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1 September 2005

Volume 192, Number 5
The Journal of Infectious Diseases 2005;192:720–727
© 2005 by the Infectious Diseases Society of America. All rights reserved.
0022-1899/2005/19205-0003$15.00
DOI: 10.1086/432483
MAJOR ARTICLE

Antiretroviral Concentrations in Breast‐Feeding Infants of Women in Botswana Receiving Antiretroviral Treatment

Roger L. Shapiro,1,2

Diane T. Holland,5

Edmund Capparelli,5

Shahin Lockman,1,3

Ibou Thior,1

Carolyn Wester,1

Lisa Stevens,1

Trevor Peter,1

Max Essex,1

James D. Connor,5 and

Mark Mirochnick4

1Department of Immunology and Infectious Diseases, Harvard School of Public Health, 2Division of Infectious Diseases, Beth Israel Deaconess Medical Center, 3Infectious Disease Unit, Brigham and Women’s Hospital, and 4Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts; 5Division of Clinical Pharmacology and Developmental Therapeutics, University of California, San Diego, Department of Pediatrics, San Diego

Background.The magnitude of infant antiretroviral (ARV) exposure from breast milk is unknown.

Methods.We measured concentrations of nevirapine, lamivudine, and zidovudine in serum and whole breast milk from human immunodeficiency virus type 1 (HIV‐1)–infected women in Botswana receiving ARV treatment and serum from their uninfected, breast‐feeding infants.

Results.Twenty mother‐infant pairs were enrolled. Maternal serum concentrations of nevirapine were high (median, 9534 ng/mL at a median of 4 h after nevirapine ingestion). Median breast‐milk concentrations of nevirapine, lamivudine, and zidovudine were 0.67, 3.34, and 3.21 times, respectively, those in maternal serum. The median infant serum concentration of nevirapine was 971 ng/mL, at least 40 times the 50% inhibitory concentration and similar to peak concentrations after a single 2‐mg/kg dose of nevirapine. The median infant serum concentration of lamivudine was 28 ng/mL, and the median infant serum concentration of zidovudine was 123 ng/mL, but infants were also receiving zidovudine prophylaxis.

Conclusions.HIV‐1 inhibitory concentrations of nevirapine are achieved in breast‐feeding infants of mothers receiving these ARVs, exposing infants to the potential for beneficial and adverse effects of nevirapine ingestion. Further study is needed to understand the impact of maternal ARV treatment on breast‐feeding HIV‐1 transmission, infant toxicity, and HIV‐1 resistance mutations among infected infants.

Received 6 December 2004; accepted 3 March 2005; electronically published 27 July 2005.

Reprints or correspondence: Dr. Roger Shapiro, Div. of Infectious Diseases, Beth Israel Deaconess Medical Center, 110 Francis St., Ste. GB, Boston, MA 02215 ().

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  • Presented in part: 42nd Infectious Disease Society of America Conference, Boston, 30 September–3 October 2004 (abstract LB‐1).

    Potential conflicts of interest: none reported.

    Financial support: National Institutes of Childhood Health Development (PPRU Network grants 3U01 HD31318‐0981 to the University of California, San Diego and Boston University and 1U10 HD045937‐01 and R01‐HD37793 to the University of California, San Diego).

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