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Research and services adapted for transgender populations includes staff training and procedures for ensuring gender affirmation and provision of gender affirming hormone therapy. PrEP acceptability studies among MSM and TGW have typically included few TGW, with no consideration for the sociocultural and perhaps anatomical differences between these two dissimilar communities 11 , Guidelines may assume similar practices and efficacies in MSM and transgender populations. Inclusion and exclusion criteria for the iPrEx trial have been reported in detail previously People assigned male sex at birth were eligible for the iPrEx study, regardless of their current gender identity.

Current gender identity was self-reported using a computer assisted self-interview CASI , which asked whether the participant currently identified as a man or a woman trans was not given as an option. Use of feminizing hormones, including the use of hormones obtained without a prescription, was assessed and recorded as concomitant medications at every visit by medical history, and was coded using the Uppsala Monitoring Centre WHO Drug Dictionary Enhanced Sweden.

Information about gender affirming surgeries was extracted from the medical record. Feminizing hormones were defined as any estrogen, progestagen, or anti-androgen. Finasteride was not included as a TGW-defining characteristic, as this medication was primarily used for androgenic alopecia rather than feminization.

Testing for emtricitabine and tenofovir and their active metabolites was performed by liquid chromatography and tandem mass spectroscopy as previously described. There was an additional scheduled visit at week 16 in the RCT. Hormone therapy was not provided to study participants by any of the study sites. Using the case-cohort, the probability of selection for testing was known by the design of our case cohort study.

The reciprocal of the probability of selection was incorporated as a probability weight in the OLE analyses of the risk HIV acquisition by drug level using Poisson regression which permits estimation of average rates, estimated person years and rate ratios. Abbreviations: FU is Followup.

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BLQ is below limit of quantitation. MSM is men who have sex with men. The proportional hazards assumption was verified by Schoenfeld test. Comparisons in bone mineral density and creatinine values used the t-test with unequal variances. Normal quantile plots suggested the normal assumptions were approximately satisfied. Very similar results were obtained using the Mann-Whitney U-test.

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Comparison of proportions between groups were adjusted for study site by logistic regression with the relevant group and study site as the factors in the logistic regression otherwise specified. Logistic regression model fits were verified by the methods of Hosmer and Lemeshow. All p-values were two sided. The Bill and Melinda Gates Foundation and Gilead Sciences had no role in protocol development or the interpretation of results.

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The sponsor and funders of the study had no role in data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. The distribution of TGW participants as well as sub-identities within this group did not differ between the intervention and placebo arms.

Gender and hormone use were assessed at enrollment. A depicts the proportion of participants with any TFV-DP detection vs below limit of quantitation BLQ , representing approximately 1 or more tablets taken in the past 4 weeks. Proportion of participants by consistency of drug detection, gender, and non-condom receptive anal intercourse ncRAI. Among TGW, moderate and severe adverse events AEs were rare, and there was no difference comparing the active and placebo arms 31 vs.

There were 2 deaths among TGW: one in the placebo arm was due to homicide and another in the active arm was due to acute liver failure probably due to lymphoma that occurred after at least days of no detectable PrEP drugs in blood plasma or PBMC. PrEP use in transgender populations is protective in the setting of drug adherence; none of the TGW who became infected in the RCT had detectable drug at the time of seroconversion in the randomized phase. The lack of protection appears to be due primarily to low adherence leading to low drug exposure, as measured by drug concentrations.

To be effective, medications used for PrEP must be at a protective concentration at the time of exposure to HIV infection. This is of particular concern given that TGW reported greater overall exposure to HIV more partners, less condom use, more sexually transmitted infections and had lower overall adherence.

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In contrast, the positive associations observed between PrEP adherence and indicators of sexual risk among MSM likely account for why PrEP effectiveness was commensurate with drug exposure in that group. These trials also found a negative association between behavioral factors associated with HIV incidence and detection of drug levels 24 , 25 , as we have found for TGW. This may reflect less PrEP adherence among TGW whose concerns about drug-drug interactions that were not fully addressed during the trial.

FTC and TDF are cleared in the kidney while estrogens and progestogens are metabolized in the liver, so no systemic drug-drug interactions are expected. TDF has been found to have no interactions with a coformulated oral contraceptive OCP consisting of ethinyl estradiol and norgestimate 27 , and PrEP use does not appear to diminish contraceptive efficacy of hormonal medications Analysis by progestogen use was not performed in the current study as none of the subjects who reported only progestogen use without estrogens had DBS levels obtained. No pharmacological interaction studies have been done in TGW using both PrEP and gender affirming feminizing hormones, which differ from contraceptives in several respects.

For example, in order to achieve consistent ovulation suppression oral contraceptives contain the synthetic estrogen ethinyl estradiol, while most recommended regimens for feminization utilize beta estradiol Potent anti-androgens, such as spironolactone, may be included in feminizing hormone therapy but is not used in contraceptives.

Future study of potential interactions between PrEP and feminizing hormone regimensshould include drug transporters that are affected by both nucleoside analogues and female sex hormones and could affect PrEP drug concentrations in cells infected by HIV 31 , Interactions between exogenous female sex hormones and HIV susceptibility are also important for PrEP protection, which can be overcome if viral exposure efficiently leads to transmission during gaps in PrEP use.

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While estrogens preserve pelvic tissues, including anal epithelium, and reduce viral susceptibility in an animal model reviewed in 33 , medroxyprogesterone acetate may decrease vaginal thickness and increase HIV susceptibility in non-transgender women How this effect translates to the anal epithelium is unknown. To the extent that feminizing hormone regimens typically utilize estrogens in place of or in addition to progestogens, these hormonal effects might decrease HIV susceptibility overall.

TGW often prioritize hormone use over other health concerns, and some HIV-positive TGW report hesitance to use antiretroviral medications out of a fear of negative interactions between PrEP and hormones 35 , Information about drug-drug interactions was not provided routinely to TGW in this study, as little information was available and no such interactions were predicted. PrEP programs aimed at TGW should include education strategies on what is known about the coadministration of these two treatments. As has been seen in the arena of HIV treatment, negative experiences with clinics and providers unsupportive of transgender identities or not fluent in transgender culture either in the past or in a current PrEP program may make transgender women less likely to engage in PrEP programs or use PrEP when provided.

The primary limitation of this subgroup analysis is that the study was not designed to detect differences in effectiveness among TGW and MSM, or to confirm efficacy in either subgroup. The other primary limitation arises from difficulties encountered in identifying TGW. This challenge was compounded by reliance on hormone use data collected by self-report, and by the inclusion of participants defined by a range of terminology, languages and cultures spanning four continents. While best practices for collection of gender identity have been described for populations in the United States 4 , future study of global populations should engage local communities to inform gender identity collection methods to be used in each cultural and linguistic setting.

This study identified multiple differences between MSM and TGW and sexual practices and PrEP use; there may be unmeasured or unknown factors that explain these differences. Best practices for PrEP services among TGW could arise from gender-affirming clinical settings that integrate PrEP with hormone therapy and other sexual health services.

HIV pre-exposure prophylaxis in transgender women: A subgroup analysis of the iPrEx trial

We thank study participants for trusting that the research could improve the lives of their communities. The iPrEx study team includes Robert M. We thank John Carroll for preparation of graphics. DG performed the statistical analysis. VM coordinated both phases of iPrEx. All authors critically reviewed and contributed to the final manuscript. RMG has received a consulting fee and a research grant from ViiV, a manufacturer of an investigational compound being investigated for use as PrEP. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication.

As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form.

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Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. National Center for Biotechnology Information , U. Lancet HIV. Author manuscript; available in PMC Dec 1. Madeline B. Deutsch , MD, 1 Prof. David V. Kallas , MD, 4 Prof. Suwat Chariyalertsak , MD, 5 and Prof. Robert M. Esper G. Suwat Chariyalertsak. Author information Copyright and License information Disclaimer. However, any flaws in structure and writing are over-ruled by the gripping plot, which gets better and better as the story progresses. An awesome subversion of the genre. Nice nods to both American Psycho and the classic Story of O.

Please be warned: Enormous amounts of violence that have realistic and permanant physical repercussions.