Tuesday, November 2, 2010

Telbivudine Given to Mothers with Hepatitis B Reduces Infection Rate in Infants

We knew that, Telbivudine is an antiviral drug used in the treatment of hepatitis B infection. It is marketed by Swiss pharmaceutical company Novartis under the trade names Sebivo (Europe) and Tyzeka (United States). Clinical trials have shown it to be significantly more effective than lamivudine or adefovir, and less likely to cause resistance.

Now researchers from American Association for the Study of Liver Diseases (AASLD), lead by Dr. Calvin Pan, have come up with some interesting finding, i.e., Telbivudine in the second to third trimesters of pregnancy lead to  no transmission of HBV to newborns was detected at 28 weeks postbirth.  The study concluded that both the mothers and new born. 

For this study, pregnant women with high level 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 percent prior to delivery and 62 percent four weeks after delivery. None of the patients in the control arm achieved SVR at either point. 

Only four percent of newborns in the treatment arm tested positive for hepatitis B, whereas 23 percent 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 realizes 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. Though more studies are needed in the field to provide a comprehensive strategy to prevent HBV vertical transmission, in my opinion its is significant achievement......

Ref : http://www.aasld.org/lm/press/Pages/PressReleaseTelbivudine.aspx   

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