re : IDIX pre-AASLD and 3Q06 CC notes
Just a few random nuggets of info I picked up from the presentation :
One of the slides had a footnote stating that 90% of antiviral nukes with successful P1/P2 trials have eventually received FDA approval. Also they said that resistance to non-nukes develops more rapidly than resistance to nukes , something I hadn't thought about but which makes sense. These two characteristics probably explain , at least partially , IDIX' choice(s) in antiviral drug candidates.
You mentioned the probable underestimation of the HCV-infected population. Another slide showed how only 10 out of 100 patients diagnosed with HCV receives treatment. More patient-friendly and effective treatments will thus expand the market greatly by bringing in more patients from both diagnosed and undiagnosed populations.
The NM-283 results so far ( in combo with pegifn ) in tx.-naive gen1 patients resulted in 68% undetected at 24 wks. , which they said compares favorably to the ~53% rate with SOC ( pegifn plus riba ). SOC results in SVR rates of ~42-46 % , but when making projections , keep in mind that SOC figures are almost universally based on assay cutoffs of 50 IU ( or higher , in older studies ), while the IDIX results are at a cutoff of 20 IU , and are thus more robust. VRTX showed at DDW that results are very different at cutoffs of 30 vs. 10 IU/ml , though I haven't seen any comparisons of 20 vs. 10. VRTX uses 10 IU cutoffs in their studies , which is why I believe that the 6 out of 7 VX950-treated patients who are still HCV-negative after stopping therapy ( 5 are 12 wks. out , 1 is 6 wks. out ) will likely achieve SVR.
Dr. Dieterich said that he thought the recently-reported in-vitro ( replicon system ) results showing a negative interaction between riba and NM-283 would not carry over into in-vivo studies. I'd be more inclined to trust him on this if not for some of the other questionable statements he made.
Those who don't want to listen to the 2 hour webcast could simply do a quick review of the slides , which contain the bulk of the contents of the presentation. They did a nice job.