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BARACLUDE(R) (entecavir) Data Continue to Demonstrate Low Incidence of Resistance Through Five Years of Treatment in Nucleoside-naive Chronic Hepatitis B Patients
Date:3/24/2008

- Data Indicate Pre-existing Lamivudine Resistance Predisposes Patients to

Higher Rates of BARACLUDE Resistance -

PRINCETON, N.J., March 24 /PRNewswire-FirstCall/ -- New BARACLUDE(R) (entecavir) data presented today demonstrated a continued low incidence of resistance in nucleoside-naive patients through five years of treatment. In the nucleoside-naive chronic hepatitis B patients analyzed, no additional patient developed resistance in the fifth year (n=108). Through five years of treatment, the cumulative probability of developing mutations in the virus that confer resistance to BARACLUDE (also called genotypic resistance) was 1.2 percent. Bristol-Myers Squibb Company (NYSE: BMY) announced the results at the 18th Conference of the Asia-Pacific Association for the Study of the Liver (APASL) in Seoul, Korea.

In lamivudine-refractory patients who received BARACLUDE after treatment with lamivudine failed, the cumulative probability of genotypic BARACLUDE resistance was 51 percent through the fifth year. This finding is consistent with prior observations that the pre-existence of lamivudine-resistant mutations results in an increase in the rate of BARACLUDE resistance.

"Many chronic hepatitis B patients require long-term treatment. Unfortunately, the initial benefits of therapy can be lost after the development of resistance. These five-year BARACLUDE data that demonstrate long-term minimal resistance at 1.2 percent in nucleoside-naive patients can be of great importance for patients," said Professor Ching-Lung Lai, Chief, Division of Gastroenterology and Hepatology, University of Hong Kong.

Drug resistance occurs when the hepatitis B virus (HBV) mutates, thereby avoiding the effects of the medicat
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SOURCE Bristol-Myers Squibb
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