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Tenofovir alafenamide plasma concentrations are reduced in pregnant women living with HIV: data from the PANNA Network
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Clinical Infectious Diseases 05 December 2021 Vera E Bukkems1, Coca Necsoi2 , Carmen Hidalgo Tenorio3, Coral Garcia3, Irene Alba Alejandre4, Fabian Weiss4, John S Lambert5, 6, 7, Astrid van Hulzen8, Olivier Richel9, Lindsey HM te Brake1, Eric van der Meulen1, David Burger1, Deborah Konopnicki2, Angela Colbers1, on behalf of the PANNA network
Abstract
Background
Tenofovir alafenamide (TAF), a prodrug of tenofovir (TFV), is included in the majority of the recommended first-line antiretroviral regimens for patients living with 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.
Methods
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 AUCtau below the target of 53.1 ng*h/mL was determined. Clinical efficacy and safety outcome parameters were reported.
Results
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 <53.1 ng*h/mL was 6% at third trimester and 0% postpartum. One out of 20 women had a viral load >50 copies/mL at third trimester and no mother-to-child transmission occurred.
Conclusions
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.
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