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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
335
HBsAg- and HBeAg-positive pregnant women at 28-32 weeks of gestation are given with telbivudine (oral 600 mg/day) until 4 weeks after delivery. Newborn infants are administered 100-200 IU HBIG within 12 hours after birth and vaccinated against hepatitis B with yeast recombinant hepatitis B vaccine (10 µg) at 0, 1, and 6-month schedule. HBV DNA and ALT levels are measured before the use of telbivudine, at delivery, and 1-2 months after stopping the drug. HBV serological markers, including HBsAg, anti-HBs, and anti-HBc, HBeAg and anti-HBe are tested in infants at age of 7-12 months.
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Taixing People's Hospital
Taishing, Jiangsu, China
Zhenjiang Fourth People's Hospital
Zhenjiang, Jiangsu, China
HBV serologic markers and alanine transaminase (ALT) levels in infants
HBsAg and HBeAg are tested in umbilical blood and peripheral blood collected at the age of 10 months respectively. ALT is measured at 10 months old.
Time frame: 10 months after birth
HBV DNA quantification and ALT levels in mothers
HBV DNA and ALT levels in the pregnant women are measured before taking telbivudine, at birth, 1-2 months after stopping the drug, and 10 months postpartum.
Time frame: Up to 10 months postpartum
Women and infants with adverse events
Adverse events in pregnant women during pregnancy, complications at delivery and postpartum, Apgar score, newborn infant deformity, infant growth and development will be recorded during the study period (up to 10 months after delivery/birth).
Time frame: Up to 10 months after delivery/birth
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