University of California, San Francisco, CA, USA.
University of California, San Francisco, CA, USA.
Lancet HIV. 2015 Dec;2(12):e512-9. doi: 10.1016/S2352-3018(15)00206-4. Epub 2015 Nov 6.
Pre-exposure prophylaxis (PrEP) with oral emtricitabine and tenofovir disoproxil fumarate is used to prevent the sexual acquisition of HIV in groups at high risk such as transgender women. We used data from the iPrEx study to assess PrEP efficacy, effectiveness, and adherence in transgender women.
The iPrEx trial was a randomised controlled trial of PrEP with oral emtricitabine plus tenofovir disoproxil fumarate compared with placebo in men who have sex with men (MSM) and transgender women, followed by an open-label extension. Drug concentrations were measured in blood by liquid chromatography and tandem mass spectroscopy. We did unplanned exploratory analyses to investigate differences in PrEP outcomes among transgender women and between transgender women and MSM.
Of the 2499 participants enrolled in the randomised controlled trial, 29 (1%) identified as women, 296 (12%) identified as trans, 14 (1%) identified as men but reported use of feminising hormones, such that 339 (14%) reported one or more characteristics and are classified as transgender women for the purpose of this study. Compared with MSM, transgender women more frequently reported transactional sex, receptive anal intercourse without a condom, or more than five partners in the past 3 months. Among transgender women, there were 11 HIV infections in the PrEP group and ten in the placebo group (hazard ratio 1·1, 95% CI 0·5-2·7). In the PrEP group, drug was detected in none of the transgender women at the seroconversion visit, six (18%) of 33 seronegative transgender women (p=0·31), and 58 (52%) of 111 seronegative MSM (p<0·0001). PrEP use was not linked to behavioural indicators of HIV risk among transgender women, whereas MSM at highest risk were more adherent.
PrEP seems to be effective in preventing HIV acquisition in transgender women when taken, but there seem to be barriers to adherence, particularly among those at the most risk. Studies of PrEP use in transgender women populations should be designed and tailored specifically for this population, rather than adapted from or subsumed into studies of MSM.
US National Institutes of Health and the Bill & Melinda Gates Foundation.
口服恩曲他滨和替诺福韦酯富马酸在高风险群体如跨性别女性中用于预防艾滋病毒的性传播。我们使用 iPrEx 研究的数据评估了跨性别女性的 PrEP 疗效、效果和依从性。
iPrEx 试验是一项随机对照试验，比较了口服恩曲他滨加替诺福韦酯与安慰剂在男男性行为者（MSM）和跨性别女性中的预防效果，并进行了开放标签扩展。通过液相色谱-串联质谱法测量血液中的药物浓度。我们进行了非计划性探索性分析，以调查跨性别女性和 MSM 之间 PrEP 结果的差异。
在随机对照试验中，2499 名参与者中有 29 人（1%）为女性，296 人（12%）为跨性别者，14 人（1%）为男性，但报告使用了女性化激素，因此 339 人（14%）报告了一个或多个特征，并为本研究目的被归类为跨性别女性。与 MSM 相比，跨性别女性更频繁地报告有商业性性行为、无保护措施的接受肛交或过去 3 个月内有超过 5 个性伴侣。在跨性别女性中，PrEP 组中有 11 例 HIV 感染，安慰剂组中有 10 例（风险比 1.1，95%CI 0.5-2.7）。在 PrEP 组中，在确诊感染前的就诊时，没有一名跨性别女性的药物检测呈阳性，33 名阴性的跨性别女性中有 6 名（18%）（p=0.31），111 名阴性的 MSM 中有 58 名（52%）（p<0.0001）。PrEP 的使用与跨性别女性的 HIV 风险行为指标无关，而高危 MSM 的依从性更高。
PrEP 在接受治疗时似乎能有效预防跨性别女性感染艾滋病毒，但似乎存在依从性障碍，尤其是在风险最高的人群中。应该专门为跨性别女性人群设计和调整 PrEP 使用研究，而不是从 MSM 研究中改编或归入此类研究。
美国国立卫生研究院和比尔及梅琳达·盖茨基金会。
