-- Six BARACLUDE(R) (entecavir)-treated patients and 16 adefovir-treated
patients discontinued therapy prior to week 96.
- No BARACLUDE-treated patients and one adefovir-treated patient
discontinued due to adverse events.
- No BARACLUDE-treated patients and six adefovir-treated patients
discontinued due to investigator-determined treatment failure or lack
- Three BARACLUDE-treated patients and four adefovir-treated patients
met the treatment response criteria at 52 weeks and entered a 24- or
48-week off-treatment follow-up monitoring phase.
- Two BARACLUDE-treated patients and one adefovir-treated patient were
lost to follow-up, one BARACLUDE-treated patient was non-compliant,
two adefovir-treated patients withdrew consent, one adefovir-treated
patient became pregnant, and one adefovir-randomized patient was
treated with BARACLUDE.
Week 12 (primary endpoint)
-- BARACLUDE-treated patients achieved a mean change in viral load of
-6.23 log(10) copies/mL from baseline, compared to adefovir-treated
patients who achieved a mean change of -4.42 log(10) copies/mL
(p < 0.0001).
-- 12 percent of BARACLUDE-treated patients and 9 percent of
adefovir-treated patients had undetectable viral load (HBV DNA <300
Additional Cumulative Safety Results of the E.A.R.L.Y. Study at 96 Weeks
-- 83 percent of patients in the BARACLUDE arm (n=30) and 82 percent of
patients in the adefovir arm (n=27) experienced any adverse event.
-- Eight percent of patients receiving BARACLUDE (n=3) and 15 percent of
patients receiving adefovir (n=5) experienced any Grade 3-4 adverse
-- Three percent of patients receiving BARACLU
|SOURCE Bristol-Myers Squibb Company|
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