Efficacy and safety of tenofovir dipivoxil in preventing mother-to-child transmission of hepatitis B virus during late pregnancy

Abstract

Abstract: Objective To investigate the efficacy and safety of tenofovir dipivoxil in preventing mother-to-child transmission of hepatitis B virus (HBV) in carriers during late pregnancy. Methods Our study included 112 pregnant women with HBV who were diagnosed and treated at Jiading District Central Hospital between January 2018 and December 2020. The participants were divided into two groups: a control group and an observation group. The observation group received tenofovir disoproxil fumarate from 26-28 weeks of gestation until delivery, while the control group did not receive antiviral treatment. All infants from both group were administered 100 IU of hepatitis B immunoglobulin within 24 hours after birth and received the hepatitis B vaccine at 0, 1 and 6 months. We compared ALT levels, HBV DNA, HBsAg and HBeAg, neonatal growth and development, and adverse reactions in pregnant women between the two groups. Results The HBV DNA levels in the control group before treatment and 12 weeks postpartum were (7.3±0.6) log₁₀ IU/mL and (7.1±0.8) log₁₀ IU/mL, respectively (P<0.05). In the observation group, the HBV DNA levels were (7.4±0.3) log₁₀ IU/mL before treatment and (6.9±0.9) log₁₀ IU/mL 12 weeks postpartum (P<0.05). The HBV DNA level in the observation group before delivery was (3.2±0.7) log₁₀ IU/mL, significantly lower than that of the control group (7.2±0.4) log₁₀ IU/mL, with a statistically significant difference(P<0.05). The HBsAg positive rate, HBeAg positive rate, and HBV DNA positive rate in newborns from the observation group were lower than those in the control group at birth, and at 6 and 12 months. Furthermore, the HBV infection rate in newborns from the observation group was significantly lower compared to the control group (P<0.05). No cass of abortion, liver or kidney dysfunction, or postpartum hemorrhage occurred in either group of pregnant women. Fetal growth and development were satisfactory in both groups. Conclusion The use of tenofovir disoproxil fumarate during the third trimester of pregnancy in women with hepatitis B virus shows strong antiviral efficacy, is safe, and significantly reduces the rate of mother-to-child transmission.

Key words: Hepatitis B virus, Late pregnancy, Tenofovir dipivoxil, Blocking, Maternal to child transmission

FAN Hui-jie, JIANG Guo-wei. Efficacy and safety of tenofovir dipivoxil in preventing mother-to-child transmission of hepatitis B virus during late pregnancy[J]. Chinese Hepatolgy, 2024, 29(10): 1247-1250.

References

[1] Nguyen MH, Wong G, Gane E, et al. Hepatitis B virus: Advances in prevention, diagnosis, and therapy[J]. Clin Microbiol Rev,2020,33(2):e00046-19.
[2] Boora S, Sharma V, Kaushik S, et al. Hepatitis B virus-induced hepatocellular carcinoma: a persistent global problem[J]. Braz J Microbiol,2023,54(2):679-689.
[3] Mason WS, Jilbert AR, Litwin S. Hepatitis B virus DNA integration and clonal expansion of hepatocytes in the chronically infected liver[J]. Viruses,2021,13(2):210.
[4] Meng Z, Chen Y, Lu M. Advances in targeting the innate and adaptive immune systems to cure chronic hepatitis B virus infection[J]. Front Immunol,2020,10:3127.
[5] Xiao J, Wang F, Wong NK, et al. Global liver disease burdens and research trends: Analysis from a Chinese perspective[J]. J Hepatol,2019,71(1):212-221.
[6] Ahodantin J, Bou-Nader M, Cordier C, et al. Hepatitis B virus X protein promotes DNA damage propagation through disruption of liver polyploidization and enhances hepatocellular carcinoma initiation[J]. Oncogene,2019,38(14):2645-2657.
[7] Nie YZ, Zheng YW, Miyakawa K, et al. Recapitulation of hepatitis B virus-host interactions in liver organoids from human induced pluripotent stem cells[J]. EBioMedicine,2018,35:114-123.
[8] Hu AQ, Cai QY, Zhang M, et al. Overt and occult hepatitis B infection after neonatal vaccination: mother-to-infant transmission and HBV vaccine effectiveness[J]. Int J Infect Dis,2021,104:601-609.
[9] May S, Mandal S, Keel P, et al. Hepatitis B virus immunization and neonatal acquisition of persistent infection in England and Wales[J]. J Infect Dis,2018,218(5):726-733.
[10] Papatheodoridis GV, Lekakis V, Voulgaris T, et al. Hepatitis B virus reactivation associated with new classes of immunosuppressants and immunomodulators: A systematic review, meta-analysis, and expert opinion[J]. J Hepatol,2022,77(6):1670-1689.
[11] Xu J, Tao LL, Ma LX. Efficacy and safety of telbivudine to prevent mother-to-child transmission of hepatitis B virus in middle- and late-stage pregnancy with high viral loads[J]. J Med Virol,2019,91(12):2153-2157.
[12] Wang H, Fang JW, Gu ZW, et al. Application of hepatitis B immunoglobulin in prevention of mother-to-child transmission of chronic hepatitis B in HBsAg- and HBeAg-positive mother[J]. J Obstet Gynaecol,2022,42(5):877-882.
[13] Okenwa UJ, Dairo MD, Bamgboye E, et al. Maternal knowledge and infant uptake of valid hepatitis B vaccine birth dose at routine immunization clinics in Enugu State-Nigeria[J]. Vaccine,2020,38(12):2734-2740.
[14] Okenwa UJ, Dairo MD, Uba B, et al. Maternal reasons for non-receipt of valid Hepatitis B birth dose among mother-infant pairs attending routine immunization clinics, South-east, Nigeria[J]. Vaccine,2019,37(46):6894-6899.
[15] 俞顺章. 通过“预防为主”切断母婴传播促进我国乙型肝炎和肝癌发病率持续下降[J]. 中华流行病学杂志,2019,40(12):1650-1653.
[16] 徐鹤翔, 王莉娟, 余亚新, 等. 替比夫定阻断HBV母婴传播效果及安全性的荟萃分析[J]. 中华肝脏病杂志,2012,20(10):755-760.
[17] Ding Y, Cao L, Zhu L, et al. Efficacy and safety of tenofovir alafenamide fumarate for preventing mother-to-child transmission of hepatitis B virus: a national cohort study[J]. Aliment Pharmacol Ther,2020,52(8):1377-1386.
[18] Zeng QL, Yu ZJ, Ji F, et al. Tenofovir alafenamide to prevent perinatal hepatitis B transmission: A multicenter, prospective, observational study[J]. Clin Infect Dis,2021,73(9):e3324-e3332.
[19] Funk AL, Lu Y, Yoshida K, et al. Efficacy and safety of antiviral prophylaxis during pregnancy to prevent mother-to-child transmission of hepatitis B virus: a systematic review and meta-analysis[J]. Lancet Infect Dis,2021,21(1):70-84.
[20] Wedemeyer H, Schöneweis K, Bogomolov P, et al. Safety and efficacy of bulevirtide in combination with tenofovir disoproxil fumarate in patients with hepatitis B virus and hepatitis D virus coinfection (MYR202): a multicentre, randomised, parallel-group, open-label, phase 2 trial[J]. Lancet Infect Dis,2023,23(1):117-129.
[21] Karahoda R, Ceckova M, Staud F. The inhibitory effect of antiretroviral drugs on the L-carnitine uptake in human placenta[J]. Toxicol Appl Pharmacol,2019,368:18-25.