Int J Med Sci 2018; 15(8):796-801. doi:10.7150/ijms.25047
Efficacy and safety of nucleos(t)ide analogues to prevent hepatitis B virus mother-to-child transmission in pregnant women with high viremia: real life practice from China
1. Department of Infectious Disease, Shengjing Hospital, China Medical University, Shenyang 110022, China
2. The Sixth People's Hospital of Shenyang, Shenyang 110006, China
Sheng Q, Ding Y, Li B, Han C, Li Y, Zhang C, Bai H, Wang J, Zhao L, Xia T, An Z, Zhang M, Dou X. Efficacy and safety of nucleos(t)ide analogues to prevent hepatitis B virus mother-to-child transmission in pregnant women with high viremia: real life practice from China. Int J Med Sci 2018; 15(8):796-801. doi:10.7150/ijms.25047. Available from http://www.medsci.org/v15p0796.htm
Purpose: To evaluate the efficacy and safety of nucleos(t)ide analogues, especially telbivudine (LdT) for the prevention of mother-to-child transmission (MTCT) of hepatitis B virus (HBV) in women with high viremia.
Methods: We conducted a prospective, open-label, multicenter study of LdT for treating pregnant women having high viral loads of hepatitis B virus (HBV DNA>5 log10 IU/mL) but normal levels of alanine aminotransferase (ALT). Maternal HBV DNA, HBV serologic status and ALT were measured at baseline, 4 weeks after therapy, before delivery, 4 weeks after delivery, and 12 weeks after delivery. Infant HBV serologic status and HBV DNA levels were measured at 7 months. We calculated the MTCT rate of LdT-treated and LdT-untreated groups and analyzed the efficacy and safety of LdT.
Results: Ninety-one women (the treatment group) were treated with LdT, and twenty-one patients (the observation group) did not undergo antiviral therapy. The baseline HBV DNA levels were 8.15±0.82 log10 IU/mL in the treatment group, and 8.09±1.04 log10 IU/mL in the observation group. The MTCT rate was 0% in the treatment group, and 9.5% in the observation group (p=0.042). In the treatment group, HBV DNA levels were 5.02±0.74 log10 IU/mL at one month after therapy, and 3.95±0.94 log10 IU/mL before delivery. Both groups had significant differences from baseline levels in HBV DNA levels (p<0.001). In total, five patients had elevated ALT levels but without evidence of decompensate liver function. No severe adverse events or complications were observed in women or infants.
Conclusions: For pregnant women with HBV DNA greater than 5 log10IU/mL, LdT therapy was effective in reducing HBV MTCT. If serum HBV DNA was detectable at delivery, discontinuation of LdT immediately was found to be safe and rarely induced off-treatment hepatitis flare.
Keywords: HBV, chronic hepatitis B, pregnancy, mother-to-child-transmission, antiviral therapy, nucleos(t)ide analogues, telbivudine