THURSDAY, June 16, 2016 (HealthDay News) — Use of tenofovir disoproxil fumarate (TDF) during pregnancy can reduce the rate of mother-to-child transmission of hepatitis B virus (HBV), according to a study published in the June 16 issue of the New England Journal of Medicine.
Calvin Q. Pan, M.D., from New York University in New York City, and colleagues randomized 200 mothers who were positive for hepatitis B e antigen and had an HBV DNA level above 200,000 IU/mL to receive usual care without antiviral therapy or to receive TDF from 30 to 32 weeks of gestation until postpartum week four. Follow-up was until postpartum week 28.
The researchers found that 68 and 2 percent of mothers in the TDF and control groups, respectively, had an HBV DNA level of less than 200,000 IU/mL (P < 0.001). The rate of mother-to-child transmission was significantly lower in the TDF versus control group at postpartum week 28, in both the intention-to-treat analysis (transmission to 5 versus 18 percent of infants; P = 0.007) and the per-protocol analysis (0 versus 7 percent; P = 0.01). The TDF and control groups had similar maternal and infant safety profiles, including rates of birth defects; an increase in the creatine kinase level was seen for more mothers in the TDF group.
“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,” the authors write.
The study was funded by Gilead Sciences, the manufacturer of tenofovir disoproxil fumarate.
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