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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

ion. This can decrease the efficacy of the current medication and may compromise future treatment options. To date, studies have shown that multiple mutations are required to develop BARACLUDE(R) (entecavir) resistance.

"These long-term BARACLUDE data continue to support the observations seen in the first years of treatment and are reflective of BARACLUDE's high genetic barrier to resistance," said Helena Brett-Smith, M.D., Group Director of Clinical Research at Bristol-Myers Squibb. "More importantly, we believe the data support BARACLUDE as an important initial treatment choice for chronic hepatitis B, which is a disease that results in a large global health burden."

About the Analysis

More than 700 patients across six studies initiated therapy on BARACLUDE and were monitored for treatment response and resistance.

The year five analysis expands upon previous analyses, adding in information on patients who received treatment with BARACLUDE during the fifth year of follow-up (n=108 for patients in nucleoside-naive studies and n=33 for patients in lamivudine-refractory studies).

In this comprehensive analysis, all patients enrolled in Bristol-Myers Squibb clinical trials ETV-014, -015, -022, -027, -026 and -901 who experienced a virologic breakthrough(1) or whose virus had not yet reached undetectable levels(2) at weeks 48, 96, 144, 192, 240 or end of dosing, were sequenced to determine if any changes occurred in the genetic code of the virus that would result in resistance or loss of effectiveness of BARACLUDE.

Nucleoside-naive patients in this analysis were initially treated with BARACLUDE 0.5 mg in studies ETV-022 and -027 and continued treatment with BARACLUDE 1 mg by enrolling in study ETV-901 with a treatment gap of less than or equal to 35 days. Lamivudine-refractory patients in this analysis initiated therapy on BARACLUDE 1 mg in studies ETV-014, -015, and -026 and continued treatment in study ETV-901 with a treatment
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SOURCE Bristol-Myers Squibb
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