Liegeon G. auteur aut IRD Ngo-Giang-Huong Nicole auteur aut IRD Salvadori N. auteur aut IRD Bunpo P. auteur aut IRD Cressey R. auteur aut IRD Achalapong J. auteur aut IRD Kanjanavikai P. auteur aut IRD Ayudhaya O. P. N. auteur aut IRD Prommas S. auteur aut IRD Siriwachirachai T. auteur aut IRD Sabsanong P. auteur aut IRD Mary J. Y. auteur aut IRD Jourdain Gonzague auteur aut IRD Itap Study Team auteur aut IRD text journalArticle eng text/pdf born digital access Background Data evaluating the risk of proximal tubular dysfunction in women receiving tenofovir disoproxil fumarate for the prevention of mother-to-child transmission (PMTCT) of HBV are scarce. Objectives To assess the risk of proximal tubulopathy in pregnant women receiving tenofovir disoproxil fumarate for PMTCT of HBV. Patients and methods We used urine samples collected from HBV monoinfected pregnant women who participated in a Phase III, multicentre, randomized, double-blind, placebo-controlled clinical trial assessing a tenofovir disoproxil fumarate short course from 28 weeks gestational age (28-wk-GA) to 2 months post-partum (2-months-PP) for PMTCT of HBV in Thailand. Markers of tubular dysfunction, including retinol binding protein, kidney injury molecule-1, alpha 1-microglobuin and beta 2-microglobulin, were assayed at 28- and 32-wk-GA and 2-months-PP visits. Proximal tubulopathy was defined as the presence of >= 2 of the following: tubular proteinuria, euglycaemic glycosuria and increased urinary phosphate. Results A total of 291 women participated in the study. No kidney-related adverse events were severe, and none led to tenofovir disoproxil fumarate discontinuation. At 2-months-PP, 3 of the 120 (3%) evaluated women in the tenofovir disoproxil fumarate group experienced proximal tubulopathy versus 3 of 125 (2%) in the placebo group (P = 1.00). None of the six women met the criteria for proximal tubulopathy at 12-months-PP but proteinuria persisted in three of them. No growth abnormalities were found at 1 year of age in infants born to mothers with proximal tubulopathy at 2-months-PP. Conclusions In these HBV-infected pregnant and breastfeeding women, tenofovir disoproxil fumarate administered from 28-wk-GA to 2-months-PP was not associated with a higher risk of proximal tubulopathy. specialized THAILANDE 050 052 77 4 1111-1118 2022 0305-7453 https://www.documentation.ird.fr/hor/fdi:010084594 10.1093/jac/dkab490 0305-7453 [F B010084594] https://www.documentation.ird.fr/hor/fdi:010084594 https://www.documentation.ird.fr/intranet/publi/2022-05/010084594.pdf Accès réservé (Intranet de l'IRD) IRD - Base Horizon / Pleins textes 2022-05-04 2025-02-24 fdi:010084594 fre