I did see in the VRUS trial info the statement "Stratified by IL28B and baseline HCV RNA", but I didnt quite understand how that was applied. I didnt see another reference to just how that was applied in the trial patient selection. I didn't see info comparing the various common predictors, just the statement that it basically didn't matter. I'm questioning this because I've come to realize that in reading trial results sometimes what is NOT said can mean quite a bit. As far as I can tell the trials could have selectively been with the easier to treat patients with low viral loads, European decent and with other high predictors of SVR. I've seen drug companies do much worse that just leave out significant data. I try to work under the theme of "Trust your fellow man, but cut the cards"
The FDA will look very closely at viral load data. I've heard posters on this MB complain how VRUS picks the easy to treat patients but wouldn't that be self-defeating under FDA analysis?
PSI-7977 has shown high levels of efficacy (during mid-stage testing) in all patients regardless of their IL28B status. The late-stage design intends to demonstrate to the FDA that interferon usage and stratification of patients for IL28B status is a thing of the past.
As I said before, what is left out of the data presented can sometimes speak volumes. People on this board have also witnessed Schering-Plough release information on trial results where there were patients missing in the final data, resulting in higher SVR data. They also fudged on the description of what a "null responder" was, leaving out the part of that group that is hardest to treat, also resulting in higher SVR claims in the data. I'm not saying that VRUS has been playing such a game, what I'm saying is that before I assume that everything adds up correctly, I want to see the numbers. I appreciate the info that you post, but I see a lot of it is assumption. If data backing up these claims is being released before the end of the year then it looks like I'll have to wait until then. I just want to see the data before I accept it. The info I'm looking for is not something unusual, and I'm a little suspect since it was not included in the VRVS release.
"PSI-7977 has shown high levels of efficacy (during mid-stage testing) in all patients regardless of their IL28B status." -------------------- They have data for genotype 2&3 that are very easy to treat--high SVR even with the old SOC regimen.
Do they have any results for their all oral regimen for Genotype 1 that inclues all 3 allels?