Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels

Telbivudine reduces DNA and normalizes alanine aminotransferase levels (ALT) in chronic hepatitis B patients with few adverse effects, but its use during pregnancy has not been explored. In this open-label, prospective study from the second trimester to post-partum week 28. This trial is to study the efficacy, safety and tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women with high level of serum HBV DNA and elevated alanine aminotransferase levels.

Inclusion Criteria:

• age between 20-40 years
• gestational age between 12-30 weeks
• serum HBsAg and HBeAg positivity
• HBV DNA levels >6log10 copies/mL
• ALT >1x ULN (40 IU/mL) and < 10x ULN.

Exclusion Criteria:

• co-infection with hepatitis A, C, D, E or HIV
• evidence of hepatocellular carcinoma; decompensated liver disease or significant renal, cardiovascular, respiratory or neurological co-morbidity
• concurrent treatment with immune-modulators, cytotoxic drugs, or steroids
• clinical signs of threatened miscarriage in early pregnancy
• evidence of fetal deformity by 3-dimensional ultrasound examination
• the biological father of the child had CHB