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Vertex Pharmaceuticals Incorporated Message Board

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  • thirdmeinvestor thirdmeinvestor Oct 29, 2011 12:29 PM Flag

    Conference call

    This statement by a low key person is highly significant. He commented again on the subject of this all-oral-triple in the Q&A session adding <don't forget (the fact)>. Without the safety-caused dropouts and viral breakthroughs I expect a gain of about 10% in the SVR rate (that is about the rate of discontinuation in IFN based triple).
    The probability of SVR for the two arms could reach the 80% range. But the most important gain in the all-oral DAA is that one does not have to deal with the compounded side effects the interferon brings in with the current triple. Patients suffer less with higher SVR rates. A truly amazing era is unfolding.

    If the SVR rate from this all-oral combo is in the 80s, Vertex could add additional all-oral arms to the CONCISE study to accelerate the all-oral program. I think that even without Interferon a patient with the CC allele of IL28B will have a higher SVR rate. Then, we could see all-oral combo in 2014 ahead of anyone else.

    I should add here that BI's all-oral PI+non-nuc-RBV combo had considerable breakthrough rates as reported by an AASLD abstract.

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    • johnf50 Oct 29, 2011 1:43 PM Flag

      Third - I really appreciate your background here.

      I was thinking that as well, while I am well read, I do not have the background in medicine to put it together as well as you do.

      That said... regarding the BI issue... the furthest dated clinical trial I have found for them places completion December of 2016.



      Assuming the trial is completed, this places earliest market approval in early 2017.

      Do you agree with this thesis? If not, why?


      ~ J.

      • 1 Reply to johnf50
      • I think that both Tibotec/Medivir's PI and BI's PI will be approved by the FDA in 2014. But they won't be sold very much because all-oral drug combos just as effective will be out by 2015. Patients would delay their treatment until an all-oral drug comes out. This is why it is of utmost importance for Vertex to develop the combo Incivek/222/RBV by 2015.

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