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Baraclude (entecavir) Therapy Resulted in Undetectable Levels of,Hepatitis B Virus in Cohort of Patients Who Re-Started Treatment

nts who discontinued study therapy in ETV-027, and subsequently restarted treatment in rollover study ETV-901, with a greater than 60 day gap between end of treatment in study ETV-027 and start of treatment in study ETV-901.

    -- ETV-027 compared 0.5 mg of BARACLUDE vs. 100 mg of lamivudine in
nucleoside-naive chronic HBeAg-negative chronic hepatitis B patients.
-- Rollover study ETV-901 was established as an open-label, follow-up
protocol for patients in phase II and III studies of BARACLUDE.
-- Due to ongoing blinding of study ETV-027, most patients retreated in
ETV-901 initially received a combination of 1 mg of BARACLUDE plus 100
mg of lamivudine, and were subsequently switched to 1 mg of BARACLUDE
monotherapy.

The analysis cohort was defined regardless of treatment response at the end of dosing in study ETV-027, and independent of virologic or ALT measurements at the start of dosing in study ETV-901. During off-treatment follow-up, the majority of patients had recurrent levels of hepatitis B virus in the blood (viremia) and increases in ALT.

    Data Results
At the end of dosing for study ETV-027:
-- 94 percent (n=93/99) of the re-treatment cohort had undetectable viral
load
-- 78 percent (n=77/99) had ALT normalization
At entry into ETV-901:
-- Four percent (n=4/99) of patients had undetectable viral load
-- Eight percent (n=8/97) of patients had ALT normalization
Following re-treatment in study ETV-901:
-- 93 percent (n=82/88) of patients had undetectable viral load (HBV DNA
<300 copies/mL) by week 48 of re-treatment with BARACLUDE
-- 83 percent (n=79/95) of patients had ALT normalization (ALT less than
or equal to 1 times the upper limit of normal) by week 48 of re-
treatment BARACLUDE
Adverse events in study ETV-027/901 re-treatment cohort:
-- 67 percent (n=66/99) of patients experienced an adverse event. The most
common adverse events occurring in greater than ten percent of patients
were abdominal pain, fa
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