MedicalResearch.com Interview with:
Kenneth K. Mugwanya MBChB, MS
Department of Epidemiology andDepartment of Global Health
University of Washington, Seattle, Washington, USA
Division of Disease Control, School of Public Health
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Women living in regions with high HIV prevalence are at high risk of HIV acquisition in pregnancy and postpartum because they infrequently use condoms, do not know their partner’s HIV status, and have biologic changes or changes in their partner’s sexual partnerships that increase susceptibility. Moreover, acute HIV infection during pregnancy or breastfeeding period is associated with high rates of mother-to child HIV transmission because of high circulating level of HIV virus in blood. Oral antiretroviral pre-exposure prophylaxis (PrEP) is a powerful HIV prevention strategy recommended by both the World Health organization and US Centers for Diseases Control and Prevention. PrEP is an attractive prevention strategy for women as it can be used discreetly and independent of sexual partners. However, there is limited research about the safety of PrEP in HIV-uninfected pregnant or breastfeeding mothers and their infants.
Therefore in our study we wanted to understand whether drugs currently used for PrEP (i.e tenofovir and emtricitabine) are excreted into breast milk and then absorbed by the breastfeeding infant in clinically significant concentrations when taken orally by their HIV-uninfected mothers to reduce their risk of acquiring HIV. We found that the concentrations of PrEP medications (i.e tenofovir and emtricitabine) in infant blood were very low, and tenofovir was undetectable in 94% of the infant blood samples. Based on breast milk concentrations, breastfeeding infants would have exposures to tenofovir 12,500-fold lower, and to emtricitabine 200-fold lower, than those achieved with pediatric therapeutic dosing (<0.01% and 0.5% of therapeutic dose, respectively) that has not shown safety concerns.
MedicalResearch.com: What should readers take away from your report?
Response: These finding confirm that very low concentrations of tenofovir are excreted in breast milk when used as PrEP, with minimal infant absorption via breastfeeding and strongly suggest that tenofovir based-PrEP can safely be given to breastfeeding women without putting their infants at risk of adverse effects.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: As PrEP becomes widely used in heterosexual populations, the next important step is to explore in implementation science studies adherence to PrEP and long-term infant growth outcomes in women who choose to use PrEP throughout their pregnancy or breastfeeding.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Pre-exposure Prophylaxis Use by Breastfeeding HIV-Uninfected Women: A Prospective Short-Term Study of Antiretroviral Excretion in Breast Milk and Infant Absorption
Kenneth K. Mugwanya ,Craig W. Hendrix,Nelly R. Mugo,Mark Marzinke,Elly T. Katabira,Kenneth Ngure,Nulu B. Semiyaga,Grace John-Stewart,Timothy R. Muwonge,Gabriel Muthuri, Andy Stergachis,Connie L. Celum, Jared M. Baeten
Published: September 27, 2016
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