Safety evaluation of telbivudine application throughout pregnancy in women with chronic hepatitis B / 中华传染病杂志

ABSTRACT

Objective To observe the safety of telbivudine (LdT) application throughout pregnancy in women with chronic hepatitis B (CHB),and to provide evidence-based treatment recommendations for women of childbearing age with chronic hepatitis B.Methods Women with hepatitis B virus (HBV) infection who took LdT before pregnancy and in early pregnancy were followed up prospectively for evaluating maternal and newborn adverse events.All newborns received block of HBV mother-to-child transmission (MTCT) after birth and were followed up for neonatal disorders and effects of maternal and child block.Results Among the 145 cases of pregnant women,143 were diagnosed as CHB and 2 decompensated cirrhosis.One hundred and five (72.4％) patients had HBV DNA＜500 copy/mL and 125 (86.0％) had positive hepatitis B e antigen.There were total 154 times pregnancies including 17 spontaneous abortions,4 ectopic gestation and 9 pregnancies after abortion.One hundred and one cases finished pregnancy,with 100 full term deliveries,1 preterm delivery and 2 twin pregnancies.One fetal with cleft lip and palate was aborted by induced labor in 24 weeks gestation.One baby was born with right double ears; one had benign lymph node under the left ear; and another one was diagnosed with congenital heart disease.Seven of the pregnant women had creatine kinase increased.Eight developed drug resistance.However,none had disease progression during pregnancy.None of the 63 infants was hepatitis B surface antigen positive over the 6 months of follow-up.The prevention of HBV MTCT was 100％ successful.Conclusion It is safe and effective for women with chronic HBV infection to receive LdT treatment throughout pregnancy.