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Maternal or Infant Antiretroviral Drugs to Reduce HIV-1 Transmission

2010; Massachusetts Medical Society; Volume: 362; Issue: 24 Linguagem: Inglês

10.1056/nejmoa0911486

1533-4406

Charles S. Chasela, Michael G. Hudgens, Denise J. Jamieson, Dumbani Kayira, Mina C. Hosseinipour, Athena P. Kourtis, Francis Martinson, Gerald Tegha, R. J. Knight, Yusuf Ahmed, Deborah Kamwendo, Irving Hoffman, Sascha Ellington, Zebrone Kacheche, Alice Soko, Jeffrey Wiener, Susan A. Fiscus, Peter N. Kazembe, Innocent Mofolo, Maggie Chigwenembe, Dorothy Sichali, Charles M. van der Horst,

HIV/AIDS drug development and treatment

We evaluated the efficacy of a maternal triple-drug antiretroviral regimen or infant nevirapine prophylaxis for 28 weeks during breast-feeding to reduce postnatal transmission of human immunodeficiency virus type 1 (HIV-1) in Malawi.We randomly assigned 2369 HIV-1-positive, breast-feeding mothers with a CD4+ lymphocyte count of at least 250 cells per cubic millimeter and their infants to receive a maternal antiretroviral regimen, infant nevirapine, or no extended postnatal antiretroviral regimen (control group). All mothers and infants received perinatal prophylaxis with single-dose nevirapine and 1 week of zidovudine plus lamivudine. We used the Kaplan-Meier method to estimate the cumulative risk of HIV-1 transmission or death by 28 weeks among infants who were HIV-1-negative 2 weeks after birth. Rates were compared with the use of the log-rank test.Among mother-infant pairs, 5.0% of infants were HIV-1-positive at 2 weeks of life. The estimated risk of HIV-1 transmission between 2 and 28 weeks was higher in the control group (5.7%) than in either the maternal-regimen group (2.9%, P=0.009) or the infant-regimen group (1.7%, P<0.001). The estimated risk of infant HIV-1 infection or death between 2 and 28 weeks was 7.0% in the control group, 4.1% in the maternal-regimen group (P=0.02), and 2.6% in the infant-regimen group (P<0.001). The proportion of women with neutropenia was higher among those receiving the antiretroviral regimen (6.2%) than among those in either the nevirapine group (2.6%) or the control group (2.3%). Among infants receiving nevirapine, 1.9% had a hypersensitivity reaction.The use of either a maternal antiretroviral regimen or infant nevirapine for 28 weeks was effective in reducing HIV-1 transmission during breast-feeding. (ClinicalTrials.gov number, NCT00164736.)