Clinical effect and short-term safety of telbivudine in blocking mother-to-child transmission of HBV

Objective To evaluate the clinical effect and short-term safety of telbivudine administered in late pregnancy for blocking mother-to-child transmission of HBV in pregnant women with high HBV DNA load. Methods Pregnant women with positive HBsAg and HBe Ag and HBV DNA ≥2 × 106 IU/ml who underwent blockade of mother-to-child transmission in The First Hospital of Jilin University from July 2012 to June 2015 were enrolled. These patients were informed of current methods for blocking mother-to-child transmission of hepatitis B, and according to their own will, they were divided into active/passive immunization + telbivudine ( telbivudine group) and active/passive immunization group ( immunization group) . The patients in the telbivudine group were given oral telbivudine ( 600 mg, once a day) from week 32 of pregnancy to delivery, and those in the immunization group were not given antiviral therapy. The infants in both groups were given 20 μg hepatitis B vaccine combined with 100 IU hepatitis B immunoglobulin after birth. Positive HBsAg in infants at an age of 7months was defined as failed blockade of mother-to-child transmission. The t-test was used for comparison of normally distributed continuous data between groups, and the Wilcoxon rank sun test was used for comparison of non-normally distributed continuous data between groups; the chi-square test or the Fisher's exact test was used for comparison of categorical data between groups. Results A total of 447 pregnant women were enrolled, and there were 81 pregnant women in the telbivudine group and 366 women in the immunization group. Compared with the immunization group, the telbivudine group had a significantly higher mean age ( 28. 8 ± 3. 3 years vs 27. 6 ± 3. 8 years, t =-2. 55, P = 0. 01) and a significantly higher proportion of pregnant women with HBV DNA load > 108 IU/ml ( 82. 7% vs 61. 5%, χ2=13. 21, P < 0. 001) . There were no significant differences in alanine aminotransferase level, delivery mode, and feeding pattern between the two groups ( all P > 0. 05) . No infants in the telbivudine group had positive HBsAg at an age of 7 months, while among the 370 infants in the immunization group, 21 had positive HBsAg; there was a significant difference in positive rate between the two groups ( 0 vs 5. 7%, P =0. 02) . No women experienced eclampsia, premature rupture of membranes, or postpartum bleeding, and there were no significant differences between the two groups of infants in premature birth rate, body length, body weight, and Apgar score ( all P > 0. 05) . Conclusion In addition to active and passive immunization for neonates, antiviral therapy for pregnant women with a high viral load in late pregnancy can significantly improve the blocking rate of mother-to-child transmission of HBV and achieve no mother-to-child transmission of hepatitis B, and the neonates have good short-term safety.