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SciClone Pharmaceuticals, Inc. Message Board

  • lov2invest lov2invest Dec 5, 2002 1:28 AM Flag

    Story from HCV Patient

    Here's an interesting read from someone with HCV who talks about Zadaxin.
    ---------------------------------------------

    Beyond Hope: A Journey of Faith, by Miles Keatopn Andrew

    Let's begin at the beginning. My hepatitis C profile: Male, genotype 1a,
    over 45, probably infected for more than 30 years, former non-responder to
    Rebetron therapy, bridging stage: III - IV (early cirrhosis, extensive
    fibrosis). Besides the damage to my liver, I'm experiencing what is
    becoming known as the HCV syndrome: Diabetes (insulin dependent),
    hypertension, chronic fatigue, arthritic-type symptoms, co-infected with
    cytomegalovirus and Epstein-Barr virus. There's a good chance I'm also
    developing glaucoma. That's the bad news.

    Here's the good news: I'm one of few Americans getting to try out the
    latest drugs: Pegasys, Ribavirin, and Zadaxin. My insurance pays for the
    peg-riba combination. Zadaxin comes out of my own pocket - about $15,000
    for a year of treatment. Zadaxin is an immune system enhancer. It's
    available in 36 countries now. It won't be FDA approved for HCV in the USA
    until late 2003 - early 2004. I can't wait that long. Without scientific
    detail, let me just say that as far as viral clearance is concerned, the
    Sustained Virological Response (SVR) of pegylated interferon + Zadaxin is
    about the same as peg + ribavirin. In other words, I'm adding significantly
    to my chances of survival. Early results of this triple-combination
    therapy, used only with former non-responders with or without cirrhosis is
    approximately 78%. However, given my profile, triple therapy gives me a
    50/50 chance. This is where the faith part comes in. I wonder if I should
    be celebrating life or picking out my casket. I mean, when you're on
    protocol, you're pretty sure you're going to die anyway. That's how awful
    the treatment is.

    cont...

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    • cont..

      I chose Pegasys instead of Peg-Intron because the Pegasys molecule is
      heavier - 40kd, almost twice as heavy as the Peg-Intron molecule. Another
      possible advantage of Pegasys is that it metabolizes in the liver itself.
      Peg-Intron metabolizes in the kidneys. Like Peg-Intron, Pegasys is
      administered once a week. However, I have read some news briefs suggesting
      that the Peg-Intron injection doesn't last a full week. The heavier
      molecule of Pegasys gives me that extra edge I may need.

      I'm going to try to add to this page as often as possible throughout the
      course of my treatment. The first 12 weeks are critical, as Early
      Virological Response (EVR) is a known predictor of SVR. If my viral load
      has decreased after 12 weeks, there's a good chance I'll clear the virus
      within a year. If I'm HCV-free after 6 months of therapy, most sources will
      tell you that I'm as cured as you can possibly be. Unless I relapse, of
      course.

      I'm keeping this journal online for 2 reasons: 1; So that those of you
      infected with HCV can follow my progress on these new drugs - an experiment
      of sorts. 2; I'm already familiar with the psychiatric effects of
      Interferon + Ribavirin - actually, I should make that psychotic effects.
      Anybody who's been on ribavirin knows what I'm talking about. During my
      first round of Rebetron therapy, I remember the lies: Expect mild to
      moderate flu-like symptoms. Well, that's what I was expecting. After my
      first shot, I remembered how many people have died from the flu. I thought
      I was going to be one of them - got the chills so bad I thought I'd break a
      bone. They didn't even bother to tell me what happens when you take
      ribavirin. This is one evil drug, man. Several months after I completed
      therapy, Roche admitted that ribavirin causes "psychiatric event" in people
      who have never experienced "psychiatric event." What is psychiatric event?
      It's what Charles Whitman did from the tower in Austin, Texas. So I'm
      getting prepa
      red. My antidepressant is Wellbutrin. I'm already on 3Mg. per day of Xanax,
      so my shrink is going to have to come up with elephant tranquilzer to calm
      me down on ribavirin. Anyway, it will be my priviledge as a writer to share
      with you my psychiatric events. Hell, we can trade stories.

      I'll be starting protocol soon. I'd love your prayers. You have mine in
      return.

      Today I ordered Pegasys and Ribavirin. They will arrive tomorrow. I prefer
      not to start them until I visit my psychiatrist next week. Meanwhile, I'm
      getting ready. I'm re-learning how to drink a gallon of water every day. I
      hate water. I prefer coffee, but I can't drink it while I'm on ribavirin -
      it's like overdosing on Ritalin. I'm going to buy an electric blanket and a
      space heater. Oh yeah, and a case of Ensure. Eating is the toughest part
      for me. Everything tastes like coins in my mouth. Still, the thing I'm
      dreading the most is the morning after my first shot.
      So the really crazy thing is that I wrote this novel about death - a comedy
      that takes place in a funeral home. I used to be an undertaker, and I wrote
      a comedy about death, not knowing that I was carrying a potentially fatal
      disease. I wrote an article about that. It's short, and you can read it by
      clicking here.

      cont...

      • 1 Reply to lov2invest
      • cont.....

        About Zadaxin
        Okay, here's what I know about the mechanism of Zadaxin. It's classified as
        an immune system enhancer (ISE). HCV is an elusive bug. It survives by
        tricking the immune system - it calls for a response from the T-Helper
        cells, Th2. Unfortunately, Th2 will not kill the virus. Meanwhile, the Th1
        cells are just sitting there doing nothing, because they think Th2 has got
        the situation under control, and it's the Th1 cells that enable the immune
        system to kill the virus. The problem with interferon has always been it's
        tendency to cancel itself out. Interferon does stimulate the production of
        Th1 cells, but it also stimulates Th2, and usually fails to shift the
        immune system into a Th1 response. Zadaxin not only stimulates Th1, it
        suppresses Th2, and discloses the location of the virus to Interferon and
        Ribavirin. Every recorded case of spontaneous recovery from HCV has shown a
        definite "Th1 shift" in the immune system. Zadaxin alone cannot cure HCV.
        The drug is an adjuvant - it opens a door in the immune system. Since 1999,
        I've followed the progress of adjunctive therapy from Milk Thistle to
        Amantadine. Zadaxin made it into 36 countries for HCV, HBV, malignant
        melanoma, and has been declared an orphan drug by the FDA for the treatment
        of hepatocellular carcinoma. Zadaxin has no side effects, except in those
        persons with autoimmune problems such as lupus and transplant recipents, in
        which case the immune system must be suppressed. Now the numbers: I've seen
        them as high as 78% overall with Zadaxin + Peg-Intron and ribavirin, all in
        studies with previous non-responders with a high viral load, genotype 1a,
        with or without cirrhosis. However, it's probably closer to a 50/50 chance
        with the heavier Pegasys molecule - it's 36% with Peg-Intron. Of course,
        nobody wants to be exact, and they do want to sell their product. Zadaxin
        is made by SciClone Pharmaceuticals in San Mateo, CA. It is not approved by
        the FDA for the treatment of HCV, but you can order it from another country
        with a prescription. Zadaxin is now in Phase 3 FDA trials. Last I heard, it
        should be approved late 2003 - early 2004. My doctor says I can't wait that
        long.

        Oh yeah, here's something else you might want to ask your doctor about -
        ketoprofen. It's sold under the brand name, Orudis. It is an NSAID, similar
        to ibuprofen, only much longer lasting. There are a few abstracts out there
        stating that ketoprofen might raise the SVR numbers. The reason for this is
        not clear, but it is believed that ketoprofen prolongs the metabolism of
        interferon. If not, I have read reports that ketoprofen helps with side
        effects for some better than Tylenol - especially that deep bone pain.

        M K Andrew.com home.

        Monday, Dec 2, 2002Tuesday, Dec 3,2002

 
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