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Thursday, July 27, 2006 6:16:03 PM
I think the only thing we have to go with is that the single dose study worked better in humans than animals. They expected no significant change in viral titers based on animal studies and got a .8 log reduction (one person had a 1.5 log reduction). Not sure BOTs 70/30 effectiveness thinking is correct but it was made clear its working better in humans than animals.
It might be apples and oranges but half the pigs made a complete recovery from a different but deadly virus (greater than 4 log?) on multi-dosing versus presumably very small (and not enough) progress on single dosing.
I'm not aware of any other Hepc drug giving Bavi's effectiveness after only one dose. The closest is probably Vtrx which claims 2 log reduction at highest dose within only three days of mult-dosing in its 1b study. But I'd guess a rebound of virus if VRTX bothered to checked later on after such a short dosing. They published that virus levels went back up on lower dose levels.
Indenix had an average 1.1 log reduction for its phase I/II (daily dosing -15 days- on naive and nonresponders-87%).
I could go on but the 1a results on non-responders was great and has my hopes up for multi-dosing.
My personal feeling is that Wall Street may yawn at a 2 log reduction at the highest dose levels but that would certainly keep PPHM in the HCV game. But well above 2 and especially 3 and 4 for a portion of the trial and the excitement will get very loud.
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