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BMS' S ENTECAVIR SHOWS BENEFIT OVER LAMIVUDINE

March 10, 2006

Baraclude (entecavir) demonstrated greater benefit in treating nucleoside-naive chronic hepatitis B patients compared to lamivudine, the most commonly used antiviral therapy for treatment of chronic hepatitis B worldwide, according to two studies published in The New England Journal of Medicine. Baraclude, discovered and developed by Bristol-Myers Squibb (BMS), is a prescription medicine indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The multinational, Phase III clinical trials found that Baraclude treatment resulted in significantly greater improvements in liver histology and reductions of HBV DNA to undetectable levels (defined as less than 300 copies/mL) compared to treatment with lamivudine in both nucleoside-naive hepatitis B e-antigen (HBeAg) positive and HBeAg negative chronic hepatitis B patients at 48 weeks. In both studies, no evidence of virologic rebounds due to resistance to Baraclude was detected, and safety was comparable between the two treatments.