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Randomized Controlled Trial
. 2010 Jun 17;362(24):2282-94.
doi: 10.1056/NEJMoa0907736.

Antiretroviral regimens in pregnancy and breast-feeding in Botswana

R L Shapiro  1 , 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
Affiliations
Randomized Controlled Trial

Antiretroviral regimens in pregnancy and breast-feeding in Botswana

R L Shapiro et al. N Engl J Med. .

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.)

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Figures

Figure 1
Figure 1. Enrollment and Follow-up of Study Participants
Women assigned to the nucleoside reverse-transcriptase inhibitor (NRTI) group received coformulated abacavir, zidovudine, and lamivudine. Women assigned to the protease-inhibitor group received lopinavir– ritonavir plus zidovudine–lamivudine. Women assigned to the observational group received nevirapine plus zidovudine–lamivudine. In the observational group, one woman who delivered a live-born twin and a stillborn twin was included in the live-born category. HAART denotes highly active antiretroviral therapy, and HIV-1 human immunodeficiency virus type 1.
Figure 2
Figure 2. Analyses of Selected Outcomes, According to Study Group
See this image and copyright information in PMC

Comment in

References

    1. Public Health Service Task Force. Recommendations for use of antiretroviral drugs in pregnant HIV-1 infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. [Accessed May 21, 2010]. (at http://aidsinfo.nih.gov/.) - PubMed
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    1. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: towards universal access: recommendations for a public health approach — 2006 version. Geneva: World Health Organization; 2006. - PubMed
    1. Lockman S A5208/OCTANE Study Team. Lopinavir/ritonavir+tenofovir/emtricitabine is superior to nevirapine+tenofovir/emtricitabine for women with prior exposure to single-dose nevirapine: A5208 (OCTANE). Presented at the 16th Conference on Retroviruses and Opportunistic Infections; February 16–19, 2009; Montreal. abstract.
    1. DART Virology Group and Trial Team. Virological response to a triple nucleoside/nucleotide analogue regimen over 48 weeks in HIV-1-infected adults in Africa. AIDS. 2006;20:1391–1399. - PubMed

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