The provision of antiretroviral drugs for the prevention of mother-to-child HIV transmission has been rising sharply in low- and middle-income countries. Changes to the World Health Organization guidelines support further extension of these programs. The result will be a greatly expanded population of HIV-exposed but uninfected children with substantial exposure to antiretroviral drugs, both in utero and while breastfeeding. There are limited data on possible toxicities in this burgeoning population, and the large number of confounding factors limits any conclusions. Although the evidence on birth defects and mitochondrial toxicity remains equivocal, considerable data link protease inhibitors to preterm delivery and low birth-weight. Transient hematologic toxicities are also likely. The drug impact later in life is an open question. Larger and longer cohort studies are necessary to properly balance the risks and benefits of large-scale infant exposure to antiretroviral agents.
From the *Research Promotion Department, International AIDS Society, Geneva, Switzerland; †Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA; ‡Department of Paediatrics and Child Health, Stellenbosch University and Tygerberg Children's Hospital, Cape Town, South Africa; §Harvard School of Public Health, Boston, MA, USA; ∥Elizabeth Glaser Pediatric AIDS Foundation, Los Angeles, CA, USA; ¶Fundacion Huesped, Buenos Aires, Argentina; #Makerere University College of Health Sciences, Kampala, Uganda.
Received for publication November 10, 2010; accepted April 27, 2011.
Competing interests: S. Heidari is an employee of the International AIDS Society, which receives unrestricted educational grants from the following pharmaceutical companies: Abbott, Boehringer Ingelheim, Gilead, Merck, Pfizer and Tibotec. E. Katabira and L. Mofenson have no competing interests. M. F. Cotton is an investigator on Tibotec, GSK, and Boehringer Ingelheim trials. R. Marlink has served as an advisor to the BMS Foundation and the Merck Company Foundation. P. Cahn has served as Advisory Board member in Avexa, Gilead, GSK, Myriad, Merck, Pfizer, Pharmasset, Schering Plough, Tibotec; Investigator in Avexa, Boehringer Ingelheim, Gilead, GSK, Roche, Merck, Pfizer, Pharmasset, Schering Plough, Tibotec, Abbott, BMS; Speaker (content and design performed by the speaker, no company control) for Abbott, BMS, Boehringer Ingelheim, GSK, Merck, Pfizer, Tibotec; and Scientific Advisor for Merck Sharp & Dohme, Pfizer, GSK, Avexa, Tibotec. He is not a shareholder, nor does he have any commercial interest or investment in any pharmaceutical company.
Correspondence to: Shirin Heidari, PhD, International AIDS Society, 71 Avenue Louis-Casai, 1216 Cointrin, Geneva, Switzerland (e-mail: firstname.lastname@example.org).