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9th Invest in ME International ME Conference, 2014 - Part 1: Autoimmunity and ME
Mark Berry begins a series of articles on the 9th Invest in ME International ME Conference in London, with a look at three presentations on autoimmunity
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In Brief: Viruses and ME

Discussion in 'Phoenix Rising Articles' started by Firestormm, Sep 30, 2013.

  1. leokitten

    leokitten Senior Member

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    I do agree with you on your hypothesis, as a scientist and researcher based on what I know, the research and literature I've read, and my own disease I think viruses are not the root cause.

    Just wanted to tell you there are two upcoming antivirals in late stage clinical trials which when approved by FDA for their indications will be able to be used off-label by doctors for CFS treatment. They are an improvement on the current arsenal.

    CMX001 (Brincidofovir), Chimerix, Inc.

    Lipid conjugate version of powerful and broad spectrum antiviral cidofovir. Unlike cidofovir it can be taken orally, has very good bioavailablity, much higher intracellular concentrations, and far reduced renal toxicity (due to the fact that the conjugate is cleaved releasing active cidofovir drug only inside cells, thus cidofovir isn't flowing around in the blood stream where it can get to kidneys and cause damage) http://www.chimerix.com/therapeutic-programs/category/cmx001

    Valomaciclovir (EPB-348), Epiphany Biosciences, Inc.

    Strong antiviral against many herpesviruses, looks like it might replace the much more toxic Valganciclovir for CFS treatment because it is effective against not only HSV, EBV, but also CMV and HHV-6. http://www.epiphanybio.com/

    I believe these two drugs will be approved in 2015 or so and afterwards will be used off-label for CFS treatment.
  2. SOC

    SOC Moderator and Senior Member

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    That is great news, leokitten! I didn't realize that there were 3 new antivirals which should be available in 2015. That should make a big difference for some PWME.

    It might be next to impossible for most ME/CFS patients to get access to those antivirals, though, because off-label use is frequently not covered by insurance and new antivirals are very pricey. Just look at the consumer cost of Valcyte. Very few of us can afford that and the new antivirals will be even more costly, I'll bet.

    One thing we need is better testing and test interpretation for viruses so that more doctors properly identify chronic infections. Then the antiviral use will be for the chronic infection, for which the meds would be "on-label" and therefore covered by insurance, rather than for ME/CFS, for which antivirals are considered very much off-label and not covered by insurance.
    Little Bluestem and vli like this.
  3. leokitten

    leokitten Senior Member

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    My apologies I should have been more clear... these upcoming drugs, just like Valcyte, Famvir, Valtrex, could be used by doctors off-label for chronic viral infections commonly found in CFS patients. Unless your doctor determines that your are suffering from a chronic/reactivated viral infection you should not take these medications.

    "On-label" use like use say is only for the specific indications that are FDA approved.

    Off-label use is any use that is not the specific indication(s) the FDA approved for the drug. For example if you have a chronic CMV and HHV-6 infection, Valcyte treatment is off-label because it is only FDA approved for AIDS-related CMV retinitis and transplant associated CMV organ disease. Insurance will still cover it because it is a "reasonable" use of the drug since your doctor believes, based on examination, symptoms, and antibody tests, that you have a chronic infection of viruses that will respond to Valcyte treatment.
    aimossy and SOC like this.
  4. Sushi

    Sushi Moderator and Senior Member Albuquerque

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    Thanks leokitten,

    Earlier this year we were told that CMX001 was being "fast-tracked" and might even be available late this year. Do you have a way to check on this and let us know if 2015 is still the projected date on this drug?

    Thanks,
    Sushi
    aimossy, SOC and vli like this.
  5. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    Im guessing that they will be more expensive then valcyte is right now but these drugs could drop the price of already available drugs?? That could be good for those who want to use valcyte.
    I know valcyte is generic in India as they didnt obey the patent laws but anyone know when valcyte goes generic in the rest of the world?;)
  6. leokitten

    leokitten Senior Member

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    No 2015 is the earliest date it can be approved, here's why:

    FDA fast tracking means that after all the clinical trials are completed and results are in which show efficacy and safety then after this does an accelerated "fast track" process occur within the FDA to get the drug approved.

    Chimerix just announced the study design for their CMX001 SUPPRESS Phase III clinical trial which I believe will be the last one. Results from this trial won't be in until 2015 and only after this if everything is good will the FDA fast track drug approval.

    Please read more here: http://ir.chimerix.com/releasedetail.cfm?ReleaseID=789441

    Sushi and Valentijn like this.
  7. leokitten

    leokitten Senior Member

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    I don't think you will have to wait until 2015 for cheaper Valcyte.

    Technically Roche's patent for Valcyte expires in 2015, but there have already been lawsuits filed by generic firms Ranbaxy and Sandoz challenging this. I believe Roche settled out of court with Ranbaxy and Ranbaxy will get FDA approval to start making a generic version this year in 2013. But I remember reading in the news that Ranbaxy is delayed in launching the drug so lets say 2014?

    As you might know since Ranbaxy was the "first to file" for generic approval they will be given 180 day marketing exclusivity for the generic version, read more here:

    http://www.prnewswire.com/news-rele...nciclovir-hydrochloride-tablets-57542227.html

    http://www.business-standard.com/ar...-boost-likely-for-ranbaxy-113032500013_1.html
  8. Waverunner

    Waverunner Senior Member

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    Thanks for your comments, Leokitten. May I ask what you think about the cause of CFS? For me it seems, that CFS is a highly heterogeneous disease. Patients get labeled as PWCs very easily. CFS may be an outflow of a lack of diagnostics and a lack of molecular understanding of disease. Only a few years ago it was found out, that breast cancer is not one disease, but at least ten different diseases with distinct genetic and molecular differences. Could it be, that CFS is not one disease but hundreds of diseases? Or do you think, that CFS mostly has the same cause?
    Firestormm likes this.
  9. RUkiddingME

    RUkiddingME Senior Member

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    hey heaps! hope you are doing well. I'm in Canada and my insurance plan wants me to switch to the generic which became available here last month by Apotex (Canadian company)
    SOC likes this.

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