(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 March 8 issue of the New England Journal of Medicine.
Gonzague Jourdain, MD, PhD, 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 2 months postpartum. Hepatitis B immune globulin was administered at birth and hepatitis B vaccine was given at birth and at 1, 2, 4, and 6 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 3 in the placebo group were infected in the primary analysis (0 vs 2%; 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.
- Jourdain G, Ngo-Giang-Huong N, Harrison L, et al. Tenofovir vs placebo to prevent perinatal transmission of hepatitis B. N Eng J Med. 2018 March 8. doi: 10.1056/NEJMoa1708131