HBV Advocate Blog: Telbivudine Effectively Prevents Infection of Newborns Born to Infected Mothers

Another study has confirmed the effectiveness of using antivirals—in this case telbivudine (Tyzeka)—to lower a pregnant woman’s high viral load and prevent her from infecting her newborn.

While treating pregnant women with antivirals has not yet been approved by the U.S. Food and Drug Administration, increasingly doctors are treating women with HBV DNA levels exceeding 10 million international units per milliliter (IU/mL) to prevent infection of newborns.

Medical guidelines call for immediate immunization and administration of hepatitis B immune globulin (HBIG) in babies born to infected mothers, but this approach often fails to protect babies born to women with high viral loads.

In a study published in the September issue of the journalClinical Gastroenterology and Hepatology, Chinese researchers treated 279, HBV-infected pregnant women with 600 mg daily of telbivudine from weeks 24-32 of their pregnancy. They also monitored 171 pregnant HBV-infected women who were unwilling to take the antivirals. All women in the study had very high viral loads.

All newborns were vaccinated and treated with HBIG in accordance with medical guidelines. Six months after birth, none of the infants born to telbivudine-treated mothers tested positive for hepatitis B, while 14.7% of babies born to untreated women tested positive for the hepatitis B surface antigen (HBsAg), which indicates an active hepatitis B infection.

They also reported that a significantly higher proportion of telbivudine-treated women had undetectable levels of HBV DNA in their umbilical cord blood (99.1%) compared to the control group, of whom only 61.5% had undetectable HBV DNA.

HBV DNA levels also decreased among women treated with telbivudine; 23.2% had undetectable HBV DNA before delivery. None of the control group had undetectable viral loads.

“Telbivudine significantly reduces vertical transmission of HBV from pregnant women to their infants; it is safe and well tolerated by women and infants,” Chinese researchers wrote.(1)

Recent studies have endorsed both telbivudine and tenofovir (Viread) as safe antiviral choices for highly viremic pregnant women.

An unrelated study published in a Chinese medical journal found that women treated with telbivudine since the early stages of their pregnancy did well and there was no negative impact on their newborns. The study followed 69 women who received telbivudine and compared their results to an untreated control group of 34.

The women treated with the antiviral had a higher rate of successful deliveries, and only 1.8% of their babies became infected. In contrast, among the control group, 16.6% of babies became infected (2). Both groups of babies were immunized and received HBIG at birth.