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BARACLUDE(R) (Entecavir) Treatment Resulted In Greater Viral Load Suppression Compared to Adefovir at 96 Weeks In Antiviral-Naive Adult Chronic Hepatitis B E-Antigen Positive Patients
Date:4/26/2008

MILAN, Italy, April 26 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY) today announced new data from the E.A.R.L.Y. study (ETV-079), in which treatment of antiviral-naive adult chronic hepatitis B patients with BARACLUDE(R) (entecavir) resulted in greater long-term viral load reduction than adefovir at 96 weeks -- consistent with earlier 12-week results (primary endpoint). Suppression of viral load to undetectable levels is a measure of antiviral treatment response and is an important goal of chronic hepatitis B treatment. These data were presented today in Milan, Italy, at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL).

The E.A.R.L.Y. study is an open-label, randomized, viral kinetics study of 69 antiviral-naive chronic hepatitis B e-antigen (HBeAg) positive patients, comparing the antiviral activity of BARACLUDE and adefovir. All patients in this study had a high viral load at study entry.(1) Of the 49 patients who remained in the study at 96 weeks, 79 percent (n=23/29) of BARACLUDE-treated patients and 50 percent (n=10/20) of adefovir-treated patients achieved undetectable viral load.(2) The mean reduction in viral load from baseline in patients treated with BARACLUDE was -7.82 log(10) copies/mL and was -5.96 log(10) copies/mL in patients treated with adefovir at week 96.

"BARACLUDE maintains considerable antiviral efficacy through two years of treatment in this analysis," said Nancy Leung, M.D., of the Alice Ho Miu Ling Nethersole Hospital, Hong Kong, China. "This is important information for health care providers to consider when evaluating initial treatment options to suppress viral load in antiviral-naive chronic hepatitis B patients."

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SOURCE Bristol-Myers Squibb Company
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