Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV

Telbivudine in the Third Trimester of Pregnancy to Prevent Mother-to-infant Transmission of HBV

Infants of hepatitis B virus (HBV)-infected mothers with positive hepatitis B e antigen (HBeAg) have an increased risk of becoming infected with HBV. This study will determine whether telbivudine among both hepatitis B surface antigen (HBsAg) and HBeAg positive pregnant women during the third trimester, in addition to standard immunoprophylaxis in infants, will be more effective than standard immunoprophylaxis alone at preventing HBV infections in these infants.

Infants of HBV-infected mothers with positive HBeAg have an increased risk of becoming infected with HBV. Standard immunoprophylaxis against mother-to-infant transmission of HBV includes administration of hepatitis B immunoglobulin (HBIG) and hepatitis B vaccine; however, approximately 5-15% of the infants are not protected despite having received these preventive measures. It is reported that antiviral prophylaxis among HBV-infected pregnant women can reduce mother-to-infant transmission of HBV. However, more research is needed to obtain the definite conclusion. This study will determine whether telbivudine among HBsAg- and HBeAg-positive pregnant women during the third trimester, in addition to standard immunoprophylaxis in infants, will be more effective than standard immunoprophylaxis alone at preventing HBV infections in these infants.

Inclusion Criteria:

• pregnant women at 28-32 weeks of gestation
• both HBsAg and HBeAg positive
• good compliance

Exclusion Criteria:

• Coinfection of HAV, HCV, HEV, HIV, and STD
• With history of antiviral treatment against HBV
• With chronic disease, such as heart and kidney disease, asthma, diabetes, hyperthyroidism, severe anemia, bleeding disease, autoimmune diseases
• With threatened miscarriage or relevant treatment during the pregnancy
• With pregnant complications such as pregnancy hypertension, preeclampsia, etc
• With history of fetal deformity, or fetal deformity detected by ultrasound examination
• With ALT >10 times upper limit, or total bilirubin >3 times upper limit, of normal value