TDF/FTC Considered Safe Among Pregnant Women Per Objective TFV-DP Levels
A group of researchers compared pre-exposure prophylaxis (PrEP) use with birth outcomes using objective levels of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) of women during the second or third trimester of pregnancy. Their findings were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2023 in Seattle, WA.
Although previous studies examined the safety of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in pregnant and lactating people taking PrEP, the methodology for measuring exposure involved self-reported recent adherence, which can lead to an over- or under-reporting of actual use. This study, however, was one of the first to use objective levels of TFV-DP to compare birth outcomes among women using PrEP.
Researchers enrolled in the study 300 pregnant women older than 15 years of age without HIV at the first antenatal care visit. After HIV counseling, the women were offered PrEP. The researchers quantified TFV-DP levels in DBS in women who reported taking PrEP within the past 30 days in the second or third trimester of pregnancy. They used logistic regression models and generalized estimating equations to evaluate pregnancy and birth outcomes by TFV-DP (any vs none) and adjusted for age, gestational age, and gravidity.
There was an adverse pregnancy or birth outcome in 12% of women with TFV-DP, compared with 11% in women without TFV-DP. Overall, pregnancy and birth outcomes did not differ by PrEP exposure per TFV-DP levels.
“Our study provides further evidence that TDF is safe in pregnancy and highlights the importance of counseling women on the effective use and safety of TDF/FTC as PrEP in pregnancy,” the researchers concluded.
Davey DJ, Nyemba DC, Mvududu R, et al. Pregnancy and birth outcomes following oral PrEP use by objective levels of TDF/FTC. Talk presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 19-22, 2023; Seattle, WA. Accessed March 10, 2023.