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BARACLUDE(R) (Entecavir) Treatment Resulted In Greater Viral Load Suppression Compared to Adefovir at 96 Weeks In Antiviral-Naive Adult Chronic Hepatitis B E-Antigen Positive Patients

eroconversion compared with 25 percent (n=5/20) adefovir-treated


-- 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

of efficacy.

- 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
Copyright©2008 PR Newswire.
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