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Researchers find Tyzeka reduces HBV mother-to-child transmission

Tyzeka was safe and effective in reducing hepatitis B virus infection viral loads in mothers with the virus and helped to prevent vertical transmission from mother to child, according to newly published data.

“If we are to decrease the global burden of hepatitis B, we need to start by addressing mother-to-infant transmission, which is the primary pathway of HBV infection,” Yuming Wang, MD, Institute for Infectious Diseases, Southwest Hospital, Chongqing, China, said in a press release. “We found that telbivudine not only eliminated vertical transmission of HBV from pregnant women to their infants, but that it is also safe and well tolerated by women and infants.”

Wang and colleagues conducted a cohort study with 450 pregnant women, aged 18 to 40 years, who were positive for hepatitis B e antigen and had HBV DNA levels greater than 10⁶ IU/mL. Of these women, 279 women received 600 mg of Tyzeka (telbivudine, Novartis) per day during weeks 24 to 32 of gestation and continued treatment until delivery or a month post-birth; 171 women acted as controls who did not want to undergo antiviral therapy.

All infants were vaccinated with HBV vaccines at 4 and 24 weeks and also received hepatitis B immune globulin at birth and 1 month, according to the research.

Six months after birth, none of the infants whose mothers underwent telbivudine therapy were positive for HBV compared with 14.7% of infants in the control group.

HBV DNA levels decreased among women who underwent therapy with telbivudine. Of these, 23.2% (40/172) given telbivudine had undetectable HBV DNA levels before delivery versus zero controls. More women given telbivudine had undetectable levels of HBV DNA in cord blood compared with than controls (99.1% vs. 61.5%).

No severe adverse events or complications were observed in women or infants.

“The long-term follow-up results of this study suggest that telbivudine is effective and safe in preventing [mother-to-child transmission], and it is an appropriate choice for HBV-infected pregnant women with a high viral load,” the researchers concluded. “However, the long-term influence of using telbivudine, when compared with tenofovir, particularly in viral resistance during re-treatment with [nucleoside analogs], remain to be explored.” – by Melinda Stevens

Disclosure: Wang reports no relevant financial disclosures. Please see the study for a list of other authors’ relevant financial disclosures.