Tenofovir for Prevention of Mother-to-Child Transmission of Hepatitis B.

ABSTRACT

In this trial, 200 mothers, who were positive for hepatitis-B e antigen (HBeAg) and who had hepatitis-B virus (HBV) DNA level >200,000 IU/mL, were randomly assigned to receive usual care without antiviral therapy or to receive tenofovir (TDF) at an oral dose of 300 mg/d from 30 to 32 weeks of gestation until postpartum week 4; the participants were followed until postpartum week 28. All the infants received immunoprophylaxis. The primary outcomes were the rates of mother-to-child transmission and birth defects. The secondary outcomes were the safety of TDF, the percentage of mothers with an HBV DNA level of <200,000 IU/mL at delivery, and loss or seroconversion of HBeAg or hepatitis B surface antigen at postpartum week 28. At delivery, 68% of the mothers in the TDF group (66 of 97 women), as compared with 2% in the control group (2 of 100), had an HBV DNA level <200,000 IU/mL. At postpartum week 28, the rate of mother-to-child transmission was significantly lower in the TDF group than in the control group, both in the intention-to-treat analysis (5% vs. 18%, P=0.007) and the per-protocol analysis (0 vs. 7%, P=0.01). The maternal and infant safety profiles were similar in the TDF group and the control group, including birth defect rates (2% vs. 1%, P=1.00), although more mothers in the TDF group had an increase in the creatine kinase level. After the discontinuation of TDF, alanine aminotransferase elevations above the normal range occurred more frequently in mothers in the TDF group than in those in the control group (45% vs. 30%, P=0.03). The authors concluded that in HBeAg-positive mothers with an HBV DNA level >200,000 IU/mL during the third trimester, the rate of mother-to-child transmission was lower among those who received TDF therapy than among those who received usual care without antiviral therapy.