Efficacy and safety of tenofovir disoproxil fumarate in pregnancy for the prevention of vertical transmission of HBV infection

AIM:To evaluate the effects of tenofovir disoproxil fumarate(TDF)use during late pregnancy to reduce hepatitis B virus(HBV)transmission in highly viremic mothers.METHODS:This retrospective study included 45 pregnant patients with hepatitis B e antigen(+)chronic hepatitis B and HBV DNA levels>107copies/mL who received TDF 300 mg/d from week 18 to 27 of gestation(n=21).Untreated pregnant patients served as controls(n =24).All infants received 200 IU of hepatitis B immune globulin(HBIG)within 24 h postpartum and 20μg of recombinant HBV vaccine at 4,8,and 24 wk.Perinatal transmission rate was determined by hepatitis B surface antigen and HBV DNA results in infants at week 28.RESULTS:At week 28,none of the infants of TDFtreated mothers had immunoprophylaxis failure,whereas2(8.3%)of the infants of control mothers had immunoprophylaxis failure(P=0.022).There were no differences between the groups in terms of adverse events in mothers or congenital deformities,gestational age,height,or weight in infants.At postpartum week 28,significantly more TDF-treated mothers had levels of HBV DNA<250 copies/mL and normalized alanine aminotransferase compared with controls(62%vs none,P<0.001;82%vs 61%,P=0.012,respectively).CONCLUSION:TDF therapy during the second or third trimester reduced perinatal transmission rates of HBV and no adverse events were observed in mothers or infants.