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

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorDEUTSCH, Madeline B.
dc.contributor.authorGLIDDEN, David V.
dc.contributor.authorSEVELIUS, Jae
dc.contributor.authorKEATLEY, Joanne
dc.contributor.authorMCMAHAN, Vanessa
dc.contributor.authorGUANIRA, Juan
dc.contributor.authorKALLAS, Esper G.
dc.contributor.authorCHARIYALERTSAK, Suwat
dc.contributor.authorGRANT, Robert M.
dc.contributor.groupauthorIPrEx Investigators
dc.date.accessioned2016-07-04T13:52:02Z
dc.date.available2016-07-04T13:52:02Z
dc.date.issued2015
dc.description.abstractBackground 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. Methods 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. Findings 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. Interpretation 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.
dc.description.indexMEDLINE
dc.description.sponsorshipUS National Institutes of Health
dc.description.sponsorshipBill & Melinda Gates Foundation
dc.identifier.citationLANCET HIV, v.2, n.12, p.E512-E519, 2015
dc.identifier.doi10.1016/S2352-3018(15)00206-4
dc.identifier.issn2352-3018
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/13878
dc.language.isoeng
dc.publisherELSEVIER INC
dc.relation.ispartofLancet Hiv
dc.rightsrestrictedAccess
dc.rights.holderCopyright ELSEVIER INC
dc.subject.otherhormonal contraceptives
dc.subject.otherdisoproxil fumarate
dc.subject.otherafrican women
dc.subject.otherrisk
dc.subject.otherprevention
dc.subject.otherinfection
dc.subject.othertenofovir
dc.subject.othercohort
dc.subject.othersex
dc.subject.otherpharmacokinetics
dc.subject.wosImmunology
dc.subject.wosInfectious Diseases
dc.titleHIV pre-exposure prophylaxis in transgender women: a subgroup analysis of the iPrEx trial
dc.typearticle
dc.type.categoryoriginal article
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.affiliation.countryPeru
hcfmusp.affiliation.countryTailândia
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryisous
hcfmusp.affiliation.countryisope
hcfmusp.affiliation.countryisoth
hcfmusp.author.externalDEUTSCH, Madeline B.:Univ Calif San Francisco, San Francisco, CA 94115 USA
hcfmusp.author.externalGLIDDEN, David V.:Univ Calif San Francisco, San Francisco, CA 94115 USA
hcfmusp.author.externalSEVELIUS, Jae:Univ Calif San Francisco, San Francisco, CA 94115 USA
hcfmusp.author.externalKEATLEY, Joanne:Univ Calif San Francisco, San Francisco, CA 94115 USA
hcfmusp.author.externalMCMAHAN, Vanessa:Gladstone Inst, San Francisco, CA USA
hcfmusp.author.externalGUANIRA, Juan:INMENSA, Lima, Peru
hcfmusp.author.externalCHARIYALERTSAK, Suwat:Chiang Mai Univ, RIHES, Chiang Mai 50000, Thailand
hcfmusp.author.externalGRANT, Robert M.:Univ Calif San Francisco, San Francisco, CA 94115 USA; Gladstone Inst, San Francisco, CA USA; San Francisco AIDS Fdn, San Francisco, CA USA
hcfmusp.citation.scopus207
hcfmusp.contributor.author-fmusphcESPER GEORGES KALLAS
hcfmusp.description.beginpageE512
hcfmusp.description.endpageE519
hcfmusp.description.issue12
hcfmusp.description.volume2
hcfmusp.origemWOS
hcfmusp.origem.pubmed26614965
hcfmusp.origem.scopus2-s2.0-84959932232
hcfmusp.origem.wosWOS:000368263200007
hcfmusp.publisher.citySAN DIEGO
hcfmusp.publisher.countryUSA
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