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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

DE (n=1) and 12 percent of

patients receiving adefovir (n=5) experienced a serious adverse event.

-- No deaths were observed in either treatment group.

-- No patients in the BARACLUDE arm and one patient in the adefovir arm

experienced an ALT flare (defined as ALT greater than two times

baseline and greater than 10 times the upper limit of normal).

About the Study

The E.A.R.L.Y. study (ETV-079) is a randomized, open-label, comparative viral kinetics study of antiviral-naive chronic HBeAg-positive patients evaluating antiviral activity as measured by mean reduction in viral load, or levels of hepatitis B virus (HBV DNA) in the blood. HBeAg or e-antigen, is a viral protein associated with hepatitis B infections, and is found in the blood only when there is virus present.

The primary endpoint for the study was mean reduction in HBV DNA levels at week 12. The secondary endpoints included the mean change in viral load from baseline through week 96, the proportion of patients in each treatment group who achieved ALT normalization, HBeAg loss and HBe seroconversion, and safety.

Sixty-nine patients were randomized in the study and of these, 65 completed the first 12 weeks. Patients in this study received either 0.5 mg of BARACLUDE(R) (entecavir) once daily (n=33) or 10 mg of adefovir once daily (n=32) for a minimum of 52 weeks. Patients in the BARACLUDE treatment group had a mean baseline viral load of 10.26 log(10) copies/mL. Patients in the adefovir treatment group had a mean baseline viral load of 9.88 log(10) copies/mL.

According to study protocol, patients who achieved a treatment response at 52 weeks discontinued treatment and entered a follow-up monitoring phase. Three BARACLUDE-treated patients and four adefovir-treated patients met this criterion and entered the follow-up monitoring phase lasting up to 48 weeks. Patients who did not achieve a treatment response at 52 weeks continued on study
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SOURCE Bristol-Myers Squibb Company
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