Please use this identifier to cite or link to this item:
Full metadata record
DC FieldValueLanguage
dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP-
dc.contributor.authorANDERSON, Peter L.-
dc.contributor.authorGLIDDEN, David V.-
dc.contributor.authorLIU, Albert-
dc.contributor.authorBUCHBINDER, Susan-
dc.contributor.authorLAMA, Javier R.-
dc.contributor.authorGUANIRA, Juan Vicente-
dc.contributor.authorMCMAHAN, Vanessa-
dc.contributor.authorBUSHMAN, Lane R.-
dc.contributor.authorCASAPIA, Martin-
dc.contributor.authorMONTOYA-HERRERA, Orlando-
dc.contributor.authorVELOSO, Valdilea G.-
dc.contributor.authorMAYER, Kenneth H.-
dc.contributor.authorCHARIYALERTSAK, Suwat-
dc.contributor.authorSCHECHTER, Mauro-
dc.contributor.authorBEKKER, Linda-Gail-
dc.contributor.authorKALLAS, Esper Georges-
dc.contributor.authorGRANT, Robert M.-
dc.identifier.citationSCIENCE TRANSLATIONAL MEDICINE, v.4, n.151, article ID 151ra125, 8p, 2012-
dc.description.abstractDrug concentrations associated with protection from HIV-1 acquisition have not been determined. We evaluated drug concentrations among men who have sex with men in a substudy of the iPrEx trial (1). In this randomized placebo-controlled trial, daily oral doses of emtricitabine/tenofovir disoproxil fumarate were used as pre-exposure prophylaxis (PrEP) in men who have sex with men. Drug was detected less frequently in blood plasma and in viable cryopreserved peripheral blood mononuclear cells (PBMCs) in HIV-infected cases at the visit when HIV was first discovered compared with controls at the matched time point of the study (8% versus 44%; P < 0.001) and in the 90 days before that visit (11% versus 51%; P < 0.001). An intracellular concentration of the active form of tenofovir, tenofovir-diphosphate (TFV-DP), of 16 fmol per million PBMCs was associated with a 90% reduction in HIV acquisition relative to the placebo arm. Directly observed dosing in a separate study, the STRAND trial, yielded TFV-DP concentrations that, when analyzed according to the iPrEx model, corresponded to an HIV-1 risk reduction of 76% for two doses per week, 96% for four doses per week, and 99% for seven doses per week. Pro-phylactic benefits were observed over a range of doses and drug concentrations, suggesting ways to optimize PrEP regimens for this population.-
dc.description.sponsorshipNational Institutes of Health (NIH) [R21MH085598, UO1 AI084735, RO1 AI062333, UO1 AI064002, UL1 RR024131]-
dc.relation.ispartofScience Translational Medicine-
dc.subject.otherhiv prevention-
dc.titleEmtricitabine-Tenofovir Concentrations and Pre-Exposure Prophylaxis Efficacy in Men Who Have Sex with Men-
dc.rights.holderCopyright AMER ASSOC ADVANCEMENT SCIENCE-
dc.contributor.groupauthoriPrEx Study Team-
dc.subject.wosCell Biology-
dc.subject.wosMedicine, Research & Experimental-
dc.type.categoryoriginal article-
dc.type.versionpublishedVersion-, Peter L.:Univ Colorado Denver, Aurora, CO 80045 USA-, David V.:Univ Calif San Francisco, San Francisco, CA 94143 USA-, Albert:San Francisco Dept Publ Hlth, HIV Res Sect, San Francisco, CA 94102 USA-, Susan:Univ Calif San Francisco, San Francisco, CA 94143 USA; San Francisco Dept Publ Hlth, HIV Res Sect, San Francisco, CA 94102 USA-, Javier R.:Invest Med Salud, Lima 14, Peru; Asociac Civil Impacta Salud & Educ, Lima, Peru-, Juan Vicente:Asociac Civil Impacta Salud & Educ, Lima, Peru-, Vanessa:Gladstone Inst Virol & Immunol, San Francisco, CA 94158 USA-, Lane R.:Univ Colorado Denver, Aurora, CO 80045 USA-, Martin:Asociac Civil Selva Amazon, Iquitos, Maynas, Peru-, Orlando:Fdn Ecuatoriana Equidad, Guayaquil, Ecuador-, Valdilea G.:Fundacao Oswaldo Cruz, Inst Pesquisa Clin Evandro Chagas, BR-21040900 Rio De Janeiro, Brazil-, Kenneth H.:Brown Univ, Providence, RI 02912 USA; Fenway Inst, Boston, MA 02215 USA-, Suwat:Chiang Mai Univ, Res Inst Hlth Sci, Chiang Mai 50200, Thailand-, Mauro:Univ Fed Rio de Janeiro, Projeto Praca Onze, Hosp Escola Sao Francisco de Assis, BR-20210030 Rio De Janeiro, Brazil-, Linda-Gail:Univ Cape Town, Desmond Tutu HIV Ctr, ZA-7925 Cape Town, South Africa; Univ Cape Town, Dept Med, ZA-7925 Cape Town, South Africa-, Robert M.:Univ Calif San Francisco, San Francisco, CA 94143 USA; Gladstone Inst Virol & Immunol, San Francisco, CA 94158 USA-
hcfmusp.relation.referenceAnderson PL, 2011, 18 C RETR OPP INF BO-
hcfmusp.relation.referenceAnderson PL, 2012, 19 C RETR OPP INF SE-
hcfmusp.relation.referenceAnton P, 2011, 18 C RETR OPP INF BO-
hcfmusp.relation.referenceBaheti G, 2011, ANTIMICROB AGENTS CH, V55, P5294, DOI 10.1128/AAC.05317-11-
hcfmusp.relation.referenceBaral S, 2007, PLOS MED, V4, P1901, DOI 10.1371/journal.pmed.0040339-
hcfmusp.relation.referenceBorroto-Esoda K, 2006, ANTIVIR THER, V11, P377-
hcfmusp.relation.referenceBushman LR, 2011, J PHARMACEUT BIOMED, V56, P390, DOI 10.1016/j.jpba.2011.05.039-
hcfmusp.relation.referenceCastillo-Mancilla J., 2012, 19 C RETR OPP INF SE-
hcfmusp.relation.referenceDelahunty T, 2009, J CHROMATOGR B, V877, P1907, DOI 10.1016/j.jchromb.2009.05.029-
hcfmusp.relation.referenceDonnell D, 2012, 19 C RETR OPP INF SE-
hcfmusp.relation.referenceGarcia-Lerma JG, 2010, SCI TRANSL MED, V2, DOI 10.1126/scitranslmed.3000391-
hcfmusp.relation.referenceGlidden DV, 2004, STAT MED, V23, P369, DOI 10.1002/sim.1599-
hcfmusp.relation.referenceGrant R., 2011, 6 IAS C HIV PATH TRE-
hcfmusp.relation.referenceGrant RM, 2010, NEW ENGL J MED, V363, P2587, DOI 10.1056/NEJMoa1011205-
hcfmusp.relation.referenceKarim SSA, 2011, LANCET, V378, P279, DOI 10.1016/S0140-6736(11)60878-7-
hcfmusp.relation.referenceKashuba ADM, 2012, LANCET, V379, P2409, DOI 10.1016/S0140-6736(11)61852-7-
hcfmusp.relation.referenceKeller MJ, 2011, PLOS ONE, V6, DOI 10.1371/journal.pone.0016475-
hcfmusp.relation.referenceKiser JJ, 2008, ANTIMICROB AGENTS CH, V52, P631, DOI 10.1128/AAC.00761-07-
hcfmusp.relation.referenceLITTLE RJA, 1988, J BUS ECON STAT, V6, P287, DOI 10.2307/1391878-
hcfmusp.relation.referenceLiu A., 2010, 17 C RETR OPP INF SA-
hcfmusp.relation.referencePatterson KB, 2011, SCI TRANSL MED, V3, DOI 10.1126/scitranslmed.3003174-
hcfmusp.relation.referencePRENTICE RL, 1978, BIOMETRIKA, V65, P153, DOI 10.1093/biomet/65.1.153-
hcfmusp.relation.referenceSchafer JL, 1999, STAT METHODS MED RES, V8, P3, DOI 10.1191/096228099671525676-
hcfmusp.relation.referenceStataCorp, 2011, STAT 12 1-
hcfmusp.relation.referenceThigpen MC, 2011, 6 IAS C HIV PATH TRE-
hcfmusp.relation.referenceVan Damme L, 2012, 19 C RETR OPP INF SE-
Appears in Collections:

Artigos e Materiais de Revistas Científicas - FM/MCM
Departamento de Clínica Médica - FM/MCM

Artigos e Materiais de Revistas Científicas - HC/ICHC
Instituto Central - HC/ICHC

Artigos e Materiais de Revistas Científicas - LIM/60
LIM/60 - Laboratório de Imunologia Clínica e Alergia

Files in This Item:
File Description SizeFormat 
  Restricted Access
publishedVersion (English)390.17 kBAdobe PDFView/Open Request a copy

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.