Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women

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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.authorLANDOVITZ, Raphael J.
dc.contributor.authorDONNELL, Deborah
dc.contributor.authorCLEMENT, Meredith E.
dc.contributor.authorHANSCOM, Brett
dc.contributor.authorCOTTLE, Leslie
dc.contributor.authorCOELHO, Lara
dc.contributor.authorCABELLO, Robinson
dc.contributor.authorCHARIYALERTSAK, Suwat
dc.contributor.authorDUNNE, Eileen F.
dc.contributor.authorFRANK, Ian
dc.contributor.authorGALLARDO-CARTAGENA, Jorge A.
dc.contributor.authorGAUR, Aditya H.
dc.contributor.authorGONZALES, Pedro
dc.contributor.authorTRAN, Ha V.
dc.contributor.authorHINOJOSA, Juan C.
dc.contributor.authorKALLAS, Esper G.
dc.contributor.authorKELLEY, Colleen F.
dc.contributor.authorLOSSO, Marcelo H.
dc.contributor.authorMADRUGA, J. Valdez
dc.contributor.authorMIDDELKOOP, Keren
dc.contributor.authorPHANUPHAK, Nittaya
dc.contributor.authorSANTOS, Breno
dc.contributor.authorSUED, Omar
dc.contributor.authorHUAMANI, Javier Valencia
dc.contributor.authorOVERTON, Edgar T.
dc.contributor.authorSWAMINATHAN, Shobha
dc.contributor.authorRIO, Carlos del
dc.contributor.authorGULICK, Roy M.
dc.contributor.authorRICHARDSON, Paul
dc.contributor.authorSULLIVAN, Philip
dc.contributor.authorPIWOWAR-MANNING, Estelle
dc.contributor.authorMARZINKE, Mark
dc.contributor.authorHENDRIX, Craig
dc.contributor.authorLI, Maoji
dc.contributor.authorWANG, Zhe
dc.contributor.authorMARRAZZO, Jeanne
dc.contributor.authorDAAR, Eric
dc.contributor.authorASMELASH, Aida
dc.contributor.authorBROWN, Todd T.
dc.contributor.authorANDERSON, Peter
dc.contributor.authorESHLEMAN, Susan H.
dc.contributor.authorBRYAN, Marcus
dc.contributor.authorBLANCHETTE, Cheryl
dc.contributor.authorLUCAS, Jonathan
dc.contributor.authorPSAROS, Christina
dc.contributor.authorSAFREN, Steven
dc.contributor.authorSUGARMAN, Jeremy
dc.contributor.authorSCOTT, Hyman
dc.contributor.authorERON, Joseph J.
dc.contributor.authorFIELDS, Sheldon D.
dc.contributor.authorSISTA, Nirupama D.
dc.contributor.authorGOMEZ-FELICIANO, Kailazarid
dc.contributor.authorJENNINGS, Andrea
dc.contributor.authorKOFRON, Ryan M.
dc.contributor.authorHOLTZ, Timothy H.
dc.contributor.authorSHIN, Katherine
dc.contributor.authorROONEY, James F.
dc.contributor.authorSMITH, Kimberly Y.
dc.contributor.authorSPREEN, William
dc.contributor.authorMARGOLIS, David
dc.contributor.authorRINEHART, Alex
dc.contributor.authorADEYEYE, Adeola
dc.contributor.authorCOHEN, Myron S.
dc.contributor.authorMCCAULEY, Marybeth
dc.contributor.authorGRINSZTEJN, Beatriz
dc.contributor.groupauthorHPTN 083 Study Team
dc.date.accessioned2021-12-16T14:25:02Z
dc.date.available2021-12-16T14:25:02Z
dc.date.issued2021
dc.description.abstractInjectable Cabotegravir for Prevention of HIV Infection Antiviral medication has emerged as an important tool in the prevention of HIV infection. In this randomized, controlled trial, an injectable long-acting agent, cabotegravir, was found to be superior to daily oral tenofovir disoproxil fumarate-emtricitabine in preventing incident HIV infection in cisgender men and transgender women who have sex with men. Background Safe and effective long-acting injectable agents for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection are needed to increase the options for preventing HIV infection. Methods We conducted a randomized, double-blind, double-dummy, noninferiority trial to compare long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor [INSTI]) at a dose of 600 mg, given intramuscularly every 8 weeks, with daily oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) for the prevention of HIV infection in at-risk cisgender men who have sex with men (MSM) and in at-risk transgender women who have sex with men. Participants were randomly assigned (1:1) to receive one of the two regimens and were followed for 153 weeks. HIV testing and safety evaluations were performed. The primary end point was incident HIV infection. Results The intention-to-treat population included 4566 participants who underwent randomization; 570 (12.5%) identified as transgender women, and the median age was 26 years (interquartile range, 22 to 32). The trial was stopped early for efficacy on review of the results of the first preplanned interim end-point analysis. Among 1698 participants from the United States, 845 (49.8%) identified as Black. Incident HIV infection occurred in 52 participants: 13 in the cabotegravir group (incidence, 0.41 per 100 person-years) and 39 in the TDF-FTC group (incidence, 1.22 per 100 person-years) (hazard ratio, 0.34; 95% confidence interval, 0.18 to 0.62). The effect was consistent across prespecified subgroups. Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF-FTC group. In the participants in whom HIV infection was diagnosed after exposure to CAB-LA, INSTI resistance and delays in the detection of HIV infection were noted. No safety concerns were identified. Conclusions CAB-LA was superior to daily oral TDF-FTC in preventing HIV infection among MSM and transgender women. Strategies are needed to prevent INSTI resistance in cases of CAB-LA PrEP failure. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 083 ClinicalTrials.gov number, .)eng
dc.description.indexMEDLINEeng
dc.description.sponsorshipNational Institute of Allergy and Infectious DiseasesUnited States Department of Health & Human ServicesNational Institutes of Health (NIH) - USANIH National Institute of Allergy & Infectious Diseases (NIAID) [UM1AI068613, UM1AI068617, UM1AI068619] Funding Source: Medline
dc.description.sponsorshipNIAID NIH HHSUnited States Department of Health & Human ServicesNational Institutes of Health (NIH) - USANIH National Institute of Allergy & Infectious Diseases (NIAID) [UM1 AI068613, UM1 AI154468, UM1 AI068617, UM1 AI069519, UM1 AI069496, UM1 AI068619, UM1 AI069399, P30 AI045008] Funding Source: Medline
dc.identifier.citationNEW ENGLAND JOURNAL OF MEDICINE, v.385, n.7, p.595-608, 2021
dc.identifier.doi10.1056/NEJMoa2101016
dc.identifier.eissn1533-4406
dc.identifier.issn0028-4793
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/43854
dc.language.isoeng
dc.publisherMASSACHUSETTS MEDICAL SOCeng
dc.relation.ispartofNew England Journal of Medicine
dc.rightsrestrictedAccesseng
dc.rights.holderCopyright MASSACHUSETTS MEDICAL SOCeng
dc.subject.otherpreexposure prophylaxiseng
dc.subject.otherprotects macaqueseng
dc.subject.otherantiretroviral prophylaxiseng
dc.subject.otherdouble-blindeng
dc.subject.otherhigh-riskeng
dc.subject.othertenofovireng
dc.subject.othersexeng
dc.subject.otheremtricitabineeng
dc.subject.otherinfectioneng
dc.subject.otherphase-3eng
dc.subject.wosMedicine, General & Internaleng
dc.titleCabotegravir for HIV Prevention in Cisgender Men and Transgender Womeneng
dc.typearticleeng
dc.type.categoryoriginal articleeng
dc.type.versionpublishedVersioneng
dspace.entity.typePublication
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryPeru
hcfmusp.affiliation.countryTailândia
hcfmusp.affiliation.countryArgentina
hcfmusp.affiliation.countryÁfrica do Sul
hcfmusp.affiliation.countryisous
hcfmusp.affiliation.countryisope
hcfmusp.affiliation.countryisoth
hcfmusp.affiliation.countryisoar
hcfmusp.affiliation.countryisoza
hcfmusp.author.externalLANDOVITZ, Raphael J.:Univ Calif Los Angeles, David Geffen Sch Med, Ctr Clin AIDS Res & Educ, Los Angeles, CA 90095 USA
hcfmusp.author.externalDONNELL, Deborah:Fred Hutchinson Canc Res Ctr, 1124 Columbia St, Seattle, WA 98104 USA
hcfmusp.author.externalCLEMENT, Meredith E.:Louisiana State Univ, Hlth Sci Ctr, New Orleans, LA USA
hcfmusp.author.externalHANSCOM, Brett:Fred Hutchinson Canc Res Ctr, 1124 Columbia St, Seattle, WA 98104 USA
hcfmusp.author.externalCOTTLE, Leslie:Fred Hutchinson Canc Res Ctr, 1124 Columbia St, Seattle, WA 98104 USA
hcfmusp.author.externalCOELHO, Lara:Inst Nacl Infectol Evandro Chagas Fiocruz, Rio De Janeiro, Brazil
hcfmusp.author.externalCABELLO, Robinson:Via Libre, Lima, Peru
hcfmusp.author.externalCHARIYALERTSAK, Suwat:Chiang Mai Univ, Res Inst Hlth Sci, Chiang Mai, Thailand
hcfmusp.author.externalDUNNE, Eileen F.:Harbor UCLA Med Ctr, Lundquist Inst, Torrance, CA 90509 USA; Emory Univ, Div HIV AIDS Prevent, Ctr Dis Control & Prevent, Atlanta, GA 30322 USA
hcfmusp.author.externalFRANK, Ian:Univ Penn, Perelman Sch Med, Philadelphia, PA 19104 USA
hcfmusp.author.externalGALLARDO-CARTAGENA, Jorge A.:Univ Nacl Mayor San Marcos, Lima, Peru
hcfmusp.author.externalGAUR, Aditya H.:St Jude Childrens Res Hosp, 332 N Lauderdale St, Memphis, TN 38105 USA
hcfmusp.author.externalGONZALES, Pedro:Asoc Civil Impacta Salud & Educ, Lima, Peru
hcfmusp.author.externalTRAN, Ha V.:Univ N Carolina, Chapel Hill, NC 27515 USA
hcfmusp.author.externalHINOJOSA, Juan C.:Asociac Civil Selva Amazon, Iquitos, Peru
hcfmusp.author.externalKELLEY, Colleen F.:Emory Univ, Sch Med, Atlanta, GA USA
hcfmusp.author.externalLOSSO, Marcelo H.:Hosp Gen Agudos Jose Maria Ramos Mejia, Buenos Aires, DF, Argentina
hcfmusp.author.externalMADRUGA, J. Valdez:Ctr Referencia & Treinamento DST AIDS SP, Sao Paulo, Brazil
hcfmusp.author.externalMIDDELKOOP, Keren:Univ Cape Town, Inst Infect Dis & Mol Med, Cape Town, South Africa
hcfmusp.author.externalPHANUPHAK, Nittaya:Inst HIV Res & Innovat, Bangkok, Thailand
hcfmusp.author.externalSANTOS, Breno:Hosp Nossa Senhora Conceicao, Porto Alegre, RS, Brazil
hcfmusp.author.externalSUED, Omar:Fdn Huesped, Buenos Aires, DF, Argentina
hcfmusp.author.externalHUAMANI, Javier Valencia:Asoc Civil Impacta Salud & Educ, Lima, Peru
hcfmusp.author.externalOVERTON, Edgar T.:Univ Alabama Birmingham, Birmingham, AL USA
hcfmusp.author.externalSWAMINATHAN, Shobha:Rutgers New Jersey Med Sch, Newark, NJ USA
hcfmusp.author.externalRIO, Carlos del:Emory Univ, Sch Med, Atlanta, GA USA; Emory Univ, Rollins Sch Publ Hlth, Atlanta, GA 30322 USA
hcfmusp.author.externalGULICK, Roy M.:Weill Cornell Med, New York, NY USA
hcfmusp.author.externalRICHARDSON, Paul:Johns Hopkins Univ, Baltimore, MD USA
hcfmusp.author.externalSULLIVAN, Philip:Johns Hopkins Univ, Baltimore, MD USA
hcfmusp.author.externalPIWOWAR-MANNING, Estelle:Johns Hopkins Univ, Baltimore, MD USA
hcfmusp.author.externalMARZINKE, Mark:Johns Hopkins Univ, Baltimore, MD USA
hcfmusp.author.externalHENDRIX, Craig:Johns Hopkins Univ, Baltimore, MD USA
hcfmusp.author.externalLI, Maoji:Fred Hutchinson Canc Res Ctr, 1124 Columbia St, Seattle, WA 98104 USA
hcfmusp.author.externalWANG, Zhe:Fred Hutchinson Canc Res Ctr, 1124 Columbia St, Seattle, WA 98104 USA
hcfmusp.author.externalMARRAZZO, Jeanne:Univ Alabama Birmingham, Birmingham, AL USA
hcfmusp.author.externalASMELASH, Aida:FHI 360, Durham, NC USA
hcfmusp.author.externalBROWN, Todd T.:Johns Hopkins Univ, Baltimore, MD USA
hcfmusp.author.externalANDERSON, Peter:Univ Colorado Anschutz Med Campus, Aurora, CO USA
hcfmusp.author.externalESHLEMAN, Susan H.:Johns Hopkins Univ, Baltimore, MD USA
hcfmusp.author.externalBRYAN, Marcus:FHI 360, Durham, NC USA
hcfmusp.author.externalBLANCHETTE, Cheryl:FHI 360, Durham, NC USA
hcfmusp.author.externalLUCAS, Jonathan:FHI 360, Durham, NC USA
hcfmusp.author.externalPSAROS, Christina:Massachusetts Gen Hosp, Boston, MA 02114 USA
hcfmusp.author.externalSAFREN, Steven:Univ Miami, Coral Gables, FL 33124 USA
hcfmusp.author.externalSUGARMAN, Jeremy:Johns Hopkins Univ, Baltimore, MD USA
hcfmusp.author.externalSCOTT, Hyman:San Francisco Dept Publ Hlth, San Francisco, CA USA
hcfmusp.author.externalERON, Joseph J.:Univ N Carolina, Chapel Hill, NC 27515 USA
hcfmusp.author.externalFIELDS, Sheldon D.:Penn State Univ, State Coll, University Pk, PA 16802 USA
hcfmusp.author.externalSISTA, Nirupama D.:FHI 360, Durham, NC USA
hcfmusp.author.externalGOMEZ-FELICIANO, Kailazarid:FHI 360, Durham, NC USA
hcfmusp.author.externalJENNINGS, Andrea:FHI 360, Durham, NC USA
hcfmusp.author.externalKOFRON, Ryan M.:Univ Calif Los Angeles, David Geffen Sch Med, Ctr Clin AIDS Res & Educ, Los Angeles, CA 90095 USA
hcfmusp.author.externalHOLTZ, Timothy H.:Off AIDS Res, Rockville, MD USA
hcfmusp.author.externalSHIN, Katherine:NIAID, Div AIDS, NIH, Rockville, MD USA
hcfmusp.author.externalROONEY, James F.:Gilead Sci, Foster City, CA USA
hcfmusp.author.externalSMITH, Kimberly Y.:ViiV Healthcare, Res Triangle Pk, NC USA
hcfmusp.author.externalSPREEN, William:ViiV Healthcare, Res Triangle Pk, NC USA
hcfmusp.author.externalMARGOLIS, David:ViiV Healthcare, Res Triangle Pk, NC USA
hcfmusp.author.externalRINEHART, Alex:ViiV Healthcare, Res Triangle Pk, NC USA
hcfmusp.author.externalADEYEYE, Adeola:NIAID, Div AIDS, NIH, Rockville, MD USA
hcfmusp.author.externalCOHEN, Myron S.:Univ N Carolina, Chapel Hill, NC 27515 USA
hcfmusp.author.externalMCCAULEY, Marybeth:FHI 360, Durham, NC USA
hcfmusp.author.externalGRINSZTEJN, Beatriz:Inst Nacl Infectol Evandro Chagas Fiocruz, Rio De Janeiro, Brazil
hcfmusp.citation.scopus346
hcfmusp.contributor.author-fmusphcESPER GEORGES KALLAS
hcfmusp.description.beginpage595
hcfmusp.description.endpage608
hcfmusp.description.issue7
hcfmusp.description.volume385
hcfmusp.origemWOS
hcfmusp.origem.pubmed34379922
hcfmusp.origem.scopus2-s2.0-85112776909
hcfmusp.origem.wosWOS:000685313600009
hcfmusp.publisher.cityWALTHAMeng
hcfmusp.publisher.countryUSAeng
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