Research in context
Evidence before this study
On Sept 18, 2015, we searched PubMed and conference abstracts for information about pre-exposure prophylaxis (PrEP) among transgender women with the term “transgender women and HIV and prevention” without language or date restrictions. Transgender women carry a disproportionate burden of the HIV epidemic and differ from men who have sex with men (MSM) with respect to their social situation, sexual practices, use of feminising hormones, and genital anatomy. Transgender women were included with MSM in many PrEP trials and demonstration projects, although the numbers of transgender participants has been low or unclear. A separate analysis of PrEP safety and efficacy among transgender women has not been reported. US Centers for Disease and Control recommendations for PrEP do not mention transgender women.
Added value of this study
This study presents the first separate analysis of transgender women who received oral emtricitabine plus tenofovir disoproxil fumarate PrEP in a randomised controlled trial and during an open-label extension. Compared with MSM, 339 transgender women had lower drug exposure and less consistent PrEP use over time, especially in situations conferring greater exposure to HIV. The relation between high drug concentrations and low HIV incidence were similar among MSM and transgender women. No transgender women who had drug concentrations suggesting use of four or more PrEP tablets per week acquired HIV. Bone mineral density tended to be less affected by PrEP among transgender women than in MSM, which might show less use of PrEP or a protective effect of feminising hormones. There was no evidence of liver toxicity.
Implications of all the available evidence
More information is needed about interactions between feminising hormones and PrEP medications, and the relation between PrEP use and drug concentrations among transgender women. Better ways to foster effective use of PrEP among transgender women are needed, and might arise from community support groups and programmes that integrate PrEP with gender affirming services, including provision of feminising hormones. Transgender women should be included in PrEP recommendations, with guidance about how to adapt services to meet their needs.