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BMS hepatitis B drug shines in phase 3

WASHINGTON, March 8 (UPI) -- The New England Journal of Medicine said Wednesday that BMS's Baraclude is better than lamivudine for hepatitis B.

Bristol-Myers Squibb said that, in two studies published in the journal, its drug showed a greater benefit in treating nucleoside-naive chronic hepatitis B patients, compared to the most widely used therapy for chronic hepatitis B, lamivudine.

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"Hepatitis B is a highly infectious disease and remains a serious global public health issue, with approximately 400 million people chronically infected worldwide despite the availability of a vaccine," said Ting-Tsung Chang, one of the investigators in the studies and professor of medicine at National Cheng Kung University Medical College in Tainan, Taiwan.

"Currently, only a small percentage of diagnosed chronic hepatitis B patients worldwide are treated with prescription therapy," he added.

"It is important for physicians and patients to understand the benefits of taking an active approach to managing chronic hepatitis B when prescription therapy is appropriate."

In the phase 3 studies of more than 1,600 patients, 67 percent of Baraclude-treated patients showed a significantly greater improvement in liver histology and reductions of viral DNA to undetectable levels, or fewer than 300 copies/mL, compared to treatment with lamivudine (36 percent).

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The benefit was seen at 48 weeks in two groups of patients, those who had nucleoside-naive hepatitis B of the "e-antigen positive" variety, and those who had an "HBeAg negative" form of the disease, BMS said.

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