HOW ANTIRITROVIRAL DRUGS ELIMINATE MOTHER TO CHILD HIV TRANSMISSION

The researchers enrolled 2,431 pairs of HIV-infected mothers and their HIV-uninfected infants at clinical research sites in South Africa, Malawi, Tanzania, Uganda, Zambia, Zimbabwe and India between June 2011 and October 2014

US, July 18, 2016 – Mothers infected with the Human Immunodeficiency Virus(HIV) can still breastfeed their babies if they take the necessary precaution, researchers at the US National Institute of Health have said.

According to the research, HIV-infected mothers whose immune system is in good health, and takes a three-drug antiretroviral regimen during breastfeeding essentially eliminates HIV transmission by breast milk to their infants.

This result of a large scale clinical trial conducted in sub-Saharan Africa and India 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 recommended lifelong antiretroviral therapy for all pregnant and breastfeeding women living with HIV.

PROMISE investigators, according to the NIH 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”, the NIH said adding “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,” he added.

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, tomorrow July 19.

The findings 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, according to the NIH identified the superiority of a three-drug regimen for the mother over other regimens for preventing perinatal HIV transmission during pregnancy and delivery.

The new findings stem from a component of PROMISE that compares the safety and efficacy of two antiretroviral regimens for preventing mother-to-child transmission of HIV during breastfeeding.

The longer an HIV-infected mother breastfeeds, the greater the risk for HIV transmission to the infant. In comparison, in the absence of any intervention, rates of HIV transmission from a HIV-infected mother to her child during either pregnancy, labor, delivery or breastfeeding historically have ranged from 15 to 45 percent, according to WHO

“This component included mother-infant pairs living in resource-limited settings where breastfeeding is common and recommended for infant health”, the NIH noted adding that HIV-infected mothers in areas that lack safe, clean water may be encouraged to breastfeed because of the health benefits for the infant and the risk for infants from mixing formula with an unsafe water supply. Breastfeeding, it noted helps prevent malnutrition, adding that antibodies from breast milk protect babies against potentially life-threatening diarrheal and respiratory infections.

The researchers enrolled 2,431 pairs of HIV-infected mothers and their HIV-uninfected infants at clinical research sites in South Africa, Malawi, Tanzania, Uganda, Zambia, Zimbabwe and India between June 2011 and October 2014.

“On average, the women were asymptomatic and had relatively high CD4+ cell levels — a marker of good immune system health. Investigators randomly assigned the mothers and their newborns to one of two regimens.

“One regimen included triple-drug antiretroviral therapy for the mother that continued through the period of study follow up and daily doses of nevirapine for the infant until 6 weeks after birth. The second regimen consisted of triple-drug antiretroviral therapy for the mother until 1 week after delivery and daily doses of nevirapine for the infant beginning from the first week after birth and continuing through completion of study follow up. The participants were followed for 18 months or until the mother stopped breastfeeding (on average 15 months after childbirth), whichever came first.

“The researchers found that maternal three-drug antiretroviral therapy, as well as infant nevirapine, offered protection against HIV transmission from mother to child”, the researchers noted adding that the rate of perinatal transmission did not differ between the two study arms and was very low — 0.3 percent at 6 months of age and 0.6 percent at 1 year of age.

“The longer an HIV-infected mother breastfeeds, the greater the risk for HIV transmission to the infant. In comparison, in the absence of any intervention, rates of HIV transmission from a HIV-infected mother to her child during either pregnancy, labor, delivery or breastfeeding historically have ranged from 15 to 45 percent, according to WHO.

“Adverse events in mothers and babies occurred at a similarly low rate in both study arms. Infant mortality in resource-limited countries can be high, but in this study, nearly 99 percent of babies lived to see their first birthday”, the NIH said.