Valcyte observations from conference

Discussion in 'Fibromyalgia Main Forum' started by dvdav2000, Jan 15, 2007.

  1. dvdav2000

    dvdav2000 New Member

    Hi all,
    Ok.. lets start commentary on Valcyte.
    First, the HHV-6 Foundation seems to be taking a great interest and a " correctly paced " lead on bringing Valcyte, and other forms of the drug to the spotlight. I met the HHV-6 foundation people and appreciated their participation in the conference. Dr. Ablashi ( who discovered HHV-6) is scientific advisor, Dr. Montoya will be conducting the study at Stanford, Dr. Susan Levine, and others have done recent studies associated with testing procedures and the like.
    Dr. Jose Montoya of Stanford has been awarded a 1.5 million dollar grant ( from Roche pharma., the maker ) to do a 6 month double blind study starting the first quarter of 2007. From what I learned they are targeting HHV-6, and related virals associated with CFIDS. Dr. Montoya said we are at the beginning of this exciting research.

    I will add more info. as I review my notes. There was alot of presentation, and discussion regarding the Valcyte family of drugs.


    [This Message was Edited on 01/15/2007]
  2. Forebearance

    Forebearance Member

    The study is really exciting! I bet this drug will help a lot of people.

  3. phoenixrising2

    phoenixrising2 New Member

    I don't know anything about Valcyte, but I would like to hear what everyone has to say.

    dvdav: I'm looking forward to reading the info from your notes.

  4. foxglove9922

    foxglove9922 New Member


    Just saw a segment on the local news saying "ground breaking cure of CFS" from conference in Florida. Valcyte will cure CFS......yup......just about that short.

    I'm a patient of Dr. Levine and she is proceeding cautiously with this AV. Sounds promising.....keeping my fingers and toes crossed.

    Basically, what I've heard is all of the small number of PWC treated with this med have been cured. Now a larger double blind study needs to be put into place.

    I guess it's called HOPE and hope in itself is some powerful medicine.

    Would be interested in what others have to say about this. Isn't this the drug of choice used by Dr. Lerner?

    Best wishes,

  5. spacee

    spacee Member

    That everyone has been waiting for. (My opinion). In one of my earlier posts, I said that we will have funding when a drug company has an interest in us. Now, we have one!!! And at Stanford University at that. This is good news.

    When you check your notes, could you mention anything you heard about side effects, how long patients took the drug.



  6. foxglove9922

    foxglove9922 New Member

    Bumping for a response to Spacee's question......

    So many questions? dosage? durantion? side-effects? total recovery to previous state?

    This is the FIRST promising thing I've heard of in quite some time......

    Hoping for responses.

  7. dvdav2000

    dvdav2000 New Member

    Hi All,
    Valcyte is very strong stuff. It could effect the marrow in the body and must be monitored very carefully through lab work... with that... some of the pro's at the conf. were excited about it... there was very active, interesting, and lively discussion.
    Another concern is prescribing it when there is not enough, or perceived false positive labs. Patients can start saying " let's give it a try " and pro's would be in a tough spot. I know that even some of the best prescrip. programs will not cover it. The study Dr. Levine has been conducting is starting to " smoke " out the variables in HHV-6, and EBV testing. When I get my conf. DVD, etc. I will amplify further. That should arrive within 10 days.

    It all looks promising... Dr. Montoya is doing the 6 month double blind, there is awareness in the media, it was a major topic at the CFS conference, and the HHV-6 foundation is ( from what I have seen ) very pro-active in getting the info., and data out there.

  8. pawprints

    pawprints New Member


    I was also at the conference and that was the main thing I took away. His original study was not double blind. The new one will use the drug for 6 months and be double blind.

    As you are also from Florida, I wondered if you think any local doctor would treat using this drug prior to the results being published from the study? The drug is available now and the toxicity is low, except blood tests for the WBC must be monitored carefully. They also said patients who responded got worse initially.

    It was alot of information to absorb but hopefully the HHV6 Foundation is moving things along.

  9. foxglove9922

    foxglove9922 New Member

    Hi Folks,

    Got this off the Stanford University Website

    New therapy for chronic fatigue syndrome to be tested at Stanford
    STANFORD, Calif. — A preliminary study suggests there may be hope in the offing for some sufferers of chronic fatigue syndrome with a new therapy being tested by researchers at the Stanford University School of Medicine.

    José Montoya, MD, associate professor of medicine (infectious diseases), and postdoctoral scholar Andreas Kogelnik, MD, PhD, have used the drug valganciclovir — an antiviral often used in treating diseases caused by human herpes viruses — to treat a small number of CFS patients.

    The researchers said they treated 25 patients during the last three years, 21 of whom responded with significant improvement that was sustained even after going off the medication at the end of the treatment regimen, which usually lasts six months. The first patient has now been off the drug for almost three years and has had no relapses. A paper describing the first dozen patients Montoya and Kogelnik treated with the drug was published in the December issue of Journal of Clinical Virology.

    “This study is small and preliminary, but potentially very important,” said Anthony Komaroff, MD, professor of medicine at Harvard Medical School, who was not involved in the study. “If a randomized trial confirmed the value of this therapy for patients like the ones studied here, it would be an important landmark in the treatment of this illness.”

    Montoya has received a $1.3 million grant from Roche Pharmaceutical, which manufactures the drug under the brand name Valcyte, to conduct a randomized, placebo-controlled, double-blind study set to begin this quarter at Stanford. The study will assess the effectiveness of the drug in treating a subset of CFS patients.

    Montoya is speaking about his efforts at the biannual meeting of the International Association for Chronic Fatigue Syndrome in Fort Lauderdale on Jan. 11 and 12.

    Chronic fatigue syndrome has baffled doctors and researchers for decades, because aside from debilitating fatigue, it lacks consistent symptoms. Although many genetic, infectious, psychiatric and environmental factors have been proposed as possible causes, none has been nailed down. It was often derided as “yuppie flu,” since it seemed to occur frequently in young professionals, though the Centers for Disease Control and Prevention says it’s most common in the middle-aged. But to those suffering from it, CFS is all too real and its effects are devastating, reducing once-vigorous individuals to the ranks of the bedridden, with an all-encompassing, painful and sleep-depriving fatigue.

    More than 1 million Americans suffer from the disorder, according to the CDC. The disease often begins with what appears to be routine flulike symptoms, but then fails to subside completely — resulting in chronic, waxing and waning debilitation for years.

    Valganciclovir is normally used against diseases caused by viruses in the herpes family, including cytomegalovirus, Epstein-Barr virus and human herpes virus-6. These diseases usually affect patients whose immune systems are severely weakened, such as transplant and cancer patients. Montoya, who had used the drug in treating such patients for years, decided to try using it on a CFS patient who came to him in early 2004 with extremely high levels of antibodies for three of the herpes family viruses in her blood. At the time, she had been suffering from CFS for five years.

    When a virus infects someone, the levels of antibodies cranked out by the immune system in response typically increase until the virus is overcome, then slowly diminish over time. But Montoya’s patient had persistently high antibodies for the three viruses. In addition, the lymph nodes in her neck were significantly enlarged, some up to eight times their normal size, suggesting her immune system was fighting some kind of infection, even though a comprehensive evaluation had failed to point to any infectious cause.

    Concerned about the unusual elevations in antibody levels as well as the swelling of her lymph nodes, Montoya decided to prescribe valganciclovir. “I thought by giving an antiviral that was effective againstherpes viruses for a relatively long period of time, perhaps we could impact somehow the inflammation that she had in her lymph nodes,” said Montoya.

    Within four weeks, the patient’s lymph nodes began shrinking. Six weeks later she phoned Montoya from her home in South America, describing how she was now exercising, bicycling and going back to work at the company she ran before her illness. “We were really shocked by this,” recalled Montoya.

    Of the two dozen patients Montoya and Kogelnik have since treated, the 20 that responded all had developed CFS after an initial flulike illness, while the non-responders had suffered no initial flu.

    Some of the patients take the drug for more than six months, such as Michael Manson, whose battle with CFS has lasted more than 18 years. The former triathlete was stricken with a viral infection a year after his marriage. After trying unsuccessfully to overcome what he thought were lingering effects of the flu, he had no choice but to drastically curtail all his activities and eventually stop working.

    During his longest period of extreme fatigue, 13½ weeks, Manson said, “My wife literally thought I was passing away. I could hear the emotion in her voice as she tried to wake me, but I couldn’t wake up to console her. That was just maddening.”

    Now in his seventh month of treatment, Manson is able to go backpacking with his children with no ill after-effects. Prior to starting the treatment, Manson’s three children, ages 9 to 14, had never seen him healthy.

    Montoya and Kogelnik emphasized that even if their new clinical trial validates the use of valganciclovir in treating some CFS patients, the drug may not be effective in all cases. In fact, the trial will assess the effectiveness of the medication among a specific subset of CFS patients; namely, those who have viral-induced dysfunction of the central nervous system.

    “This could be a solution for a subset of patients, but that subset could be quite large,” said Kristin Loomis, executive director of the HHV-6 Foundation, which has helped fund a significant portion of the preparatory work for the clinical trial. “These viruses have been suspected in CFS for decades, but researchers couldn’t prove it because they are so difficult to detect in the blood. If Montoya’s results are confirmed, he will have made a real breakthrough.”

    “What is desperately needed is the completion of the randomized, double-blind, placebo-controlled clinical trial that we are about to embark on,” Montoya said.

    People interested in participating in the clinical trial must live in the San Francisco Bay Area. More information about the clinical trial is available online at

    Dr. Levine told me is concerned about bone marrow loss and will be closely monitoring any patient with this protocol.

  10. Slayadragon

    Slayadragon New Member

    My doctor has used all the anti-virals, including Valcyte. I am currently on the AV Famvir and am going to be moving to Valcyte in a few months.

    He said that Famvir is extremely similar to Valcyte but less potent (in terms of efficacy and side effects). I agree that the strategy of using Famvir to knock off a lot of viruses and Valcyte to get rid of more seems a good one.

    (Montoya apparently does not agree with this. See my post "A Strategic Plan to Getting Truly Well" for a comparison of the approaches.)

    My doc has used Valcyte on 35 patients and has yet to see bone marrow problems. He was under the impression that neither Dr. Lerner, Dr. Montoya or Dr. Petersen have seen this either.

    Delia says that her doctor, Dr. Brewer, has used Valcyte for some time and has not seen any bone marrow problems either.

    I am giving detailed reports of my AV experiences, and will continue to do so when I start on the Valcyte. The current ones are titled "Famvir Status Report Week X."
  11. mezombie

    mezombie Member

    As I fall within the CFS subgroup Montoya is studying, I can't help but feel optimistic!

    And the study is getting reported throughout the world: A story was published in the International Herald Tribune within the last 24 hours or so!

    I look forward to his results, as well as any feedback from board members who have tried Valcyte. As others have said, many questions remain.

    I'm just so thrilled that the concept of viral infection of the CNS is finally becoming more mainstream!

    [This Message was Edited on 01/16/2007]
  12. foxglove9922

    foxglove9922 New Member


    Dr. Levine has personally told me she has seen the bone marrow problem with Valcyte. You must be monitored closely on this med.

  13. Slayadragon

    Slayadragon New Member

    My doctor does monitor closely, of course. Thanks for the info regarding Dr. Levine's having seen the problem.

    Who is Dr. Levine?

    Also, who are you working with re the Valtrex?[This Message was Edited on 01/16/2007]
  14. foxglove9922

    foxglove9922 New Member

    Dr. Susan Levine is a great doc located in Manhattan.

    She was at the conference and I have a phone consult with her later this week. Can't wait to talk to her.

  15. Slayadragon

    Slayadragon New Member

    Great to hear about someone else who's working on this.

    Please give us the details of your consult.
  16. dvdav2000

    dvdav2000 New Member

    I was at the conference... I have been a patient of Susan Levine, M.D. for over 4 years. I have sort of left the NYC area but see her at least twice a year to keep the file current. We are lucky to have her on our side. It was a pleasure to see her presentation, and say hi to her... I believe these doctors go to the conferences on " their own nickel ".... Many blessings Dr. Levine, and all who care for the ill.

  17. Slayadragon

    Slayadragon New Member

    What did Dr. Levine talk about at the conference?
  18. deliarose

    deliarose New Member

    I did not say that Dr Brewer has not seen bone marrow problems in the patients he put on Valcyte.

    I don't know whether they have or not. That issue didn't come up.

    Clearly it's a toxic drug that needs to be monitored.. but other than that, I don't have good info on it.

  19. dvdav2000

    dvdav2000 New Member

    Hi Lisa,
    Dr. Levine presented on let's say... laboratory consistency research. I think she took samples and sent to multiple lab sources ( world class international, university level, commercial lab, for consistency and accuracy. I think HHV-6, and EBV were the " ill du jour " to affirm data that the HHV-6 foundation can use.
    Levine's data was very concise.. she even threw in a younger variable ( 19 years old, her son ) to see the effect. Seems people under 25 have a natural greater activation of EBV under stress, etc. The " meat " of the study was with subjects over 25. I hope I got this right...

  20. Forebearance

    Forebearance Member

    You can find the side effects of Valcyte listed on WebMD.

    There was an article in the Paolo Alto CA newspaper on this study today. (Is it the San Jose Star? I'm not sure what it's called.)

    [This Message was Edited on 01/16/2007]

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