Author | Saines, Karin Nielsen | |
Author | Watts, Heather | |
Author | Veloso,Valdiléa G. | |
Author | Bryson, Yvonne J. | |
Author | João Filho, Esaú Custódio | |
Author | Pilotto, Jose Henrique da Silva | |
Author | Gray, Glenda E. | |
Author | Theron, Gerhard | |
Author | Santos, Breno Riegel | |
Author | Fonseca, Rosana Campos da | |
Author | Kreitchmann, Regis | |
Author | Pinto, Jorge | |
Author | Pinhata, Marisa Marcia Mussi | |
Author | Ceriotto, Mariana | |
Author | Machado, Daisy | |
Author | Bethel, James | |
Author | Morgado, Mariza Gonçalves | |
Author | Dickover, Ruth | |
Author | Camarca, Margaret | |
Author | Mirochnick, Mark | |
Author | Siberry, George | |
Author | Grinsztejn, Beatriz | |
Author | Moreira, Ronaldo | |
Author | Bastos, Francisco Inácio Pinkusfeld Monteiro | |
Author | Xu, Jiahong | |
Author | Moye, Jack | |
Author | Mofenson, Lynne M. | |
Access date | 2013-03-27T13:23:08Z | |
Available date | 2013-03-27T13:23:08Z | |
Document date | 2012 | |
Citation | NIELSEN-SAINES Karin et al. Three Postpartum Antiretroviral Regimens to Prevent Intrapartum HIV Infection. The New England Journal of Medicine, Massachusetts, v. 366, n. 25, p. 2368-2379, 21 jun. 2012 | en_US |
ISSN | 0028-4793 | |
ISSN | 1533-4406 | |
URI | https://www.arca.fiocruz.br/handle/icict/6404 | |
Sponsorship | The Eunice Kennedy Shriver National Institute of Child Health and Human Development [NICHD] and others | en_US |
Language | eng | en_US |
Publisher | Massachusetts Medical Society | en_US |
Rights | open access | en_US |
Title | Three Postpartum Antiretroviral Regimens to Prevent Intrapartum HIV Infection | en_US |
Type | Article | en_US |
DOI | 10.1056/NEJMoa1108275 | |
Abstract | Background
The 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.
Methods
Within 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 threedrug
regimen. | en_US |
Affilliation | University of California Los Angeles David Geffen School of Medicine, CA, Estados Unidos | en_US |
Affilliation | Eunice Kennedy Shriver National Institute Of Child Health And Human Development. Maryland, MD, Estados Unidos | en_US |
Affilliation | Fundação Oswaldo Cruz. Instituto de Pesquisa Clinica Evandro Chagas. Centro de Pesquisa Clínica Em Hiv Aids.Riod e Janeiro, RJ, Brasil | en_US |
Affilliation | University of California Los Angeles David Geffen School of Med icine, CA, Estados Unidos | en_US |
Affilliation | Hospital dos Servidores do Estado, Rio de Janeiro, RJ, Brasil | en_US |
Affilliation | Hospital Geral de Nova Iguaçu, Rio de Janeiro, RJ, Brasil | en_US |
Affilliation | University of Witwatersrand. Perinatal HIV Research Unit. , South Africa | en_US |
Affilliation | Faculty of Medicine. Department of Obstetrics and Gynecology.Tygerberg, South Africa | en_US |
Affilliation | Grupo Hospitalar Conceição. Hospital Nossa Senhora da Conceição. Departamento de Doenças Infecciosas. Porto Alegre, RS, Brasil | en_US |
Affilliation | Hospital Fêmina. Porto Alegre, RS, Brasil | en_US |
Affilliation | Irmandade da Santa Casa de Misericordia de Porto Alegre. Porto Alegre, RS, Brasil | en_US |
Affilliation | Universidade Federal de Minas Gerais. Faculdade de Medicina. Departamento de Pediatria. Minas Gerais, MG, Brasil | en_US |
Affilliation | Universidade de São Paulo. Faculdade de Medicina de Ribeirão Preto. Departamento de Puericultura e Pediatria. Ribeirão Preto, SP, Brasil | en_US |
Affilliation | Foundation for Maternal and Infant Health, Buenos Aires, BS, Argentina | en_US |
Affilliation | Universidade Federal de Sao Paulo. Sao Paulo, SP, Brasil | en_US |
Affilliation | The Children's Hospital of Philadelphia Research Institute. Pensilvania, PA, Estados Unidos | en_US |
Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Departamento de Imunologia. Rio de Janeiro, RJ, Brasil | en_US |
Affilliation | University of California Davis, California, CA, Estados Unidos | en_US |
Affilliation | National Institute of Child Health and Human Development . Maryland, MD, Estados Unidos | en_US |
Affilliation | Boston University School of Medicine. Massachusetts, MA, Estados Unidos | en_US |
Affilliation | Eunice Kennedy Shriver National Institute Of Child Health And Human Development. Maryland, MD, Estados Unidos | en_US |
Affilliation | University of Witwatersrand and Chris Hani Baragwanath Hospital.Johannesburgo, JNB, Africa do Sul | en_US |
Affilliation | Fundação Oswaldo Cruz.Instituto de Comunicação e Informação Cientifica e Tecnológica em Saúde. Rio de Janeiro, RJ, Brasil | en_US |
Affilliation | Fundação Oswaldo Cruz.Instituto de Comunicação e Informação Cientifica e Tecnológica em Saúde. Rio de Janeiro, RJ, Brasil | en_US |
Affilliation | Eunice Kennedy Shriver National Institute Of Child Health And Human Development. Maryland, MD, Estados Unidos | en_US |
Affilliation | Eunice Kennedy Shriver National Institute Of Child Health And Human Development. Maryland, MD, Estados Unidos | en_US |
Affilliation | Eunice Kennedy Shriver National Institute Of Child Health And Human Development. Maryland, MD, Estados Unidos | en_US |
Subject | Kaplan-Meier Estimate | en_US |
Subject | Antiretroviral Therapy, Highly Active /utilization | en_US |
Subject | Zidovudine /therapeutic use | en_US |
Subject | Prenatal Diagnosis /utilization | en_US |
Subject | HIV-1 /pathogenicity | en_US |
Subject | Nevirapine /therapeutic use | en_US |
Subject | HIV Antigens /therapeutic use | en_US |
Subject | Americas /epidemiology | en_US |
Subject | Africa /epidemiology | en_US |
DeCS | Estimativa de Kaplan-Meier | en_US |
DeCS | Terapia Antirretroviral de Alta Atividade /utilização | en_US |
DeCS | Zidovudina /uso terapêutico | en_US |
DeCS | Diagnóstico Pré-Natal /utilização | en_US |
DeCS | HIV-1 /patogenicidade | en_US |
DeCS | Nevirapina /uso terapêutico | en_US |
DeCS | Antígenos HIV /uso terapêutico | en_US |
DeCS | Américas /epidemiologia | en_US |
DeCS | África /epidemiologia | en_US |