In a clinical trial, HIV-infected women who took a three-drug antiretroviral regimen during breast-feeding did not pass the virus to their babies, according to a July 18, 2016 NIH news release.
“These findings from the ongoing Promoting Maternal and Infant Survival Everywhere study, funded by the National Institutes of Health, support the World Health Organization guidelines introduced in 2015 that recommend lifelong antiretroviral therapy for all pregnant and breastfeeding women living with HIV,” the news release stated. “PROMISE investigators found that both three-drug maternal antiretroviral therapy and daily infant nevirapine were safe and effective at preventing HIV transmission during breast-feeding. 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, MD, director of NIH’s National Institute of Allergy and Infectious Diseases, in the release. “Maternal antiretroviral therapy safely minimizes the threat of HIV transmission through breast milk while preserving the health advantages of breast-feeding, as the high infant survival in this study underscores.”
The trial involved 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, women were asymptomatic and had relatively high CD4+ cell levels — a marker of good immune system health, according to the release.
Mothers and their newborns were randomly assigned to one of two regimens of the triple-drug antiretroviral therapy for the mother, daily doses of nevirapine for the infant and follow up. The participants were followed for 18 months or until the mother stopped breast-feeding.
Researchers found maternal three-drug antiretroviral therapy, as well as infant nevirapine, offered protection against mother-to-child transmission. The rate of transmission was 0.3% at 6 months and 0.6% at 1 year of age.
The World Health Organization reports that in the absence of any intervention, transmission rates range from 15% to 45%. “This rate,” the WHO website states, “can be reduced to below 5% with effective interventions during the periods of pregnancy, labour, delivery and breastfeeding.”
“The accelerated roll-out of ART for pregnant women was an important factor in the success of the Global Plan towards the elimination of new HIV infections among children by 2015 and keeping their mothers alive,” according to the WHO website. “Between 2009 and late 2014, many countries saw the number of new infections in children drop by over 60%; these countries are now closer than ever to eliminating mother-to-child transmission as a public health concern.”
Several clinical trials are ongoing through the PROMISE program, which began in 2010, and aims to determine how best to safely reduce mother-to-baby HIV transmission risk. An NIH 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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Read the CE module “Preventing Perinatal HIV Transmission.”