Three Postpartum Antiretroviral Regimens to Prevent Intrapartum HIV Infection

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dc.contributor.authorNielsen-Saines, Karin
dc.contributor.authorWatts, Heather
dc.contributor.authorVeloso, Valdilea G.
dc.contributor.authorBryson, Yvonne J.
dc.contributor.authorJoao, Esau C.
dc.contributor.authorPilotto, Jose Henrique
dc.contributor.authorGray, Glenda
dc.contributor.authorTheron, Gerhard
dc.contributor.authorSantos, Breno
dc.contributor.authorFonseca, Rosana
dc.contributor.authorKreitchmann, Regis
dc.contributor.authorPinto, Jorge
dc.contributor.authorMussi-Pinhata, Marisa Marcia
dc.contributor.authorCeriotto, Mariana
dc.contributor.authorMachado, Daisy Maria [UNIFESP]
dc.contributor.authorBethel, James
dc.contributor.authorMorgado, Mariza Goncalves
dc.contributor.authorDickover, Ruth
dc.contributor.authorCamarca, Margaret
dc.contributor.authorMirochnick, Mark
dc.contributor.authorSiberry, George
dc.contributor.authorGrinsztejn, Beatriz
dc.contributor.authorMoreira, Ronaldo I.
dc.contributor.authorBastos, Francisco I.
dc.contributor.authorXu, Jiahong
dc.contributor.authorMoye, Jack
dc.contributor.authorMofenson, Lynne M.
dc.contributor.authorNICHD HPTN 040 PACTG Protocol Team
dc.contributor.institutionUniv Calif Los Angeles
dc.contributor.institutionEunice Kennedy Shriver Natl Inst Child Hlth & Hum
dc.contributor.institutionWestat Corp
dc.contributor.institutionFundacao Oswaldo Cruz Fiocruz
dc.contributor.institutionHosp Fed Servidores Estado
dc.contributor.institutionHosp Geral Nova Iguacu
dc.contributor.institutionUniv Witwatersrand
dc.contributor.institutionChris Hani Baragwanath Hosp
dc.contributor.institutionUniv Stellenbosch
dc.contributor.institutionTygerberg Hosp
dc.contributor.institutionHosp Conceicao
dc.contributor.institutionHosp Femina
dc.contributor.institutionIrmandade Santa Casa Misericordia Porto Alegre
dc.contributor.institutionUniversidade Federal de Minas Gerais (UFMG)
dc.contributor.institutionUniversidade de São Paulo (USP)
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionUniv Calif Davis
dc.contributor.institutionFdn Maternal & Infant Hlth
dc.contributor.institutionBoston Univ
dc.date.accessioned2018-06-18T11:15:22Z
dc.date.available2018-06-18T11:15:22Z
dc.date.issued2012-06-21
dc.description.abstractBACKGROUNDThe safety and efficacy of adding antiretroviral drugs to standard zidovudine prophylaxis in infants of mothers with human immunodeficiency virus (HIV) infection who did not receive antenatal antiretroviral therapy (ART) because of late identification are unclear. We evaluated three ART regimens in such infants.METHODSWithin 48 hours after their birth, we randomly assigned formula-fed infants born to women with a peripartum diagnosis of HIV type 1 (HIV-1) infection to one of three regimens: zidovudine for 6 weeks (zidovudine-alone group), zidovudine for 6 weeks plus three doses of nevirapine during the first 8 days of life (two-drug group), or zidovudine for 6 weeks plus nelfinavir and lamivudine for 2 weeks (three-drug group). The primary outcome was HIV-1 infection at 3 months in infants uninfected at birth.RESULTS A total of 1684 infants were enrolled in the Americas and South Africa (566 in the zidovudine-alone group, 562 in the two-drug group, and 556 in the three-drug group). The overall rate of in utero transmission of HIV-1 on the basis of Kaplan-Meier estimates was 5.7% (93 infants), with no significant differences among the groups. Intrapartum transmission occurred in 24 infants in the zidovudine-alone group (4.8%; 95% confidence interval [CI], 3.2 to 7.1), as compared with 11 infants in the two-drug group (2.2%; 95% CI, 1.2 to 3.9; P=0.046) and 12 in the three-drug group (2.4%; 95% CI, 1.4 to 4.3; P=0.046). The overall transmission rate was 8.5% (140 infants), with an increased rate in the zidovudine-alone group (P=0.03 for the comparisons with the two-and three-drug groups). On multivariate analysis, zidovudine monotherapy, a higher maternal viral load, and maternal use of illegal substances were significantly associated with transmission. The rate of neutropenia was significantly increased in the three-drug group (P < 0.001 for both comparisons with the other groups).CONCLUSIONS In neonates whose mothers did not receive ART during pregnancy, prophylaxis with a two-or three-drug ART regimen is superior to zidovudine alone for the prevention of intrapartum HIV transmission; the two-drug regimen has less toxicity than the three-drug regimen. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development [NICHD] and others; ClinicalTrials.gov number, NCT00099359.)en
dc.description.affiliationUniv Calif Los Angeles, David Geffen Sch Med, Div Infect Dis, Los Angeles, CA 90095 USA
dc.description.affiliationEunice Kennedy Shriver Natl Inst Child Hlth & Hum, NIH, Bethesda, MD USA
dc.description.affiliationWestat Corp, Rockville, MD USA
dc.description.affiliationFundacao Oswaldo Cruz Fiocruz, Lab Pesquisa Clin DST & AIDS, Inst Pesquisa Clin Evandro Chagas, Rio De Janeiro, Brazil
dc.description.affiliationFundacao Oswaldo Cruz Fiocruz, Lab AIDS & Imunol Mol, Inst Oswaldo Cruz, Rio De Janeiro, Brazil
dc.description.affiliationFundacao Oswaldo Cruz Fiocruz, Lab Informacoes Saude, Inst Informacao Cient & Tecnol Saude, Rio De Janeiro, Brazil
dc.description.affiliationHosp Fed Servidores Estado, Rio De Janeiro, Brazil
dc.description.affiliationHosp Geral Nova Iguacu, Rio De Janeiro, Brazil
dc.description.affiliationUniv Witwatersrand, Perinatal HIV Res Unit, Johannesburg, South Africa
dc.description.affiliationChris Hani Baragwanath Hosp, Johannesburg, South Africa
dc.description.affiliationUniv Stellenbosch, Cape Town, South Africa
dc.description.affiliationTygerberg Hosp, Cape Town, South Africa
dc.description.affiliationHosp Conceicao, Porto Alegre, RS, Brazil
dc.description.affiliationHosp Femina, Porto Alegre, RS, Brazil
dc.description.affiliationIrmandade Santa Casa Misericordia Porto Alegre, Porto Alegre, RS, Brazil
dc.description.affiliationUniv Fed Minas Gerais, Belo Horizonte, MG, Brazil
dc.description.affiliationUniv Sao Paulo, BR-14049 Ribeirao Preto, SP, Brazil
dc.description.affiliationUniv Fed Sao Paulo, Sao Paulo, Brazil
dc.description.affiliationUniv Calif Davis, Davis, CA 95616 USA
dc.description.affiliationFdn Maternal & Infant Hlth, Buenos Aires, DF, Argentina
dc.description.affiliationBoston Univ, Sch Med, Boston, MA 02118 USA
dc.description.affiliationUnifespUniv Fed Sao Paulo, Sao Paulo, Brazil
dc.description.sourceWeb of Science
dc.description.sponsorshipNICHD
dc.description.sponsorshipHIV Prevention Trials Network
dc.description.sponsorshipNational Institute of Allergy and Infectious Diseases (NIAID)
dc.description.sponsorshipNational Institute of Mental Health
dc.description.sponsorshipIDNICHD: HHSN267200800001C
dc.description.sponsorshipIDNICHD: N01-HD-8-0001
dc.description.sponsorshipIDNational Institute of Allergy and Infectious Diseases (NIAID): U01 AI047986
dc.description.sponsorshipIDNational Institute of Allergy and Infectious Diseases (NIAID): U01 AI068632
dc.description.sponsorshipIDNational Institute of Mental Health: AI068632
dc.format.extent2368-2379
dc.identifierhttp://dx.doi.org/10.1056/NEJMoa1108275
dc.identifier.citationNew England Journal Of Medicine. Waltham: Massachusetts Medical Soc, v. 366, n. 25, p. 2368-2379, 2012.
dc.identifier.doi10.1056/NEJMoa1108275
dc.identifier.issn0028-4793
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/45036
dc.identifier.wosWOS:000305451700006
dc.language.isoeng
dc.publisherMassachusetts Medical Soc
dc.relation.ispartofNew England Journal Of Medicine
dc.rightsinfo:eu-repo/semantics/openAccess
dc.titleThree Postpartum Antiretroviral Regimens to Prevent Intrapartum HIV Infectionen
dc.typeinfo:eu-repo/semantics/article
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