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Background Effective strategies are urgently needed to reduce mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) through breast-feeding in resource-limited settings.
Methods Women with HIV-1 infection who were breast-feeding infants were enrolled in a randomized, phase 3 trial in Blantyre, Malawi. At birth, the infants were randomly assigned to one of three regimens: single-dose nevirapine plus 1 week of zidovudine (control regimen) or the control regimen plus daily extended prophylaxis either with nevirapine (extended nevirapine) or with nevirapine plus zidovudine (extended dual prophylaxis) until the age of 14 weeks. Using Kaplan–Meier analyses, we assessed the risk of HIV-1 infection among infants who were HIV-1–negative on DNA polymerase-chain-reaction assay at birth.
Results Among 3016 infants in the study, the control group had consistently higher rates of HIV-1 infection from the age of 6 weeks through 18 months. At 9 months, the estimated rate of HIV-1 infection (the primary end point) was 10.6% in the control group, as compared with 5.2% in the extended-nevirapine group (P<0.001) and 6.4% in the extended-dual-prophylaxis group (P=0.002). There were no significant differences between the two extended-prophylaxis groups. The frequency of breast-feeding did not differ significantly among the study groups. Infants receiving extended dual prophylaxis had a significant increase in the number of adverse events (primarily neutropenia) that were deemed to be possibly related to a study drug.
Conclusions Extended prophylaxis with nevirapine or with nevirapine and zidovudine for the first 14 weeks of life significantly reduced postnatal HIV-1 infection in 9-month-old infants. (ClinicalTrials.gov number, NCT00115648
[ClinicalTrials.gov]
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Source Information
From the Bloomberg School of Public Health (N.I.K., Q.L., T.M., T.E.T.) and School of Medicine (M.G.F.), Johns Hopkins University, Baltimore; Rutgers University, Piscataway, NJ (D.R.H.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (L.M.M.); Centers for Disease Control and Prevention, Atlanta (M.C.T., M.B.); and the University of Malawi College of Medicine (G.K.) and Johns Hopkins University–College of Medicine Research Project (L.M., K.N.), Blantyre, Malawi.
This article (10.1056/NEJMoa0801941) was published at www.nejm.org on June 4, 2008.
Address reprint requests to Dr. Taha at Rm. E7138, Department of Epidemiology, Bloomberg School of Public Health, 615 N. Wolfe St., Baltimore, MD 21205, or at ttaha{at}jhsph.edu.
Related Letters:
Antiretroviral Prophylaxis to Reduce Breast-Milk HIV-1 Transmission
Román-Poueriet J. A., Kley N. C., Beck-Sagué C. M., Waweru C., Mills J., Coovadia H. M., Coutsoudis A., Rollins N. C., Taha T. E., Kumwenda N., Kafulafula G., Kuhn L., Sinkala M., Aldrovandi G., Gray G. E., Saloojee H.
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N Engl J Med 2008;
359:1845-1848, Oct 23, 2008.
Correspondence
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