Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/6404

Type
Article
Copyright
Open access
Collections
Share

Statistics
Metadata
Show full item record

THREE POSTPARTUM ANTIRETROVIRAL REGIMENS TO PREVENT INTRAPARTUM HIV INFECTION
Saines, Karin Nielsen et al. | Date Issued: 2012
Author
Saines, Karin Nielsen
Watts, Heather
Veloso,Valdiléa G.
Bryson, Yvonne J.
João Filho, Esaú Custódio
Pilotto, Jose Henrique da Silva
Gray, Glenda E.
Theron, Gerhard
Santos, Breno Riegel
Fonseca, Rosana Campos da
Kreitchmann, Regis
Pinto, Jorge
Pinhata, Marisa Marcia Mussi
Ceriotto, Mariana
Machado, Daisy
Bethel, James
Morgado, Mariza Gonçalves
Dickover, Ruth
Camarca, Margaret
Mirochnick, Mark
Siberry, George
Grinsztejn, Beatriz
Moreira, Ronaldo
Bastos, Francisco Inácio Pinkusfeld Monteiro
Xu, Jiahong
Moye, Jack
Mofenson, Lynne M.
Affilliation
University of California Los Angeles David Geffen School of Medicine, CA, Estados Unidos
Eunice Kennedy Shriver National Institute Of Child Health And Human Development. Maryland, MD, Estados Unidos
Fundação Oswaldo Cruz. Instituto de Pesquisa Clinica Evandro Chagas. Centro de Pesquisa Clínica Em Hiv Aids.Riod e Janeiro, RJ, Brasil
University of California Los Angeles David Geffen School of Med icine, CA, Estados Unidos
Hospital dos Servidores do Estado, Rio de Janeiro, RJ, Brasil
Hospital Geral de Nova Iguaçu, Rio de Janeiro, RJ, Brasil
University of Witwatersrand. Perinatal HIV Research Unit. , South Africa
Faculty of Medicine. Department of Obstetrics and Gynecology.Tygerberg, South Africa
Grupo Hospitalar Conceição. Hospital Nossa Senhora da Conceição. Departamento de Doenças Infecciosas. Porto Alegre, RS, Brasil
Hospital Fêmina. Porto Alegre, RS, Brasil
Irmandade da Santa Casa de Misericordia de Porto Alegre. Porto Alegre, RS, Brasil
Universidade Federal de Minas Gerais. Faculdade de Medicina. Departamento de Pediatria. Minas Gerais, MG, Brasil
Universidade de São Paulo. Faculdade de Medicina de Ribeirão Preto. Departamento de Puericultura e Pediatria. Ribeirão Preto, SP, Brasil
Foundation for Maternal and Infant Health, Buenos Aires, BS, Argentina
Universidade Federal de Sao Paulo. Sao Paulo, SP, Brasil
The Children's Hospital of Philadelphia Research Institute. Pensilvania, PA, Estados Unidos
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Departamento de Imunologia. Rio de Janeiro, RJ, Brasil
University of California Davis, California, CA, Estados Unidos
National Institute of Child Health and Human Development . Maryland, MD, Estados Unidos
Boston University School of Medicine. Massachusetts, MA, Estados Unidos
Eunice Kennedy Shriver National Institute Of Child Health And Human Development. Maryland, MD, Estados Unidos
University of Witwatersrand and Chris Hani Baragwanath Hospital.Johannesburgo, JNB, Africa do Sul
Fundação Oswaldo Cruz.Instituto de Comunicação e Informação Cientifica e Tecnológica em Saúde. Rio de Janeiro, RJ, Brasil
Fundação Oswaldo Cruz.Instituto de Comunicação e Informação Cientifica e Tecnológica em Saúde. Rio de Janeiro, RJ, Brasil
Eunice Kennedy Shriver National Institute Of Child Health And Human Development. Maryland, MD, Estados Unidos
Eunice Kennedy Shriver National Institute Of Child Health And Human Development. Maryland, MD, Estados Unidos
Eunice Kennedy Shriver National Institute Of Child Health And Human Development. Maryland, MD, Estados Unidos
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.
Keywords
Kaplan-Meier Estimate
Antiretroviral Therapy, Highly Active /utilization
Zidovudine /therapeutic use
Prenatal Diagnosis /utilization
HIV-1 /pathogenicity
Nevirapine /therapeutic use
HIV Antigens /therapeutic use
Americas /epidemiology
Africa /epidemiology
 
DeCS
Estimativa de Kaplan-Meier
Terapia Antirretroviral de Alta Atividade /utilização
Zidovudina /uso terapêutico
Diagnóstico Pré-Natal /utilização
HIV-1 /patogenicidade
Nevirapina /uso terapêutico
Antígenos HIV /uso terapêutico
Américas /epidemiologia
África /epidemiologia
 
Publisher
Massachusetts Medical Society
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
DOI
10.1056/NEJMoa1108275
ISSN
0028-4793
1533-4406