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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
Date:4/26/2008

was comparable between the treatment groups through 96 weeks. Three percent of patients receiving BARACLUDE(R) (entecavir) (n=1) and 12 percent of patients receiving adefovir (n=5) experienced a serious adverse event. No deaths were observed in either treatment group. The most common adverse events occurring in greater than 10 percent of patients in either treatment group were headache, nasopharyngitis, upper respiratory tract infection, influenza, pyrexia, urinary tract infection, cough, back pain, and diarrhea.

Data Results

By week 96, 22 of the 69 enrolled patients had discontinued the study. Of these, two patients receiving adefovir discontinued due to investigator-determined lack of treatment efficacy between the beginning of year two dosing and the 96-week analysis. The 96-week data reported below represent the results of the 49 patients who entered year two dosing (29 BARACLUDE-treated patients and 20 adefovir-treated patients), using the non-completer = failure (NC=F) method of analysis.

Week 96

-- BARACLUDE-treated patients achieved a mean change in viral load of

-7.82 log(10) copies/mL from baseline, and adefovir-treated patients

achieved a mean change of -5.96 log(10) copies/mL.

-- 79 percent (n=23/29) of BARACLUDE-treated patients and 50 percent

(n=10/20) of adefovir-treated patients had undetectable viral load (HBV

DNA less than 300 copies/mL, measured by the polymerase chain reaction

or PCR assay).

-- No BARACLUDE-treated patient (n=0/29) and 35 percent (n=7/20) of

adefovir-treated patients had viral load greater than or equal to 10^5

copies/mL.

-- 97 percent (n=28/29) of BARACLUDE patients achieved ALT normalization

(ALT of less than or equal one time the upper limit of normal) compared

with 85 percent (n=17/20) of adefovir-treated patients.

-- 24 percent (n=7/29) BARACLUDE-treated patients achieved HBe

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SOURCE Bristol-Myers Squibb Company
Copyright©2008 PR Newswire.
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