Wha'ts the take of our regular contributors on todays press release by Gilead on ION 1? Any comments from knowledgeable board regulars like Third, Dr. White, or Rojospan?
FWIW, my impression is that the SVR 4 rates may be unimpressive e.g. in the 60-70% range, with the final SVR 24 numbers to be even lower as a ceratin percentage of those achieving SVR4 will likely relapse over the next 20 weeks. Prior press releases of interim results using 7977 trumpeted 90+% SVR 4 rates in Phase 2 trials. Those were small patient populations, and created much of the hype around 7977 that prompted Gilead's acquisiton of Pharmasett for $11 billion. Yet in this press relase, the SVR rate is only disclosed as meeting the minimum requirement of 60% or better to allow continued enrollment of the study. Not exactly inspiring, given the Phase two SVR 4 and 12 24 rate of 90 to 100% reported in Abbot's IFN free quad regimen, and Vertex's IFN/RBV TVR VX 222 regimen. The final data will speak the true effiacy of all these clinical trials, but the goal of SVR 24 is still what patients ultimately will need to be cured, and a less efficacious regiemn will not elimnate the use of more effective regimens even if they require a larger number of medications, (and in the harder to treat subpopulations, may still require IFN/and or RBV). This race to the ideal treatment regimen for the various subpopulations of hep C remains up in the air until many more clinical trials have been completed.
I don't know that I would extrapolate that assertion from the statements that were made.
The market is clear in it's consensus that PS-7997 is the market lead for HCV at the moment. Without solid data from VRTX on VX-135, any failures by any other companies won't move the Vertex needle. My opinion.
Vertex is a CF story for the time being. This is the year that will make or break Vertex in that regard.
Monetary interests aside, for the sake of the children, I hope they are successful.
there is not enough data to make any conclusion, the trial will continue because "the observed SVR4 rates exceeding the predefined threshold of 60 percent and the absence of significant safety issues. Enrollment of the remaining 600 patients in ION-1 is now underway."
Pappa and Johnf50. Thanks for your thoughtful replies. I agree that there is not enough data revealed to make any conclusion so far, and that 7977 is certainly still the street's consenus for the next big success in treating hep C. But the fact that Gilead did not reveal just how high the SVR 4 rates actually were in ION 1 to date suggests to me a less than expected efficacy (compared to prior interim data releases during Phase 2 testing of 7977 that specified very high SVR 4 rates exceeding those of telaprevir and boceprevir in comibnination with IFN/RBV). Of course, time will tell when the completed study results are revealed.