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Clinical Trial
. 2022 Mar 31;77(4):1111-1118.
doi: 10.1093/jac/dkab490.

Proximal tubular dysfunction in pregnant women receiving tenofovir disoproxil fumarate to prevent mother-to-child transmission of hepatitis B virus

Geoffroy Liegeon  1   2 , Nicole Ngo-Giang-Huong  2   3 , Nicolas Salvadori  2   3 , Piyawan Bunpo  4 , Ratchada Cressey  4 , Jullapong Achalapong  5 , Prateep Kanjanavikai  6 , Orada Patamasingh Na Ayudhaya  7 , Sinart Prommas  8 , Thitiporn Siriwachirachai  9 , Prapan Sabsanong  10 , Jean Yves Mary  11 , Gonzague Jourdain  2   3
Affiliations
Clinical Trial

Proximal tubular dysfunction in pregnant women receiving tenofovir disoproxil fumarate to prevent mother-to-child transmission of hepatitis B virus

Geoffroy Liegeon et al. J Antimicrob Chemother. .

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.

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Figures

Figure 1.
Figure 1.
Flow chart of women enrolled in the study. TDF, tenofovir disoproxil fumarate.
See this image and copyright information in PMC

References

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