For HIV-infected mothers whose immune system is in good health, taking a three-drug antiretroviral regimen during breastfeeding essentially eliminates HIV transmission by breast milk to their infants, according to results from a large clinical trial conducted in sub-Saharan Africa and India.


These findings from the ongoing Promoting Maternal and Infant Survival Everywhere (PROMISE) study, funded by the National Institutes of Health, support the World Health Organization (WHO) guidelines introduced in 2015 that recommend lifelong antiretroviral therapy for all pregnant and breastfeeding women living with HIV. PROMISE investigators found that both three-drug maternal antiretroviral therapy and daily infant nevirapine were safe and effective at preventing HIV transmission during breastfeeding. Overall, infant mortality in the study was extremely low, with nearly all babies surviving their first year of life.

“These findings add to the considerable body of evidence confirming the benefits of antiretroviral therapy for every person living with HIV,” said Anthony S. Fauci, M.D., director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID). “Maternal antiretroviral therapy safely minimizes the threat of HIV transmission through breast milk while preserving the health advantages of breastfeeding, as the high infant survival in this study underscores.”

PROMISE is funded by NIAID and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), both part of NIH, and is conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trials network. Researchers will present the new results in a poster at the 21st International AIDS Conference in Durban, South Africa, on July 19. The findings also were presented at the pre-conference 8th International Workshop on HIV Pediatrics on July 16.

PROMISE, which began in 2010, is a multi-component study that aims to determine how best to safely reduce the risk of HIV transmission from HIV-infected women to their babies during pregnancy, delivery and after childbirth, while preserving the health of both mother and child. Study results reported in 2014 identified the superiority of a three-drug regimen for the mother over other regimens for preventing perinatal HIV transmission during pregnancy and delivery.

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