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Vertex Pharmaceuticals Incorporated Message Board

  • magkfrog magkfrog Jun 19, 2008 3:39 PM Flag

    do not doubt the need....

    When Mr. Boger says release of Telaprevir NEXT year for those of us that have failed previously makes a difference in lives...well, do not doubt it.

    I am reasonable healthy, 50+ white female with no history of IVDU who learned in 2001 that I had Hep C after seeing THREE doctors for chronic fatigue and upper right quadrant pain. I was lucky in that I found a doctor who finally diagnosed me correctly. Since then, I have tried SOC and failed and have waited patiently for a better drug. A biopsy last year showed the beginning of stage 3 or cirrosis. Along with fatigue and nausea, it's becoming harder for me to eat any serious proteins..meat or eggs or cheese. I have fevers sometimes in the evening that wack out my sleeping and if I work too hard at something, it's guaranteed I will be in bed with muscle aches and pains the next day. It sucks. And all this goes on every day of my life. You can probably imagine my stress level, for someone with Hep C, the knowledge that the disease keeps destroying the liver no matter what I do is very incapacitating.

    So it does matter, this early approval, to my life and about 100,000 more non responders, most of us over 40, a big part of us are veterans and a lot of us running out of time. Pegulated interferon was first used in about 2000, I believe and has been the only NEW drug for eight years now, with absolutely LOUSY side effects and a cure rate of only about 40%. Right now, there is something better and it is Telaprevir. No freakin foolin around.

    So hell yes, the FDA better look over the data and do it damn soon. We all know not one person has died from Telaprevir, but I have taked with folks who can say they are "cured" from it. It's a damn no brainer from where I sit.

    Willow

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    • Hi Willow, Looks like the cure is coming your way and Vertex is doing what they can for early approval. This is good news. You can look for a trial in the fall or wait until next summer but either way you should be able to treat and have good odds at clearing and then healing.Never to early to be thankful for the good fortune that is on the way. Writing the FDA should help. If this was a cancer drug it would already be approved but it will be approved. Good luck.

      • 1 Reply to xhrles
      • xhrles,

        I should never post when I don't feel good or when I am frustrated...I get too dramatic. My personal business should stay personal...still, I agree with you. This is the closest I have felt like there may be some sort of help on the horizon soon.

        I also agree if Telaprevir was a cancer drug, all would be done already. Hence my frustration..and my dramatic post..I'm not sure the folks in charge understand "life with Hep C" and it makes me crazy sometimes.

        You are always so positive...I gotta thank you for that. Hope all is well for you.

        Willow

    • Your need is shared by millions of hep C sufferers. Clearly prior SOC treatment failure patients such as yourself are the highest priority given the likelihood of further advanced liver disease. The FDA would be more motivated to give a third quarter approval to patients such as yourself, given the fact that lives are at stake. Since telaprevir cures a higher percentage of prior SOC treatment failures than retreatment with SOC alone, and has an acceptable side effect profile, it makes sense to organize Hep C patients to contact Hep C advocacy organizations to lobby the FDA and congressional subcomittees with FDA oversight to have the FDA allow an early NDA filing when PROVE 3 final results are available for submission. Tens of thousands of hep C patients are dying each year waiting for a better treatment. No one has died from the effects of telaprevir. The FDA will give expedited consideration in these kinds of situations, and in an election year, politicians and the FDA are likely to be more responsive to lobbying on issues such as this.

    • Magk,
      I pray that you will get treatment long before 2010, hopefully early 2009. In the meantime, have you tried to get into a clinical trial? The link below shows the TVR trials currently recruiting. Don't know if it is of any help, but thought I would pass it on.

      http://clinicaltrials.gov/ct2/show/NCT00627926?term=Telaprevir&recr=Open&type=Intr&fund=2&rank=1

    • Mag, hang in there. It will be here before you know it. Is the hepatitis community going to start a drive to encourage the FDA for a speedy consideration of making it available for non responders. I also wonder if FDA responds to any political pressures.

 
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