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TDF reduces perinatal mother-to-child transmission of HBV
SAN FRANCISCO — Highly viremic mothers who received tenofovir disoproxil fumarate therapy late in pregnancy showed reduced risk for perinatal mother-to-child transmission of hepatitis B virus infection, according to study findings presented at The Liver Meeting 2015.
In this study, Calvin Q. Pan, MD, FACP, FACG, of the division of gastroenterology and hepatology, New York University Langone Medical Center, New York University School of Medicine, and colleagues randomly assigned 197 pregnant women positive for hepatitis B e antigen (HBeAg) to a dosage of either tenofovir disoproxil fumarate (TDF; n = 97) from gestation (30-32 weeks) to 4 weeks postpartum, or no treatment (n = 100), to determine the mother-to-child transmission rate. The mothers were followed until 28 weeks postpartum and all infants received immunoprophylaxis after birth.
Secondary endpoints of the study included: the safety and efficacy of TDF, HBV DNA reduction in the mother at delivery and HBeAg or hepatitis B s antigen (HBsAg) loss/seroconversion at 28 weeks postpartum.
Overall, 180 mothers completed the study. On per protocol analysis, the mother-to-child transmission rate was lower in infants from mothers treated with TDF (6.82%) compared with infants from non-treated mothers (0%; P = .013). The same was also indicated on intention-to-treat analysis (18% vs. 5.16%; P = .007).
“The safety profile was similar between groups, with no difference in birth defect rates,” the researchers wrote.
In TDF-treated mothers with HBV DNA levels greater than 200,000 IU/mL at baseline, 68% had HBV DNA levels less than 200,000 IU/mL before delivery (n = 66) compared with 2% of non-treated mothers (n = 2; P < .001).
The researchers concluded: “TDF therapy should be strongly considered for mothers whose HBV DNA levels exceeded 200,000 IU/mL and started at gestation week 30 to 32.” – by Melinda Stevens
Reference:
Pan CQ, et al. Abstract 209. Presented at: The Liver Meeting; Nov. 13-17, 2015; San Francisco.
Disclosure: Pan reports multiple financial relationships with AbbVie, Bristol-Myers Squibb, Gilead Sciences and Janssen.
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This was a multicenter, retrospective randomized and controlled study.
I think this is very important because mother-to-child transmission of hepatitis B remains to be a major concern.
In both groups of mothers, it is very clear there is a significant reduction in the treated group in the number of infants who had hepatitis B infection at follow up, suggesting that the treatment of mothers at the gestation period of 30 to 32 weeks through the remaining part of pregnancy really has a major impact in reducing the virus transmission rate to the newborn.
This is a very important point because in pregnant women, hepatologists, even non-hepatologists, tend to be very concerned giving any kinds of medications. However, previous studies indicated similar results [to this study] and it’s good to see that in a larger cohort of 200 patients that this is well-tolerated and really has positive effects.