Telbivudine prevents transmission of HBV to newborns from mothers: Study

The study presenter and co-investigator Calvin Pan, MD, anticipates a "very powerful impact in the field, as hepatitis B is difficult to eradicate and currently there is no treatment modality that can cure the disease. Blocking the vertical transmission from mother to infant will eventually decrease the disease burden in the future generations with the hope to eradicate HBV from the earth."

Current vaccines and HBIG given to a newborn do not work well when the mother has a high viral load and is HBeAg positive. According to Dr. Pan, "Transmission rate to the newborn in this population is about 15 to 30%, resulting in a newborn with lifelong HBV infection 90% of the time."

For this study, pregnant women with high levels of HBVDNA enrolled in the treatment arm of the study were given 600 mg daily of Telbivudine. All newborns received three doses of hepatitis B vaccine. Patients in the treatment arm achieved sustained virologic response rate (SVR) of 53% prior to delivery and 62% four weeks after delivery. None of the patients in the control arm achieved SVR at either point.

Few tested positive

Only 4% of newborns in the treatment arm tested positive for hepatitis B, whereas 23% of newborns from the control group tested positive. None of the patients treated with Telbivudine had to stop treatment due to adverse events. No congenital deformities were observed up to 28 weeks after birth. There were no measurable differences in postpartum health issues for mothers and newborns between the treatment and control groups.

Dr. Pan realises the limitations of this study: "The infant follow up is limited to 28 weeks after birth. Even though it is good enough to define the failure rate of transmission prevention, the long term safety data for the infant is missing. Hypothetically, antiviral therapy and immunoprophylaxis can be effective in blocking transmission that occurs during late pregnancy or delivery, but the mechanism of intrauterine transmission remains a puzzle. More studies are needed in the field to provide a comprehensive strategy to prevent HBV vertical transmission."

The message he wants to convey is still a positive one and shows a different way of attacking the problem of HBV. "Because we are struggling in combating the pandemic of hepatitis B worldwide, and frustrated in the limited resources we can allocate for treating our patients," said Dr. Pan, "Maybe we should be putting more efforts and allocating more resources on preventing HBV vertical transmission."

Source: American Association for the Study of Liver Diseases (AASLD)