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6-month drug regimen cuts HIV risk for breastfeeding infants, NIH study finds
Mar 2, 2011 - 5:00:00 AM

Giving breastfeeding infants of HIV-infected mothers a daily dose of the antiretroviral drug nevirapine for six months halved the risk of HIV transmission to the infants at age 6 months compared with giving infants the drug daily for six weeks, according to preliminary clinical trial data presented today.

The longer nevirapine regimen achieved a 75 percent reduction in HIV transmission risk through breast milk for the infants of HIV-infected mothers with higher T-cell counts who had not yet begun treatment for HIV.

The study was presented at the 18th Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.

Extended breastfeeding reduces infant mortality in places that lack safe, clean water by protecting babies from common childhood diseases because breast milk contains protective antibodies from the mother that formula feeding does not provide, says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, which funds the trial. These findings show that giving the infants of HIV-infected mothers an antiretroviral drug daily for the full duration of breastfeeding safely minimizes the threat of HIV transmission through breast milk while preserving the health benefits of extended breastfeeding.

The new findings apply to mothers and infants in developing nations, where infectious diseases such as gastroenteritis and pneumonia often pose a life-threatening risk to very young children. The U.S. Department of Health and Human Services recommends that HIV-infected mothers in the United States feed their babies with infant formula, not breast milk, because safe and affordable formula is available, infant deaths due to infections are low and only total avoidance of breastfeeding will completely protect these infants from HIV transmission through breast milk.

This advanced-stage clinical trial known as HPTN 046 is co-funded by NIAID, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Drug Abuse and the National Institute of Mental Health, all part of NIH. The HIV Prevention Trials Network and the International Maternal, Pediatric and Adolescent AIDS Clinical Trials Network are conducting the trial under the leadership of Hoosen Coovadia, M.D., M.B.B.S., of the University of the Witwatersrand in Durban, South Africa. Bonnie Maldonado, M.D., of Stanford University in Stanford, Calif., presented the study results for Dr. Coovadia on March 2, 2011, at CROI.

More than 1,500 mother-infant pairs in South Africa, Tanzania, Uganda and Zimbabwe are participating in HPTN 046, which began in February 2007 and will conclude in July 2011. The participating infants received daily nevirapine for the first six weeks after birth. Those infants who remained free of HIV then were assigned at random to receive either daily nevirapine or a placebo until six months after birth or the cessation of breastfeeding, whichever came first. Study investigators compared the rates of HIV infection in the two groups of infants, and evaluated and compared the safety and tolerance of nevirapine in the infants.

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