Viral load reduction in chronic hepatitis B patients treated with BARACLUDE(R) (entecavir) in nucleoside-naive and lamivudine-refractory studies was also evaluated.
Results from these studies prior to this year five analysis were
previously announced on April 14, 2007.
-- 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
-- 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).
-- 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
|SOURCE Bristol-Myers Squibb|
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