Valcyte safety question (for those taking it or considering)

Discussion in 'Fibromyalgia Main Forum' started by sophiekk, Jan 23, 2007.

  1. sophiekk

    sophiekk New Member

    Hi all. I'm considering Valcyte but both I and my doctor have some concerns about safety. The product leaflet is quite scary, and in animal studies it seemed to be carcinogenic at very low doses, much lower than those prescribed to humans. Has anyone seen any studies that might reassure me? For those taking it, how did your doctors explain the risks to you and how did you decide to proceed? Thanks! Sophie
  2. Slayadragon

    Slayadragon New Member

    I need to go look at the literature again. With regard to cancer, is it talking about cancers of the bone marrow?

    One would be leukemia (the ability of the bone marrow to make white blood cells).

    The other would be what is sometimes called "pre-leukemia" (the ability of the bone marrow to make red blood cells). It has another longer name that I can't recall at the moment.

    Let me know what the information says if you want. Otherwise I'll look it up soon and get back to you.

    Who is the doctor who is considering prescribing it?
  3. sophiekk

    sophiekk New Member

    Thanks for your reply, Lisa - here's the study I saw.,M1

    If you go to page 34, you can see some results of the animal carcinogenicity studies. However, I haven't seen anything indicating that the same thing happened in humans; I don't know if this data is out there and I can't find it, or if cancers have occurred but no one has made the connection - or if the drug company has not made it public. If you had any literature you could post or PM me, I would so appreciate it!
  4. mrdad

    mrdad New Member

    Are you aware of a study that Dr. Montoya of Stanford U.
    will be conducting concerning Valcyte that is to begin in
    Feb.? I knew a Gentleman that was treated by him that had
    experienced CFS for about 20 years. He had, at that time,
    arrived at 70% improvement but don't know how he is doing

    There was a Post here (and may still be) concerning the
    study. I'm sure you will be able to find it without much

    Best Wishes,
  5. sophiekk

    sophiekk New Member

    Thanks, I've read about the study. But that literature only mentions the bone marrow/blood count side effects, and I'm interested in carcinogenicity and fertility suppression. I couldn't find anything addressing long-term safety in any of Dr Montoya's published papers or elsewhere. (The paper of his I've seen was the one from the Journal of Clinical Virology, #37, 2006).
  6. mezombie

    mezombie Member

    I saw the information on Valycyte causing cancer in animal studies as well. It is cause for concern, I think.

    I suspect the FDA approved it despite this for HIV/AIDS and organ transplant patients because people in both those groups could die from a viral infection targeted by Valcyte if they didn't take the drug.

    Remember, the use of Valcyte for CFS is off-label; therefore not FDA approved for us.

    That doesn't mean the risk isn't worth it. Many doctors believe that CFS (or whatever is causing CFS) may lead to cancer, as well.

    And there are many drugs that have not been on the market long enough for anyone to know what the long-term side effects might be.

    Of course, there is also the quality of life issue. People whose lives have been severly compromised for many years may opt for the risk.

    Hopefully, Montoya and others will track patients for signs of cancer over the coming years and we'll slowly get some more data to help us make an informed decision.
    [This Message was Edited on 01/23/2007]
  7. sophiekk

    sophiekk New Member

    Thanks, that was my thought too - that CMV in transplant patients is so dangerous that a long-term risk is worth taking. I can understand that CFIDS patients who are very, very ill would be more willing to take these risks. I'm in my twenties, not suffering too much from my symptoms and am able to work part-time, so I'm questioning whether or not I am...
  8. FM58

    FM58 New Member

    I haven't received the info from my doctor yet,so I have not had the chance to read the information.

    My doc did mention the safety concerns regarding bone marrow - if I agree to use Valcyte, I will have to have weekly blood work. I feel a little more re-assured about going for weekly blood work.
  9. Slayadragon

    Slayadragon New Member


    Mezombie's take seems to me to be the exact right way to look at this, based on what we know at this point.

    I think it's reasonably likely that Valcyte increases the likelihood of cancer in humans at least a little bit. On the other hand, I think it's fairly certain that viruses (and there are a whole lot of them hanging around in my body at the moment) cause cancer (not to mention heart disease and other things that cause death) too.

    Weighing the risks of which one is more likely to cause cancer at some point in the future is purely a judgment call.

    The same thing is true with fertility. Based on what I have read, CFS patients have a very hard time conceiving to begin with. Miscarriage rates are extremely high. And at least some patients reach menopause very early.

    (I'm going to put a question on the board about when people reached menopause, since I haven't seen much hard data about this.)

    There may be reports to the contrary, but it is my impression is that pregnancy is especially hard on CFS sufferers (with negative effects showing up both before and/or after the birth) even when they do manage to conceive. This is especially the case if medications that help the CFS (I'm thinking specifically of adrenal supplements like DHEA) are discontinued, which many doctors recommend that they be in order to protect the fetus.

    And of course, it is hard to care for a baby (especially if you want to have anything else in your life too) if you have CFS.

    I am particularly sensitive to this since I got the "killer flu" that started my CFS shortly after getting pregnant for the first time. I miscarried about four weeks later.

    My husband and I were still interested in having children, and so we discussed all these issues for years after I got sick. We never came up with a plan that seemed reasonable, and so we eventually dropped the idea.

    Now that I'm well past my childbearing years (I'm 42 but reached menopause a few years ago), this is not a consideration with regard to my taking Valcyte. Even if I were younger and hoped to have children, though, I likely would have considered it after weighing the infertility risk against the issues stacked up against having kids with CFS.

    However, since Valcyte is in very early trials, women who want to have kids shouldn't be the first to use it, I don't think. We need to get a better idea of not only whether it's effective but also how the best way is to use it to minimize its dangers.

    For what it's worth, Dr. Brewer (I think in St. Louis) has been using Valcyte for some time. To my understanding, he told Delia (one of the board members here) that he didn't think that the cancer risk was a major issue but that he didn't want her to take it at this time because she was still interested in having kids.

    I'm glad that you brought this matter up. I was planning to read up on Valcyte more soon, and this was a good excuse to do it.

    My doctor's plan is to treat me with four months of a moderate dose of Famvir and then two months of a moderate dose of Valcyte. Famvir kills off a lot of viruses, but Valcyte gets at ones that Famvir may not (or at least may not without very extended therapy).

    I think this is a good plan. Whether this will be enough time on the drugs to get me wholly well, I'm not sure. I am still herxing on the Famvir (after three months of it), and so it may be better to continue with it a few months longer before switching to Valcyte. I am going to see my doctor in another month and will talk to him about it then.

  10. sophiekk

    sophiekk New Member

    Thanks, guys. mezombie and lisapetrison, I really appreciate your informative and common-sense take on the issue - just the perspective I was looking for, and it's really helpful for me to bounce these thoughts off others in the same position as me. Thank you!

    Has anyone seen any statistics on CFIDS and cancer? I know there was one study that suggested that CFIDS patients who died from cancer died at a much earlier age, but that a larger study refuted those claims...
  11. Slayadragon

    Slayadragon New Member

    I've not heard of any such studies that have any even vaguely convincing scientific method behind them being done.

    Considering that CFS wasn't even recognized as a disease until a year or so ago, that is not surprising.

    However, please see my post called "Bone Marrow, CFS and Valcyte" for a discussion or information relevant to this matter.

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