RT Journal Article
T1 Tenofovir Alafenamide Plasma Concentrations Are Reduced in Pregnant Women Living With Human Immunodeficiency Virus (HIV): Data From the PANNA Network.
A1 Bukkems, Vera E
A1 Necsoi, Coca
A1 Hidalgo Tenorio, Carmen
A1 Garcia, Coral
A1 Alba Alejandre, Irene
A1 Weiss, Fabian
A1 Lambert, John S
A1 van Hulzen, Astrid
A1 Richel, Olivier
A1 Te Brake, Lindsey H M
A1 van der Meulen, Eric
A1 Burger, David
A1 Konopnicki, Deborah
A1 Colbers, Angela
K1 HIV
K1 mother-to-child transmission
K1 pharmacokinetics
K1 pregnancy
K1 tenofovir alafenamide
AB Tenofovir alafenamide (TAF), a prodrug of tenofovir (TFV), is included in the majority of the recommended first-line antiretroviral regimens for patients living with human immunodeficiency virus (HIV), but there are limited data on TAF use in pregnant women. We aimed to examine the plasma pharmacokinetics of TAF and TFV in pregnant women from Europe. Pregnant women living with HIV were included from treatment centers across Europe, and intensive pharmacokinetic sampling in the third trimester and postpartum was performed. Pharmacokinetic parameters of TAF and TFV were determined with noncompartmental analysis. The proportion of women with a TAF area under the curve (AUClast) below the target of 53.1 ng∗h/mL was determined. Clinical efficacy and safety outcome parameters were reported. In total, 20 pregnant women living with HIV were included. At the third trimester, geometric mean TAF AUClast and Cmax were decreased by 46% and 52%, respectively, compared with postpartum. TFV AUC0-24h, Cmax, and Ctrough decreased by 33%, 30%, and 34%, respectively. The proportion of women with a TAF AUClast  50 copies/mL at third trimester and no mother-to-child transmission occurred. TAF plasma concentrations were reduced by about half in women living with HIV during third trimester of pregnancy but remained above the predefined efficacy target in the majority of the pregnant women. TFV concentrations were reduced by approximately 30% during third trimester. Despite the observed exposure decrease, high virologic efficacy was observed in this study.
YR 2022
FD 2022
LK http://hdl.handle.net/10668/19737
UL http://hdl.handle.net/10668/19737
LA en
DS RISalud
RD Apr 12, 2025