Objective: To investigate the efficacy and safety of telbivudine for blocking mother-to-child transmission of hepatitis B virus (HBV) in pregnant women with high viremia.
Methods: A total of 128 pregnant women with high HBV load (HBV DNA ≥ 1.0*10⁷ copies/ml and positive for hepatitis B surface antigen (HBsAg)) were enrolled in the study from January 2009 to January 2013 and divided into the following three groups:group A (n=42) treated with telbivudine at 12 weeks of gestation until postpartum 12 weeks; group B (n=41) treated with telbivudine at 20 to 28 weeks of gestation until postpartum 12 weeks; group C (n=45; control group) with no telbivudine treatment.All study participants were given compound giyeyrrhizin for liver protection. All infants born to the women from the three groups were vaccinated with hepatitis B immunoglobulin (200 IU) and the HBV vaccine (20 tg) ager birth. The mother-to-infant transmission of HBV was indicated by the presence of HBsAg in infants at 7 months after birth.The maternal HBV DNA levels of the women in the three groups were statistically compared with the HBsAg positive rates in their neonates.
Results: There were no significant differences in the HBV DNA levels between the three groups before treatment (P more than 0.05). The pre-delivery level of HBV DNA in group A (0.553 ± 1.588 log10 copies/ml) and in group B (0.486 ± 1.429 log10 copies/ml) was significantly decreased compared to that in group C (7.698 ± 0.255 log10 copies/ml) (both P < 0.01).The post-delivery (12 weeks) level of HBV DNA in group A (0.381 ± 1.116 log10 copies/ml) and in group B (0.335 ± 1.073 log10 copies/ml) was significantly decreased compared to that in group C (7.728 ± 0.277 log10 copies/ml) (both P < 0.01).There were no significant differences in the HBV DNA levels between group A and group B (P > 0.05). No infants in group A or group B were HBsAg-positive,while the HBsAg-positive rote was 17.4% in group C (P=0.012; P=0.015).
Conclusions: Telbivudine treatment starting from the 12th week of gestation or from the 20-28th week of gestation can significantly decrease the serum HBV DNA level in peripheral blood of pregnant women with high viremia and reduce the infection rate of HBV in their neonates.