·盖茨基金会资助; ClinicalTrials.gov编号NCT 00557245）
Antiretroviral pre-exposure prophylaxis (PrEP) reduces the incidence of acquisition of human immunodeficiency virus type 1 (HIV-1) in men who have sex with men and is a promising approach for preventing HIV-1 in heterosexual populations. We conducted a randomized, three-arm trial of oral antiretroviral PrEP among heterosexual couples from Kenya and Uganda in which one member was HIV-1 seronegative and the other HIV-1 seropositive. Seronegative partners were randomly assigned to once-daily tenofovir (TDF), combination emtricitabine/tenofovir (FTC/TDF), or matching placebo and followed monthly for up to 36 months. At enrollment, HIV-1 seropositive partners were not eligible for antiretroviral therapy under national guidelines. All couples received standard HIV-1 treatment and prevention services, including individual and couples risk-reduction counseling and condoms. 4758 couples were enrolled; for 62%, the HIV-1 seronegative partner was male. For HIV-1 seropositive participants, the median CD4 count was 495 cells/μL (interquartile range 375–662). Of 82 post-randomization HIV-1 infections, 17 were among those assigned TDF (incidence 0.65 per 100 person-years), 13 among those assigned FTC/TDF (incidence 0.50 per 100 person-years), and 52 among those assigned placebo (incidence 1.99 per 100 person-years), indicating a 67% relative reduction in HIV-1 incidence for TDF (95% CI 44 to 81, p<0.001) and 75% for FTC/TDF (95% CI 55 to 87, p<0.001). HIV-1 protective effects of FTC/TDF and TDF were not significantly different (p=0.23), and both study medications significantly reduced HIV-1 incidence in both men and women. The rate of serious medical events was similar across the study arms. Oral TDF and FTC/TDF provided substantial protection against HIV-1 acquisition in heterosexual men and women, with comparable efficacy of TDF and FTC/TDF. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number NCT00557245)