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FDA Panel: Study Hepatitis B Drug in Children : Entecavir was approved for chronic HBV infection therapy in adults subsequent to the panel meeting.


 

The safety profiles and malignancy rates were comparable in the entecavir and lamivudine-treated groups, according to the company. Entecavir also has a favorable resistance profile compared with lamivudine, according to Bristol-Myers Squibb.

During the discussion on adult use, Leonard Seeff, M.D., senior scientist for hepatitis research at the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Md., said there was “no question” that entecavir is very effective at reducing viral load. “We need other treatments, and this drug has advantages that others don't—namely, at least at this point, a lower rate of mutant strains developing and no nephrotoxicity,” he remarked.

Bristol-Myers Squibb has proposed a pharmacovigilance study that would aim to enroll 12,500 patients worldwide, randomize them to entecavir or another HBV drug treatment, and follow them for malignancies and progression of liver disease for 5-8 years. The panel agreed that the trial would be critical in determining whether the drug's malignancy risk would increase, and whether resistant strains would develop with a longer duration of treatment.

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