HealthDay News — Maternal use of tenofovir disoproxil fumarate (TDF) in addition to administration of hepatitis B immune globulin and hepatitis B vaccine to infants born to hepatitis B e antigen (HBeAg)-positive pregnant women does not further lower the rate of hepatitis B virus transmission, according to a study published in the the New England Journal of Medicine.
Gonzague Jourdain, M.D., Ph.D., from Chiang Mai University in Thailand, and colleagues randomized HBeAg-positive pregnant women with an alanine aminotransferase level of 60 IU or less per liter to receive TDF (168 women) or placebo (163 women) from 28 weeks of gestation to two months postpartum. Hepatitis B immune globulin was administered at birth and hepatitis B vaccine was given at birth and at one, two, four, and six months.
The researchers found that the median time from birth to administration of hepatitis B immune globulin and hepatitis B vaccine was 1.3 and 1.2 hours, respectively. None of the infants in the TDF group and three in the placebo group were infected in the primary analysis (0 versus 2 percent; P = 0.12). There was no significant difference between the groups in the rate of adverse events.
“In a setting in which the rate of mother-to-child HBV transmission was low with the administration of hepatitis B immune globulin and hepatitis B vaccine in infants born to HBeAg-positive mothers, the additional maternal use of TDF did not result in a significantly lower rate of transmission,” the authors write.