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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Antiretroviral regimens in pregnancy and breast-feeding in Botswana
New England Journal of Medicine, Volume 362, No. 24, Year 2010
Notification
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Description
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, ≥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 zido vudine - 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.) Copyright © 2010 Massachusetts Medical Society. All rights reserved.
Authors & Co-Authors
Shapiro, Roger L.
Unknown Affiliation
Hughes, Michael D.
Unknown Affiliation
Ogwu, Anthony C.
Unknown Affiliation
Kitch, Douglas
Unknown Affiliation
Lockman, Shahin
Unknown Affiliation
Moffat, Claire
Unknown Affiliation
Makhema, Joseph M.
Unknown Affiliation
Moyo, Sikhulile M.
Unknown Affiliation
Thior, Ibou
Unknown Affiliation
McIntosh, Kenneth
Unknown Affiliation
van Widenfelt, Erik
Unknown Affiliation
Leidner, Jean
Unknown Affiliation
Powis, Kathleen M.
Unknown Affiliation
Asmelash, Aida
Unknown Affiliation
Tumbare, Esther A.J.
Unknown Affiliation
Zwerski, Sheryl L.
Unknown Affiliation
Sharma, Usha Kiran
Unknown Affiliation
Handelsman, Edward L.
Unknown Affiliation
Mburu, Kimani Stephen
Unknown Affiliation
Jayeoba, Oluwemimo
Unknown Affiliation
Moko, Evans
Unknown Affiliation
Souda, Sajini
Unknown Affiliation
Lubega, E.
Unknown Affiliation
Akhtar, M.
Unknown Affiliation
Wester, Carolyn William
Unknown Affiliation
Tuomola, R.
Unknown Affiliation
Snowden, Wendy B.
Unknown Affiliation
Martinez-Tristani, M.
Unknown Affiliation
Mazhani, Loeto
Unknown Affiliation
Essex, Max E.
Unknown Affiliation
Statistics
Citations: 517
Authors: 30
Affiliations: 10
Identifiers
Doi:
10.1056/NEJMoa0907736
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Infectious Diseases
Maternal And Child Health
Sexual And Reproductive Health
Study Locations
Botswana
Participants Gender
Female