CFS Viral conference Baltimore July 23

Discussion in 'Fibromyalgia Main Forum' started by consuegra, Jun 23, 2008.

  1. consuegra

    consuegra New Member

    Dr. Jose Montoya gave a follow up talk today in Baltimore. The talk was on the relation between elevated antibodies to EBV and HHV6 and the response to Valcyte. The review was performed on 56 Stanford CFS patients between 2004 and 2007. Each patient was either a responder or a non-responder (or a “patient of undetermined response”). Twenty-four patients were responders, and 18 were non-responders (11 were in the third category). Responders reported at least a 30% increase in activity, confirmed by clinical assessment. 18 of the 24 responders had high antibodies to both viruses. Only five of the non-responders had these high antibodies. The conclusion was that patient with elevated antibodies to EBV and HHV6 appear to be more likely to respond to Valcyte treatment. The median increase for responders, self-rated activity, was 63%.

    Today’s conference had a series of fascinating talks by Kerr, deMeirleir, Chia, Peterson, Vernon, Klimas, and Evengard - among others. These presenters are a small band of determined individuals, dedicated to unlocking a very complicated puzzle. Several press releases have been issued and are available online.

    Some physicians, including Klimas, are still not inclined to use Valcyte, citing the need for large-scale safety and efficacy trials. There was an excitement in the air in regards to new treatment modalities and studies, including gene expression.

    At the end there was an informal exchange of treatment ideas between various practitioners, which was of particular interest.

    The real question is if there is enough evidence coming out of this trial to encourage Roche to feel confident to stage another, larger trial. Money is the issue. Time will tell.


  2. gapsych

    gapsych New Member

    Thank you for sharing this very important information.

    Take care.

  3. ladybugmandy

    ladybugmandy Member

    once do an invaluable service for this board:)
    thank you
  4. Lichu3

    Lichu3 New Member

    If Roche doesn't sponsor a follow-up, I hope someone in the audience (NIH, anyone?) is willing to.

    A small study on a specific population of CFS sufferers but still..........conservatively that's 42% of people who showed an improvement (at least 30% on the physical side is nothing to laugh at) in an illness with currently NO good treatment at all.
  5. acer2000

    acer2000 New Member

    Interesting that Klimas thinks that Valcyte needs more safety studies. I wonder what her reasoning is. On the surface that seems kind of ridiculous. Its been in use in other patient populations for almost 20 years. And thus far, both stanford studies have show it to be no less safe in CFS patients.

    Sometimes I wonder if these "immune dysfunction" researchers are really making this more complicated than it needs to be... perhaps in these patients, the "immune dysfunction" was really just "immune fucntion" against HHV6...

    When else in history have they made up an immune dysfunction syndrome to account for the fact that they can't diagnose an infection correctly. Makes you wonder...
  6. Slayadragon

    Slayadragon New Member

    I suppose it's possible that the only reason that we have low NKC activity is because HHV6 damages it.

    That would be a circular argument though, since low NKC activity causes HHV6 (as well as other herpes-family viruses) to grow unchecked.

    Another thing I've not yet heard about this study is whether NKC activity (and other things like Rnase-L and LMW Rnase-L) showed improvements afterwards. Surely they must have tested for these things. I can't tell if they're not being reported in these notes because there was no improvement or because the reports are incomplete.

    CFS patients' immune deficiencies seem to extent to other things too. Chlamydia pneumoniae and mycoplasma, if nothing else. Supposedly other viruses like PIV-5. And I'd put lyme and candida in this group too (as does Paul Cheney), though I know those are "controversial" problems.

    Considering how hard this drug is on people, how some people do not recover from the experience for many months (maybe ever), and the fact that we have no idea whether having gone through this experience will help people in the long run, I do not think it is unreasonable for Nancy Klimas to be hesitant to start prescribing it off-label until further studies are done. I know a long-time patient of hers who has an appointment in a few weeks though, and perhaps I will find out more from him about her current thoughts on the matter.

    [This Message was Edited on 06/24/2008]
  7. acer2000

    acer2000 New Member

    Yes, please do report back if you talk to her patient. I am curious about what she says. And I agree, I don't think its as clear as people claim that Valcyte is effacacious for CFS. However, I was commenting on the safety of the drug, and I don't think anyone in the studies has experienced any of the known hazards of taking Valcyte (anemia, liver damage, cancer, infertility) etc... or at least not thats been reported. And those people who did have LFT elevations, etc.. it went back to normal when they stopped the drug (not uncommon with some drugs). That doesn't mean it hasn't made people feel crappy, or that it has neccesarily worked in all cases.

    And yes.. I tend to agree with you, immune parameters out of wack -> infection does seem circular. Any infection that is any good is going to try its best to throw the immune system to survive. If your immune system relies on NK cells to eliminate it, sure it has evoloved to mess with NK cells. This is a well known mechanism of defence by pathogens - for example there are studies that show Multi-Drug resistant TB also reduces NK cell activity. Probably as a defence mechanism, but I'm not sure...

    I guess the interesting point here is that for 20 or so years, because there wasn't an "obvious" pathogen, people have looked at this "immune dysfunction" angle. With the exception of NK cell activity, to my knowledge they have never found any significant trends. Some people have high TNF-a, some people IL-2, some RNASE (some not), etc... Because they coulnd't pin down a pathogen by PCR, for the most part doctors haven't treated CFS patients empirically (the old way - if symtpoms fit, see if there is a response to treatment).

    Then comes along a guy (Montoya) who is totally ignorant of this immune dysfunction construct, who says "if it looks like a duck, walks like a duck, etc.. it must be a duck" and puts people with high HHV6 titers on Valcyte and low and behold some of them get better. Sometimes it takes someone who isn't "too close" to the current theory to try something logical to get a breakthrough. Thats all I'm concerned about with the "immune dysfunction" research.

    [This Message was Edited on 06/24/2008]
    [This Message was Edited on 06/24/2008]
  8. ladybugmandy

    ladybugmandy Member

    does anyone know when the other parameters will be released (RNase L, etc.)?

    i wonder if they checked if the non-responders had adequate levels of drug in their system or other factors.

  9. 013101

    013101 New Member

    This post interested me because I fall into the category of one of the patients who took Valycte through Dr. Montoya but wasn't in the double-blind six month study. I had high titers but did not improve on Valcyte. I was on it for a year.

    Here's the interesting part: Someone left a message on my answering machine saying they were doing the follow-up referred to here. When I called back the next day, he said "Never mind. I had to turn in the paper already so we won't be counting your results." Hmm.
    [This Message was Edited on 06/24/2008]
  10. kanejo

    kanejo New Member

    Hi! I have been searching for the press releases using hhv6 valcyte, and montoya and have found only one article, about an old virus being present in cfs. There are no links on the hhv6 foundation site. Any tips on where I might find these press reports?

  11. ladybugmandy

    ladybugmandy Member
  12. erica741

    erica741 New Member

    Did anyone notice this article is under "Depression News"?
  13. waltz

    waltz New Member

    So that means that since the preliminary study, there have been 15 responders and 15 non-responders. And that's if this third "undetermined" category isn't hiding a disproportionate number of non-responders.

    I really wish they would put some brain cycles into other types of treatments. There are so many anecdotal stories of people getting better or at least much improved on things like macrobiotic diets, juice fasting, veganism, vitamin C, malic acid, etc. These are all cheap! And non-toxic! How much would it cost to do a study on those? Especially a preliminary study where the patients are probably paying for the doctor visits themselves.

    Btw, the press releases can be found here:
  14. ladybugmandy

    ladybugmandy Member

    hmmm..looks like they want to fudge the numbers a little...i'm not surprised.

    i guess it all has to be taken with a huge grain of salt :-/

  15. Lichu3

    Lichu3 New Member

    This data seems to about those who have been on Valcyte and does not seem to be about those on placebo.

    Thus, in the way written above, it doesn't seem we can draw conclusions about the whole 30 people in the second trial, just the 20 on Valcyte. (It is however, fine to use the 10 as placebo control.)

    As far as I know, the 10 people who were on placebo were informed of it just in April and were then offered the chance to be on Valcyte. Assuming all of them took that chance, that's 10 people who could be in the "undetermined" category because they've only been on it for 2-3 months.

    People are anxious to know what is happening to those on Valcyte so maybe that's why the data was reported that way. Also, Montoya should have left out the people who didn't have the appropriate high titers -- it is interesting to note there are 6 responders who didn't fit the titer criteria.
  16. ladybugmandy

    ladybugmandy Member

    6 responders who didn't fit titre criteria? i guess that goes to show antibodies don't mean much.

    my fog is so bad i can't even make sense of anything...blah

  17. waltz

    waltz New Member

    Hi consuegra -

    I just noticed that 24 responders + 18 non-responders + 11 undetermined = 53 patients.

    We are off by 3 somewhere...?

    "The review was performed on 56 Stanford CFS patients between 2004 and 2007. Each patient was either a responder or a non-responder (or a “patient of undetermined response”). Twenty-four patients were responders, and 18 were non-responders (11 were in the third category)."

    One more question:

    Do these numbers include or exclude the 20 clinical trials patients receiving Valcyte?

    [This Message was Edited on 06/26/2008]
  18. consuegra

    consuegra New Member

    There were three patients who responded positively only to "cognitive function".

    i believe the 19 patients are within the 56. One patient dropped out after three months for a cancer that was unrelated to the trial or Valcyte.

  19. mezombie

    mezombie Member

    is my worst problem.

    I still haven't found a treatment that helps with this symptom, and believe me, I have tried a *lot* of treatments.
  20. ladybugmandy

    ladybugmandy Member

    cognitive has been my worse symptom too....

    i wish so much they were doing brain biopsies somewhere. i would just go there and get it done.

    i know they are dangerous and can cause complications, but i am so sick of being sick and guessing at what is living in my brain.

    i do not think brain biopsies should be used only for dying patients. we are dying too..just more slowly....and watching our lives pass us by!

    i was told there is no way they will ever be done in the states for CFS....