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Replies to #36506 on Biotech Values
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dewophile

10/30/06 11:07 AM

#36524 RE: DewDiligence #36506

baraclude vs tyzeka:

I find it curious that werber feels baraclude is a best in class. Someone ought to challenge him on the basis of this statement. Firstly, it is risky comparing outcomes when the drugs have not been studied head to head, as variables between study populations can differ greatly. secondly, the results outright do not support an efficacy advantage of baraclude if you look real hard at the data.
In HBV e neg patients (the largest patient population):

baraclude: 90% undetectable post-therapy
tyzeka 82% undetectable

but dig jsut a little deeper and you find the lamivudine positive control response in the baraclude population with 72% undetectable rate compared with 57% undetectable rate in tyzeka study. and similar differences are noted in hepb e-positive population

So one doesn;t have to be a rocket scientist to realize that the populations are NOT equal based on response to lamivudine, that idenix population had worse overall prognosis (higher VL, mroe aggresive HBV strain, who knows), and in fact the discrepancy or added advantage of tyzeka over lamivudine was greater than baraclude over lamivudine (82% vs 57% for tyzeka and 90% vs 72% for baraclude)!

so again this highlights the pitfalls of comparing response rates in 2 seperate populations, and I would welcome a head to head study (which i humbly disagree may very well be done in the future, albeit without pharmaceutical support (it would not be onerous to set up a multicenter comparison with a modicum of funding)).