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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