JCV and BG-12

Discuss Tecfidera (BG-12, dimethyl fumarate) as an oral treatment for multiple sclerosis.
nairb86
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JCV and BG-12

Post by nairb86 »

Do we know if people who test positive for JCV will be be at more risk to adverse effects on BG-12?

Thanks so much,

Brian
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Re: JCV and BG-12

Post by MrsMomTo6 »

I was recommended to start BG 12 upon it's release after Betaseron complications, and then Copaxone Complications.
It was expected to come out in May 2013, and apparently, was released in April 2013.

When I came in for a problem visit with my Neuro's PA, they were eager to start me on BG12, aka, Tecfidera. I was in to let them know that my endocrinologist had found me to have elevated calcium levels, and of course the typical MS patient, LOW VIT. D levels, and I had been Dx. with Primary HyperParaTHryoidism. I wanted my Neuro to know this, because I had been being put on High dose Vit. D for the 2+years prior for persistent Low Vit. D, and I had learned that Primary HPT patients should NOT TAKE VIT D SUPPLEMENTS, and wanted to know what the association with MS and PHPT was. Technically, it irritated the PA that I asked so many questions and, he did not have the answers to my questions.

Because of new spasticity complaints and recurrent nerve pain in my face, it was recommended I start BG12. They signed me up that day. Before the next 2 weeks were out, I was getting a call from the specialty pharmacy letting me know that I was approved to get the med with Pt. Assistance at $10/month!

My research uncovered that PML had been in 4 patients taking this medicine, all died. And, what I learend was that the JC VIrus is what is the cause of PML and that you should KNOW FIRST if you are NEGATIVE OR POSITIVE for the JC Virus (John Cunningham Virus) before you start a drug like BG12 or Tysarbri(sp?). Sadly, none of my doctors have ever tested me for the JC Virus, so, my faith in them was reduced after reading about this. I am even a medical person, who always does my research, and I had never head of JC Virus.

I also learned that the people who had complications with this drug also had some issues with their lymphocytes. Interestingly, I too, had some abnormalities with my lymphocytes a year ago, and no one even discussed that with me before eagerly putting me on BG12.

I decided I wanted to get another Neuro opinion, before I started on some new expensive name brand drug, that had such a quick way to get my costs down for their new drug.

I was surprised when the 'new' neuro told me that he was concerned that so many docs were jumping on the Tecfidera bandwagon, when the 'pure form of the drug was available for $8/month vs. $$thousands/month. The pure form being, "dimethyl fumarate".

I am hoping to get some reading done on the 'pure form' this week, and learn more. But, for now, this is discouraging for me...and I was hoping to feel confident in my Neuro's recommendations, and I do not, and I have just met my 'new' Neuro...these meds are so hard on the body with enough complications...you wonder if it is worth it to take them...?

Any other researching MS patient out there feeling the same?
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Re: JCV and BG-12

Post by giddiupgal »

Wow, that is a lot of good information. Thanks for sharing. I like to wait a while before jumping on the bandwagon of new drugs. I mean, all the new computers are coming out with Windows 8 and it is terrible. My son and husband just got new laptops and they hate it (son is 15, husband is 43, so good diversity).

You never know with these new releases.....

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Re: JCV and BG-12

Post by CureOrBust »

MrsMomTo6 wrote:My research uncovered that PML had been in 4 patients taking this medicine, all died. And, what I learend was that the JC Virus is what is the cause of PML and that you should KNOW FIRST if you are NEGATIVE OR POSITIVE for the JC Virus (John Cunningham Virus) before you start a drug like BG12 or Tysarbri(sp?). Sadly, none of my doctors have ever tested me for the JC Virus, so, my faith in them was reduced after reading about this. I am even a medical person, who always does my research, and I had never head of JC Virus.
As I am sure your research also found, but you didn't mention in your post for others. For people going on Tysabri which also has a high risk for JCV, they not only check for JCV status before starting someone on the drug, they also perform regular checks while someone is on the drug to ensure their JCV Positive status dose not change.

MrsMomTo6 wrote:I also learned that the people who had complications with this drug also had some issues with their lymphocytes. Interestingly, I too, had some abnormalities with my lymphocytes a year ago, and no one even discussed that with me before eagerly putting me on BG12.
Have you saved any links to a description of what these "abnormalities" are or could be or how they are tested for?
MrsMomTo6 wrote:I am hoping to get some reading done on the 'pure form' this week, and learn more. But, for now, this is discouraging for me...and I was hoping to feel confident in my Neuro's recommendations, and I do not, and I have just met my 'new' Neuro...these meds are so hard on the body with enough complications...you wonder if it is worth it to take them...?
You may get some research leads out of the following link regarding the contents / differences between the "pure form" and BG12 from NHE's post at http://www.thisisms.com/forum/tecfidera ... ml#p199047

and at:
http://www.ipaustralia.com.au/applicant ... 010242064/
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Re: JCV and BG-12

Post by MrsMomTo6 »

Article Discussing the origin of the name of the 'JC Virus'
http://bmartinmd.com/2012/01/who-the-he ... ngham.html

Who the Hell Was John Cunningham?

By bmartin on January 23, 2012 10:29 AM | Permalink

Friday the FDA announced that it's permitting the marketing of the first test for antibodies to the JC virus (Stratify JCV Antibody ELISA test; Quest Diagnostics), the cause of progressive multifocal leukoencephalopathy (PML) in immunocompromised individuals and now an official risk factor for the disease in patients taking Tysabri (generic name, natalizumab; Biogen Idec). (Delayed clarification: JC virus is the cause of PML, and antibodies to the JC virus are now an official risk factor for the disease in patients taking Tysabri.) The presence of anti-JC virus antibodies is added to the previously identified risk factors for PML of 1) a longer duration of Tysabri treatment (>2 years) and 2) previous immunosuppresant therapy. The risk of PML in the presence of all 3 factors is 11 in 1000, or 1.1%. The FDA reports that there have been 201 reported cases of PML among approximately 96,582 patients who have been treated with Tysabri (for the indicated conditions of multiple sclerosis or Crohn's disease) as of January 4th; the overall PML rate is consequently 0.21%.

The "JC" in JC virus stands for John Cunningham, and like the previously anonymous Henrietta Lacks of the immortal HeLa cells, this John Cunningham remains largely unknown. The virus itself is ubiquitous and harmless in most people (40%-60% of the general population are seropositive), but it creates a potentially devastating and often fatal white matter disease in immunocompromised persons.

A cursory search leads to a Google-available (or really, partially available) book entitled Human Polyomavirus, which was edited by Kamil Khalili and Gerald Stoner and published in 2001. The first 3 chapters concern the search for the cause of PML, which was first described or recognized in 1958 (first published paper by Astrom et al..."a hitherto unrecognized complication of chronic lymphatic leukaemia and Hodgkin's disease"). Chapter 2, written by Dr. Gabriele M. Zu Rhein, a codiscover of JC virus, reveals that John F. Cunningham was a patient at the VA Hospital in Wood, Wisconsin, in the summer of 1970. Cunningham had Hodgkin's disease and "rather rapidly progressing neurologic deficits." He was given a diagnosis of PML during life on the basis of a brain biopsy and thereafter "expressed the wish that his brain should aid research into this fatal disease." A "new human polyoma virus" was subsequently detected by Rhein and her colleagues in Cunningham's postmortem brain tissue, and the virus was named JC virus in honor of the patient.

A Wisconsin death record reveals that John F. Cunningham was 36 (born August 30, 1933) when he died on July 12, 1970, in Milwaukee. As a military veteran, his likely service would have been in the Korean or Vietnam War.

01/26/12 follow-up: The 1971 Lancet article by Padgett et al indicates that Cunningham was 38 in 1970 (although his death certificate indicates that he was about 6 weeks shy of his 37th birthday at the time of his death). Cunningham had been diagnosed with Hodgkin's disease for 8 years before he developed a "progressive left central facial palsy, left hypoglossal palsy, and palsy of the left upper extremity" in the Spring of 1970. (His cancer had been treated with nitrogren-mustard derivatives since 1968.) These neurologic deficits were attributed to PML, a diagnoses confirmed by brain biopsy (which showed "pathognomonic oligodendrocytes along the periphery of demyelinating lesions") during life. He reportedly granted permission for the postmortem examination of his brain only (examination occurred 10½ hours after death). Gross and microscopic study confirmed the diagnosis of PML, and extracts of his brain were used to grow and identify the newly recognized intracellular virions in culture—which were dubbed JC virus.
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Re: JCV and BG-12

Post by MrsMomTo6 »

In the above article, entitled: "Who the Hell was John Cunningham" the following was eerily familiar with my health concerns at present, and phrase, in quotes, did concern me, and motivated me to research more about this JC Virus.

Here is the quote from the article:

" Cunningham had been diagnosed with Hodgkin's disease for 8 years before he developed a "progressive left central facial palsy, left hypoglossal palsy, and palsy of the left upper extremity" in the Spring of 1970. (His cancer had been treated with nitrogren-mustard derivatives since 1968.) These neurologic deficits were attributed to PML"

I do NOT have Hodgkins. However, in Jan. 2011, due to a 'mystery virus' elevating all my liver profiles, (being labled 'Hepatitis, while all Hepatitis studies showed negative for A, B & C) which lasted around 3 months, I was sent for Immunological studies. In those studies, something made them concerned for lymphoma, and thus, I was sent to a Hematological Oncologist. By, the time I got the appointment, the virus had passed, as had the low grade fevers, and my labs started normalzing, thus making them say, 'let's just watch your blood work to see if you are 'pre' lymphomic...' I was diagnosed 'officially' with MS in August, of that same year...and, I moved out of state, and have since, never followed with a Hematologist again.

However, symptoms that I regularly called my MS Neuro with were...Right Facial Palsey, with significant nerve pain in the face, and then just a month ago, my tongue, was numb, on the same side, with slight droop of that side lips, and I could not swallow normally. I thought it was abnormal enough to go to see the docs...these symptoms always involved weakness of the upper arms of the affected facial side...' I have been told, because they don't have any idea why I am doing it, 'Your MS is letting you know, you are doing too much, and you need to rest. " That always concerened me...because it felt like, they really don't know why I have these occurences...and it was NOT comforting to read about it happening in MR. John Cunningham...

I started a search of this 'Human Polyomavirus" mainly because while I was in the care of the Infectious Disease Doc. during that 2011 sickness (because of the 3 month viral syndrome) who found me positive for multiple viruses, ALL at the same time...(Epstein Bar, Shingles Virus, Mycoplasma & Cytomegalovirus-all found positive in the acute/active form-not in the past/prior exposure form) they were so perplexed with how that could happen, and how one patient could have ALL those viruses (poly-viral) at the same time...they concluded I could not have ALL of them, and it must be that I have 'something' that was making me 'look' like I did...but, did not know why, I would do that??? That conclusions of course, was not helpful...

At that same time, I tested positive for "polyclonal gammopathy," and had a mild spike of a "monoclonal gammopathy"...that was decided by the hematologist, that the monoclonal spike, was likely 'not significant, just incidental' (apparently a 'MONOclonal spike is present in cancer and a POLYclonal could be evidence of a MONOclonal to come?) But, the immunologist thought the polyclonal spike should be 'watched...' but, she too, was baffled. (I had abnormalities with my T-cell activity as well)

AGain, I had not been formally diagnosed with MS yet. So, when they all found that I had been formally DX with MS, they assumed it was the MS that caused all these abnormalities in me. My hematologist even said, 'yeah...you can see poly-viruses with MS, as well as T cell abnormalities with MS patients, leading up to their diagnosis?!?!' My neuro did confirm this to be true...

All I knew, 'a LOT was wrong with me...and no one really knew why this, then, 42 year old mother of 6, suddenly started a rapid decline, with lots of abnormal labs, demylenation of my brain that was progressing that NO neurologoist could agree why the demylinazation was happening, and, no one knew what the labs really meant...'

The doctors kept me so confused, and frustrated, that my MS brain at times, got overwhelemd with the research...and would have a hard time putting the pieces of my research back together...because, well...I apparently, 'did' have MS, in the end, and well, MS patients have brain fog apparently, so, that gave me the 'reason' for why my brain kind of 'came and went.' But, living with this decline in my brain functioning, baffled me. I could no longer do basic math with my kids, but, I could read medical journals without any comprehension problems? A cognitive study later did show, sure enough, short term memory delays, cognitive decline of the 'simples tasks' and high functioning IQ in the complex? I could at least say, 'that' was a perk! But, any mental changes, are scary...

I have copies of all my labs over these last 3 years. No ONE has tested me for the JC Virus. At this point, I assume the test looks like JCV, or JC Virus on the results? Still need a clarification on that.

Searching still...

Michele
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Re: JCV and BG-12

Post by Ladymac »

It is very frustrating when people claim gloom and doom and erroneous information, deliberately, that sends others into stress, panic, and our own hypochondria that we already have to deal with having MS.

The JCV and PML are NOT part of the Tecfidera medicine or protocol. All questions about this need to be answered by calling MS Active Source. There is erroneous CRAP on the internet and people read only a piece of an article and then run with it and make false claims.

If you drink too much water all at once you can get water poisoning. FACT. NO one has got PML from Tecfidera. FACT.

If you have Multiple Sclerosis and you do not have a Neurologist who is a specialist in MS AT an MS Center, get one. Then you can see your local Neurologist in between your Annual Visit with an Expert in MS. You will also have a direct line for all factual information and proper supports. Since the MS Centers are all involved in clinical research and trials, they know about the effects of different non-MS meds as well as any other medical complications you may have and whether you would be a proper candidate for any particular treatment, and be there for you if you have questions!

The National MS Society is also a great resource for accurate information from them directly.

Don't we already have enough to worry about without having people pushing CUCKOO JUICE, VITAMINS, CRAZYY DIETS, or other theories on us?

If other issues are not resolved before you start a new medication, it makes sense to wait until things get resolved before you start something. Otherwise, how are you doing to know what caused what? I had to wait 10 days after I received the meds to start the trial pack for that very reason. If we are sick or don't have other physical symptoms or complications under control, our MS specialist wants us to succeed!

I wish all these alarmists would get off this site and let us deal with our illness in peace and HOPE.
Blessings,

Ladymac
RRMS diagnosed 2006
Tecfidera Started April 2013
:)
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Re: JCV and BG-12

Post by MSBOB »

Anyone can read the paperwork that comes with their drugs and look online at some of the published whitepapers. BG-12 is extremely promising for neuroprotection and immune suppression. I quite am considering taking it myself. JC virus is slightly associated with dimethyl fumarate (DMF), but not at the doses of BG-12. It does make one think that, like Tysabri, it may take some time to really know for sure. I also believe is rational to be concerned if you were tested for a precondition to JC and are considering BG-12.

As stated by others, many small molecule drugs are destroyed in the stomach and need special coating to get to the intestine. This fact is disappointing for all the amazing polyphenols that have neuroprotective potential -- in petri dishes.

Even though DMF is a very cheap chemical, I think it would be very unwise to try making this at home or substituting other drugs with DMF at higher dosages.

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Re: JCV and BG-12

Post by xpsychiatricmd »

Kudos Ladymac, I love your postings. Yes indeed, there is much out there in terms of diet, special protocols etc. I think that trust is important and the faith you deposit in your treatment is of vital importance. Placebo can account for 30%. So if you believe in what you are doing, better, you have the placebo response on your side. With a disease like MS, we have to trust the experts, those that deliver our care. I is OK to have healthy skepticism, but ultimately you have to trust. Trust vs. Mistrust represent the first stage in Erickson's developmental theory. This is not to say that we should have 'blind faith', but we have to follow the evidence. With Tecfidera, because of what happened with Fumaderm, it pays to check the lymphocyte counts from time to time. I am supposed to check them in a month! I think that ordinarily it would be once a year. When I was practicing, I used to make a point to my patients, that it would be OK to ask questions, bring suggestions, even add vitamins, herbs etc. provided it did not interfere with the treatment and if you believed in them. Just know, my neurologist told me to stop Protandim which is a Nrf2 Synergizer like Tecfidera. Ididn't see th point, but I trust him, so I have stopped it. Recently, I visited a doctor of Oriental Medicine and discussed diets; Paleo Diet, Gluten Free diet, low animal protein etc. He told me to eat what felt good! Of course, no excesses. I followed your Egg McMuffin suggestion and it has worked beautifully. No GI problems. Thank you again!
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Re: JCV and BG-12

Post by xpsychiatricmd »

So, follow your treatment and what you believe with guide from your team!

Followed at the MS Center of Melbourne, FL.
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Re: JCV and BG-12

Post by MSBOB »

I second the kudos to ladymac. Way to be mature and straight forward!
MrsMomTo6
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Re: JCV and BG-12

Post by MrsMomTo6 »

Being new to this forum...I think a reply is due? I am assuming ladymac is referring to my post, in the accusal of being an alarmist?

I concur, there is 'erroneous crap on the internet.' I strive to avoid it. I am a Registered Nurse, and strive to read scholarly articles, research and other medical community sources. Yet, even in some of the scholarly medical journals, there has been disagreements, or updates to past research, so, it is challenging, at best, to wade through it all...especially with an MS brain. But, I hope this forum will allow opportunity for those of us researching, or those newly diagnosed, or overwhelmed with the magnitude of research ahead of them, especially the lay person, who does not have a medical background, to be able to share what they are reading, with the hope of gleaning from experience, and wisdom of others on this site, vs. attacking people who are genuinely seeking answers...

If the topic is so frustrating to a reader, that it robs them of “peace and hope” to hear other struggling MS patients express their concerns/fears/apprehensions of powerful drugs affects on their bodies spoken on an MS forum...why are they on this forum topic themselves? And, why is 'this' kind of post, considered 'mature' and 'straight forward,' worthy of kudos?

And, 'follow your treatment and what you believe with guide from your team...' is counsel? 'TEAM?" who exactly is that?

I was first told I ‘might’ have MS in 2009. Two Mayo Clinic MS Neurologists, and 2 major MS clinics between two states, with at least 4 Neurologist volleying me in between them while ‘my team’ had their own illnesses, and family crisis and emergencies to deal with and I was being canceled, rescheduled, not called back, messages lost on nurse call lines, and even forgotten by ‘my team’ all together in their own vacations, and real life struggles, I learned that me, and my family, were the only ‘team’ I had. I have been in the care of leading MS Neurologist, and all the above is true. No credentials are sufficient or adequate enough for me to follow the ‘lead’ of anyone not willing to give me answers to my concerns without proof that they are really vested in my care, and know my case, and pre-existing conditions, ‘before’ putting me on a new medication.

So, thus far, in the discussion of BG12 & the JCVirus I have learned ‘to ultimately trust’ my ‘team’ and ‘ check the lymphocyte counts from time to time’ while on BG12...and to brace myself for MS patients who are hostile toward people skeptical of a drug that may cause ‘severe and prolonged lymphopenia.”

To MSBOB, thank you for sharing beneficial & knowledgable information that has already helped me read more. You are giving me hope for answers, that my ‘medical-team’ thus far is NOT providing.
MS Patients don’t need more stress in their lives.
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Re: JCV and BG-12

Post by Ladymac »

xpsychiatricmd wrote:So, follow your treatment and what you believe with guide from your team!

Followed at the MS Center of Melbourne, FL.

Hi There,

How are you doing? Are you taking the twice a day 240mg yet?

Today starts month #2 on Tecfidera. First week was the 120mg twice a day for me, then just finished 3 weeks at the 240mg a day. Doing pretty good. Last week I was getting a little nausea about 2:30 - 3pm in the afternoon, but that's gone now. Flushing really was only a couple of times, none for over 2 weeks now. As long as I eat with the regimine, I am good. I found out for me pasta with red Italian sauce or anything spicy at evening meal is a no no, but I have GERD and take Prevacid twice day. I am taking my evening one 1 hour before my evening meal with the Tecfidera and Aspirin and that helped a lot. Feeling more energy in the AM and had blood test last week everything looks good with white blood cells counts.

Hope you are doing well. I am seeing the side effects subsiding :-D

Blessings,
Blessings,

Ladymac
RRMS diagnosed 2006
Tecfidera Started April 2013
:)
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Re: JCV and BG-12

Post by MrsMomTo6 »

Testing Methodology for JC Virus per Quest Diagnostics
http://www.questdiagnostics.com/testcen ... _BK_JC_PCR


BK and JC Virus DNA, Real-Time PCR

Clinical Use
Detect and monitor BK virus infection
Detect and monitor JC virus infection

Clinical Background
BK virus (BKV) and JC virus (JCV) are double-stranded DNA, human polyomaviruses. More than 70% of the adult population has antibodies to BKV and JCV, with primary infections typically occurring in childhood.1 In the US, 50% of children develop antibodies to BKV by 3 to 4 years of age and to JCV by 10 to 14 years of age.1 In immunocompetent individuals, primary BKV infections usually cause a mild respiratory illness and, rarely, cystitis, whereas primary JCV infections are typically asymptomatic. After initial infection, polyomaviruses establish latency in various tissues. The primary sites of latency are uroepithelial cells for BK virus and B-lymphocytes and renal tissue for JCV. Additional sites of latency for both viruses include the ureters, brain, and spleen. BKV and JCV viruria is found in up to 3% of pregnant women but is not associated with disease.1

Reactivation of latent as well as primary BKV and JCV infections may occur in immunocompromised individuals. BKV infections can lead to interstitial nephritis, hemorrhagic cystitis, and kidney allograft rejection.2-4 BKV nephropathy is associated with BK viremia of >5,000 copies/mL (plasma) and BK viruria >107 copies/mL and is seen in approximately 8% of kidney transplant recipients.2 Though latency is typically associated with the absence of viremia, low levels (<2,000 copies/mL plasma) are seen in some asymptomatic individuals.2 JCV is responsible for progressive multifocal leukoencephalopathy, a fatal demyelinating disease of the central nervous system seen in up to 70% of AIDS patients.5 Additionally, BKV and JCV viruria are found in approximately 40% of bone marrow transplant patients.2-4
PCR detects the presence of the virus, not antibodies to the virus; thus, the detection of viral DNA may be indicative of an active infection. The identification of viral DNA may warrant the institution of antiviral therapies and/or a decrease of immunosuppressive therapies.2-4 Determination of viral DNA presence or concentration is also useful in establishing the cause of allograft rejection.

Individuals Suitable for Testing
Transplant recipients receiving immunosuppressive therapies
Individuals with immunosuppressive diseases, eg, AIDS

Method
Real-time polymerase chain reaction
DNA primers and fluorogenic probes directed at highly conserved sequences of the BKV and JCV genomes
Analytical sensitivity: varies with specimen type and organism; contact Focus Diagnostics (1-800-445-4032) for more information.

Analytical specificity: no cross-reactivity with 20 viral and non-viral pathogens
Reportable range (Quantitative BKV): 500 to 39,000,000 copies/mL

Interpretive Information
A not detected result in the BKV and JCV qualitative assays indicates viral DNA either is not present in the specimen or is present in a concentration below the assay's limit of detection. A detected result indicates viral DNA is present. Similarly, in the BKV quantitative assay, a result <500 copies/mL indicates viral DNA is not present in the sample or the concentration is less than the detectable limit.
Inhibitors present indicates the presence of non-specific PCR inhibitors in the sample. Inhibitors will slow the PCR reaction and may result in falsely decreased values.
An increase or decrease in viral DNA concentration may indicate a worsening or resolution of an active infection, respectively. While the presence of viral DNA may indicate an active infection, DNA results should not be the sole basis for diagnosis of active infection, as low viral concentrations are sometimes seen in asymptomatic individuals.2,3 Results should be interpreted in conjunction with other laboratory and clinical findings.
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Re: JCV and BG-12

Post by Ladymac »

There is no evidence or correlation between TECFIDERA (formerly known as BG-12) and PML.

There is evidence that TYSABRI patients if they have the JCV Virus have a risk of developing PML.

Who cares what the Lab's protocol is for analyzing samples for JCV or BKV? This is not relevant to the information ERRONEOUSLY stated trying to get everyone in an uproar about something that DOES NOT EXIST. There is NO EVIDENCE or CASE of ANYONE with PML because of Tecfidera. Please STOP!
Blessings,

Ladymac
RRMS diagnosed 2006
Tecfidera Started April 2013
:)
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