Antiretroviral regimens in pregnancy and breast-feeding in Botswana
R L Shapiro, M D Hughes, A Ogwu, D Kitch, S Lockman, C Moffat, J Makhema, S Moyo, I Thior, K McIntosh, E van Widenfelt, J Leidner, K Powis, A Asmelash, E Tumbare, S Zwerski, U Sharma, E Handelsman, K Mburu, O Jayeoba, E Moko, S Souda, E Lubega, M Akhtar, C Wester, R Tuomola, W Snowden, M Martinez-Tristani, L Mazhani, M Essex, R L Shapiro, M D Hughes, A Ogwu, D Kitch, S Lockman, C Moffat, J Makhema, S Moyo, I Thior, K McIntosh, E van Widenfelt, J Leidner, K Powis, A Asmelash, E Tumbare, S Zwerski, U Sharma, E Handelsman, K Mburu, O Jayeoba, E Moko, S Souda, E Lubega, M Akhtar, C Wester, R Tuomola, W Snowden, M Martinez-Tristani, L Mazhani, M Essex
Abstract
Background: 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%. (ClinicalTrials.gov number, NCT00270296.)
2010 Massachusetts Medical Society
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Source: PubMed