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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

gap of less than or equal to 35 days.

Viral load reduction in chronic hepatitis B patients treated with BARACLUDE(R) (entecavir) in nucleoside-naive and lamivudine-refractory studies was also evaluated.

Data Results

Results from these studies prior to this year five analysis were previously announced on April 14, 2007.

Nucleoside-naive data

-- The incidence of BARACLUDE resistance in patients in

nucleoside-naive studies over time is low, with a cumulative

probability of genotypic BARACLUDE resistance of 1.2 percent

through five years.

-- No nucleoside-naive patient developed resistance (n=108) in year

five.

-- 93 percent of the nucleoside-naive patients taking BARACLUDE were

able to achieve and maintain an undetectable viral load

(HBV DNA <300 copies/mL) through year five (n=108).

Lamivudine-refractory data

-- The results in lamivudine-refractory patients in years one through

five were consistent with the finding that the pre-existence of

lamivudine-resistant substitutions resulted in an increase in the

emergence of BARACLUDE resistance, with a cumulative probability of

genotypic resistance of 51 percent through five years.

-- In year five, 43 percent of lamivudine-refractory patients had

virologic breakthrough with BARACLUDE resistance (n=33).

-- During this resistance monitoring program, 68 of the 187

lamivudine-refractory patients achieved undetectable viral load

(<300 copies/mL) and of these, one patient developed virologic

breakthrough due to BARACLUDE resistance.

Indication and Important Safety Information About BARACLUDE(R) (entecavir) 0.5 mg/1 mg Tablets

BARACLUDE(R) (entecavir) is a prescription medicine used for chronic infection with hepatitis B virus (HBV) in adults where the virus is multiplying and
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SOURCE Bristol-Myers Squibb
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