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Ninety-one Percent of BARACLUDE(R) (entecavir) Treated Patients in a Four-Year Cohort Demonstrated Virologic Suppression to Undetectable Levels
Date:11/2/2007

nical program. Patients with HBV DNA levels of greater than or equal to 300 copies/mL at weeks 48, 96, 144, 192, or at the end of dosing were genotyped and a phenotype was determined for all novel emerging substitutions. All patients experiencing a virologic breakthrough (greater than or equal to 1 log(10) increase from nadir) were phenotyped even if they did not have emerging substitutions.

Study Results

-- At week 192 of BARACLUDE(R) (entecavir) treatment, 91 percent

(n=98/108) of nucleoside-naive chronic HBeAg-positive patients in this

cohort achieved undetectable viral load (HBV DNA <300 copies/mL) and 86

percent (n=96/112) of patients achieved ALT normalization (ALT less

than or equal to 1 times the upper limit of normal).

-- During years three and four, an additional 41 percent (n=39/96) of

patients lost HBeAg and 16 percent (n=15/96) of patients achieved HBeAg

seroconversion.

-- Resistance monitoring in this cohort identified one patient with

genotypic resistance to BARACLUDE who later experienced virologic

breakthrough.

-- Safety events were consistent with previous experience. Additional

cumulative safety results of patients reported in this four-year

cohort:

-- Ninety percent of patients had any adverse event.

-- Grade 3-4 adverse events were reported in 13 percent of

patients.

-- There were no discontinuations due to adverse events in this

cohort.

-- Less than one percent of patients experienced on-treatment ALT

flares during the fourth year.

About BARACLUDE(R) (entecavir)

Discovered at Bristol-Myers Squibb, BARACLUDE is a nucleoside analogue indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication with either evidence of persistent elevations in serum aminotransferas
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SOURCE Bristol-Myers Squibb Company
Copyright©2007 PR Newswire.
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