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Telbivudine Prevents Mother-to-Child Hepatitis B Virus Transmission

Women with a high hepatitis B viral load who were treated with the antiviral drug telbivudine (Tyzeka) had a lower risk of transmitting the virus to their babies during pregnancy or birth -- in fact, none did so -- compared to untreated women whose infants only received standard immunoprophylaxis, according to a Chinese study reported in the June edition of Clinical Gastroenterology and Hepatology.

Hepatitis B virus (HBV) is a blood-borne pathogen than can be transmitted from mother-to-child during gestation or delivery. In areas where HBV is endemic, as is the case in much of Asia and Africa, vertical transmission is a major route of infection.

Quanxin Wu and Yuming Wangfrom Southwest Hospitalin Chongqing, China, and colleagues evaluated theefficacy and safety of telbivudine in preventing HBV transmission to infants born to women with high viral loads. This prospective study included 450 hepatitis B "e" antigen (HBeAg) positive pregnant women with HBV DNA levels greater than 1,000,000 IU/mL.

A total of 279 women in this open-label study received telbivudine (600 mg/day) during weeks 24 to 32 of gestation, while 171 women who were not willing to take antiviral drugs during pregnancy served as controls. In addition, all newborns received standard immunoprophylaxis using hepatitis B immune globulin (HBIG) and the first dose of a recombinant HBV vaccine.

Results

• None of the infants born to mothers treated with telbivudine tested positive for hepatitis B surface antigen (HBsAg) at 6 months after birth, compared with 14.7% of babies in the control group.
• 23.3% of women receiving telbivudine had undetectable HBV DNA levels before delivery, compared with none in the control group.
• Women taking telbivudine were also significantly more likely to have undetectable HBV DNA in umbilical cord blood than those in the control group (99.1% vs 61.5%, respectively).
• No severe adverse events or complications were observed in either the women or their infants.

"Telbivudine significantly reduces vertical transmission of HBV from pregnant women to their infants," the study authors concluded.

"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," Wang stated in an American Gastroenterological Association press release. "We found that telbivudine not only eliminated vertical transmission of HBV from pregnant women to theirs infants, but that it is also safe and well tolerated by women and infants."

Of note, the women in this study took telbivudine during the second or third trimester, while the risk of adverse effects due to drug toxicity is usually greatest during the first trimester. Long-term outcomes of telbivudine treatment during pregnancy -- especially compared to other recommended antivirals such as tenofovir (Viread) or entecavir (Baraclude) -- remains to be explored.

6/18/15

Reference

Q Wu, H Huang, X Sun, Y Wang, et al. Telbivudine Prevents Vertical Transmission of Hepatitis B Virus From Women with High Viral Loads: A Prospective Long-Term Study. Clinical Gastroenterology and Hepatology 13(6):1170-1176. June 2015.

Other Source

American Gastroenterological Association. Drug Prevents Passage of HBV During Pregnancy. Press release. June 1, 2015.