The main objective of this study is to compare the mother-to-infant transmission rates of hepatitis B between pregnant women receiving treatment with tenofovir alafenamide and those receiving treatment with tenofovir disoproxil fumarate, after administering the hepatitis B vaccine and hepatitis B immunoglobulin to their infants at birth. Investigators define the mother-to-infant transmission rate of hepatitis B as the proportion of infants who are HBsAg positive and have serum HBV DNA \>20 IU/mL at 28 weeks of age among all live births in the experimental group.
Additionally, this study will also compare the incidence of congenital defects/malformations in infants born to mothers treated with tenofovir alafenamide and tenofovir disoproxil fumarate during the perinatal period to assess drug safety.
Pregnant women aged between 20 and 40 years old
Pregnancy duration between 20 to 28 weeks (screening for eligible patients can start from the 20th week of gestation)
Clinically diagnosed with compensated chronic hepatitis B, HBsAg positive for more than 6 months, with clinical history, signs, and test results consistent with compensated chronic hepatitis B
HBsAg and HBeAg positive in maternal serum during screening
Creatinine clearance < 100 mL/min (calculated using the Cockcroft-Gault method based on serum creatinine and ideal body weight), or hypophosphatemia (below normal range).
History of adverse renal reactions induced by Adefovir or history of Adefovir resistance.
Meeting one of the following criteria: hemoglobin < 80 g/L, neutrophil count < 1000/μL, ALT > 5 times the upper limit of normal, total bilirubin > 20 mg/L, albumin < 25 g/L, abnormal levels of creatinine or urea nitrogen.
Pregnant women with a history of miscarriage, history of giving birth to a child with congenital malformations, or history of fetal infection with hepatitis B virus.
Parallel
TAF group
DrugPregnant women will start TAF treatment (25 mg tablet taken orally once daily) from 28 weeks of gestation until delivery. After that, they will be randomly assigned to two subgroups among postpartum mothers without treatment indications: one subgroup will stop treatment, while the other subgroup will continue with an additional 12 weeks of TAF treatment. The mothers and their infants will be followed up at 28 weeks postpartum. Infants will receive the hepatitis B vaccine and HBIG within 12 hours after birth, as well as booster doses of the hepatitis B vaccine at 4 weeks and 24 weeks.
TDF group
DrugThe mother will start receiving TDF treatment (300 mg tablet taken orally once daily) at 28 weeks of pregnancy until delivery. After that, mothers without treatment indications will be randomly assigned to two subgroups: one subgroup will stop treatment, while the other subgroup will receive an additional 12 weeks of TDF treatment. Infants will be vaccinated with the hepatitis B vaccine and HBIG within 12 hours after birth, as well as receive booster doses of the hepatitis B vaccine at 4 weeks and 24 weeks.
The mother-to-child transmission rate of HBV
Compare the difference in HBV mother-to-infant transmission rates between pregnant women receiving TAF treatment and vaccinating their infants with hepatitis B vaccine and HBIg, and those receiving TDF treatment with the same vaccination for their infants. Here, the mother-to-infant transmission rate is defined as the proportion of infants in the experimental group who have serum HBV DNA \>20 IU/mL and are HBsAg positive at 28 weeks of age among all live births.
Congenital defects/malformations in infants
Determine the incidence of congenital defects/malformations in infants born to mothers treated with TAF and TDF during the perinatal period, and then conduct a comparative analysis of these data.
The percentage of mothers in each group of pregnant women with HBV DNA below 200,000 IU/mL
The percentage of mothers in each group of pregnant women with HBV DNA below 200,000 IU/mL at the time of delivery will be used as a key secondary efficacy endpoint to evaluate the extent of HBV DNA reduction in mothers receiving TDF/TAF treatment.
The percentage of mothers who experienced HBeAg/HBsAg clearance or seroconversion
The percentage of mothers who experienced HBeAg/HBsAg clearance or seroconversion during the study period was used as a secondary efficacy endpoint, and comparisons were made between the two groups.
ALT levels during or after TDF/TAF treatment
Observe the proportion of mothers with elevated ALT levels during or after TDF/TAF treatment (i.e., levels 5.1 to 10 times the upper limit of normal) or severe ALT elevation (levels more than 10 times the upper limit of normal), and conduct stratified and subgroup analyses after discontinuation of TDF/TAF (at delivery or at 12 weeks postpartum).
HBV DNA levels below 20 IU/mL
Summarize the percentage difference in HBV DNA levels below 20 IU/mL during delivery between the two groups of pregnant women.
Placental abnormalities
Evaluate and compare the percentage of mothers with placental abnormalities in the two groups.
Change in bone mineral density
Evaluate the percentage of change (especially decline) in bone mineral density (BMD) among maternal groups during antiviral treatment and after the treatment ends.
Depression, MASLD, or liver fibrosis
Evaluate the percentage of mothers with depression, MASLD, or liver fibrosis in each group before using TAF/TDF, during antiviral treatment, and after treatment.
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