Immune Response - how to interpret values? (Ev... - CLL Support

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Immune Response - how to interpret values? (Evusheld)

Mumu1 profile image
17 Replies

Hello,

My oncologist insists that per current measurement result for SARS-CoV-2 Abs semi-Quant of > 2500.00 U/mL (High), “you have a strong protection” [against COVID]. I received Evusheld shots half strength in February and again in March 2022 (after dose recommendation was doubled), and asked for the second round beginning of September before I go on vacation abroad. He said, I wouldn’t need it yet due to the “strong protection”.

That statement does not give me any confidence since Labcorps recently changed their threshold to > 25,000.00 U/mL  which 10 times the value. Are there any guidelines as to where Evusheld should get you with regard to threshold values?

Any I put highly appreciated!

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Mumu1 profile image
Mumu1
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17 Replies
gardening-girl profile image
gardening-girl

Mumu1, please send your oncologist a copy of the FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR EVUSHELDTM (tixagevimab co-packaged with cilgavimab) fda.gov/media/154701/download

A month ago ikahan posted a notice that FDA was recommending Evusheld repeat dosing at six month intervals. healthunlocked.com/cllsuppo...

The EUA Fact Sheet for Evusheld states the following:

Repeat Dosing

The repeat dosage of EVUSHELD in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) is 300 mg of tixagevimab and 300 mg of cilgavimab administered every 6 months, refer to Table 1 below. Repeat dosing should be timed from the date of the most recent EVUSHELD dose.

You might also want to contact your PCP, because in a number of cases oncologists are referring patients to their PCPs for access to Evusheld.

It is true that Evusheld has a half-life longer than typical monoclonal antibodies, but it is still eliminated over time.

Mumu1 profile image
Mumu1 in reply togardening-girl

Thank you very much, gardening girl. The oncologist refuses to provide the second shot 10 days short of the 6 months because I show a response > 2500.00 U/mL (tested 2 days ago), and only give the 2nd shot after I come back from the overseas trip. He stated that “> 2500.00 U/mL is proof of solid protection” for which I cannot find any proof. I’m now worried to travel to Europe [to finally see my family again after 3 years].

gardening-girl profile image
gardening-girl in reply toMumu1

Mumu1, There have been a few studies attempting to determine correlates of protection for levels of anti-spike antibodies produced in response to vaccination. One of those studies estimated that at a titer of 2,500 BAU/ml an individual would have a <10% chance of a severe COVID infection. The graph below is taken from that publication with a modification showing a 2,500 BAU/ml titer level in orange. The BAU/ml unit is roughly equivalent to the U/ml that Roche/Labcorp uses to report antibody titers.

Relative risk of primary symptomatic COVID-19 among vaccine recipientsNature Medicine volume 27, pages 2032–2040 (2021)

nature.com/articles/s41591-...

Anti-spike Correlates of Protection
gardening-girl profile image
gardening-girl in reply togardening-girl

In terms of Evusheld, the predicted minimum protective serum concentration was initially 2.2 μg/mL. I know that that doesn't tell you anything about your protection from >2,500 U/ml titer, but it might help you understand the 6 month dosing schedule. In the PROVENT and STORM CHASER clinical trials, 50% of participants still had levels higher than the 2.2 ug/ml level, 12 months after the single 300 mg IM dose. Folks now are getting 600 mg IM doses. Because of the evolution of the Omicron strains, “an updated target minimum protective serum concentration value was derived to be 3.3 μg/mL."

ema.europa.eu/en/documents/...

Given these results I can see why your doctor might feel that you have relatively strong protection from severe COVID, at least as far as antibodies are concerned. Nothing is 100% guaranteed, especially when you are in treatment and immunocompromised in other ways. If your >2500 U/ml antibodies are from Evusheld, they are even more protective than the antibodies produced through vaccination, since the Evusheld antibodies are designed to be neutralizing.

Evusheld antibody levels over time
Mumu1 profile image
Mumu1 in reply togardening-girl

Good Morning, Gardening-Girl, Again, thank you very, very much for your explanation and attached documents. This is very helpful and provides insight/explanations I would have expected from the oncologist. I will spend some more time to go through the publications you were so kind to attach. I’m very grateful. (It turned out that my levels were already above >2500 prior to receiving Evusheld (after a “regular BionTech booster in Oct. 2021) measured at the time of the first Evusheld shot in February 2022, shots were given before results were in which I don’t quite understand. The answers I received from the oncologist did not satisfy a curious “engineering mind ;) )

Bottom line: I’m very grateful for your time and information that helps to make sense of this. I will study it further and use it wisely for the time to come! Thank you very much!

P.S. Are you located in Europe? Or a “night owl”?

gardening-girl profile image
gardening-girl in reply toMumu1

Mumu1, I'm in Tennessee. Actually I could have posted my response earlier but I couldn't remember the updated ug/ml of Evusheld that is thought to be protective, and it took some time to locate it in the 155 page document (p57). Also, I wanted to be as accurate as possible in placing the 2,500 BAU/ml mark in the correlates of protection plot, so I had to make an Excel log scale and superimpose it on the plot to place the line. So maybe we have that 'engineering' thing in common!

I'm off to an IVIG infusion and definitely will be up all night tonight due to the decadron. I hope that you do get to go on vacation in abroad!

Mumu1 profile image
Mumu1 in reply togardening-girl

I could tell that you put a lot of effort into your presentation and back-up of the results, very clear and easy to follow. Much appreciated.It may or may not help: during chemo treatment - one of the meds of each round was decadron - they recommended to take Benadryl at night to counteract its effects and „wind you down“... Seemed to have worked for me.

I’m wishing you all the best for an uneventful treatment that hopefully brings you the desired results! Be well. Kindly,

ElMaga profile image
ElMaga in reply togardening-girl

I had evusheld in March and my second booster in July; my hospital does the spike protein tests (not Labcorp); two weeks after vaccine my score was positive 42K+ (I had gone off Ibrutinib for weeks, as it makes a huge difference in the effectiveness of the vaccine for me; with doc permission) ; 6 weeks later it was 25,912.0 AU/mL <50.0 AU/mL<50.0 AU/mL I don't really understand the range but I definitely had over 50 both times. My second test was after I had resumed ibruinib for the 6 weeks. Ibrutinib really mediates the vaccine. Given this rapid drop in numbers, I believe I should still get my scheduled Evusheld in September (which is 6 months after the first dose). What do you all think?

Yalokin profile image
Yalokin

healthunlocked.com/cllsuppo...

Yalokin profile image
Yalokin

what is the good immunity in BAU/ml after a booster - the very good levels are over 2000. This is for healthy people. I am telling you this only as a guide. For nearly 2 years, the laboratories had to give results only in BAU/ml, otherwise some thousands, some millions.

If it doesn't say what meter they measured with, then you need to call the lab and ask them. The link to my recent post has relevant coefficients. There are probably other brands of meters. So it's best they give you results in BAU/ml.

Yalokin profile image
Yalokin

degruyter.com/document/doi/...

"A threshold of 2,000 BAU/mL is highly predictive of strong MNT response in vaccinated individuals and may represent a good surrogate marker of protective response. It remains to be established whether the present results can be extended to BAU titers obtained with other assays."

Mumu1 profile image
Mumu1

Thank you very much for the input and document!

Ibru profile image
Ibru

My husband had his spike protein antibodies tested 3 weeks after evusheld and again 4 months after Evusheld. They dropped 4 fold in that time period. Don't assume that what you have today will still be present in September.

Mumu1 profile image
Mumu1

Hello Ibru, Hope that your husband will have enough antibodies to fight a potential infection.

Strange enough, my level was >2500 at the time of the first Evusheld shot[s] in Febr., 3 months later (May), and still is at that level.

We all react differently, hard to see a pattern unless looking at clinical studies ... and even then: all we have are guidelines.

All the best to you.

skipro profile image
skipro

The lab report should give you the span or max. Report max values are 250 at some labs, 25,000 at IHC, and now 25,000 at lab corp.

So in consideration of your 2,500 value, you should find out if the test was run when the max was 2,500 or at 25,000. If it say >2,500, they likely did it on the scale that used 2,500 as max.

snowshoe

Mumu1 profile image
Mumu1 in reply toskipro

Males perfect sense, Skipro. Thanks!

SeymourB profile image
SeymourB

Mumu1 -

Nobody tests whether a given spike level prevents infection entirely - it's too much trouble to test people daily, and do the daily viral cultures necessary to prove that. So they have in the past tested at longer intervals, and looked for symptomatic disease, hospitalization, and death outcomes. Nobody tests a person's actual immune system function. It's all group averages.

Even at higher spike levels, you can still get infected, and may have at least an unpleasant time lasting several days to several weeks. Multiple people in this forum, myself included, have gotten symptomatic infections after Evusheld. High levels probably protect against death, but there's always a percentage of people who do indeed die, and I'm sure they each had a story of comorbidities.

I personally tested at 3150 U/mL - 6 weeks after 2nd half dose of Evusheld and 6 weeks after sympomatic infection on the LabCorp Spike IgG test. The situation that led to my infection could probably have been prevented by masking, but we (as a family) had relaxed after Evusheld, and took more chances. I'm alive, though.

If you are otherwise well, and you don't mind masking indoors or in crowds, you'll probably fare well. Dining outdoors is probably safer than dining indoors.

=seymour=

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