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Drug Combo in Pridgen Antiviral Fibromyalgia Trial Identified – Some Results Available

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Reprinted with the kind permission of Cort Johnson and Simmaron Research.

A lengthy article originating on the University of Alabama website and an abstract presented to the American College of Rheumatology Conference indicates that the two drugs Dr. William “Skip” Pridgen and virologist Carol Duffy, PhD used in their Fibromyalgia antiviral trial were famciclovir, better known as Famvir and celexicob, best known as Celebrex.

The report also indicates that Duffy found only herpes simplex-1 viruses (HSV-1) in the gastrointestinal tissues of the FM patients. Neither of these drugs nor this type of herpes virus have been commonly used or associated with chronic fatigue syndrome.

We also learned Pridgen discovered the two drug combo similar to the way Fluge/Mella uncovered Rituximab in chronic fatigue syndrome – by observation. Suspecting that herpes viruses might be to blame for the gastrointestinal issues in his patients, Pridgen started them off on Famvir. The drug helped but symptoms remained.

After Pridgen noticed much greater improvement in the symptoms of the patients also put on Celebrex for their arthritis he combined the two drugs – for everyone.

In the University of Alabama article, Duffy reported the improvement on the two drug combo was immense.

“The patients who took both drugs, however, came back and said everything was better. Their fibromyalgia was gone. Their chronic fatigue was gone. Their headaches were gone. All of these things had cleared up. When the first few patients approached him, he thought it was a fluke, but as more and more and more patients said the same thing, he knew it couldn’t be a coincidence.”

The Triad

That drug combo never been used in herpes virus infected patients before, but it made sense to Duffy. She knew that some herpes viruses increase the production of COX-2, a pro- inflammatory enzyme. While Famvir stopped the herpes viruses from replicating, Celebrex weakened the viruses, making them “unstable”. Since Celebrex also has some antiviral properties, the drug combo hit the virus in three ways.

Famvir

Valtrex, Valcyte and Vistide are often used to treat herpesvirus infections in chronic fatigue syndrome but Famvir is rarely mentioned. (Dr. Dantini appears to use Famvir frequently to treat his ME/CFS/FM patients.)

One of the reasons may be that Famvir is mostly used to treat herpes virus infections such as herpes simplex virus, herpes simplex virus 2 (genital herpes) and herpes labialis that have not been typically associated with ME/CFS.

The Newcomer – Herpes Simplex

Duffy scoured the gastrointestinal tissues of 45 patients for a virus. In the end it wasn’t EBV, cytomegalovirus or HHV-6 that showed up, but herpes simplex virus-1 (HSV-1) – the very virus she’s been studying in her lab. (That’s a little scary, but a technique called immunoblotting was used to ensure contamination had not occurred.)

Herpes simplex virus is best known for its ability to cause cold sores and genital herpes, but according to a Wikipedia article can also cause herpetic whitlow, herpes gladiatorum, ocular herpes, cerebral herpes infection encephalitis, Mollaret’s meningitis, neonatal herpes, and possibly Bell’s palsy.

HSV-1 can infect various organs in the body including the peripheral and central nervous systems, upper respiratory tract, and gastrointestinal tract. It may play a major role in Alzheimer’s. It’s able to deplete mitochondrial DNA. One article suggests herpes simplex virus may be better adapted to take advantage of poorly functioning natural killer cells than any other herpes virus.

The group believes HSV-1 may be responsible for fibromyalgia, irritable bowel syndrome, chronic fatigue syndrome and perhaps other disorders. A video on the Innovative Med Concepts website indicates the virus can attack the facial, gastrointestinal and pelvic regions and that it ultimately takes up residence in the vagus nerve.

It took Pridgen and Duffy about a year to raise the $4 million dollars for the 100 person plus phase II trial to assess the drug combo’s efficacy and safety. Along the way they enrolled a member of the drug team that brought Savella to market in FM, and a past president of Pfizer in their effort at Innovative Med Concepts. Noted FM researcher Daniel Clauw joined their advisory board.

Conference Abstract Provides Results

An abstract presented at the ACR conference in November suggested the drug combo produced strong improvement in some measures and not as strong improvement in others. The changes in pain using the revised Fibromyalgia Impact Form appeared impressive (p< 001) as did changes in function and symptoms (p<.004) and overall impact (p<.003). Fatigue was significantly improved but less so (p<.02).

However, only 33% of patients (vs 19% of those not on it) met the criteria for a secondary measure called the Global Impression of Change Scale which asked about changes in a person’s activity, limitation, symptoms, emotions and quality of life. It’s not clear how to parse the more impressive results in some of the tests with less impressive results in the last one.

The drug combination was judged very safe with more adverse events found in the placebo group than in the patients taking the drug.

Improving Efficacy Efforts Underway

If the trial wasn’t a complete win it nevertheless produced significant improvements in a notoriously difficult to treat illness. Since fibromyalgia, like chronic fatigue syndrome, is believed to be a quite heterogeneous illness asking any drug or drug combo to be effective in everyone is unrealistic.

Phase III Trial Will Tell the Tale

Designed to assess basic aspects of efficacy and safety, Phase II trials are not the last word in efficacy. As the Pridgen/Duffey team proceeds to the Phase III trial they’re exploring several ways to bump up efficacy. Duffy is working on diagnostic tests to identify which FM patients are most likely to benefit from the combo, and is doing toxicology tests to determine if higher doses are feasible. The optimum doses of the drug combo will also be determined in the Phase III trial. Expect efficacy rates to rise.

Big Trial Ahead

Next up is the big third phase trial – a jaw dropping $50-100 million trial the FDA needs in order to approve the drug combo for the treatment of fibromyalgia.

No one is satisfied with the state of fibromyalgia treatment – and few have looked to the immune system or to pathogens. If the results of this trial are not breathtaking – they are still very good – and will hopefully improve as the therapy becomes better targeted. They should begin to prompt a revaluation of what’s going on FM.

The publication of the study is probably just around the corner….

_______________

About the Author: Cort Johnson has had ME/CFS for over 30 years. The founder of Phoenix Rising and Health Rising, Cort has contributed hundreds of blogs on chronic fatigue syndrome, fibromyalgia and their allied disorders over the past 10 years. Find more of Cort’s and other bloggers’ work at Health Rising.

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21 thoughts on “Drug Combo in Pridgen Antiviral Fibromyalgia Trial Identified – Some Results Available”

  1. caroli says:

    I have suffered with fibromyalgia for over 13 years. When I have taken Famvir for internal shingles, I always feel 100% better. I would tell my doctor, “Can’t I just keep taking this? I have absolutely no fibromyalgia or face pain when I am on Famvir.” But of course he would not allow me to do that. Only the 14 days. I would continue to feel better for a few weeks after and then I would get my pain back. Phase III can not go fast enough for me! I truly believe this is the key! I sure wish I could participate. Carol

  2. endfatigue says:

    We have been using antivirals Valcyte and Famvir (750 mg 3 x day for Famvir) for many years in selected folks with CFS/FMS with good success, while Valtrex was not helpful. We started adding the Celebrex around a year ago with added benefit. We usually give it for 4-6 months, then continue if needed, along with the rest of the SHINE protocol

    1. Kelly_May says:

      What are the dosages of each drug you administer? What is the SHINE Protocol?

    2. jmcqueen54 says:

      I’ve had FMS for over 30 years. I tend to believe this trial has hit it head on! I also have HSV and suffer chronic fatigue severely when the virus flares up! I’ve taken Acyclovir for the virus but it doesn’t effectively treat my symptoms. I’m so tired of the pain, depression and severe fatigue associated with FMS along with a myriad of other symptoms. They need to find an effective treatment by now! I also wish I could participate in phase III trial!

  3. ISUMI says:

    Does anyone reading this know how I could get on the wait list to participate in the trials???

  4. EndFMCF says:

    I too would like to know how you can participate in this drug trail? I am a FM and CFS suffer for 28 years now. I have myofascial pain and have been off all medications because I have not had insurance coverage.

  5. crzynana says:

    I have had fibromyalgia and fatigue for 15 years. I would love to be involved in this study.

  6. bilgre534 says:

    Does anyone else that has Fibro , also have ongoing stomach problems ( IBS) , in particular ? I have had Fibro for approx 17 years; before I was diagnosed with Fibro, I was told by Gastro Dr I had IBS. Never I’d I put the 2 together but now I’m reading that maybe it goes hand in hand. Please share your experience , if you can.
    Thank you

  7. angelofhealth says:

    Cort Johnson founded PhoenixRising but was subsequently forced out due to small-minded, petty, back-biting individuals at that site. I would not endorse them.

    Cort now owns HealthRising. I think fibromyalgia and chronic fatigue sufferers should know that bit of information before being sucked in.

  8. BeckieC says:

    I suffer Gulf War Illness, a subset of CFS. Gut problems are my most consistent and primary complaint right behind “chronic exhaustion”. I found that mainstream docs diagnose all gut problems as IBS, regardless of medical procedures results that prove otherwise. CT scans of my lower abdomen over the course of 15 years were useless in detecting clear infections that appeared as strips and rings of clear cellophane along with stool. All the while, gut problems in CFS are caused by multiple infections (both viral and bacterial); parasite infestations and microbes (some associated with mycoplasma infections); and systemic fungus, frequently triggered by misapplication of antidepressants. Since the CDC reclassified CFS to Office on Women’s Health in 2010, CFS no longer includes mental illness or clinical depression. CFS patients suffer diminished adrenal glands and low levels of cortisol, while clinically depressed patients suffer enlarged adrenals and over-production of cortisol. IBS is a rare condition compared to the much smaller number of IBS cases accurately diagnosed. IBS is a diagnosis of exclusion: Diagnosed after scopes, biopsies, and MRIs have proven there is no damage or inflammation to any other sections of the digestive tract, or to any other organs associated with digestion: pancreas, bile duct, liver. The CDC does not classified IBS as a disease at all. IBS is a set of symptoms limited to large intestine and rectum, specifically constipation and / or diarrhea. Any time the digestive tract shows damage, inflammation, or infection ahead of the large intestine and rectum, IBS should automatically be ruled out. A civilian hospital doc wrote in my medical records that I suffered both IBS and unspecified gut infections by chronically inflamed duodenum from biopsies or scopes of my small and large intestines. That was just 18 months after military-grade Hep B cocktail vaccines destroyed my immune system and my entire digestive tract ahead of large intestine / rectum. To date, my large intestine and rectum are the only parts of my digestive tract without disease or dysfunction or chronic pain. I have never heard of anyone being hospitalized for constipation and / or diarrhea associated with IBS or with dysfunction of the large intestine and rectum. By CDC definition of CFS, there is no association between the large intestine / rectum and CFS. In 2010, the CDC changed the definition of CFS symptoms to “irritable bowel” instead of IBS. IBS has long been thought to be “in your head”, closely associated to women’s poor health. CFS is caused by a number of viruses, several associated with vaccines that mothers and offspring patients received throughout their lifetimes. CMV is one of several incurable viruses that cause CFS. CMV is the green African virus found in a variety of vaccines cultured on green African monkey kidney tissue. Monkeys are the only source of CMV infection. Any mother who has received any vaccine cultured on monkey kidney tissue can pass the virus to her unborn fetus. There is no cure for CMV. And symptoms of CMV are almost a duplicate of EBV symptoms: fatigue; specific and “sensitive” white cell counts; open and oozing salivary glands; tenderness anywhere near salivary glands; tender lymph nodes on both sides or back of the neck; gut disturbances; reactivation when CMV or EBV begin “shedding” phases. CMV presents with debilitating fatigue and elevated IgG and IgM levels (both active and acute viral infections). Reactivated EBV presents only once with elevated IgM levels. Shedding EBV can cause debilitating fatigue long after initial elevated blood levels have passed just the one time. CMV is a leading cause of gut disturbance, recurring or chronic infections of the small intestine, plus associated organs: bile duct, pancreas, liver, esophogus, and stomach. In addition to CMV infection throughout my small intestine, I suffered vaccine-derived pancreatitis (called “rapid transit”); systemic fungus (responds to Diflucan and mitochonizol troches); gastro-peresis (paralysis with infection of the small intestine), which responds to Metronidazol (anti-microbial prescription drug); chronically inflamed duodenum; infections near the end of my small intestine that respond to a cocktail of antibiotics (including erythromycin). I also suffer Lactose Intolerance. Omega oil capsules with lemon extract to prevent aftertaste of fish oils are extremely helpful in quieting noisy gut and soothing persistently inflamed small intestine. I found that all-natural gas enzymes are too potent for Leaky Gut Syndrome I have suffered for more than 5 years.

  9. jenindi75 says:

    Interesting!!! I have had more digestive issues recently than when I had a gastric bypass 11 years ago. They are always quick to blame the bypass. In a recent hospitalization where I had abdominal surgery, they tried telling me I had “narcotic bowel”, meaning my bowels had been compromised by my meds for FM. When they ran my information in a “prescription” data bank, they found I was NOT taking my narcotic meds as prescribed. I was barely taking them. Therefore, it could not be this “narcotic bowel”. Its terrible to have to go on a fishing expedition to find out what’s wrong with us.

  10. Boynton says:

    This really sparks my interest after years of disappointment in finding any help for fibromyalgia. I have had a very mild, infrequent case of genital herpes for decades. I have irritable bowel syndrome. I have had fibromyalgia for 14 years. All of these things are part of the medical problem that Pridgen has been studying. If these two drugs can help me, I am ready and willing to try them. Currently, all I can do for myself is eat healthy, exercise, and use hydrocodone on a very limited basis. I pray this is the answer for all of us who suffer from constant pain and fatigue.

  11. mchluvspugs says:

    I have been diagnosed and suffering from fibromyalgia since 1996. I probably contracted genital herpes when I was 19 years old. I’m now 56! I also have past or present infections of Herpes virus 6,8, CMV and EBV. I also tested positive for H. pylori (and was supposedly treated) recently. I have also tested for Candida. I have severe allergies to gluten, gold and nickel (think expensive dental ‘restorations’). I cannot work, so am poor and in bed a good portion of the time, despite a shopping bag of prescriptions and supplements. I guess I’m a germ factory! Even I find the humor in my situation or else I’d cry! I say all this not because I want pity. I want treatment! I want to get better! Help! Call me at (510)368-4606 or post a comment if you think you can help. I’ve found a few things that have helped me keep on keeping on, which I am happy to share, but I warn you, all are expensive. Pain is inevitable, suffering is not! Thank you for listening and I welcome your response! Maggie

  12. slmyck says:

    Where can a person in Canada get put on this protocol? Where in the US, would be willing to travel. Like others said, next to fatigue, IBS is my worst symptom. No relief in over 20 years. Would do anything to try the antiviral route.

  13. Kelly_May says:

    I’m printing this article out to give a copy to all 4 of my doctors! I have suffered, and I mean suffered from fibro for 22 years. It has taken away everything I love in life. CFS is a big problem for me too. I try EVERYTHING. Desperate and I’m only 42. Everyone says how can you have a baby when you can barely take care of yourself. So when I say it has taken away my dreams, that is a big one of many. Thank you for your research, I hope I can get the “cure” soon… A life without pain? I don’t know how that feels.

  14. jmcqueen54 says:

    Wow BeckieC, I’ve never found anyone so knowledgeable about their illness like you are. You mentioned something that made me wonder. When I was in the Army back in 1977, I was pregnant and all service men and women had to receive an innoculation for the Swine flu. I believe if I’m not mistaken that it was an active virus we received back then versus the dead virus everyone receives now in their flu shot. I recall getting very ill in the winter shortly after we received that Swine Flu vaccine. I had an extreme high fever that I recall dreaming of fire. My then fiancée and now my husband took me to the ER and there was nothing they could do for me because I was pregnant except give me tylenol. I recall after I got well, I stayed so cold and had chills for months afterwards. I could never get warm and it was turning into Spring and Summer. I went down hill from there. Two years later, my FMS symptoms started. Horrendous muscle pain, severe fatigue, and chronic depression set in. The doctors always asked me if I suffered some kind of trauma or something. This is the only something I can remember and I too tested positive for high EBV antibodies. I also have gut issues and diagnosed IBS. I take probiotics which seem to help a bit but stress still causes Me an Ill gut. If I eat someone else’s food, I can’t leave the house. Sorry to say but my Mother-in-law likes to cook on a Friday and usually by Sunday, I’m in the bathroom and can’t go to Church. I hate my stomach, it’s so unpredictable yet it’s predictable?

  15. purple56 says:

    I was diagnosed with Fibromyalgia about 10 years ago. I also contracted herpes about 35 years ago. This is the second article I have read that links fibromyalgia with herpes. I recently had two bouts with shingles and found the antiviral I was taking did help my symptoms. At the time I did not see the connection, but after reading this article it does make sense. I would love to be able to participate in the new trials. I will be looking for information about how to be included.

  16. merleyroy says:

    This latest theory is very interesting, but as we know from the XMRV retrovirus theory which was supposed to be our “Holy Grail”, the promise can easily fizzle out.
    I reckon we are best advised to take it all with a pinch of salt, because, in the 30 years since I was clinically diagnosed with Fibromyalgia, I’ve seen many theories and protocols come along, yet still there is no official or reliable, bio diagnostic test available; or anything approaching a cure.
    Personally, I would rather wait for something “concrete” which actually helps me, than get overly excited and build false hopes which can be devastatingly crushing, if and when dashed.

    Anyway, the article is a bit vague on important details.
    I wish to know how the massive $50 – $100 million for the Phase III trial is to be raised? It is significantly more than the $4 million acquired to fund Phase II.
    If there is a feasible plan in place, for getting the necessary funds, what is the expected time frame?
    If it is going to take ten years or so, it’s game over for me – my whole life has been horribly blighted by this rotten illness already; I’m rapidly reaching the point of “no point” (going on)!

  17. ford51 says:

    I too have had fibromylgia and chronic fatigue syndrome for the last 12 yrs. I am having a whole host of abdominal problems. I am very interested in this study. I pray that they find something that will help us all. I want to ask everyone, how does everybody treat you, such as family, friends, etc.? I’m just wondering because of what I have been through with family and friends.

  18. ford51 says:

    I’m sitting here reading each one of your comments and we are all in the same sinking boat but it made me wonder why there is not more being done! Nobody but us who are the suffers know the magnitude of this illness and the profound effect it has on your life..like all of you, but life has been comprised because of this dreadful illness. Forgive me for what I’m about to say, but if I was given a choice of cancer or fibromylgia, I’m sorry to say but cancer would be the choice! I say with cancer you can get treated and maybe go into remission but with fibromylgia, it’s a death sentence except you don’t die!!!! I too am at the point, I can’t do this another year! I struggle through each and every day and then just to go to bed again and wake up and do it all over again!! That’s depressing in its self. Getting back to what I was saying, there isn’t a lot of public awareness like there should be. Yes its more than what it was but its not enough to let people know what suffers really go through! Do you all agree?

  19. jojomoonbeam says:

    I have had fibromyalgia for about 3yrs. I have been on all fibromyalgia approved meds at one time the latest being cymbalta in which I had to and still am detoxing off of. I have IBS this started about a year ago and festered into a horrible downward spiral. I wasn’t able to eat or drink anything and everyday I knew that the fibromyalgia and ibs have something in common. I just want some answers and most of all some relief. I am too young for all these symptoms, side affect and issues …I can’t work anymore. My sleeping and eating habits are horrible. Mood swings from all the side effects of medications I been on. I am 38 and I feel 70. I read all the sufferers for 15 and 20 yrs . I cannot imagine living like this for that long. Please if this research proves to be affective , get the drug out quickly and make the cost affordable for everyone.

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