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  #1  
Old 08-01-2010, 10:08 PM
Crispy Crispy is offline
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JC Virus Diagnosis after 2 months of Tysabri

My doctor called last week to tell me that I had tested positive for the JC virus after just 2 months of Tysabri infusions. All of the information I have read talks about finding the virus much later. I have an appoinrment with my doctor next Monday to discuss treatment options. Does anyone have a knowledge about having the plasma exchange or options that are available? Does everyone develop PML after the JC diagnosis. If you are going through this or have gone through it do you have any information that would be helpful? My MS type is remitting relapsing.
  #2  
Old 08-01-2010, 10:46 PM
0485c10 0485c10 is offline
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No yoyu are confusing the JCV virus with PML. The JCV virus is a virus siimilar to herpes that about 50% of the population has been exposed to. It is a virus that lies dormant in the body, like cold sore flare up occassionaly.

The JCV virus test is an antibody test that means at some point in your life you were exposed to the JCV virus and your body made antibodies against that virus. It may have just been a cold or something like that but since you ar positive for antibodies against it, likely you have the JCV virus lying dormant in your body somewhere. It haas been suggested it may lie dormat in the bones kidney or throat.

This virus can then mutate into one that travel into the brain and causes PML. People immune system prevents thayt from happening in the 50% of people who have been exposed top JCV---unless they are uusing Tysabri which prevents the immune system from getting into thre braion to fight the JCV virus which can result in PML for a small precent of people using Tysabri.

What is known about the test, is that all people who have gotten PML have had JCV antibodies. What is not know is if anyone with JCV antibodies will get PML?

Actually the test you had was just a trial yet, because they are not sure what it means

Tysabri did not cause you to get the JCV virus. You had it before you started Tysabri. Its lying dormant in your body somewhere, just like the virus that causes cold sores.

What is not know & was not known before your doc startred prescribing Tysabri for you, does this make you at a greater risk of PML? You had that virus lying dormat in your body causing no problem and never woulfd have in the future, its just that now that you are using Tysabri it might cause very big problems--PML

So far no one has ever gotten PML from the virus before 12 infusions. So perhaps you are thinking people get PML much later & that is true. But a person has the JCV virus before starting Tysabri or not. You ar in the 50% who does have it. It will be interesting if your doc lets you continue with Tysabri, now. But you are at no risk of PML before 12 infusions.

Plasma exchange is for PML. No treatment is needed fdor the JCV virus. It causes no problem unless a person is severly immune suppressed or on a med lik Tysabri.

Likely your doc will take you off TYsabri or let you continue to the risk time of 12 infusions.

Perhaps this means that you will have to go to the oral med Gilinea when it comes out early next year. In September the FDA will give its final approval & soon after that it should be on the market.

Tysabri is 60% effective at slowing MS and Gilinea is 77% effective in trial.
  #3  
Old 08-02-2010, 05:41 AM
0485c10 0485c10 is offline
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Originally Posted by 0485c10 View Post
The JCV virus test is an antibody test that means at some point in your life you were exposed to the JCV virus and your body made antibodies against that virus. It may have just been a cold or something like that but since you are positive for antibodies against it, likely you have the JCV virus lying dormant in your body somewhere.

Should read..... at some point in your life you were exposed to the You may have thought it was just a cold or something like that but it was the JCV virus, since you are.....
  #4  
Old 08-04-2010, 11:45 AM
Crispy Crispy is offline
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I am in a clinical trial that tests the blood for the JC Virus. The doctor has stated that the virus is active in me. It was not before taking the Tysabri. Does that make more sense now?
  #5  
Old 08-06-2010, 02:05 PM
0485c10 0485c10 is offline
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Originally Posted by Crispy View Post
I am in a clinical trial that tests the blood for the JC Virus. The doctor has stated that the virus is active in me. It was not before taking the Tysabri. Does that make more sense now?

Thanks for responding with the extra information, Crispy. Its a trial so we are all anxiously waiting to see what it means. You have written another possibility, that the antibody test can tell if it is anactive or imactive virus. I read the NIH trial plan and it seemed to me it was one test and yearly test afterward, once in the trial. But you have gotten 2 tests in just 2-3months, one that showed an inactive virus and one 2 months later that showed an active virus. The trial just started that I was not expecting. July 2010 with a plan to test 24,000 people and you have gotten 2 tests already? Something doesn't add up in your explanation to the trial plan. The trial plan calls for annual tests. Are you certain it tests the active & inactive state? And you have gotten 2 already in 2 months?
Many times doc are not very good at describing details to patients. Could that have happened? If you figure it out or find more info on it, please post as I am waiting for when I get in line and what I will do with my results...I probably won't get in line until after the trial is complete. I think there are about 48,000(? not sure of that number its just a guess) people on Ty in the US & they are planning to test 24,000 in the trial in the US. Many won't be testred until after the trial is complete in 2 years.

Stratisfy 2

Official Title: JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2

Primary Outcome Measures:

* Correlation of JCV Antibody positivity and development of PML. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures: Define the sero prevalence of JCV Antibody in this US representative sample of MS patients. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Detailed Description:

This study requires a blood collection at enrollment and annually thereafter for up to two years.

http://clinicaltrials.gov/ct2/show/N...ri&rank=1%3Cbr
  #6  
Old 08-07-2010, 08:54 PM
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MrsBones MrsBones is offline
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Quote:
Originally Posted by 0485c10 View Post
So far no one has ever gotten PML from the virus before 12 infusions. So perhaps you are thinking people get PML much later & that is true.
To be 100% accurate, 1 person has. No one with MS, true....but 1 person got PML after 8 infusions in the trial.

http://www.tysabri.com/en_US/tysb/si...TYSABRI-pi.pdf

They had Crohns disease. That person is not often mentioned for that very reason. Their medical history and previous treatments would have been different than ours.

The JC virus is extremely common with 70 to 90% of the human population carrying it. That's why the trial you're in is so important. Knowing that the virus is active could be an important first step in heading off PML.

As 0485c10 said, there wouldn't be treatment in the average person for the JC virus, they wouldn't likely know they even had it. However, your doctors may have a plan in place to provide a treatment or at least stop Ty given the circumstances. I have searched, but I don't find specific regarding active JC virus. It seems as if PML= active virus, but active virus doesn't always = PML.
  #7  
Old 08-08-2010, 08:26 AM
0485c10 0485c10 is offline
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Originally Posted by MrsBones View Post
To be 100% accurate, 1 person has. No one with MS, true....but 1 person got PML after 8 infusions in the trial.

They had Crohns disease. That person is not often mentioned for that very reason. Their medical history and previous treatments would have been different than ours.

I have searched, but I don't find specific regarding active JC virus. It seems as if PML= active virus, but active virus doesn't always = PML.
I follow this (PML)very closely... the gentleman who died from PML from Tysabri after 8 infusions was being treated for crohns disease. He was in his 60's(immunescence -weakening of the immune system due to age---begins around then)

he had a history of strong immunosuppressive use in the past for his crohns disease.

and his 8 infusions of Tysabri occurred during 18 months, because he had to stop numerous times for health issues and then resume.

I have copied the letter biogen sent to health care providers(4/2005) & read about it in the NE Journal of medicine.

He would not be someone allowed to use Tysabri now, much less continue after all the times he had to stop...so I no longer even mention him. I just report PML cases in people using Tysabri for the treatment of MS.

That 8 month case was way too "screwy" to be mentioned.--it could not happen again, because with his health issues, age and past immune suppressant medication he would not be allowed to use Tysabri. He shouldn't have been even back then in the trial.

One of the person who died from PML, on autopsy it was found she didn't even have MS--so it was the treatment for a disease that she didn't have that killed her. 3 people got PML in trial and of the 2 that died neither one had MS. One had Crohns & one thought she had MS but by autopsy it was found she didn't.... Anita Smith

The 3rd one who got PML in trial for the treatment of MS was left severely disabled.

And the JCV virus, being active.... Its more complicated than that. Once a person has been exposed to the JCV virus their body makes anti bodies to it and it is harmless in the body because the body contains it.

The JCV lays dormant then...sometimes in the bones, kidney,spleen, throat(? probably more than that)

It has to disloge from where it is lying dormant and become mobile in the blood stream. Then it has to mutate into a virus that can cross the blood brain barrier and cause PML. In people using Tysabri the body can't fight the brain virus and PML results.

Its incredibly long odds that this could all happen, but obviously it can--as the people with PML prove.

There are multiple points in this process they need to investigate. First if a person has ever been exposed to the JCV virus that can turn into PML with Tysabri? The presence of JCV antibodies prove if they have.

Then does Tysabri in any way assist the virus laying dormat get into the blood stream where it is mobile and can mutate??

I read an article that proposed Tysabri may assist JCV lying dormat in the bones leach to the blood stream?.....EVERYTHING IS SO UNKNOWN. EVERYTHING PROPOSED COULD BE RIGHT? AND MAY NOT BE RIGHT?

Its all theories of what it is?? But it really is a long sequence of improbable actions that have to happen to cause PML and they are happening unpredictably in a very small # of people using Tysabri compared to the # it is not happening in.

So even knowing if the JCV is active will not help, what needs to be known is if a mutated form of the JCV that can cross the BBB exists and if that mutated form is active.

I really don't think they have gotten that far to identify if its active...much less identifying the mutated form and if that is active. So far we have to be satisfied with just knowing if we have notr been exposed to the JCV and if that tells us we are at lower risk for PML with Tysabri use.
  #8  
Old 08-08-2010, 11:48 AM
lindaincolorado lindaincolorado is offline
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0485c10, you stated in your first post (at the bottom) that Gilenia (formerly known as FTY720 or Fingolimod) was 77% effective. In the MSQR in an article titled Emerging Medications for MS the figures are on patients given 0.5 mg of Gilenia 52% and for 1.25 mg 38%. It also states the benefit to risk factor is still being researched.
Linda
  #9  
Old 08-08-2010, 06:36 PM
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MrsBones MrsBones is offline
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Quote:
Originally Posted by 0485c10 View Post
I follow this (PML)very closely... the gentleman who died from PML from Tysabri after 8 infusions was being treated for crohns disease. He was in his 60's(immunescence -weakening of the immune system due to age---begins around then)

he had a history of strong immunosuppressive use in the past for his crohns disease.

and his 8 infusions of Tysabri occurred during 18 months, because he had to stop numerous times for health issues and then resume.

I have copied the letter biogen sent to health care providers(4/2005) & read about it in the NE Journal of medicine.

He would not be someone allowed to use Tysabri now, much less continue after all the times he had to stop...so I no longer even mention him. I just report PML cases in people using Tysabri for the treatment of MS.

That 8 month case was way too "screwy" to be mentioned.--it could not happen again, because with his health issues, age and past immune suppressant medication he would not be allowed to use Tysabri. He shouldn't have been even back then in the trial.

One of the person who died from PML, on autopsy it was found she didn't even have MS--so it was the treatment for a disease that she didn't have that killed her. 3 people got PML in trial and of the 2 that died neither one had MS. One had Crohns & one thought she had MS but by autopsy it was found she didn't.... Anita Smith

The 3rd one who got PML in trial for the treatment of MS was left severely disabled.

And the JCV virus, being active.... Its more complicated than that. Once a person has been exposed to the JCV virus their body makes anti bodies to it and it is harmless in the body because the body contains it.

The JCV lays dormant then...sometimes in the bones, kidney,spleen, throat(? probably more than that)

It has to disloge from where it is lying dormant and become mobile in the blood stream. Then it has to mutate into a virus that can cross the blood brain barrier and cause PML. In people using Tysabri the body can't fight the brain virus and PML results.

Its incredibly long odds that this could all happen, but obviously it can--as the people with PML prove.

There are multiple points in this process they need to investigate. First if a person has ever been exposed to the JCV virus that can turn into PML with Tysabri? The presence of JCV antibodies prove if they have.

Then does Tysabri in any way assist the virus laying dormat get into the blood stream where it is mobile and can mutate??

I read an article that proposed Tysabri may assist JCV lying dormat in the bones leach to the blood stream?.....EVERYTHING IS SO UNKNOWN. EVERYTHING PROPOSED COULD BE RIGHT? AND MAY NOT BE RIGHT?

Its all theories of what it is?? But it really is a long sequence of improbable actions that have to happen to cause PML and they are happening unpredictably in a very small # of people using Tysabri compared to the # it is not happening in.

So even knowing if the JCV is active will not help, what needs to be known is if a mutated form of the JCV that can cross the BBB exists and if that mutated form is active.

I really don't think they have gotten that far to identify if its active...much less identifying the mutated form and if that is active. So far we have to be satisfied with just knowing if we have notr been exposed to the JCV and if that tells us we are at lower risk for PML with Tysabri use.
Thank you. As I said, different circumstances. Having taken Ty myself, I also learned what you've mentioned here and am well aware of the factors that preclude you from taking Ty.

Being immuno-suppressed was already a known factor to contracting PML since before the newer drugs that contribute to contracting it , it was primarily AIDS patients (obviously one disease contributing to another) and organ transplant recipients (drugs keeping the immune system suppressed to prevent rejection) who contracted PML. The question that needs to be answered is how Ty and the other drugs that are implicated in PML cases replicate the circumstances, regardless of the disease they are being treated for.

The point of this trial as you yourself mentioned earlier was to determine a correlation between JVC antibody positivity and PML as well as the sero prevalence after the 2 years. Having the higher count at the end of 2 years may show that Ty (or the number of Ty doses) is the x-factor so to speak, reactivating the dormant virus.

Since this is open to anyone taking Ty and the OP is, she would have been tested. Should her antibody level have been high enough, it might have been an indicator she has active JCV (previously, people had to be tested for the JCV DNA in their systems, which was useless as most of us have it) . If she did have a high count, any responsible doctor and/or researcher would have checked the results with a second test to verify their results and to protect the health of the patient as best they could.

There definitely needs to be a lot more research on all of it and I thank Crispy for helping us all in that regard.
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Old 08-09-2010, 04:53 AM
0485c10 0485c10 is offline
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Should her antibody level have been high enough, it might have been an indicator she has active JCV (previously, people had to be tested for the JCV DNA in their systems, which was useless as most of us have it) . If she did have a high count, any responsible doctor and/or researcher would have checked the results with a second test to verify their results and to protect the health of the patient as best they could.

There definitely needs to be a lot more research on all of it and I thank Crispy for helping us all in that regard.
Thank you I had not thought of the fact that the count could be high---and that count is obtained isn't published. I thought it was a simple 'yes you have JCV antibodies' or no you don't...not a level of antibodies.

I will watch for that distinction if published anywhere before the end of the trial in 2 years, for my own info & if/when I get the anti body test....mostly if the tie to JCV antibodies and PML is a valid one, will be known when someone negative for JCV antibodies gets PML. Then it will be proven not a predictor of PML risk.
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Old 08-09-2010, 05:11 AM
0485c10 0485c10 is offline
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I don't know if a count is obtained? This description of labratory procedure describes a color change---not a count. A positive or negative result. Like UTI testimg is done, it positive for a UTI or negative. I thought that was what the JCV anti body test was? positive or negative, not a count.
I did read that one person got an inconclusive result, which hadn't occurred to me as a possibility--her doc called Biogen to request a 2nd blood draw test to get a definitive test result.

Laboratory Test Method indicating a color change--positive or negative result, not count.

http://www.labtestsonline.org/unders...methods-3.html

And this Wikki Drescription of an anti body test-- describes a "color level" tha indicates how much antibody is present, so perhaps the question is "how positive is the person for anti bodies?

Newer ELISA-like techniques utilize fluorogenic, electrochemiluminescent, and real-time PCR reporters to create quantifiable signals.

Thus in the case of fluorescence ELISA, when light of the appropriate wavelength is shone upon the sample, any antigen/antibody complexes will fluoresce so that the amount of antigen in the sample can be inferred through the magnitude of the fluorescence.

http://en.wikipedia.org/wiki/ELISA

Thank you for bring up a detail I had not thought of. Much appreciated.
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Old 08-09-2010, 09:05 PM
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MrsBones MrsBones is offline
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Originally Posted by 0485c10 View Post
I don't know if a count is obtained? This description of labratory procedure describes a color change---not a count. A positive or negative result. Like UTI testimg is done, it positive for a UTI or negative. I thought that was what the JCV anti body test was? positive or negative, not a count.
I did read that one person got an inconclusive result, which hadn't occurred to me as a possibility--her doc called Biogen to request a 2nd blood draw test to get a definitive test result.

Laboratory Test Method indicating a color change--positive or negative result, not count.

http://www.labtestsonline.org/unders...methods-3.html

And this Wikki Drescription of an anti body test-- describes a "color level" tha indicates how much antibody is present, so perhaps the question is "how positive is the person for anti bodies?

Newer ELISA-like techniques utilize fluorogenic, electrochemiluminescent, and real-time PCR reporters to create quantifiable signals.

Thus in the case of fluorescence ELISA, when light of the appropriate wavelength is shone upon the sample, any antigen/antibody complexes will fluoresce so that the amount of antigen in the sample can be inferred through the magnitude of the fluorescence.

http://en.wikipedia.org/wiki/ELISA

Thank you for bring up a detail I had not thought of. Much appreciated.

No problem! I'm not sure if the test would come back x number of antibodies, a certain color or brightness but surely there's a way (I hope,since other antibody tests for other diseases can show a level) to tell. All part of the picture! I hope they put it together soon... the drug has helped many people. It could save lives and would ease the minds of many new to the drug if only they had a way to say who would be more at risk than others.
 

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