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
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.