Hepatitis B Infection Clinical Trial
Official title:
Tenofovir Disoproxil Fumarate in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus in Highly Viremic Mothers
Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission remains
a concern and has been reported in approximately 8-15% of infants born to hepatitis B e
antigen (HBeAg) positive mothers with high levels of HBV DNA. Maternal HBV DNA > 6log10
copies/mL (or >200,000 IU/mL) is the major risk for the mother-to-child transmission. Prior
observational studies have shown that antiviral therapy including lamivudine or telbivudine
use during late pregnancy can safely reduce the rate of vertical transmission in this special
population compared to untreated patients.
Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes
serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with few adverse
effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this
study:
1. The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA > 6log10
copies/mL (or > 200,000 IU/mL) during late pregnancy and infants.
2. Its efficacy in the reduction of HBV vertical transmission rate.
Eligible mothers will be randomized (1:1) to either TDF-treated group or untreated group with about 100 subjects in each arm. The treatment group will receive TDF starting at week 30-32 of gestation until week 4 postpartum; follow up will continue until post-partum week 28 and infants age of 28 weeks. Untreated group will receive the standard of care with similar follow-up schedule as the treatment group. ;
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