Shapiro, R.L.Hughes, M.D.Ogwu, AnthonyKitch, DougLockman, ShahinMoffat, C.Makhema, JosephMoyo, SikhulileThior, IbouMcIntosh, Kennethvan Widenfelt, E.Leidner, JeanPowis, KathleenAsmelash, A.Tumbare, E.Zwerski, S.Sharma, UpasnaHandelsman, E.Mburu, K.Jayeoba, O.Moko, E.Souda, Shashidhar VamanLubega, E.Akhtar, M.Wester, CTuomola, R.Snowden, W.Martinez-Tristani, M.Mazhani, L.Essex, Myron2016-04-212010Shapiro, R.L., M.D. Hughes, A. Ogwu, D. Kitch, S. Lockman, C. Moffat, J. Makhema, et al. 2010. “Antiretroviral Regimens in Pregnancy and Breast-Feeding in Botswana.” N Engl J Med 362 (24) (June 17): 2282–2294. doi:10.1056/nejmoa0907736.0028-4793http://nrs.harvard.edu/urn-3:HUL.InstRepos:26718770BACKGROUND: The most effective highly active antiretroviral therapy (HAART) to prevent mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) in pregnancy and its efficacy during breast-feeding are unknown. METHODS: We randomly assigned 560 HIV-1-infected pregnant women (CD4+ count, > or = 200 cells per cubic millimeter) to receive coformulated abacavir, zidovudine, and lamivudine (the nucleoside reverse-transcriptase inhibitor [NRTI] group) or lopinavir-ritonavir plus zidovudine-lamivudine (the protease-inhibitor group) from 26 to 34 weeks' gestation through planned weaning by 6 months post partum. A total of 170 women with CD4+ counts of less than 200 cells per cubic millimeter received nevirapine plus zidovudine-lamivudine (the observational group). Infants received single-dose nevirapine and 4 weeks of zidovudine. RESULTS: The rate of virologic suppression to less than 400 copies per milliliter was high and did not differ significantly among the three groups at delivery (96% in the NRTI group, 93% in the protease-inhibitor group, and 94% in the observational group) or throughout the breast-feeding period (92% in the NRTI group, 93% in the protease-inhibitor group, and 95% in the observational group). By 6 months of age, 8 of 709 live-born infants (1.1%) were infected (95% confidence interval [CI], 0.5 to 2.2): 6 were infected in utero (4 in the NRTI group, 1 in the protease-inhibitor group, and 1 in the observational group), and 2 were infected during the breast-feeding period (in the NRTI group). Treatment-limiting adverse events occurred in 2% of women in the NRTI group, 2% of women in the protease-inhibitor group, and 11% of women in the observational group. CONCLUSIONS: All regimens of HAART from pregnancy through 6 months post partum resulted in high rates of virologic suppression, with an overall rate of mother-to-child transmission of 1.1%.en-USJournal Article2016-04-2110.1056/NEJMoa0907736