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Baraclude (Entecavir) Treatment Demonstrated Greater Viral Load,Reduction Compared to Adefovir at 48 Weeks in Study of,Antiviral-Naive Chronic Hepatitis B E-Antigen Positive Patients

ctions, 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. Viral load reduction was also measured at weeks 24 and 48 of the follow-up. Patients received 0.5 mg of BARACLUDE(R) (entecavir) once daily (n=33) or 10 mg of adefovir once daily (n=32).

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. Data Results

Week 48

* BARACLUDE-treated patients achieved a mean change in viral load of -7.28
log(10) copies/mL, and adefovir-treated patients achieved a mean change
of -5.08 log(10) copies/mL (95 percent Confidence Interval -2.69, -1.03)

* 58 percent of BARACLUDE-treated patients and 19 percent of adefovir-
treated patients had undetectable viral load (HBV DNA <300 copies/mL,
measured by a common assay -- polymerase chain reaction, or PCR)

Week 24

* BARACLUDE-treated patients achieved a mean change in viral load of -6.97
log(10) copies/mL, and adefovir-treated patients achieved a mean change
of -4.84 log(10) copies/mL (95 percent Confidence Interval -2.51, -1.20)

* 45 percent of BARACLUDE-treated patients and 13 percent of adefovir-
treated patients had undetectable viral load (HBV DNA <300 copies/mL)

Week 12

* BARACLUDE-treated patients achieved a mean change in viral load of -6.23
log(10) copies/mL, and adefovir-treated patients achieved a mean change
of -4.42 log(10) copies/mL (p < 0.0001)

* 12 percent of BARACLUDE(R) (entecavir)-treated patients and 9 percent of
adefovir-treated patients had undetectable viral load (HBV DNA <300
copies/mL)

Adverse events in study ETV-079:

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