A new study published in the journal PLoS Medicine has found that breastfeeding mothers taking the antiretroviral drugs tenofovir and emtricitabine have a low risk of side effects.
Mugwanya et al studied women and infants in Kenya and Uganda. Image credit: UW Center for Global Health of Women, Adolescents and Children / Paul Brown, Global WACh.
The study, led by University of Washington researcher Kenneth Mugwanya, is one of the first looking at the safety of pre-exposure prophylaxis (PrEP).
Two antiretroviral medications – tenofovir disoproxil fumarate, also known by its brand name, Viread, and combination tenofovir/emtricitabine, also known by its brand name Truvada – taken as daily preventive therapy is known as PrEP.
Dr. Mugwanya and co-authors looked at 50 pairs of mothers and infants in Kenya and Uganda, uninfected by HIV, up to 24 weeks after birth.
The mothers took the oral PrEP combination drug emtricitabine–tenofovir disoproxil fumarate for 10 days. Drug concentrations were measured in breastmilk and infant blood.
“The study is great news for stemming a public health emergency in sub-Saharan Africa where young pregnant women have some of the highest rates of HIV infection globally,” said Dr. Lynne Mofenson, a pediatric AIDS researcher with the Elizabeth Glaser Pediatric AIDS Foundation who was not involved in this work.
“The benefits of HIV prevention in pregnant and breastfeeding women and their infants in these regions, given the currently available evidence, seem to clearly outweigh the risks observed to date.”
“Among adolescents in sub-Saharan Africa, 71 percent of new HIV infections are among females,” she said.
“And young woman in sub-Saharan Africa have the highest prevalence of adolescent pregnancy in the world (an estimated 101 births per 1,000 women aged 15-19 years).”
“That compares to an estimated 26.6 births per 1,000 women in the United State, according to the U.S. Department of Health and Human Services.”
Although this study involved a small group of women and infants, was of short duration and limited to a single blood draw from infants, the findings indicate that drug concentrations are low in breastmilk and in infants’ blood, and that the risk of adverse events is therefore likely to be small.
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K.K. Mugwanya et al. 2016. Pre-exposure Prophylaxis Use by Breastfeeding HIV-Uninfected Women: A Prospective Short-Term Study of Antiretroviral Excretion in Breast Milk and Infant Absorption. PLoS Med 13 (9): e1002132; doi: 10.1371/journal.pmed.1002132
This article is based on a press-release issued by the University of Washington.
