Telaprevir Launch Could Be Delayed to 2012

[Bill1028]

This sucks!

http://money.cnn.com/news/newsfeeds/articles/apwire/da3e9a9e4c40232cc4c40734b0762a6c.htm

[Andiamo1]

I had a two log drop by week 12 and undetectable by week 24 on SOC.  Is that considered EVR?

[Andiamo1]

I mixed my own conclusions with the Doc's.  Sorry about that.  His conclusion is that SOC fails due to our bodies inability to either deliver the drugs or our cells to process them properly, not due to interferon resistant virons.   He also believes that relapsers stand a better chance with PIs than non - responders.

My observations of people in  the prove trials seem to bear that out.  I am not aware of anybody on triple therapy that was a previous relapser that did not have RVR.  It there are any here, I hope they respond and give us more data.  If there are any non - responders that experienced RVR on triple therapy I hope they comment here as well.

Jim: your effort to relate previous SOC treatment to probability of success with PIs through test results is admirable.  I don't have the information to back that up or negate it.  I think that will be an outcome of the Prove trials.

Eric

[Willy50]

I don't claim to understand to understand it completely.  I think that they are still trying to get a handle on quantifying exactly what it does mean.  I agree Eric, it seems as if many people are simply equating the principle to mean that if you've treated with IFN in the past that you are "resistant" and that is just not so.  

I think that it is also true (so this is me expressing an opinion or what I think I understand) is that even if one were to be a null responder that if one were to treat with a more potent form of treatment (for example with triple therapy TVR or Boceprevir) that one might still overcome the IFN resistant virii.  If one had a group of 100 "null responders" the results might have a spread of results some failing completely, some failing but barely, some succeeding but barely and some succeeding perhaps even with RVR's.

It's all conjecture at this point I think but it will be less in conjecture once we get the results of the Prove 3's.  The results have yet to be posted by Vertex but those that we've seen here on the membership suggest that past treatment failures respond to triple therapy and do so in a manner never seen before (and perhaps not seen in the Boceprevir trials as well).

Getting back to the main topic of the thread I believe that if the Prove 3 results are strong it should have a tendancy to keep the trials moving forward.  A speedy trial and an effective treatment for prior failures should also equate to a raise in stock value.  (obviously the opposite will also impact on stock price)

Willy

[jmjm530]

First sentence should read in part:

"... but that previous null-responders (those without  a two-drop at week 12) will not respond when re-treated with triple therapy?

[jmjm530]

Is your doc then saying that EVRs  on SOC (two log drop by week 12 but still detectible) who relapse will potentially do well on Telaprevir triple therapy

-- but that previous null-responders (<2 log drop at week 12) will not respond when re-treated with triple therapy?

---------------------------
If the latter, I wonder whether they will use the <2 log at week 12, as the cut off for null-response, or how they will fix that point?

Also, I've seen the term "interferon resistant" at times used somewhat synonmously here with "null response" -- but in fact there may be other reasons for null response, for example under-dosing with ribavirin.

If ribavirin underdosing is the reason for null response, then I assume that even this particular subset of null-responders could benefit from triple therapy -- Assuming, of course, that they can be identified,  as opposed to those who are truly interferon resistant.

-- Jim

[Andiamo1]

And thanks for the best wishes!

Eric