BackgroundTo evaluate the efficacy and safety of telbivudine in chronic hepatitis B women during the second and third trimesters of pregnancy.MethodsThe week 12-34 of pregnant women were screened in this prospective non-intervention study, with HBV DNA>10(6)IU/mL and alanine aminotransferase >50IU/L. The patients were received telbivudine treatment as a treatment group or without antiviral treatment as a control group. All infants were received recombinant hepatitis B vaccine 10 mu g within 12h of birth, at week 4 and week 24, immunoglobulin G within 12h of birth and were detected HBV markers at the range from 7 to 12months after delivery.ResultsA total of 241 patients were finally enrolled, 139 patients in telbivudine group and 102 patients in control group. HBsAg negative rate of infants was 99.3% (135/136) in telbivudine group and was 91.9% (91/99) in control group after 7months (P=0.005), respectively. The incidence of undetectable HBV DNA levels (47.5%) was significantly lower in telbivudine-treated mothers than that in the controls (0%), and 75.5% patients alanine aminotransferase returned to normal in telbivudine group, and 51% in control group at delivery (P<0.001), respectively.ConclusionsTelbivudine can safely reduce mother-to-child transmission in chronic hepatitis B women after 12weeks of gestation.