Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission

A Study of Efficacy and Safety of Telbivudine in Pregnancy for the Prevention of Perinatal Transmission of Hepatitis B Virus Infection

The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

In the present study, we evaluated the effect of telbivudine given during the second and third trimesters of pregnancy to highly viremic, HBV DNA-positive mothers on maternal HBV DNA and HBeAg levels prior to delivery and the rate of vertical transmission of HBV to infants who received passive-active immunoprophylaxis. Additionally, we investigated the timing of the administration of telbivudine on reducing the risk of perinatal transmission and the safety of telbivudine during pregnancy.

Inclusion Criteria:

• 20-40 years old pregnant woman with gestational age of 20-32 week;
• positive serum HBsAg;
• HBV DNA≥1.0x106 copies/ml;

Exclusion Criteria:

• with previous antiviral treatment;
• with clinical sign of threatened miscarriage or related treatment in early pregnancy;
• positive serum HAV, HCV, HDV and HEV tests;
• fetus deformity by 3-D ultrasound examination;
• on other dugs, such as immune modulators, cytotoxic drugs or steroids;
• husbands are infected with HBV.