1. Patients launch $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
    Check out the website, Facebook and Twitter. Join in donate and spread the word!
Nitric oxide and its possible implication in ME/CFS (Part 2 of 2)
Andrew Gladman explores the current and historic hypotheses relating to nitric oxide problems in ME/CFS. This second article in a 2-Part series puts nitric oxide under the microscope and explores what it is, what it does and why it is so frequently discussed in the world of ME/CFS....
Discuss the article on the Forums.

Dr. Montoya's Valcyte study

Discussion in 'Antivirals, Antibiotics and Immune Modulators' started by Robin, Nov 6, 2009.

  1. Robin

    Robin Guest

    This was brought up on another thread so I thought I would post it here.

    Here's the original study, here is the press release about the follow up study.

    We've heard some rumors about it not working out. Is anyone involved in this study, or know anything about it?
  2. starryeyes

    starryeyes Senior Member

    Messages:
    1,513
    Likes:
    4
    Bay Area, California
    Thanks for asking this Robin. I think Valcyte ended up being a dud.
  3. kolowesi

    kolowesi Senior Member

    Messages:
    260
    Likes:
    14
    Central Texas
    Robin Teejkay valcyte study

    I saw Dr. Montoya for a year from Aug 2006 to July 2007. At that time, he recommended IV antivirals and told me he would be in contact with a local doctor, but wouldn't treat me at Stanford.

    Anyway, the valcyte study was just in the funding stage at that time. They definitely didn't get $30 million:) I think it was between $1 and $2 million from Roche, the patent-holder of valgancyclovir.

    I did meet a patient who improved greatly on valcyte. She had seen over 20 doctors and been in the ER 7 times after being ill around a year. She was at 85-90% pre-illness functionality and it was all due to valcyte.

    In my case, I'd been sick 9 years already and had some bacterial stuff as well as CMV, HHV-6 and EBV. Dr. Montoya didn't want me taking doxycycline and is sure he told me that, but I don't think he did. I wasn't in the study, and my first 2 appts were with residents, with a short appearance by Dr. M.

    Also, he told me that his small efficacy study of around 12 people was 75% effective, with people going back to normal life. This is from memory, and I erased all my old posts and have no other records, but I think this is right. Maybe someone else knows.

    Another doctor who has used valcyte for many years is Dr. Lerner. He was convincing that it was helpful in many cases, though he tried hard to treat bacterial infections as well because those could keep you from improving.

    Overall, my improvement was very welcome. I was on valcyte a total of 22 months, 10.5 under Montoya and 11 under Lerner. When I started, I had chest and back pain and breathing difficulty. After about 4 months, that resolved. Dr. Lerner found that I have some heart issues which he has correlated to smoldering viral infections of the heart.

    Though I'm only a 4 on his scale (and Cort's), I've had brief times of being better, and I am infinitely better than when I could not lie down to sleep. I think the infection is still in my heart as my chest aches sometimes, but I couldn't stay on valcyte.

    My impression was that Dr. Montoya's original cohort improved much faster than the group of patients in the trial. I hope there will be more investigation, and someone mentioned that many of these doctors are in touch now and sharing information. There is a poster on PH named gasolo who is able to work. Some others said they got well and left the board, so who knows how they are now.

    In some cases, especially for those of us with CMV, I think valcyte is a treatment option. I really wonder if I would have survived without it. Not a cure for some of us, though.

    Still looking,
    Kelly
  4. KC22

    KC22 Senior Member

    Messages:
    158
    Likes:
    3
    Ohio
    Kelly....

    Valcyte is very interesting. I really don't know how I would be if I hadn't done it. I was getting sicker and sicker by the day, before finding my way to Dr. Lerner.

    I just got my labs today from my last visit and the mycoplasma dropped 400 for the first time in 4 years(a drop). My hhv6 went down to 1:160 and EBV and CMV staying close to the same, a small drop.

    I believe Dr. Lerner and Dr. Montoya have been in contact in the last year. I believe where Dr. Montoya's study was flawed was that he never tested for all of the co-infections; example for mycoplasma p., etc. I would have tested for his study, but probably would not have had success because he didn't treat the co-infection.

    It would be interesting to see how many of his patients would test for co-infections.

    I just talked to a friend who also goes to Dr. Lerner. There are 5 of us from this area who see him. We have all moved 2-3 points on his scale. One girl started at a 4 1/2 and is up to a 7. We started around 2 and moved to 4. The younger patients seem to move higher, they are both 6 or 7's.

    I have been with him the longest, 2 years in Jan. and the others anywhere from 1 - 1 1/2 years. While none of us have a complete cure, we all have moved forward. For that I am grateful.

    I plan on sticking around at least 1 more year and see where it takes me. The way I look at it, I don't have anywhere else to go. No one around here knows how to deal with it.:rolleyes:
  5. m1she11e

    m1she11e Senior Member

    Messages:
    309
    Likes:
    87
    Florida
    Valcyte

    My doctor in Orlando still wants me to do Valcyte. I tried it before and got too sick to stick with it. He also treats Mycoplasma infections at the same time. He is clear that when you use Valcyte that the other infections can go wild so you have to treat them both.

    I told him I thought that Valcyte was considered a dud and that Montoya kind of dropped out of the picture. My doctor said that he himself had gotten frustrated with the Valcyte die off reactions. He spoke with Montoya who told him he has totally changed his view on the protocol and starts VERY slow.
    In cases like mine where the HHV6 is VERY high he starts as low as a half of a pill twice a week. He finds people get through the die off time easier and recover better in the end this way.

    I am still not convinced at all that I want to go that route. I asked my doctor about my already low white cell count. He said he saw white cells drop in the beginning of treatment when he treated with higher doses from the get go. He also said that they always came up higher than base line after a few months of taking Valcyte. He told me with the new very low starting doses that the white cells seems to just slowly climb and never take a nose dive.

    That is what he is telling me. I still am very afraid of Valcyte as after only trying it for a short time (less than a month) I have declined greatly. This was over a year ago.

    Anyway that is the word on Valcyte and Montoya according to my doctor.

    Im glad some one started this thread as I was wondering if everyone had just dumped the Valcyte all together...

    Michelle
  6. Robin

    Robin Guest

    kelly

    Thanks for replying Kelly, I'm glad you've gotten some relief from your chest pain/cardiac infection! Wow, that sounds scary. I'm also very glad to hear that you're not relapsing since you've stopped taking it, a concern I've heard about ampligen.

    The only way I could try Valcyte would be if it was approved for clinical treatment by insurance, so I'm interested in the Montoya trial. I wonder if the improvement would be significant enough in the second trial to beat placebo?

    Unfortunately, I don't have the physical or financial means to see Dr. Lerner. Valcyte looks expensive but it seems like there might be a generic in Canada? Did you pay out of pocket or did insurance cover it?

    I was a 5 but after a severe relapse have been a 2 for several months, so a 4 sounds good to me! Thanks for the info.
  7. Robin

    Robin Guest

    kelly

    Sorry double post!
  8. consuegra

    consuegra

    Messages:
    98
    Likes:
    25
    valcyte

    At the recent NJCFS/ME conference, Dr. Enlander said that he had treated 120 patients with Valcyte without any negative incidents. I think he was referring to elevated liver enzymes. At the moment I do not know his dosing schedule but he says that about 40% of these patients respond positively. He is in contact with Dr. Montoya.

    Dr. Guyer also uses Valcyte but is very careful with it and starts at lower doses and builds up. From what I can gather he believes it is a useful tool. Dr. Guyer makes great efforts to make sure that the patient's immune system is strong enough for Valcyte. He has had to deal with several Montoya patients that have been wiped out by large doses of Valcyte. In other words, Dr. Guyer believes the absolute opposite of what Dr. Montoya did (with seemingly so little response in the Roche trial). From what others say here, it seems now that Dr. Montoya has altered his dosing.

    Chris


    http://cfspatientadvocate.blogspot.com
  9. acer2000

    acer2000 Senior Member

    Messages:
    570
    Likes:
    201
    So... Montoya presented his findings of the larger study at the HHV6 meeting about a year ago. Although at that time they were preliminary. Supposedly he was going to publish a paper regardless of the outcome of the study. Did this every happen?
  10. Robin

    Robin Guest

    Nothing in pubmed, yet.

    I looked up the HHV-6 conference summary and here's what was presented:

    At the Baltimore Conference, the same group from Stanford University reported on a randomized, placebo-controlled trial. The study had ended just before the conference began, and only a small amount of the data had been analyzed. The patients who received the valganciclovir seemed to improve more than the patients given placebo, but further analysis of the data is required to determine the results of the study.

    That was in June 08. Not sure how long it takes to analyze, write, and submit a study for peer review. Some people have suggested that he's revised his protocol so a lot is unknown at this point.

    EDIT: I sent Kristen Loomis of the HHV-6 foundation an email to ask her about it. She responded (she is very nice!), and obviously couldn't reveal the study results, but said that Dr. Montoya has written up a draft and is continuing to follow patients.
  11. Cort

    Cort Phoenix Rising Founder

    Messages:
    7,025
    Likes:
    432
    Raleigh, NC
    The second more thorough study basically bombed. My understanding is that Dr. Montoya extended the study from 6 months to a year because Dr. Lerner and others have found that while many patients see improvement in their immune functioning and reduced viral presence in 6 months it often takes a year or so for the patient to actually feel better.

    That conference was in May of 2008; its been a year and half since he presented his 6 month findings. I don't know why its taken so long.

    http://aboutmecfs.org/Conf/HHV6PtI.aspx

    Dr. Lerner will come out with a paper soon indicating that co-infections are very important; if you have another infection then Valcyte is not going to work very well - you need to take care of that one as well.
  12. cfs since 1998

    cfs since 1998 *****

    Messages:
    577
    Likes:
    4
    I wouldn't say it bombed because there was a statistically significant improvement in cognitive functioning. So it is doing something although it is not effective as we would like. And when you say the study was extended from 6 months to a year, that is misleading, because I believe what was meant by that was that the patients took the drug for 6 months and then were followed up for another 6 months after they stopped taking it. As Dr. Lerner has said, that is really too short. It takes a good 8-9 months even for Ampligen to work. At 6 months there was not a significant difference between Amp and placebo.

    Thanks for this info, I heard he was coming out with a new paper soon but did not know the specific topic.
  13. Carlie

    Carlie Guest

    Medical Contacts

    Hi,

    I have been actively sick since 2000. For four years (2002 - 20006) I slept on my couch because it was too painful to sleep on a flat surface like a bed.

    However, without any treatment other than thyroid hormones and a great deal of rest, I have improved greatly. That is the short version of a long story.

    My immunologist is aware of Montoya's work. Who are the other doctors that are referred to in this tread and how may we contact them?

    As I read the thread I saw the names Lerner, Enlander and Guyer. Are there others?

    I would like my doctor to speak with physicians who now have some experience with Montoya's protocol.

    Thanks for your help.

    Carlie
  14. slayadragon

    slayadragon Senior Member

    Messages:
    1,083
    Likes:
    362
    twitpic.com/photos/SlayaDragon
    Valcyte

    Cheney says the reason that Montoya's first study was successful and the second was not was because the patients in the second study had been sick longer.

    A little update on my own Valcyte progress.

    I've been doing mold avoidance for about two years. I think of that as serving as basis for anything else I try.

    I don't know if other people need to pursue mold avoidance at the level that I am in order to make improvements, but I am certain that they're not going to make any progress at all if they're living in an moldy environment.

    Anyway, back in July, I tried Famvir. I was unable to take even a small amount back when I was living in my moldy house.

    The Famvir made my mold reactivity go up for three days. Then the mold reactivity went way down. That was quite welcome.

    In October, I added Valcyte to the Famvir. My mold reactivity went way up, so I went to the "lowest-mold" wilderness I could find (Death Valley).

    I did fine on 900 mg for about a month. I got a bit of tiredness, like a normal person would on a heavy-duty drug.

    At the end of November, the outside air got a bit of "bad mold" in it. Even in the best places, mold can be a problem in the winter.

    I decided to go down on the dosage for a little while, to 450 mg. That's been wholly tolerable. I'm thinking that soon I will raise it back again.

    My guess/hope is that eventually the Valcyte will lower my mold reactivity below where it was when I started the drug. A die-off reaction is typical of that drug, and it seems to take a long time under the best of circumstances to get the viruses under control.

    Regardless of whether it affects my mold reactivity, it's been a great thing for me in terms of my cognitive abilities. Those never returned to anywhere near my "pre-morbid" levels. Within just a few weeks after starting the Valcyte, they improved dramatically.

    More recently, I added some melatonin. This never did anything for me back in my pre-avoidance days, but the change this time is remarkable. My cognitive functioning now feels wholly like it did before I got sick, when I was excelling in a seriously rigorous Ph.D. program. I'm now buzzing through academic articles, quickly absorbing new information, piecing it together, writing clearly, focusing on work from the time I get up until when I go to bed, and remembering clearly what I've been working on.

    Hopefully it will last.

    Quite frankly, I'd rather live in the wilderness (an exaggeration) forever and keep my brain. It's a real pleasure to have it back.

    I've had CFS since 1996 and was very severely ill for a time. So I have to take a bit of issue with Cheney's comments. But I don't think he's ever seen anyone who's pursued my way of getting well either.

    Dale Guyer is my prescribing doctor for the Valcyte. He does often recommend smaller amounts of Valcyte and gave me the freedom to take as much as I can tolerate.

    Best, Lisa
  15. CBS

    CBS Senior Member

    Messages:
    1,362
    Likes:
    230
    Western US
    Stability and significance


    I refuse to use the term statistical significance and instead use the terms statistically stable and clinically significant. Statistics are measures of probability and one needs to know if they are stable. Only clinical results of a certain magnitude are significant and worth pursuing.
  16. m1she11e

    m1she11e Senior Member

    Messages:
    309
    Likes:
    87
    Florida
    My doctor keeps pushing the Valcyte issue with me. He cant even give me many cases of people getting well from it. Still he thinks my HHV6 levels are so high that I should do the Valcyte. He wants me to start with half a pill twice a week since last time I tried it I was so sick after just one pill.

    I am scared to death of the Valcyte as almost any "killing" brings on my numbness and tingling. I never know what to consider "die off" or getting worse.

    So, in general, are top docs still prescribing Valcyte? I dont see many new posts on it anywhere. Are people holding out for a better anti viral? I cant seem to figure out where HHV6 falls into the equation anymore and what the best way to treat it. I have all the natural anti virals and have never noticed any difference.

    Yes or No on Valcyte these days?????
  17. gracenote

    gracenote All shall be well . . .

    Messages:
    1,508
    Likes:
    42
    Santa Rosa, CA
    I took Valcyte for seven months. I had higher than normal EBV and HHV6 numbers, but it was my very high CMV results that got the medication approved and paid for.

    I started slowly and built up. I had to lower my dose a few times because of scary labs. I didn't have the numbness and tingling you mention, but initially I had more fevers.

    It didn't help with fatigue at all, but I now rarely have elevated afternoon temps (up to 99.4) that made me feel quite feverish and unwell, and it seems to have helped with some of my cognitive symptoms.

    I would do it again, but this is such an individual choice. If you do decide to go on it, make sure and keep up on labs every week to start and then every two weeks.

    Gracenote
  18. m1she11e

    m1she11e Senior Member

    Messages:
    309
    Likes:
    87
    Florida
    Another visit to the doctor and another push for Valcyte. He said he has treated around 500 people with Valcyte now. He also said that with the "go slow" method he has not seem one case of elevated liver enzymes or a drop in WBC's. He actually said that over time the WBC's begin to climb slowly. He is also a very humble man (yes, and a doctor...wow!). I asked him how many people get any improvement on Valcyte cause Im not seeing it on line. He said that about 75% feel a significant improvement but we didnt talk Lerner scales or any of that. He also said he is not seeing the relapses when co infections are addressed.

    The other thing that I found interesting is that he used to not be into Cortef and all the adrenal stuff. He has also found now that starting a person on Cortef first for about a month helps them to tolerate the Valcyte much better. He has had to take people off of Valcyte that were getting too sick, put them on Cortef for a month and restart them. He said they almost always can tolerate Valcyte after the addition of the Cortef.

    Im still not ready to dive in. I am going to do the Cortef for awhile and try to build my immune system as I have been doing and then decide in a month. It is just interesting that my doctor has treated so many with Valcyte with success and I know Lerner and Peterson and others are treating hundreds with Valcyte but we just dont see much good about it on these boards. We dont see much about it at all.

    Michelle
  19. consuegra

    consuegra

    Messages:
    98
    Likes:
    25
    I think the hype on Valcyte died down after Montoya's preliminary report in June 2008 was so disappointing. I think Valcyte remains part of the arsenal for viral involvement in CFS/ME.

    Dr. Enlander said in October 2009 that he has used Valcyte in 120 patients and that about 40% showed "improvements". He also said that there were no side effects, which I assumed meant that his patients did not have elevated liver enzymes as a consequence of taking the Valcyte.

    De Meirleir gives Valcyte to many patients.

    Dr. Guyer gives Valcyte to many patients. Dr. Guyer goes quite slow in dosage, always with an eye on the larger picture of immune/gut integrity.

    Dr. Lerner uses Valcyte regularly.

    From what I understand Dr. Montoya uses Valcyte at lower and slower dosages than he did awhile ago.

    Chris

    http://cfspatientadvocate.blogspot.com
  20. Navid

    Navid Senior Member

    Messages:
    409
    Likes:
    58
    i'm going to start valcyte. i want to titrate up the dose altho my doc is not 100% w/this idea, he will support it. i'm just afraid of the "feeling worse at first" part....how much worse?

    i have not really ever gone after my hi viral titres (cmv, ebv, hhv6 and parvo) w/mainstream pharmaceuticals, so i figure i gotta give it a shot.

    keep your fingers crossed for me that "feeling worse at first won't be too bad!!!!!

    thanks, lisa

See more popular forum discussions.

Share This Page