In a South African trial, pregnant women who took daily tenofovir disoproxil fumarate with emtricitabine for PrEP were not at excess risk for preterm labor or low birth weight.
In 2017, the WHO recommended preexposure prophylaxis (PrEP) in pregnant and lactating women at risk for HIV; however, such women have generally been excluded from receiving PrEP due to absence of safety data, as they were not enrolled in the landmark PrEP trials conducted in 2012. To evaluate the safety of tenofovir disoproxil fumarate with emtricitabine (TDF/FTC) for PrEP during pregnancy, investigators conducted an open-label noninferiority trial among 540 pregnant women in South Africa who were randomized to immediate PrEP (initiated at a median 19 weeks' gestation) or deferred PrEP (until cessation of breast-feeding).
In all, 93% of participants had documented pregnancy outcomes (481 livebirths, 2 spontaneous abortions, and 17 stillbirth…
Reviewing Author
DisclosuresGrant/Research SupportNIH/National Institute of Allergy and Infectious Diseases; NIH/National Institute on Drug Abuse
Editorial BoardsJAIDS: Journal of Acquired Immune Deficiency Syndromes; Vaccines
Leadership Positions in Professional SocietiesInternational Antiviral Society–USA (Board of Directors); Infectious Diseases Society of America (Past President)
DisclosuresGrant/Research SupportNIH/National Institute of Allergy and Infectious Diseases; NIH/National Institute on Drug Abuse
Editorial BoardsJAIDS: Journal of Acquired Immune Deficiency Syndromes; Vaccines
Leadership Positions in Professional SocietiesInternational Antiviral Society–USA (Board of Directors); Infectious Diseases Society of America (Past President)