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Baraclude (entecavir) Therapy Resulted in Undetectable Levels of,Hepatitis B Virus in Cohort of Patients Who Re-Started Treatment

93 Percent of Nucleoside-Naive Chronic Hepatitis B e-Antigen (HBeAg)-Negative Patients Achieved Undetectable Viral Load by Week 48 of Re-Treatment

PRINCETON, N.J., April 13, 2007 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company today announced data from a cohort of nucleoside-naive HBeAg-negative chronic hepatitis B patients (ETV-027/901, n=99). These data showed that patients who experienced recurrent levels of hepatitis B virus in the blood after interruption of treatment with BARACLUDE(R) (entecavir) achieved viral suppression and liver enzyme (ALT) normalization when re- treated for 48 weeks with BARACLUDE. The study results were presented at the 42nd Annual Meeting of the European Association for the Study of Liver Diseases (EASL) in Barcelona, Spain.

In this cohort, 93 percent of patients who were re-treated with BARACLUDE had undetectable viral load - the level of the hepatitis B virus in the blood - (HBV DNA <300 copies/mL, measured by a common assay - polymerase chain reaction or PCR) and 83 percent achieved liver enzyme normalization (ALT less than or equal to 1xULN) after 48 weeks of therapy.

"This study showed that when treated again with BARACLUDE for 48 weeks, patients achieved responses similar to those seen prior to treatment interruption, with safety results consistent with previously reported experience," said Hakan Senturk, MD, of the Ist.Univ.Cerrahpasa Tip Fak, Istanbul, Turkey.

No deaths or treatment discontinuations due to adverse events were reported in this cohort. The most common adverse events occurring in greater than 10 percent of patients were abdominal pain, fatigue, upper respiratory tract infection, nasopharyngitis, increased ALT, arthralgia, and headache.

About the Nucleoside-Naive HBeAg-Negative BARACLUDE(R) (entecavir) Re- Treatment Cohort

This analysis evaluated BARACLUDE(R) (entecavir) in nucleoside-naive chronic HBeAg-negative patie
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