Dataset from Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand

A Phase 3, randomized clinical trial to assess the efficacy and safety of tenofovir disoproxil fumarate (TDF) in hepatitis B virus (HBV) infected, s and e antigen positive, pregnant women to prevent perinatal transmission despite infant passive-active HB immunization.\nThe hypothesis was that TDF would decrease HBV DNA load in chronically HBV infected pregnant women and therefore reduce the risk of perinatal transmission.\nFrom January 2013 to August 2015, 168 women were assigned to the TDF group and 163 to the placebo group. There were 322 deliveries on study, 324 infants. None of the 147 infants in the TDF group were infected, as compared with 3 of 147 in the placebo group (P = 0.12). The rate of adverse events did not differ significantly between groups. The incidence of a maternal alanine aminotransferase level of more than 300 IU per liter after discontinuation of the trial regimen was 6% in the TDF group and 3% in the placebo group (P = 0.29).\n