Montoya in Baltimore Sunday June 22

Discussion in 'Fibromyalgia Main Forum' started by consuegra, Jun 22, 2008.

  1. consuegra

    consuegra New Member

    Dr. Jose Montoya gave early results for the Roche Valcyte/CFS trial today, in Baltimore, Sunday June 22, 2008. The timing of the conference was not prefect for the presentations of these results, as Dr. Montoya did not have all his data complete. In a twenty-minute presentation Dr. Montoya went to great care to cite a long list of others who were helpful in this work. He described his and his colleague’s work as a small part of a larger mosaic. He said that his results presented today were not the entire story and that a final presentation would be forthcoming. Dr. Montoya made special reference to the work of Dr. Lerner, who he cited as a pioneer in antiviral work with CFS. After the presentation, in the question period, Dr. Lerner congratulated Dr. Montoya on his work and on the results.

    The trial had 30 patients, 20 taking Valcyte and 10 taking a placebo. Valgancyclovir treatment “was well tolerated overall and did not result in clinically significant declines in neutrophil or platelet counts”.

    Dr. Montoya explained that there were several objectives to the trial. The first was: Was the benefit real?
    Among the 19 Valcyte patients (one dropped out for non-Valcyte reasons), a statistical significant improvement was reached in cognitive function after nine months (six months on the drug and three months follow up). On the improvement of fatigue the results were more elliptical. “At three months after discontinuation of treatment (month 9), while the overall MFI-20 (fatigue measurement) general fatigue score did not reach significance, an improvement rate of greater than 10% in the MFI-20 general fatigue subscore was found in a significantly higher proportion of patients in the Valgancyclovir group that in the placebo group.”

    The second objective of the trial was to secure biological markers for future treatment. “Test results of assays for different biomarkers are being finalized and analysis is currently underway.”

    “Valgancyclovir treatment was not discontinued due to hematologic or hepatic adverse events.”

    The conclusion was that with CFS and elevated HHV6 and EBV antibodies, Valgancyclovir therapy results in significantly improved cognitive and physical functioning and appears to be independent of a placebo effect.

    The general sense was that this was an important report, although one could sense that there were detractors, or non-believers, present also.

    The trial seemed to indicate that the drug is safe when used with CFS patients under the prescribed conditions, that it brings statistical betterment to cognitive function, that physical betterment is less clear under the current conditions of measurement (except when interpreted in subscore manner) and that future identification biomarkers for treatment will be presented later.


  2. ladybugmandy

    ladybugmandy Member

    this shows antivirals are the way to go in a large subset of CFS...and that a LONGER course of them are needed to realize the greater benefits.

    according to many CFS clinicians, the first thing to improve is congnitive function...fatigue improvement comes much later.

    i think this is great news!!!!

  3. Lichu3

    Lichu3 New Member

    Thanks for going to the conference for so many of us who cannot and reporting back early results! I'm going to wait for the press release and final results but it's good to see some improvement for some people somewhere. And good to see Montoya gracious enough to acknowledge Lerner's work and that Lerner is in attendence there. (I didn't know if he would be there or not.) We need all the help we can get.
  4. ladybugmandy

    ladybugmandy Member

    chris....we are so lucky to have you on this board!!!!

    i wonder what the biomarkers will reveal - especially the RNase L - when they are released.

    i agree with lichu...looks like lerner was on the money from the get-go. i'm glad montoya acknowledged him!

  5. Forebearance

    Forebearance Member

    Thank you so much, Chris!

  6. waltz

    waltz New Member

    Thanks for posting some of the details.

    I guess I was expecting a little better results. There is some question then as to why was his preliminary study so much more dramatic.

    Gee, so the detractors and non-believers at the conference want to argue against a randomized double blind placebo controlled study? Hah.

    I hope the press releases tomorrow are well-written.

    [This Message was Edited on 06/22/2008]
  7. Dantes

    Dantes New Member

    I believe the reason the AV results are not so amazing, is because of the wide range of sub-sets.

    Lerner and Montoya have given evidence that AV therapy does "help" but it is not the entire answer.

    Until we, as patients, are completely tested for all known CFS causing infectious diseases, we cannot expect a lot.

    Taking 1 AV for an illness that may have spiraled, out of control, into 4-5 infection, will only yield Lerner / Montoya type results.

    Progress, ABSOLUTELY ! Is it everything that people want to hear... not really.

    The key, I believe, is to find a CFS doctor that know what they are doing. They will test for all known causes of CFS/ME, then they will figure out which infection to tackle first. Or, if possible, get 2 at one time.

    Most of us have been sick so long, that we have developed other illnesses. So I am not surprised that 1 AV is not the magic bullet.

    Like Sue, and may others, has said, this is a slow process. But this big push with AV tests is very promising. I just hope that they learn to attack this thing from many fronts. If they don't, then the cycle will just continue.

    I am hopeful, I just hope that the fight continues to grow. If we can get 10-15% better (or more) from AV treatment, imagine what can be done with antibiotics and other supportive immune therapy (depending on other primary / secondary infections / dysfunctions ).

    This is a very small puzzle (relatively speaking) and AV's are a part of it. They are here to stay. Now... on to the next piece :)
  8. jasminetee

    jasminetee Member

    I'm not surprised by the results Montoya has stated so far. They seem to mirror the majority of experiences people on this MB have had with Valcyte. I do wonder about the success of that first group...that's quite a mystery.

    I think it is probable too that the AV's hit a virus or viruses that we pick up as a result of CFS. We knew all along that they weren't a cure after all. For some people maybe helping their immune system fight off HHV6 provides what they need to get back on their feet.

  9. sascha

    sascha Member

    this is my first glimpse of Dr. Montoya's presentation.

  10. landrun89

    landrun89 New Member

    The Montoya tentative results confirm what Dr Lerner told me in an appointment May 15, namely the Montoya research time frame of 6 months on valcyte is too short. More time on valcyte is needed for patients to receive more pronounced improvement. The results also reflect my own experience on valcyte and valtrex.

    [This Message was Edited on 06/23/2008]
  11. acer2000

    acer2000 New Member

    I think the problem with this study is that they stopped at 9 months. I am not a patient of Montoya, but I do recall emailing with a few of his patients who were treated outside of the trial (and responded) that despite the fact that he stopped the drug at 6 or 9 months, they continued to improve slowly once they stopped the drug. I don't know if this is true for eveyone, but just because the people in the study weren't 100% when the study finished, doesn't mean they won't regain physical strength slowly and be 100% 6 months to a year after stopping the drug....

    As for people having to stay on antivirals to maintain gains, I think when I went to lerner, he had said something about only 20% of his patients could go completely off the drugs and still feel the same. I don't know his exact stats though...

    I would like to see a list of parameters that they measured for this study. Surely they didn't use the "energy index" to decide it worked or didn't work. They must have used objective tests such as V.02max and AT, as well as standardize cognitive testing - and immune parameters. I think I remember Cat003 say she had to do exersize tests as part of the study...
  12. 013101

    013101 New Member

    I think that although it's true that six months may not have been the best length of time to have the participants on Valcyte, it's also true that staying on it longer does not prove to be therapeutic for everyone. I fit the criteria for those who should respond. I took Valcyte for a year under Dr. Montoya. I experienced marked improvement at the six month period but then went downhill. He had me stop Valcyte after a year and, six months later, am no better than before I started it 1 1/2 years ago.

    I don't want to be discouraging, but I think that where the research stands now is that some people improve on Valcyte, some don't, and the doctors don't yet know why this is. I do know that if his results show 10% improvement in fatigue and I'd been told that that's what I could expect when I undertook treatment with Valcyte, I would not have taken it. As it turned out, I took it for a year and never even got the 10% improvement.

    There's still a lot of work to be done in this area.
  13. ladybugmandy

    ladybugmandy Member

    there are obviously still a lot of unknowns. this was a pilot study and, as such, wasn't that bad in the results department. the fact that ANY improvement was shown, is good news.

    given that we still do not know how to properly define subsets, the length of time to give antivirals, and even how to properly test for active infections, it is not surprising that valcyte wasn't the miracle drug.

    i had no idea that only 20% of dr. lerner's patients could stop medication and still maintain wellness on their own - though i am not surprised at all. i think it likely depends a lot on how long the infections went untreated.

    if dr. lerner is correct that the immune system, in CFS, can't induce latency of a herpes virus on it's own before the drugs, why would it be able to after the drugs are stopped?

    people with genital herpes have to take prophylactic valtrex why not us?
  14. Rafiki

    Rafiki New Member

    Terrific report! Very grateful!

  15. anniec345

    anniec345 New Member

    I'm glad that Lerner was part of this conference - way overdue for inclusion - especially since Lerner himself is a CFIDS sufferer. Or was (suffering, that is), until Lerner treated himself to have more energy than his office staff now, even in his mid-80's.
    I'll foreward all this info to my brother, who's had bad CFIDS for 20+ years - He's been saving info on Lerner for more than a decade. A couple of years ago, we would have bought Valtrex by the truckload, if we could have. You know how it is to feel that desperate and determined.
    We didn't. He's still sick.
    Thank you - and everyone else - for posting!
    Someday there will be a cure. Someday PWCs will be respected. Someday there will be Walks for CFIDS.
    In my brother's words - NEVER GIVE UP.
  16. ladybugmandy

    ladybugmandy Member

    (lerner is 77 or 78 i think)
  17. Slayadragon

    Slayadragon New Member

    One hypothesis about the first non-scientific group of Valcyte patients is that it may have been that prior to making their way to Dr. Montoya and taking a _totally_ unproven drug, they may have explored a whole lot of other ways of improving their health.

    Insofar as these supported their systems, this may have allowed them to better tolerate the weakening effects of the drug.

    And insofar as they had taken other anti-virals or other anti-pathogen killers in the past, this may have lessened their pathogen load so that the Valcyte didn't have as many that it needed to knock off (thus lessening the burden on the immune system as it struggled to keep up).

    Note that Kelly (who did experience some positive effects from Valcyte in her experiences many months prior to that official Roche-sponsored study) did all of these.....pursuing a wide variety of treatments ("holistic" and otherwise) and taking a milder antiviral and (I think) some antibiotics before starting the drug.

    If indeed many of the study participants had not pursued these other treatments before starting on Valcyte, that would have made the sample characteristics significantly different than those of the people in the first group. It thus wouldn't be surprising to get different results.

    This is especially true since Montoya forbade the patients from taking anything to strengthen their systems while on the drug. This is all very well and good in the name of using the scientific method to prove to others that your results should be attended to, but not necessarily good in terms of getting positive results.

    LISALOO New Member

    I don't understand, in a study did in Dec 06, Montoya stated that:

    : Patients with high IgG antibody titers against HHV-6 and EBV who were suffering from central nervous system dysfunction and debilitating fatigue for more than one year (median 3 years, range 1-8 years) were treated with 6 months of valganciclovir in an open label study. RESULTS: Nine out of 12 (75%) patients experienced near resolution of their symptoms, allowing them all to return to the workforce or full time activites. In the nine patients with a symptomatic response to treatment, EBV VCA IgG titers dropped from 1:2560 to 1:640 (p = 0.008) and HHV-6 IgG titers dropped from a median value of 1:1280 to 1:320 (p = 0.271). Clinically significant hematological toxicity or serious adverse events were not observed among the 12 patients. CONCLUSION: These preliminary clinical and laboratory observations merit additional studies to establish whether this clinical response is mediated by an antiviral

    Why did those people get seemenly a lot better than these newest results?
  19. porchswinger

    porchswinger New Member

    Sorry to say, I take a very pessimistic view of the findings, so if you don't want a negative view, read no further.

    I had CFS for 20 years before I started Valcyte on Jan 1, 2008, using the Montoya protocol with my local doctor prescribing. I fit the viral antibody profile perfectly. A few weeks after starting the drug, I experienced the 2 months of symptom worsening ("optimistically called "herxing") and then that eased and then I felt great for a couple of weeks, before I went downhill again-- to my usual CFS self.

    Many people who took Valcyte reported the same thing-- they got better for a while and then got worse again. To me, this sounds just like CFS-- you have periods of feeling better and periods of feeling worse.

    As for the people in the first study who did so well, consider the method of selection for inclusion of those people in the study-- Montoya hand picked the patients who he included in the study from all the people he had treated. He picked those people to write a paper about because they got well and he attributed it to the Valcyte. They all had CFS for 7 years or less. Some people do get better from CFS, so it is not usual that some who were given the drug would get better on their own. It may have had nothing to do with the drug.

    I think the double blind study gave us our answer-- one we didn't want to hear, one we don't want to face.

    The slim improvement in fatigue that the study participants experienced is probably due to the placebo effect. I know you're thinking that it was a double blind study so how could the placebo effect come into play? Anyone who has been on Valcyte knows that when you take the drug, you know that you are on the real thing because you "herx" and sometimes your blood tests show changes in lymphocytes. Participants were given hope which was doubly affirmed when they "herxed." So yes, there had to be a placebo effect and a little over 10% is low enough that I think we can attribute it to the placebo effect.

    In addition to the placebo effect,the study participants could have improved because they were warned time and time again to rest, rest, rest! Anyone who has CFS knows that getting a lot of rest(over weeks and months, not just days) improves the condition a little.

    We all want to believe it works. Many of us (me included) believed that we would get better after we stopped taking the drug and recovered from its harmful effects. But 3 months after stopping the drug and the participants still haven't shown real improvement

    As someone else said, if I though I would pay $6000 out of pocket for a drug that my improve my fatigue 10%, I would not have tried the drug. I am suppose to take the drug till June 30th to get in the full 6 months. But now that I have heard the study results, I decided to cut the valcyte down to 1 pill a day and then cut it out altogether.

    I don't suscribe to the theory that we need to take Valcyte longer in order to see positive results. Where is the evidence to suggest that? I might beleive this if there was SOME real improvement (at least 30%) and some reduction in the viral levels after 6 months on the drug. But there is no evidence, other than some ancedotal evidence, that taking the drug for longer periods of time helps. There is no evidence that the drug even started working on fatigue. And no real evidence that fatigue follows cognitive improvement.

    Lerner keeps people on the drug for so long, that when they finally feel better (and all CFS patients do feel better at times) they attribute it to the drug. There is no evidence that the drug makes people better. So based on the latest study, I will be stopping the Valcyte because I believe there is no benefit to staying on it.

    The study results can be summed up as follows: Some of the people got better for some of the time but none of the people stayed significantly improved for most of the time.

    It's time we faced the truth and try to be resilent enough to move on.

    I am truly sorry. We took a shot, but it's time to leave the tables and try our luck somewhere else.

  20. ladybugmandy

    ladybugmandy Member

    i am not going to discount the potential for antivirals to help altogether...i believe dr. lerner when he said many of his patients improved over time and often had "complete resolution" of their symptoms, returning to "normal life".

    resting alone would not account for this.

    maybe montoya's other blood test values - such as RNase L - will tell us something?

    you do make a good point about the vast majority of responders having CFS for less than 7 years.