Results of blood work for JCV 'index" risk

[Remy9111]

These stats are a little unclear. You state they are stats for people without prior immunosuppressant use but don't mention whether this group includes patients who are both positive and negative for the JC antibody according to the new assay. If the cut-off is < .2 for a negative result, then why lump those people with all who are < .9?

Isn't this a bit of apples and oranges comparison or are you suggesting that "negative" or "positive" no longer matters, only the actual titer number?

If these numbers were presented at ENS, surely they have been published somewhere? I'm not doubting their legitimacy per se, just need more context and an official reference is simply more reliable.

Thanks.

[Myoak]

The stats are for Tysabri patients w/o prior immunosuppressant use and who are anti-JCV antibody positive. Remy, there was no intention to include JCV- people. This type of misunderstanding is good reason why your doctor should be always be consulted. Hopefully, those discussions can be more fruitful when specifics such as these stats are discussed. It is always a risk to post information because it is often misunderstood. That is why loads of what could be helpful information usually doesn’t get posted.

I agree that an official reference would be more reliable and you are right in thinking these numbers should have been published somewhere; no doubt they are. Whether patients can access it is another matter. I can do no more than pass on what was furnished. Take it or leave it is perfectly acceptable, I understand completely and it is ok. AS ALWAYS, your doctor should be your prime resource for specifics.

Also, I would like to add some additional stats for those interested. Thanks for your questions-comments Remy; hopefully your doctor will fill in the blanks for any clarifications you seek. This info is what was shared with me so I pass it on with confidence that those who have questions will talk to their doctors in order to resolve specific questions. This is just FYI. No one has any obligation to receive it. I am not an official source nor pretend to be one. This is just me talking to whoever is interested. I make no claims beyond that. It may have value; it may not.

My hope is that each person with concern will be better able to discuss it with their doctor and achieve the best possible treatment regimen for themselves or loved ones. Probably was a bad idea to post this because the misunderstandings will be endless but most people have desire to be informed so this is for those. Here is the most comprehensive info I have on Tysabri patients w/o prior immunosuppressant use who are anti-JCV antibody positive. You and your doctor will have to decide how it applies to you, if at all.

JCV index less than 0.9 = PML risk of 1 in 10,000 during months 1 to 24.
JCV index less than 0.9 = PML risk of 1 in 3,333 months 25 to 48.
JCV index less than 0.9 = PML risk of 1 in 2,500 months 49 to 72.

JCV index less than 1.1 = PML risk of 1 in 10,000 during months 1 to 24.
JCV index less than 1.1 = PML risk of 1 in 1,429 months 25 to 48.
JCV index less than 1.1 = PML risk of 1 in 1,429 months 49 to 72.

JCV index less than 1.3 = PML risk of 1 in 10,000 during months 1 to 24.
JCV index less than 1.3 = PML risk of 1 in 1,000 months 25 to 48.
JCV index less than 1.3 = PML risk of 1 in 833 months 49 to 72.


JCV index less than 1.5 = PML risk of 1 in 10,000 during months 1 to 24.
JCV index less than 1.5 = PML risk of 1 in 833 months 25 to 48.
JCV index less than 1.5 = PML risk of 1 in 769 months 49 to 72.


JCV index OVER 1.5 = PML risk of 1 in 1,000 during months 1 to 24.
JCV index OVER 1.5 = PML risk of 1 in 123 months 25 to 48.
JCV index OVER 1.5 = PML risk of 1 in 118 months 49 to 72.

All further questions should be written down and discussed with your doctor. It is easy for us to become frantic and fear mongering when what we need is rational thinking. People don’t stop driving because they may die in an accident. If people drive to for 50 years their risk of dying in a car wreck is greater than the risk of Tysabri. Google the stats. Be sober about risk and accept that everyone has an individual risk profile. Be well.

[ru4cats]

Myaok,
Thanks for posting this information. I am JC-, but I would like to discuss this with my neuro at my next appointment.

[LL60]

Do you know, Myoak, when they started doing the new test? I had mine done in September of this year and my doctor got the results as "positive." There were no numbers involved.

I have an appointment in a couple of weeks. I will request a new test.

Thank you so much for sharing with us. Now I am really anxious to see just what my numbers are. Wish I would have something to compare it with, see if they went up at all.

[Remy9111]

I'm no fear mongerer or troll trying to bash Tysabri! I love the drug and the risk is perfectly acceptable to me as a negative JC Virus antibody patient. I've been on Tysabri for 5 years and have had negative tests every 6 months since Stratify began. I see my neuro every 6 months.

It was just unclear to me in your post (since you didn't state it) that the statistics were regarding JCV - people. I didn't misinterpret, just wanted clarification.

It's always good to have links to official published material if available. Some of us have access to medical journal articles etc. and if not it's still a good idea to make note in one's records since there is so much floating around on the Internet.

Thank you for your info.

[Myoak]

The stats posted above are for JCV anti-body (Ab) positive without prior immunosuppressant use.

I don’t believe the new JCV Ab titer test was widely available last fall.

New England Journal of Medicine June 6 2013 quote, “a single measurement of viral activity such as a test for antibodies to JC virus may be USEFUL BUT NOT SUFFICIENT (my caps) to assess (PML) risk” End Quote.

This new test is only one tool and it is not perfect. Though an improved tool there are other important factors to consider so be sure to counsel with your doctor.

[Honoring The Spirit]

My range came in a little under 1.5- Scary for sure, but what is scarier is the thought of coming off back to a life of full disability. My team of doctors will monitor and scan and watch more closely because of the numbers and I will remain taking a deep breath as I walk forward. Grateful to know every day new measures are being put into place to be more aware of the risks

[alanpgh]

Mitigating the Risks of Tysabri Video from CMSC Conference Coverage

I found this video from MSWorld's recent coverage of the CMSC Annual Meeting very informative:
Mitigating Risks with Tysabri

Dr. Hunter and Dr. Kantor explain this test well.

I especially appreciated Dr. Kantor's summary, starting at time code 3:41 of the video above. He explains the new test (Jan. 2013) and what to ask your doctor to get the test done.

Watch the video... might create some helpful discussions with your personal health care team.

[alanpgh]

One more comment about last post...

As soon as I saw the video above, I asked my Neuro for the blood test that measures Titers. Within a day I took the lab test, and two days later the PA from my Neuro's office called with my results.

No need to mention my results. For me it was great that I watched the video and asked my Neuro for this test.

If I hadn't seen the video, might not have become aware of this new test for many months.

Great that the conference coverage is making information available at about the same time it is released to Health Care Professionals!

[Myoak]

JCV Antibody Index Stratifies PML Risk in Natalizumab-Treated MS Patients

https://cmscactrims.confex.com/cmsca...Paper1642.html

If you go to this site be sure to click on the box which says [pdf] to pull up charts which you can then enlarge. These charts will verify risk stats posted earlier in this thread. Also, be sure to save the pdf, information like this can get scrubbed.

At least it has happened before Remy, that is why I didn't post a link before... fear that it would get scrubbed before it was widely accessible. A few months ago I posted Biogen's PML risk stats from an investment website and it got scrubbed; it is no longer there. So if you value this new info please save a copy, and soon.


Quoting CMSC/ACTRIMS presenter Dr. Patricia K. Coyle “The JC virus is a ubiquitous DNA polyomavirus shed in the urine of 25% of normal individuals. Up to 70% of the general population is seropositive. It’s ordinarily a benign virus, yet it’s a requirement for developing PML.

An analysis of large clinical trial databases indicates that anti-JC virus antibody–negative MS patients on natalizumab have a reassuringly low risk of developing PML: roughly 1 in 10,000. The good news is that antibody-positive patients with a low antibody index appear to have a similarly low risk.”

[Myoak]

Hi Alan,

Unfortunately, the links you provided do not provide access to the videos you mentioned. Don't know what the problems is but after going to the site several times on different days I could never pull up the video. Has anyone outside MS World staff had success using the links Alan provided? I'm guessing probably not.

Also, I wonder why my previous post was placed at the top of the page in the "sticky"? Just inquisitive not knowing all the procedures. Thank you.

[LL60]

Thank you so much for this latest information. Although I could enlarge it on my computer to read it all, it would not print at the enlarged setting. I printed it out anyway. Will take it to work and enlarge it. Thanks again.

My doctor had never heard of the new JCV test. He did order it for me. The lab told me that the test still will just come back positive or negative and that my doctor will have to call the Focus Lab to get the index numbers.

I will share this information when I get it.

Thank you everyone here at MSworld who help keep us all up to date on everything ms.

[Myoak]

LL60,

Another approach to saving the information… Once you have information you want to save or print on your screen you can always hit “print screen”, create a document as you normally would, right click on the newly created document, and click paste. Then you can print and/or save your newly created document having the info you want.

Also, if you want a copy of your test results you could ask your doctor to include a phrase such as “please provide patient with copy of results” on the prescription. The test, “Stratify JCV Antibody with Reflex to Inhibition Assay” costs a little over $1400 but apparently Biogen must be picking up the tab because I have never heard of anyone having to pay for it, nor has any insurance been billed that I have heard of.

The standard seems to be testing every 6 months. However, for those JCV+ on Tysabri who have a high titer testing every 3 months would be prudent, but I wonder if the test would still be no charge to the patient? I hope someone will let us know if they are being tested every 3 months.

Of course, the idea behind more frequent testing would be to catch JCV titers in the act of spiking before PML developed or when PML is asymptomatic. Treatment of PML is most successful at an early stage. But I don’t know if Biogen will pay for a test more often than every 6 months at $1400 per test.

Since a few of those who are JCV- do convert to positive over time, I suppose everyone on Tysabri will have this test done. I think it is important to keep in mind that those who are JCV+ and have low titer # have a very low risk of PML. That is what the data shows, reflected in the charts you want to save.

[alanpgh]

Thanks Myoak for the comment that you can't view the video.
Here is the direct link:
https://conferencecenter.msworld.org...s-with-tysabri

Anyone have trouble viewing this video?
Just click on the link above, then click on the video to play. It's made to work with PC's, Mac's, and mobile devices.

As to your question about the "sticky":
We "sticky" threads to highlight so they stand out for our members. This discussion is important, especially for people who have been on Tysabri for a long time. They might want to ask their Neuro about the new test mentioned in the video.

I may adjust the Sticky into a new thread just highlighting the video. Then linking to this thread. That will highlight the video.

Thanks to everyone for you questions and suggestions.

We're all in this together!

Alan

[Myoak]

Sorry Alan, the link to the site works, however no video appears. Therefore I cannot click play because no video comes up to play.

Has anyone outside MS World staff been able to play the video Alan furnished a link to? If anyone has time please give the link a try and let us know if it worked for you. Maybe its just me.

Thanks a million!