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Baraclude (Entecavir) Treatment Demonstrated Greater Viral Load,Reduction Compared to Adefovir at 48 Weeks in Study of,Antiviral-Naive Chronic Hepatitis B E-Antigen Positive Patients

WASHINGTON, May 21, 2007/PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY) today announced new data from study ETV-079, which showed that treatment with Baraclude (entecavir) demonstrated greater viral load reduction than adefovir at 48 weeks -- a result that was also seen at weeks 12 (primary endpoint) and 24. These data from an open-label, randomized viral kinetics study of 69 antiviral-naive chronic hepatitis B e-antigen (HBeAg) positive patients were presented at the annual Digestive Disease Week(R) meeting.

Study ETV-079 evaluated the antiviral activity of BARACLUDE and adefovir, and enrolled patients who had a high viral load at study entry (HBV DNA greater than or equal to 10(8) copies/mL). In this study, 58 percent of BARACLUDE-treated patients and 19 percent of adefovir-treated patients achieved undetectable viral load at 48 weeks.

"The study results show that BARACLUDE produced greater viral load reductions than adefovir at all time points analyzed -- from the earliest at 12 weeks to this latest analysis at 48 weeks," said Nancy Leung, M.D., of the Alice Ho Miu Ling Nethersole Hospital, Hong Kong, China.

The safety profile was comparable between the treatment groups. One patient treated with adefovir discontinued due to adverse events. No deaths were observed in either treatment group. The most common adverse events occurring in greater than 10 percent of patients in either treatment group were back pain, headache, influenza, nasopharyngitis, fever, upper respiratory tract infection, and urinary tract infection.

About the Study

Study ETV-079 was a randomized, open-label, comparative viral kinetics study of antiviral-naive chronic HBeAg-positive patients evaluating antiviral activity as measured by mean reduction in viral load, or levels of hepatitis B virus (HBV DNA) in the blood. HBeAg or e-antigen, is a viral protein associated with hepatitis B infe
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