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faxorama

08/03/06 8:11 PM

#7769 RE: technicalwin #7766

TW, My opinion on the 6mg is strong but on multi-dosing my consideration that efficacy may only be somewhat better (2 logish) is just a glass half empty hypothesis (I'm hoping for better from some of the patients). That said I think the guinea pigs may have had some minor viral reduction at single dose but not enough to survive a lethal virus. It took multi-dosing to get the immune system to really kick in and get the sustained response necessary to survive. 50% lived but 50% died. I am just considering the possiblitiy that due to this version of Bavi working better in humans than guinea pigs that a large chunk of the necessary/capable sustained immune response is occuring in the single dose and that multi-dosing may not dramatically increase efficacy. It may not be as necessary as in the animal model. The immune system has been alerted to HCV...it got the message and multi-dosing may not have an overly dramatic effect in reinforcing that message. HCV is very difficult to eradicate,especially with a single drug, but getting easier to control. Keeping in mind that 50% of the rodents died in the lassa fever study its likely combo therapy will be required for eradication of HCV.

On the other hand I may be very wrong. In addition to Thorpe's animal studies results of other HCV drugs typically required multi-dosing to get meaningful efficacy.

FWIW I think Bavi already has the makings of an HVC market niche just based on its 1a results. As many here have mentioned treating co-infected non-responders would seem ideal even at efficacy already shown. However, Wall Street is fixated on VRTX and its 4+ log reduction -- even better and likely sustained when in combo.