"Listening to the VRUS conference Q&A, it is apparent what their game plan is regarding the treatment of genotype 1 HCV. My guess is that their all-oral PSI-7977/ribavirin cure rate will be very inferior to Incivek/peg-interferon/ribavirin but they will say that it is a superior regimen because most patients cannot/will not tolerate interferon.
From the conference Q&A:
"...88% of veterans who have HCV infection have not been treated. And again, a majority of those are because they are ineligible for interferon therapy." -- M. Michelle Berrey
"With respect to the competitiveness clearly an interferon free regimen, any SVR is actually a significant improvement." -- PATRICK T. HIGGINS
This is the first time I have heard that most patients are "ineligible" for interferon therapy. I think it's B.S., especially with Incivek's shortened treatment durations for many patients." ----------------------------- Swhitemd,
Outright inaccurate and false statement like the above indicates the mindset of management at VRUS.
It reminds me of SGP's hyping of Boceprevir (vitrelis) way back. They were massaging the data with all sort of tricks to make their data look better than Incivek. In fact there was an internet site citing and making fun of their shenanigans.
Of course such deception on SGP management's part worked well for their sharholders because they coned MRK to pay a hefty price to buy the company only to find that their prize drug, Victrelis, was not such a prize after all
>>They should treat null nonresponders and cirrhotic patients in double-blinded trials. <<
I don't see Vertex testing nulls with it's VX222 regimen. Though I think they both should as that would show the biggest differentiation between treatments.
As to VRUS, I think they will, they just haven't treated enough in phase II to decide what course to take. Note that the third phase III that treats G1 will take till mid 2012. They are obviously waiting for more data, More safety testing too.
Another thing you people need to be concerned about is how quick these trials are. They are using SVR12 now instead of SVR24. None of these treatments will take more than 6 months plus SVR12.
Vertex trials were 12 months plus SVR24. 18 months versus 9 now.
"How does the tough FDA allow phase 3 trials without seeing complete phase 2 data?"
Are you suggesting they are not providing the FDA with phase 2 data from the control group?
I've heard your argument on this before. The level efficacy demonstrated up to this point makes control group data hardly an issue. By the way VRUS has been running double-blind studies up till this point in time.