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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@rocketmail.com 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.

      Reference:

      NCT01343888
      NCT01297270
      NCT01399619
      NCT01330316
      NCT01358864

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

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

      Regards

      ~ 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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