Proximal tubular dysfunction in pregnant women receiving tenofovir disoproxil fumarate to prevent mother-to-child transmission of hepatitis B virus
Author:
Liegeon Geoffroy12, Ngo-Giang-Huong Nicole23, Salvadori Nicolas23, Bunpo Piyawan4, Cressey Ratchada4, Achalapong Jullapong5, Kanjanavikai Prateep6, Na Ayudhaya Orada Patamasingh7, Prommas Sinart8, Siriwachirachai Thitiporn9, Sabsanong Prapan10, Mary Jean Yves11, Jourdain Gonzague23, Jourdain G., Ngo-Giang-Huong N., Harrison L., Decker L., Khamduang W., Tierney C., Salvadori N., Cressey T. R., Sirirungsi W., Achalapong J., Yuthavisuthi P., Kanjanavikai P., Na Ayudhaya O. P., Siriwachirachai T., Prommas S., Sabsanong P., Limtrakul A., Varadisai S., Putiyanun C., Suriyachai P., Liampongsabuddhi P., Sangsawang S., Matanasarawut W., Buranabanjasatean S., Puernngooluerm P., Bowonwatanuwong C., Puthanakit T., Klinbuayaem V., Thongsawat S., Thanprasertsuk S., Siberry G. K., Watts D. H., Chakhtoura N., Murphy T. V., Nelson N. P., Chung R. T., Pol S., Chotivanich N.,
Affiliation:
1. Department of Infectious Diseases, Hôpital Saint-Louis et Lariboisière, Assistance Publique–Hôpitaux de Paris, Université de Paris, Paris, France 2. MIVEGEC, Université Montpellier, CNRS, IRD, Montpellier, France 3. Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand 4. Division of Clinical Chemistry, Faculty of Associated Medical Sciences, Chiang Mai University, Thailand 5. Department of Obstetrics, Chiangrai Prachanukroh Hospital, Chiang Rai, Thailand 6. Department of Obstetrics, Banglamung Hospital, Chonburi, Thailand 7. Department of Obstetrics, Nopparat Rajathanee Hospital, Bangkok, Thailand 8. Department of Obstetrics, Bhumibol Adulyadej Hospital, Bangkok, Thailand 9. Department of Obstetrics, Khon Kaen Hospital, Khon Kaen, Thailand 10. Department of Obstetrics, Samutsakhon Hospital, Samutsakhon, Thailand 11. INSERM U1153, Team ECSTRA, Université Paris Diderot – Paris 7, Hôpital Saint-Louis, Paris, France
Abstract
Abstract
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, α1-microglobuin and β2-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.
Funder
NICHD National Institute of Child Health and Human Development
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Pharmacology (medical),Pharmacology,Microbiology (medical)
Reference31 articles.
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