Tenofovir Alafenamide Plasma Concentrations Are Reduced in Pregnant Women Living With Human Immunodeficiency Virus (HIV): Data From the PANNA Network

Bukkems, Vera E.; Necsoi, Coca; Hidalgo Tenorio, Carmen; Garcia, Coral; Alejandre, Irene Alba; Weiss, Fabian; Lambert, John S.; Hulzen, Astrid van; Richel, Olivier; Brake, Lindsey H. M. te; Meulen, Eric van der; Burger, David; Konopnicki, Deborah und Colbers, Angela (2022): Tenofovir Alafenamide Plasma Concentrations Are Reduced in Pregnant Women Living With Human Immunodeficiency Virus (HIV): Data From the PANNA Network. In: Clinical Infectious Diseases, Bd. 75, Nr. 4: S. 623-629

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 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. 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 area under the curve (AUC(last)()) 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 AUC(last) and C-max were decreased by 46% and 52%, respectively, compared with postpartum. TFV AUC(0-24h), C-max, and C-trough decreased by 33%, 30%, and 34%, respectively. The proportion of women with a TAF AUC(last) 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. This European pharmacokinetic study included 20 pregnant women living with human immunodeficiency virus (HIV) and showed that tenofovir alafenamide plasma concentrations are reduced by approximately 50% in the third trimester compared with postpartum. No mother-to-child transmission occurred in this study.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 1058-4838
• Sprache: Englisch