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Randomized Controlled Trial
. 2021 Oct;15(5):1103-1108.
doi: 10.1007/s12072-021-10235-1. Epub 2021 Jul 26.

Efficacy and safety of tenofovir disoproxil fumarate and tenofovir alafenamide fumarate in preventing HBV vertical transmission of high maternal viral load

Baijun Li  1 , Zhaozhe Liu  2 , Xing Liu  3 , Dongchun Liu  4 , Mingyu Duan  5 , Ye Gu  6 , Qiong Liu  1 , Qiang Ma  1 , Yushi Wei  7 , Yan Wang  8
Affiliations
Randomized Controlled Trial

Efficacy and safety of tenofovir disoproxil fumarate and tenofovir alafenamide fumarate in preventing HBV vertical transmission of high maternal viral load

Baijun Li et al. Hepatol Int. 2021 Oct.

Abstract

Background: Hepatitis B virus (HBV) infection is a significant global health problem and > 42-52% of patients are infected during perinatal period. Tenofovir alafenamide fumarate (TAF) and tenofovir disoproxil fumarate (TDF) have been widely recognized as the main compounds used for antiviral treatment of hepatitis B. The present study evaluated the efficacy and safety of TAF in reducing HBV vertical transmission.

Methods: A total of 72 pregnant women, who met the inclusion criteria, were randomly divided into the TDF (300 mg/day, n = 36) and TAF (25 mg/day, n = 36) groups. Clinical and laboratory data were analyzed and compared between the two groups.

Results: No significant differences in alanine aminotransferase, total bilirubin, blood creatinine and blood urea nitrogen levels were noted between the two groups after treatment. The serum HBV DNA viral load and hepatitis B e antigen (HBeAg) levels of the two groups were significantly decreased following treatment, whereas the difference between the two groups was not statistically significant. The levels of urine retinol-binding protein and β2-microglobulin had no significant change after TAF treatment (p > 0.05), but increased significantly after TDF treatment (p < 0.05). All drug concentrations were undetectable in umbilical cord blood (UCB) and breast milk samples of the TAF group, while the drug concentration of UCB and breast milk samples in the TDF group was 2.98 ± 1.44 and 19.16 ± 15.26 ng/ml, respectively. All infants were tested negative for serum hepatitis B surface antigen, HBV DNA, and HBeAg.

Conclusions: Both TAF and TDF effectively block the mother-to-child transmission of hepatitis B. TAF was superior to TDF with regard to renal safety and breastfeeding.

Keywords: Drug safety; HBV vertical transmission; Perinatal period; Pregnant women; Tenofovir alafenamide fumarate; Tenofovir disoproxil fumarate.

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