iwfal, I couldn't go to sleep so I've been preparing a response to your post, which I'll hopefully have for you tomorrow.
In the meantime, I thought you might find this interesting- and a little bit humorous, keeping in mind that Vertex conducted this study too......
Principal results of the Phase Ib clinical trial are as follows:
· VX-950 was well-tolerated across all three dose groups with no serious adverse events reported, and no treatment discontinuations.
· Treatment with VX-950 also resulted in significant reductions in plasma HCV-RNA. Within three days of treatment, the median reduction in HCV-RNA was greater than 3 log10 in all three VX-950 dose groups.
· In the dose group receiving 750 mg of VX-950 every 8 hours, there was a further reduction in viral levels between days 3 and 14 of treatment, with mean and median HCV-RNA reductions of greater than 4 log10 at day 14.
· Trough plasma concentrations of VX-950 were highest in the 750 mg every 8 hour dose group. In the 450 mg q8h and 1250 mg q12h dose groups, maximal effects were seen between days 3 and 7 of treatment.
· Subsequently, there was an increase of approximately 1 log10 in median HCV-RNA between days 7 and 14 evident in both groups. http://www.hivandhepatitis.com/hep_c/news/2005/aa/051105feat.html =================== And something of historical significance if nothing else....
Whether hepatitis C virus will develop resistance to VX-950 or other protease inhibitors isn't known. Schiff notes that unlike HIV, the hepatitis virus doesn't hide inside cells where drugs can't reach it. So if the drug keeps viral levels low, there's a good chance the virus won't become resistant. It's even possible, Schiff says, that hepatitis C protease inhibitors will work all by themselves, without the need for combination therapy. http://www.hepcassoc.org/news/article106.html