Cheney on Valcyte

Discussion in 'Fibromyalgia Main Forum' started by mcondon, Feb 27, 2007.

  1. mcondon

    mcondon New Member

    I had a call with Cheney last week to discuss the possibility of going on Valcyte. He did the IgG tests on me for EBV and HHV-6 and said the EBV titer was above the threshold to be in Montoya's study. The HHV-6 titer was below the threshold.

    Overall, Cheney was somewhat non-committal about a trial of Valcyte.

    The obvious downside is that the drug is fairly toxic and most likely carcinogenic. Also, it is quite expensive and unlikely to be covered by insurance for a CFS diagnosis.

    He raised two other issues about downside risks. The first was that he thinks the risks of viral mutation may be significant with Valcyte. He described the use of IV acyclovir in the mid-80s in many of his and Peterson's CFS patients. High doses were effective, but patients tended to relapse and then failed to improve when given acyclovir again. He is concerned that this may be an issue with Valcyte, but it is too early to tell. Is there any evidence that this is occurring with some of Montoya's patients.

    The second issue was his claim that the patients in Montoya's first study had been sick for a median of only about 2.5 years, meaning they were relatively new patients. His concern is that patients who have been sick significantly longer than 5 years are less likely to recover the way Montoya's first study group did. Given that I have been sick for about 9 years, he thought I was less likely to see dramatic improvement from the drug.

    In any case, Cheney is contacting patients in his practice with histories of high titers to EBV and HHV-6, more severe symptoms, and (possibly) relatively recent diagnoses with CFS. His feeling is that many of these patients would have a better risk/reward trade-off from taking Valcyte. If they respond well, he thinks it might then make sense for me to try it. He also said if I wanted to be more aggressive, he would be happy to write the prescription now...he just thought in my case it would make sense to wait.

    I guess my question is whether Cheney is correct in saying most of the patients in Montoya's initial study had not been ill that long. Also, are other doctors concerned about the risk of relapse after finishing Valcyte due to viral mutations?

    Any thoughts would be much appreciated
  2. ravenpaige

    ravenpaige New Member

    From Montoya's published study, here are the patients (responders and non-responders), with the duration of illness for each:

    Responding patients
    ----Age---Duration of Illness (years)
    1---57------------7.5
    2---21------------7
    3---14------------1.5
    4---48------------3.5
    5---46------------2.5
    6---24------------1
    7---27------------1
    8---42------------8
    9---33------------1
    Median values for responders---33---2.5
    Non-responding patients
    1---52------------15
    2---49------------3
    3---28------------<1
    Median values for non-responders---49---none given

    The most important thing to notice about these numbers is that there just is not a whole lot of them. It's difficult to make any real generalizations. Yes, if you look just at the median values, responders had a median duration of 2.5, while not responders had a median of 25 (actually, I believe the 25 number came because at least one of the non-responders dropped out before the end of the study).

    But these are not enough numbers to say anything with assurance. Certainly, with 3 of the responders having a duration of over 7 years, I would not be willing to say that it is not a treatment to consider for people with a duration of over 5 years. The numbers just aren't there to say for sure. On the other hand, since the longest running patient has only been non-symptomatic now for 3 years, there is not a lot of history to judge the long-term effects. Everyone is essentially guessing a lot right now.

    Montoya has said that one of the criteria which seemed to determine the effectiveness of the treatment was whether or not the initial onset of the disease was "flu like." Of the responders, all had an initial flu-like onset, while all but one of the non-responders did not.

    Not a lot to go on at this point, but hope this helps.

    Edit note: I fixed the duration number for none responder #2, which I had listed incorrectly. Also fixed the median duration number for non-responders, as none was given. Sorry for the typos. These came from trying to copy and reformat from the pdf.
    [This Message was Edited on 02/28/2007]
  3. Slayadragon

    Slayadragon New Member

    CFS doctors do talk to one another don't they?

    If so, I would think that the best thing for Dr. Cheney to do would be to talk to Dr. Martin Lerner (near Detroit), since he's been using Valcyte for a number of years in his practice.

    I will be eager to hear what Dr. Cheney has to say about Valcyte as time goes on. Thank you for giving us your report.

    Best, Lisa

  4. Lichu3

    Lichu3 New Member

    Just like to say.......Petsmart founder was sick for 17 years. I don't think he was written up as part of the paper necessarily as 23 patients total have been treated (some in paper, some not).
    [This Message was Edited on 02/27/2007]
  5. foxglove9922

    foxglove9922 New Member

    mccondon,

    Very interesting post since I'm starting Valcyte 5/1/07.

    Unfornately, we who have been stricken with CFS seem to somehow suffer from different viral, bacterial, and fungal loads. Finding a good CFS doc who can access your particular situation is vital and it is my understanding that Dr. Cheney is one of the best. Sounds like you're in good hands.

    I had a recent reactivation of EBV with high titers of CMV and very, very high HHV6. Prior to all this I combated yeast and a mycoplasma infection that are both under control now so my CFS doc feels I'd make a good candidate for the Valcyte.

    Thanks for the post.......I believe only time will tell how this AV pans out for those of us who are EBV/CMV/HHV6 dominant.

    Somedays I think I'm just guinea pigging myself out of desperation to get rid of this illness which has gone on for 5.5 years but if I didn't then I suppose I'd feel like I was just giving up.

    Thankfully there is still some FIGHT left in me and hopefully those of us here pursuing the Valcyte road can compare notes and see what happens.

    best wishes and thanks for the post,

    Foxglove
  6. Mikie

    Mikie Moderator

    About transfer factors? I was on Famvir for 1 1/2 years before I started the TF's. The Famvir was very helpful but the TF's really made a difference. I could not believe the immune response, and eventual Herx, from the TF's. I took the TF C and the TF 200, both sold at this website. It was a full month before I could even tolerate a full capsule. Before that, I had to open them and sprinkle a bit of the powder under my tongue.

    After three months on them, I only have had to take them a couple of days every six weeks. Still, when I pulse them, I get a reaction.

    I have been through a long course of Doxycycline for mycoplasm infection and a course of Heparin injections for hypercoagulation. The Famvir and TF's are just a part of my overall regimen. In addition, I have been using probiotics, undenatured whey (which Cheney recommends) and colostrum. My own immune system now seems to go after infections like gangbusters. I seem to recover very fast from viral and bacterial infections. I do keep the Doxy and Acyclovir (ins. no longer covers Famvir) around just in case of a reactivation.

    I would be very interested in what Cheney thinks about the TF's. He is one of my heroes in the fight agains ME/CFS.

    Love, Mikie
  7. Slayadragon

    Slayadragon New Member

    And some doctors think that patients improve on Valcyte because a yet-undiscovered herpes family virus (perhaps the root cause of the whole disease) is killed, and that HHV6 and EBV just come down too mostly for the ride.

    If that's the case, than neither HHV6 nor EBV are what really matter. They are just proxy measures for whatever virus is really the villain.

    (I wonder if Montoya himself is of this belief, by the way. He doesn't seem to have stated anything one way or another with regard to cause, I don't think. On the other hand, I _think_ Dr. Lerner is more of the belief that all the viruses we have are doing bad things and that they all need to be killed, which is why he uses different AV's to target different viruses.)

    We really know almost nothing about what's going on at present, it seems. Hopefully that will change in the future.

    On another note--packfan, have you started Valcyte yet?

    Maybe you should respond on my thread (Famvir Status Report Week Sixteen) or separately though. I don't want this thread to get too off track. I hope you're doing well, in any event.

    Best, Lisa

    [This Message was Edited on 02/28/2007]
  8. cherylsue

    cherylsue Member

    Hmmmmm. I had posted under Carla nl a patient of Dr. De Meirleir's about this doctors opinion of Valcyte. My post was deleted probably because of copyright or something, and the patient's post was also deleted from his blog on his website. I don't know why.

    I wish I had made a copy of it for myself since I'm keenly trying to follow what DeMeirleir and Cheney are doing with CFS research.

    Anyway, the patient said that DeMeirleir does not believe in Valcyte because it is too toxic, and patients did relapse.

    Why this was censored I gave my reasons above, but I think patients need to know the total facts with eyes open before they embark on treatment.

    Conclusion: Dr DeMeileir doesn't use Valcyte at this time.

    CherylSue

  9. mcondon

    mcondon New Member

    I am pretty sure that Cheney at one time tested transfer factors in his practice, but I don't think they are a part of his current treatment protocol. Instead, he seems to prefer Isoprinosine and Nexavir as his anti-viral treatments. But if you are having good results with transfer factors, you should obviously keep using them. I don't think they have any downside risks. I might even try them myself, given your experience with them.

  10. Slayadragon

    Slayadragon New Member

    Wasn't it Dr. Cheney who said he had been "chasing viruses" his whole career and finally had given up on them?

    I wonder if what he meant was that he had concluded that none of the identified viruses was a root cause of CFS, and that killing those particular ones didn't address the disease in a deep or long-standing way.

    The would explain why he wasn't enthusiastic about transfer factors, since they treat only identified viruses (and other pathogens). Altering the immune system at a more fundamental way would seem to be a better way to approach this.

    If this indeed is his belief, I wonder how he feels about the idea that an as-yet unidentified virus (perhaps a herpes family one) is the root cause of the disease.

    My own hope for Valcyte is that it kills a lot of unidentified herpes family viruses, and that one of them is indeed a cause of the disease. If so, perhaps the positive effects will be more permanent (at least to the extent that the virus can be killed off entirely).

    On the other hand, it could be that Dr. Cheney has given up chasing viruses because he believes they mutate quickly into strains that are resistant to treatments used.

    Or maybe there's another reason.

    It would be interesting to hear more of his thoughts on the matter.

    Best, Lisa

  11. mcondon

    mcondon New Member

    Here are some brief notes I took from the call, which may provide some insight into Cheney's thinking:

    He spoke to Christen Loomis (sp?), President of HHV-6 Foundation. Criteria for Valcyte is Elisa > 4.0 or ISA > 1:640 on EITHER EBV-VCA or HHV-6 IgG. Responders will get worse on therapy initially.

    Montoya study -- 75% response rate. Issues: wasn't controlled double-blind and responders had median length of illness of only 2.5 years. In early illness, "response" rate is high if no treatment given. (In Lake Tahoe, many patients improved substantially first few years into illness with no intervention. Natural illness progression for some CFS cases.)

    Reminds him of anti-viral CFS study in mid-1980s:
    1986 - He and Peterson admitted CFS patients to hospital on basis of high EBV titers in order to administer acyclovir 2X per day by I.V. Some people had almost full recovery. Steven Strauss at NIH then did double-blind study in 1987. Some people in this study definitely responded. When treatment was finished, Strauss "opened the seal" and found no statistical difference between placebo and therapy. Strauss then turned against idea that CFS is a "real" illness after study, given apparent placebo effects. At the time Cheney claimed Strauss study was flawed because high-dose acyclovir caused renal toxicity in 10% of treated group, which would make them look like non-responders to the drug and bias treated group to look more like placebo group. He and Peterson kept using acyclovir even after Strauss study. BUT, some responders relapsed after 6 months. Reason is that viral resistance to acyclovir is 30% probability per 6 months of treatment. Because of viral mutation. May happen with Valcyte, but too early to tell.

    Possible Valcyte negatives:
    -very expensive --$2K per month.
    -possibly carcinogenic, though this risk is "theoretical" rather than proven
    -teratogenic (can't have children)
    -immunosuppressive - knocks out white cell counts for some during treatment
    -toxic to kidneys and bone marrow -- but can be monitored pretty well.
    -probably would be fully disabled 1-month after starting treatment but only if a responding. (If not, Valcyte won't cause sig. relapse, won't affect work status.)

    Other issue:
    In early illness, viral activity may be the "locus of control" but in later illness it may not be anymore. Would be more willing to try with newly ill patients. Analogy to idiopathic cardiomyopathy: initial cause is most likely viral, but after heart failure begins, anti-virals don't work. Pathophysiology of CFS probably similar.


    Two options:
    (1) know how people who best meet Valcyte criteria respond and then consider trial. Conservative approach.
    (2) start right away with 1-month trial. If I get sicker continue and wait for a response. If I don't get sicker after a month, stop taking it.





  12. acer2000

    acer2000 New Member

    So, when you say he said its teratogenic, did he mean you can't have kids *ever* or you just can't get pregnant or father kids when taking the drug. If its the second one, thats not really unique to Valcyte, in fact many many common drugs fall into that category including most of the anti-depressants, some blood pressure meds, and some common anti-biotics. A quick google search shows:

    http://www.medicinenet.com/pregnancy_drug_dangers/article.htm

    Which I am sure is only a short list. Many drugs aren't even tested in pregnancy.

    Not saying hes wrong, but just wondering if you can put that into perspective. As someone who is considering taking Valcyte and who is young and hasn't had kids yet, I'd like to know if I am going to chop of my nuts (literally) to spite my face. (Sounds weird, but thats what we are talking about here).
  13. acer2000

    acer2000 New Member

    I am not 100% convinced that a virus is all thats going on here either, I actually think CFS onset has a lot to do with pre-existing toxcicity and adrenal stress, but WRT to cheney's hit and run theory (or locus of control) I am not sure hes right in 100% of the cases. Lerner has been using high dose Valtrex/Valcyte for EBV/CMV for over 10 years and he actually biopsied the hearts of his patients in the first study. He says 100% of them showed persistent partial viral replication in their heart, and many of them had been sick for many years.
  14. Mikie

    Mikie Moderator

    I appreciate your response and the additional info on your call. I was prescribed the Famvir as a preventive prior to facial surgery. I Herxed and then went into a complete, but temporary, remission. My doc and I decided I could benefit from it and it appears that I did. Then, I heard about the TF's and decided they would be a better choice. HHV-6 is not responsive to Famvir but is to the TF which targets both strains. All in all, I do think the TF's have been more effective, for me, than anything else. If I had known there was one for mycoplasmas, I would likely have tried it instead of the long course of Doxycycline. Could be, though, that taking ABX and/or AV's prior to the TF's is even more effective. Everyone is different and I think at this point, we are all flying by the seats of our pants.

    I am not convinced that any pathogen causes our illnesses but I do believe they can trigger them in someone who is genetically predisposed. Still, there is the possibility that an infection can cause gene defects. Exposure to toxins could be another factor. I'm hoping that the new research will help answer some of these questions.

    All I know is that the slow progress I've made has been due to a comprehensive approach. That appears to have been the case with Rich who owns ProHealth. We are sick in too many areas for there to be any one treatment which is the magic bullet.

    Thanks again.

    Love, Mikie
  15. mcondon

    mcondon New Member

    I don't have an answer about whether Valcyte would prevent you from having children while on the drug or permanently. Frankly, I am past the point where having more children has an appeal, so I didn't ask Cheney any more about this. I am sure a good infectious disease specialist would be able to tell you what you need to know.

    Good luck
  16. cherylsue

    cherylsue Member

    Thank you for you info from Dr. Cheney. It was most informative.



    Pianowoman: Thank you posting about why my post was deleted. My apologies to the blogger. I appreciated his information as well.

    CherylSue
  17. Slayadragon

    Slayadragon New Member

    Mcondon,

    I think the biggest negative for Valcyte is that it's not clear how the best way is to use it successfully (so that relapses will not occur in the long term).

    Dr. Montoya and Dr. Lerner are so concerned about resistant strains that they give people huge amounts at the beginning, making them really sick.

    My own doctor believes that it is a much better idea to keep people as strong as possible (both by using lower doses and by building up their strength in as many other ways as possible before beginning the drug), so that their own immune systems will kick in at a certain point and total wellness will be achieved.

    (See my post "My Strategic Plan for Using Antivirals (Valcyte etc." for a more detailed explanation.)

    It may be that the addition of other treatments (e.g. transfer factor, stuff to boost NK Cell function, whatever) could be a key with regard to whether long-term success is sustained.

    Unfortunately, nobody knows what the answer is on this. And if Valcyte is used incorrectly, it is possible that (because of resistance) it will be ineffective in the future and thus that the chance to get well will have been lost.

    (I read this recently with regard to Acyclovir, for instance. One patient had used the drug for a short period of time and then pulsed it, and apparently become resistent. Montoya expressed strong disapproval of this approach in an appointment, but that doesn't mean that his own approach is ideal either.)

    Of all the worries that I have about using Valcyte, this is the big one. It actually makes me want to stick with Famvir for a long time to see how much progress I can make on it and to let other people be Valcyte guinea pigs. (It seems that my doctor has gotten many patients to 100% or more on just Famvir using the protocol I describe in my post, and so there is motivation for me to try that route. He's only been using Valcyte since last summer.)

    Even in another year, the answer to these questions should be much more clear. There definitely is a reason to wait a bit, therefore.

    None of the other stuff seems scary to me at all. (I don't really like getting blood tests every week since I often pass out--especially if I'm not feeling well--and so that's as much of a disincetive as any of the other factors even though it's trivial.)

    Losing my only chance to use Valcyte due to poor strategic use of it has kept me up a bit at night on occasion though.

    At the very least, having confidence that the strategy you're using makes sense to you seems crucial.

    Best, Lisa

  18. Slayadragon

    Slayadragon New Member

    Dr. Brewer suggested that deliarose not take Valcyte because he believes there's a long-term fertility risk. I don't know if he has evidence of this, though. Nor do I know if it applies to men as well as women.

    He recommended transfer factor instead and assured her that it would make her better (perhaps wholly better) as well.

    deliarose recently said that she was indeed getting much better (that CFS seemed to be "fading in the rearview mirror"). She is not sure whether to credit just the TF or also another treatment she's been pursuing.

    I wrote a post to her with her name in the title about this yesterday, if anyone wants to read it.

    Best, Lisa

  19. Slayadragon

    Slayadragon New Member

    My doctor seems to have some evidence that heart problems resolve on their own (or with the help of human growth hormone) after patients have gotten better from CFS in general (as a result of building up general strength as well as antiviral usage). He seems to strongly believe that the heart problems are due to viral problems.

    That doesn't mean he's right, though.

    Best, Lisa

  20. deliarose

    deliarose New Member

    my ID doc.. Joe Brewer.. told me that he doesn't use Valcyte on people who have not had families yet because of its effect on fertility.

    I took that to mean it has a permanent effect, otherwise he would just counsel you to avoid getting pregnant for the duration of treatment.

    I also brought the carcinogenic thing up to him.. and he pooh poohed it.. said that the carcinogenesis was seen in juvenile mice who are very prone to this because of their short life cycle.

    (I should have asked him if he would feel comfortable putting a family member on it..)

    Still, as someone pointed out.. you harbor these viruses long enough, you're raising your risk for cancer anyhow.

    Which brings me to the question: is anybody out there getting screened for cancers..esp. non-hodgkin's lymphoma?

    Sorry to bring it up. ..but it is kind of important.

    Delia