The purpose of this study is to evaluate the efficacy and safety of telbivudine and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.
This study enrolls HBV mono-infected pregnant women cohorts managed in outpatient clinics/delivery unit at YouAn Hospital in Beijing. Subjects are prospectively followed from gestation week 26 to postpartum week 52. Treatment naïve mothers with HBV DNA \> 6 log10 c/mL and normal ALT are eligible. Mothers with abnormal fetus, cirrhosis or evidence of hepatocellular carcinoma (HCC) are excluded. At gestation week 28, mothers will receive telbivudine (LdT) 600 mg per day or lamivudine (Lam) 100 mg per day until postpartum 4 or no treatment as per their preference. All infants will receive standard immunoprophylaxis. Data is collected from patient records using data extraction forms. Primary endpoints are vertical transmission rates at infants' age of 52 week and the safety of telbivudine or lamivudine use.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
700
LdT 600mg QD
LAM 100mg QD
Beijing YouAn Hospital
Beijing, Beijing Municipality, China
Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child
Time frame: From gestation week 26 to postpartum week 52
percentage of mothers with serum HBV DNA level reduction, ALT within normal range and HBeAg and/or HBsAg negativity with or without seroconversion
Time frame: From gestation week 26 to pastpartume week 52
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