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

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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.

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References

  1. Sheffield JS, Hickman A, Tang J, Moss K, Kourosh A, Crawford NM, Wendel GD Jr. Efficacy of an accelerated hepatitis B vaccination program during pregnancy. Obstet Gynecol 2011;117(5):1130–1135

    Article  Google Scholar 

  2. Yi P, Chen R, Huang Y, Zhou RR, Fan XG. Management of mother-to-child transmission of hepatitis B virus: propositions and challenges. J Clin Virol 2016;77:32–39

    Article  Google Scholar 

  3. Ding Y, Sheng QJ, Dou XG. Considerations of using oral nucleos(t)ide analogues to interrupt mother-to-child transmission in HBV carrier pregnant woman with high viral load. Zhonghua Gan Zang Bing Za Zhi 2019;27(2):85–87 (Chinese)

    CAS  PubMed  Google Scholar 

  4. Liu J, Liang W, Jing W, Liu M. Countdown to 2030: eliminating hepatitis B disease. China Bull World Health Org 2019;97(3):230–238

    Article  Google Scholar 

  5. Sripongpun P, Mannalithara A, Kwo PY, Kim WR. Potential benefits of switching liver transplant recipients to tenofovir alafenamide prophylaxis. Clin Gastroenterol Hepatol 2020;18(3):747–749

    Article  Google Scholar 

  6. De Clercq E. Tenofovir alafenamide (TAF) as the successor of tenofovir disoproxil fumarate (TDF). Biochem Pharmacol 2016;119:1–7

    Article  Google Scholar 

  7. Tavakolpour S, Darvishi M, Mirsafaei HS, Ghasemiadl M. Nucleoside/nucleotide analogues in the treatment of chronic hepatitis B infection during pregnancy: a systematic review. Infect Dis (Lond) 2018;50(2):95–106

    Article  CAS  Google Scholar 

  8. Liu J, Wang J, Yan T, Du D, Qi C, Cao F, et al. Efficacy and safety of telbivudine and tenofovir disoproxil fumarate in preventing hepatitis B vertical transmission: a real-life practice. J Viral Hepat 2019;26(10):1170–1177

    Article  CAS  Google Scholar 

  9. Byrne R, Carey I, Agarwal K. Tenofovir alafenamide in the treatment of chronic hepatitis B virus infection: rationale and clinical trial evidence. Therap Adv Gastroenterol 2018;11:1756284818786108

    Article  Google Scholar 

  10. Tian WY, Sheng QJ, Zhang C, Dou XG, Ding Y. Efficacy and safety of tenofovir alafenamide fumarate in pregnant women at HBV-infected immune-tolerant phase. Zhongguo Shiyong Neike Zazhi 2020;40(06):466–470 (Chinese)

    Google Scholar 

  11. Corlin DB, Heegaard NH. β(2)-microglobulin amyloidosis. Subcell Biochem 2012;65:517–540

    Article  CAS  Google Scholar 

  12. Zumrutdal A. Role of β2-microglobulin in uremic patients may be greater than originally suspected. World J Nephrol 2015;4(1):98–104

    Article  Google Scholar 

  13. Kärki M, Näntö-Salonen K, Niinikoski H, Tanner LM. Urine Beta2-Microglobulin Is an Early Marker of Renal Involvement in LPI. JIMD Rep 2016;25:47–55

    Article  Google Scholar 

  14. Gauthier C, Nguyen-Simonnet H, Vincent C, Revillard JP, Pellet MV. Renal tubular absorption of beta 2 microglobulin. Kidney Int 1984;26(2):170–175

    Article  CAS  Google Scholar 

  15. Fiseha T, Tamir Z. Urinary markers of tubular injury in early diabetic nephropathy. Int J Nephrol 2016;2016:4647685

    Article  Google Scholar 

  16. Chacar F, Kogika M, Sanches TR, Caragelasco D, Martorelli C, Rodrigues C, et al. Urinary Tamm-Horsfall protein, albumin, vitamin D-binding protein, and retinol-binding protein as early biomarkers of chronic kidney disease in dogs. Physiol Rep 2017;5(11):e13262

    Article  Google Scholar 

  17. Samuels R, Bayerri CR, Sayer JA, Price DA, Payne BAI. Tenofovir disoproxil fumarate-associated renal tubular dysfunction: noninvasive assessment of mitochondrial injury. AIDS 2017;31(9):1297–1301

    Article  CAS  Google Scholar 

  18. Jafari A, Khalili H, Dashti-Khavidaki S. Tenofovir-induced nephrotoxicity: incidence, mechanism, risk factors, prognosis and proposed agents for prevention. Eur J Clin Pharmacol 2014;70(9):1029–1040

    Article  CAS  Google Scholar 

  19. Bam RA, Yant SR, Cihlar T. Tenofovir alafenamide is not a substrate for renal organic anion transporters (OATs) and does not exhibit OAT-dependent cytotoxicity. Antivir Ther 2014;19(7):687–692

    Article  CAS  Google Scholar 

  20. Zeng QL, Yu ZJ, Ji F, Li GM, Zhang GF, Xu JH, Chen ZM, Cui GL, Li W, Zhang DW, Li J, Lv J, Li ZQ, Liang HX, Sun CY, Pan YJ, Liu YM, Wang FS. Tenofovir Alafenamide to Prevent Perinatal Hepatitis B Transmission: A Multicenter, Prospective, Observational Study. Clin Infect Dis. 2021:ciaa1939

  21. Cobo T, Kacerovsky M, Andrys C, Drahosova M, Musilova I, Hornychova H, Jacobsson B. Umbilical cord blood IL-6 as predictor of early-onset neonatal sepsis in women with preterm prelabour rupture of membranes. PLoS One. 2013;8(7):e69341

    Article  CAS  Google Scholar 

  22. Shim YJ, Choi BY, Park KH, Lee H, Jung YM, Kim YM. Inflammatory and Immune Proteins in Umbilical Cord Blood: Association with Hearing Screening Test Failure in Preterm Neonates. Mediators Inflamm. 2018;2018:4209359.

  23. Silberschmidt AL, Kühn-Velten WN, Juon AM, Zimmermann R, von Mandach U. Nifedipine concentration in maternal and umbilical cord blood after nifedipine gastrointestinal therapeutic system for tocolysis. BJOG 2008;115(4):480–485

    Article  Google Scholar 

  24. Benaboud S, Pruvost A, Coffie PA, Ekouévi DK, Urien S, Arrivé E, et al. Concentrations of tenofovir and emtricitabine in breast milk of HIV-1-infected women in Abidjan, Cote d’Ivoire, in the ANRS 12109 TEmAA Study, Step 2. Antimicrob Agents Chemother 2011;55(3):1315–1317

    Article  CAS  Google Scholar 

  25. Hu X, Wang L, Xu F. Guides concerning tenofovir exposure via breastfeeding: a comparison of drug dosages by developmental stage. Int J Infect Dis 2019;87:8–12

    Article  CAS  Google Scholar 

Download references

Acknowledgements

We thank all the patients and their families who participated in this study, as well as all of our colleagues who participated in sample preparation, testing and analysis.

Funding

This work was funded by grants from the Sixth People’s Hospital of Shenyang and The National Science and Technology Major Special Project for New Drug Development (Project number: 2018ZX09201016).

Author information

Authors and Affiliations

  1. Cadre’s Ward, The Sixth People’s Hospital of Shenyang, Shenyang, 110006, Liaoning, People’s Republic of China

    Baijun Li, Qiong Liu & Qiang Ma

  2. Oncology Department, General Hospital of Northern Theater Command, Shenyang, 110016, Liaoning, People’s Republic of China

    Zhaozhe Liu

  3. Science and Education Department, The Sixth People’s Hospital of Shenyang, Shenyang, 110006, Liaoning, People’s Republic of China

    Xing Liu & Yan Wang

  4. School of Traditional Chinese Materia Medica, Shenyang Pharmaceutical University, Shenyang, 110016, Liaoning, People’s Republic of China

    Dongchun Liu

  5. Clinical Chemistry Laboratory, Shenyang Beichuang Laboratory Co. Ltd, Shenyang, 110117, Liaoning, People’s Republic of China

    Mingyu Duan

  6. Gastroenterology Departmentepartment, The Sixth People’s Hospital of Shenyang, Shenyang, 110006, Liaoning, People’s Republic of China

    Ye Gu

  7. Liaoning University of Traditional Chinese Medicine, Shenyang, 110034, Liaoning, People’s Republic of China

    Yushi Wei

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  1. Baijun Li
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  10. Yan Wang
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Contributions

BJL, YG, QL, QM, YSW and YW contributed to the study design, patient recruitment and sample acquisition. ZZL, XL, DCL and MYD contributed to data analysis and drafted the manuscript. All the authors have read, revised and approved the final version of the manuscript.

Corresponding author

Correspondence to Yan Wang.

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Conflict of interest

No potential conflicts of interest were disclosed by Baijun Li,Zhaozhe Liu,Xing Liu,Dongchun Liu,Mingyu Duan,Ye Gu,Qiong Liu,Qiang Ma,Yushi Wei,Yan Wang.

Ethical approval

The present study was approved by the Ethics Committee of the Sixth People’s Hospital of Shenyang (2019–05-002). All procedures were performed in accordance with the ethical standards of the Institutional Review Board of the Sixth People’s Hospital of Shenyang, and the principles outlined in the Helsinki Declaration of 1975 and its later amendments.

Informed consent

Informed consent was obtained from all patients enrolled in this study.

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Li, B., Liu, Z., Liu, X. et al. Efficacy and safety of tenofovir disoproxil fumarate and tenofovir alafenamide fumarate in preventing HBV vertical transmission of high maternal viral load. Hepatol Int 15, 1103–1108 (2021). https://doi.org/10.1007/s12072-021-10235-1

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  • DOI: https://doi.org/10.1007/s12072-021-10235-1

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