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Re: DewDiligence post# 2582

Sunday, 11/02/2008 9:42:19 PM

Sunday, November 02, 2008 9:42:19 PM

Post# of 3757
Long Term Baraclude--the curmudgeon responds

The data in this study are promising, but I don't extrapolate this to a case for long term Baraclude treatment for asymptomatic pt's with previously succesful treatment.

From the PR:
The long-term histology cohort included 57 nucleoside-naive patients who received a minimum of 3 years of cumulative therapy with BARACLUDE from the start of studies ETV-022 or -0271,2 (BARACLUDE 0.5 mg) to the time of their last observed biopsy in ETV-901 (BARACLUDE 1 mg), and had adequate baseline and long-term liver biopsies. These patients were treated with BARACLUDE for a median of six years.

While cleaner liver histology after long term Baraclude sounds impressive, these are not your ordinary patients. These are patients who even after going thru a course of treatment and showing undetectable viral load, agreed to 3-6 years of Baraclude (open label) and multiple liver biopsies. These are highly motivated and, I suspect, more educated, affluent and nourished than your average hepatitis patients. So, I don't really believe that these data would extrapolate to a more general clinic population. Nor do I expect the study findings would be as impressive in a controlled, non-open label setting.