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Pregnancy and Breast-Feeding in Botswana
– Reported, January 26, 2013
Highly active antiretroviral therapy (HAART) used to prevent in utero and intrapartum mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) is among the most successful public health interventions of the HIV era. However, the use of HAART in mothers to prevent mother-to-child transmission through breast-feeding in areas of the world where replacement feeding is neither safe nor feasible remains an unproven strategy. We compared different HAART regimens used in pregnancy and during breast-feeding to determine whether the regimens differ with respect to virologic suppression during pregnancy and breast-feeding, pregnancy outcomes, and toxic effects in mothers and infants.
Infants received single-dose nevirapine (6 mg) at birth and received zidovudine (4 mg per kilogram of body weight twice daily) from birth through 4 weeks. Women were counseled to exclusively breast-feed and to complete weaning 3 days before the 6-month study visit. Infants were provided free formula and foods from the time of weaning (whenever it occurred) through 12 months.
Study drugs were provided by GlaxoSmithKline (Trizivir and Combivir) and Abbott Pharmaceuticals (Kaletra), but these companies had no other role in the design of the study, the accrual or analysis of the data, the preparation of the manuscript, or the decision to submit the manuscript for publication. The Botswana government provided nevirapine, Combivir, additional medications, and some laboratory testing. The Health Research Development Committee of Botswana and the Human Subjects Committee of the Harvard School of Public Health approved the study protocol and amendments.
In this randomized trial comparing different HAART regimens initiated in pregnancy, similarly high rates of virologic suppression were achieved at delivery and during breast-feeding among women receiving all HAART regimens. High virologic suppression was mirrored by low rates of mother-to-child transmission at delivery and throughout the breast-feeding period, with 1.1% overall mother-to-child transmission at 6 months.
Our virologic-suppression rates were similar or superior to those in cohorts of nonpregnant adults in Africa, suggesting that neither pregnancy nor breast-feeding adversely affects achievable rates of virologic suppression. Although concern has been expressed regarding the lower levels of lopinavir in the third trimester of pregnancy,these levels have not been associated with virologic failure.
In conclusion, the rates of HIV-1 RNA suppression to less than 400 copies per milliliter were similar at delivery and throughout breast-feeding in all study groups. A total of 1.1% of all infants were infected with HIV-1 at 6 months of age; this is a low rate of mother-to-child transmission for a breast-feeding cohort. These findings suggest that the use of HAART in women from early in the third trimester of pregnancy through 6 months of breast-feeding is an effective strategy for preventing mother-to-child transmission while allowing for the benefits of breast-feeding.
CREDITS:
http://www.nejm.org/
R.L. Shapiro, M.D. Hughe, 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, O. Jayeoba, E. Moko, S. Souda, E. Lubega, M. Akhtar, C. Wester, R. Tuomola, W. Snowden, M. Martinez-Tristani, L. Mazhani and M. Essex
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