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Vertex Pharmaceuticals Incorporated Message Board

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  • swhitemd50 swhitemd50 Dec 6, 2011 3:05 PM Flag

    If you are right

    I agree the FDA may approve Pharmasset's oral regimen for patients intolerant of interferon, regarless of genotype. The problem will be getting the docs who prescribe these meds to favor an expensive oral regimen with a lower cure rate over Incivek/interferon/RBV. There is a lot of talk about an oral HCV regimen being the "Holy Grail" of HCV treatment but what really matters is if you can cure the patient.

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    • you are right about the doctors,but if it will cure the 2&3s they will get the oral.Its a big market I just wish Vertex would let us know how are oral combo is comming along.As far as the FDA I dont have anything good to say about them.To let a company NOT be compared to the SOC or better yet not call Vertex the new SOC is obscure.

      • 1 Reply to mbr041076
      • "...but if it will cure the 2&3s they will get the oral.Its a big market..."

        True, but not as big a market as for geno 1 which is 70-75% of the total HCV.

        "The Centers for Disease
        Control and Prevention (CDC) conservatively estimates
        that approximately 4.1 million Americans have been infected
        with hepatitis C, which accounts for approximately 1.8% of
        the total U.S. population. Of these, the CDC estimates that
        3.2 million are chronically infected...........

        In the United States, genotype 1 accounts for approximately
        70-75% of all HCV infections, followed by genotypes 2
        and 3, which together account for approximately 30% of
        infections."

        http://www.hcvadvocate.org/hepatitis/factsheets_pdf/African_Americans_09.pdf

    • The other issue is how one defines interferon intolerence.

      It seems to me the the FDA will define it as those who have already taken it for a minimum number of weeks and decided to discontinue treatment because they showed intolerable side effects as verified by the doctor who treated them. If that is the FDA criteria, only a small percentage of patients fall into that category, e.g. those who dropped out before they completed their previous regimen. I say a small % because if you peruse through most of these HCV trials you will find out the drop out rates are not really that large--mostly into the teen percents.

      • 2 Replies to gladpick
      • And this brings up another conundrum for Pharmasset. I have yet to figure out how a trial can be run that includes only patients who are “interferon intolerant” (however that is defined) and also include only treatment naïve patients. It must be one or the other. So far, their PII results relate only to the study of treatment naïve patients, the same pool of patients who are best treated by all combination therapies. A trial protocol that no longer includes only treatment naïve patients just adds one more degree of unpredictability to the translation of PII results to those results expected from a PIII study.

        When searching PubMed using the terms <<pegylated interferon intolerant>> only 15 references are found. See http://www.ncbi.nlm.nih.gov/pubmed?term=pegylated%20interferon%20intolerant&itool=QuerySuggestion

        As seen in the most recent reference, intolerance may be due to the pegylation part and not to the recombinant IFN part. Further, since the two are usually administered together, how does one differentiate interferon intolerance from ribavirin intolerance?

      • good point gladpick;if VRUS is hand picking those who after 12 weeks or should I say before 12 weeks drop out,it seems to me that the % would even be lower than the teens.I for one have been on interferon and 12 weeks is nothing,really I mean NOTHING!So unless VRUS oral works real good on GT1 we will still controll the market.

 
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