Efficacy and safety of telbivudine in preventing mother-to-infant transmission of HBV in pregnant women with high HBV DNA load

Objective To evaluate the efficacy and safety of telbivudine given from the 12th week of gestation in preventing mother-to-infant transmission of hepatitis B virus(HBV) in pregnant women with high HBV DNA load.Methods Eighty pregnant women(at 12 weeks of gestation) with chronic hepatitis B,who had a HBV DNA load higher than 1.0×107 copies/ml,were enrolled.The patients were divided into two groups according to their personal preferences: treatment group(n=38) and control group(n=42).The treatment group received oral telbivudine(600 mg) once daily until 12 weeks after delivery and was administered compound glycyrrhizin for liver protection,while the control group was given compound glycyrrhizin for liver protection alone.All infants in both groups were vaccinated with hepatitis B immunoglobulin(200 IU) and HBV vaccine(20 μg) after birth.The mother-to-infant transmission of HBV was indicated by the presence of HBsAg and HBV DNA in infants at 7 months after birth.The HBV DNA levels in these women were measured,and the positive rate of HBsAg in infants was determined.The difference in positive rate of HBsAg was analyzed by chi-square test;the between-group comparison was analyzed by group t(t′)-test,and the before-after comparison was analyzed by paired t-test.Results The treatment group showed significantly decreased HBV DNA and alanine aminotransferase levels before delivery.The HBV DNA load of treatment group dropped rapidly after 2 weeks of treatment and then decreased slowly until delivery.The treatment group had significantly decreased HBV DNA levels before delivery and at 12 weeks after delivery(t=29.15,P0.01;t=40.06,P0.01),but the control group showed no significant changes(P0.05).The treatment group had significantly lower HBV DNA levels than the control group before delivery and at 12 weeks after delivery(P0.01).No infants in the treatment group were HBV-positive,versus a positive rate of 14.3% in the control group(χ2=3.99,P0.05).No adverse events occurred in the mothers or their infants in treatment group,but two cases of severe hepatic dysfunction were found in the control group.There were no significant differences between the two groups in terms of cesarean section rate,adverse pregnancy rate,and postpartum hemorrhage rate as well as the gestational age,body weight and height,and Apgar scores of neonates.Conclusion Telbivudine given from the 12th week of gestation can significantly decrease the serum HBV DNA level in peripheral blood among pregnant women with high HBV DNA load and reduce the infection rate of HBV in neonates,and it has high tolerability and safety.