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Title: Three Postpartum Antiretroviral Regimens to Prevent Intrapartum HIV Infection
Authors: Nielsen-Saines, Karin
Watts, Heather
Veloso, Valdilea G.
Bryson, Yvonne J.
Joao, Esau C.
Pilotto, Jose Henrique
Gray, Glenda
Theron, Gerhard
Santos, Breno
Fonseca, Rosana
Kreitchmann, Regis
Pinto, Jorge
Mussi-Pinhata, Marisa Marcia
Ceriotto, Mariana
Machado, Daisy Maria [UNIFESP]
Bethel, James
Morgado, Mariza Goncalves
Dickover, Ruth
Camarca, Margaret
Mirochnick, Mark
Siberry, George
Grinsztejn, Beatriz
Moreira, Ronaldo I.
Bastos, Francisco I.
Xu, Jiahong
Moye, Jack
Mofenson, Lynne M.
NICHD HPTN 040 PACTG Protocol Team
Univ Calif Los Angeles
Eunice Kennedy Shriver Natl Inst Child Hlth & Hum
Westat Corp
Fundacao Oswaldo Cruz Fiocruz
Hosp Fed Servidores Estado
Hosp Geral Nova Iguacu
Univ Witwatersrand
Chris Hani Baragwanath Hosp
Univ Stellenbosch
Tygerberg Hosp
Hosp Conceicao
Hosp Femina
Irmandade Santa Casa Misericordia Porto Alegre
Universidade Federal de Minas Gerais (UFMG)
Universidade de São Paulo (USP)
Universidade Federal de São Paulo (UNIFESP)
Univ Calif Davis
Fdn Maternal & Infant Hlth
Boston Univ
Issue Date: 21-Jun-2012
Publisher: Massachusetts Medical Soc
Citation: New England Journal Of Medicine. Waltham: Massachusetts Medical Soc, v. 366, n. 25, p. 2368-2379, 2012.
Abstract: BACKGROUNDThe 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; number, NCT00099359.)
ISSN: 0028-4793
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