HIV pre-exposure prophylaxis in transgender women: a subgroup analysis of the iPrEx trial.
HIV pre-exposure prophylaxis in transgender women: a subgroup analysis of the iPrEx trial.
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DOI：
10.1016/s2352-3018(15)00206-4
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发表时间：
2015-12
期刊：
影响因子：
--
通讯作者：
iPrEx investigators
中科院分区：
文献类型：
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作者：
Deutsch MB;Glidden DV;Sevelius J;Keatley J;McMahan V;Guanira J;Kallas EG;Chariyalertsak S;Grant RM;iPrEx investigators
口服恩曲他滨-富马酸替诺福韦酯（FTC/TDF）暴露前预防（PrEP）用于预防艾滋病毒的性获得。跨性别女性（TGW）具有可能与PrEP使用，有效性和安全性相关的独特特征。iPrEx试验是一项在男男性行为者（MSM）和TGW中比较口服FTC/TDF PrEP与安慰剂的随机对照试验（RCT），随后进行开放标签扩展（OLE）。通过液相色谱法和串联质谱法测量血液中的药物浓度。在2499名参与者中，29名（1%）被确定为女性，296名（12%）被确定为“反式”，14名（1%）被确定为男性，但报告使用女性化激素，因此339名（14%）报告了一个或多个这些特征（TGW）。与MSM相比，TGW在过去3个月内更频繁地报告交易性行为、接受性肛交（不使用安全套）或5名以上性伴。在TGW中，活性组有11例HIV感染，安慰剂组有10例，风险比为1.1（95% CI：0.5 - 2.7）。在活动组参与者中，在血清转换访视时，TGW中没有检测到药物，血清阴性TGW中有18%（6/37）（P=0.31），血清阴性MSM中有52%（58/111）（P < 0.0001）。PrEP的使用与TGW中艾滋病毒风险的行为指标无关，而最高风险的MSM更坚持。在药物浓度相当于每周使用4片或更多FTC/TDF片剂的TGW中没有HIV感染。接受PrEP的TGW药物浓度较低，特别是在潜在的HIV暴露时，导致该亚组中没有PrEP有效性。美国国立卫生研究院和比尔及梅林达·盖茨基金会;研究药物由吉利德科学公司捐赠。
Oral emtricitabine-tenofovir disoproxil fumarate (FTC/TDF) pre-exposure prophylaxis (PrEP) is used to prevent the sexual acquisition of HIV. Transgender women (TGW) have unique characteristics that may relate to PrEP use, effectiveness, and safety. The iPrEx trial was a randomized controlled trial (RCT) of oral FTC/TDF PrEP versus placebo among men who have sex with men (MSM) and TGW, followed by an open label extension (OLE). Drug concentrations were measured in blood by liquid chromatography and tandem mass spectroscopy. Of the 2499 participants enrolled in the RCT, 29 (1%) identified as women, 296 (12%) identified as “trans”, 14 (1%) identified as men but reported use of feminizing hormones, such that 339 (14%) reported one or more of these characteristics (TGW). Compared with MSM, TGW more frequently reported transactional sex, receptive anal intercourse without a condom, or more than 5 partners in the past 3 months. Among TGW, there were 11 HIV infections in the active arm and 10 in the placebo arm, representing a hazard ratio of 1.1 (95% CI: 0.5 to 2.7). Among active arm participants, drug was detected in none of the TGW at the seroconversion visit, 18% (6/37) of seronegative TGW (P=0.31), and 52% (58/111) of seronegative MSM (P < 0.0001). PrEP use was not linked to behavioral indicators of HIV risk among TGW, while MSM at highest risk were more adherent. There were no HIV infections among TGW having drug concentrations commensurate with use of 4 or more FTC/TDF tablets per week. TGW receiving PrEP had low drug concentrations, especially at times of potential HIV exposure, leading to no PrEP effectiveness among this subgroup. U.S. National Institutes of Health and the Bill and Melinda Gates Foundation; study medication was donated by Gilead Sciences.