COVID-19 PrEP A single dose of Regen-Cov® may be effective for pre-exposure prophylaxis (PrEP) without needing

[bkoffman]

COVID-19 PrEP A single dose of Regen-Cov® (Casirivimab and Imdevimab) may be effective for pre-exposure prophylaxis (PrEP) without needing the present protocol of monthly dosing. Dr. Koffman explains what this might mean for CLL/SLL patients.

cllsociety.org/2021/11/new-...

[Hidden]

Thanks for posting this Brian.

[cajunjeff]

When the news came out last week that regeneron infusions were producing long lasting antibodies, I saw that as a game changer for people with Cll and other immune disorders.

The attitude of most people where I live is that the danger of covid is overstated and that healthy people have less than a 1% chance of dying. If they even accept or understand what being immunocompromised means and that covid is dangerous to us, the response is “well best be careful”.

I have tried to be proactive. I took both Pfizer shots, joined the leukemia society antibody testing program, and tested negative for antibodies. When the writing was on the wall boosters might help us with Cll, I went ahead and got the j and j shot before the boosters were approved, but still tested negative for antibodies.

All the while everyone around me has been returning to normal life going on vacations, flying, going out to eat and going to ballgames. I can’t say I resent them doing so. I wish people would be more vaccine compliant. But even among understanding people, the world can’t mask and not congregate forever just for the one percent or so immunocompromised. I get that.

What it means to me is we are on our own in protecting ourselves. The only chance I saw for normalcy for me was monoclonal antibodies (mabs). It frustrated me that I had to get covid to get them. When mabs were approved for high risk people, post exposure but before an actual covid diagnosis, I put my plan in effect.

I visited my general practitioner doctor, who knows about my Cll and is sympathetic to my situation, and showed him the data that said Cll patients can have a 30% or more mortality rate with covid. I showed him my test results of no antibodies. I explained to him half my office staff is unvaccinated and that life for me has become a game of Russian roulette. Despite all my precautions, I view exposure to covid as inevitable. I am not spending my golden years isolated in my house.

He readily agreed to order me mab infusions. Under the rules, all I needed was an exposure. It has been easy enough for me to report legitimate exposures. Hardly a month goes by when I learn so and so who I might have been in the same room with later got diagnosed with covid.

My plan has been to get monthly mab infusions until longer lasting antibodies are approved. I have done three mab infusions so far. They are easy enough, a home health nurse does them at my house. I feel so much safer in the weeks immediately following the infusions. I am beyond thrilled to learn my mab infusions might be giving me 8 months or more of protection, not the one month I thought.

Now to be sure, the new data is from a very limited study. I hope it is true. We are our own best advocates. I would encourage people with Cll in places where mabs are available to discuss with their Cll doctor if they should get the infusion and how to get it. Don’t stop trying just because of some roadblock. Fight to protect yourselves.

The mab infusions are our vaccines now, even if they have not yet been specifically approved as vaccine substitutes and even if we have to report a covid exposure to be eligible. It is predictable that soon mabs will be approved as vaccine substitutes for immunocompromised people. In the meantime some of us who might have been saved my a simple infusion will die. I don’t know if someone like Colin Powell p, who had multiple myeloma, might have been saved by taking mabs as a vaccine.

I don’t really resent society for leaving me behind, to be fair if I was 40 yrs old without Cll I would be getting back to normal and not masking and social distancing indefinitely. I have just decided to do what I have to do to protect myself and bend the fuzzy rules where I can.

I’ll still be careful and will not assume my mab infusions protect me 100 %. Nevertheless, the news that mabs might be long lasting is beyond great news to me.

I hope covid mabs get broader approval everywhere for people like us. Just because someone says you are not eligible, don’t stop trying.

[Ernest2 in reply to cajunjeff]

Big thanks Jeff for sharing that, and well done for being so proactive.

Best wishes,

Ernest

[Pin57 in reply to cajunjeff]

Great reply C-Jeff, it sends a bunch of great messages. First congrats on getting the mabs, albeit it was a struggle thru the red tape to get them (and it shouldn’t have been!).

Your message to be one’s own advocate to do the right thing (and quickly), I couldn’t agree more with.

Thanks for sharing this life-saving mabs information to others on this forum. Hopefully mabs are available where others live outside US. If it’s not, why can’t US ramp-up production of the game-changer mabs bigtime and send them out to countries that need them?

[Big_Dee in reply to cajunjeff]

Hello cajunjeff

I think you have taken a very practical approach to CV-19. Blessing going forward.

[Jonquiljo]

I am in a particularly difficult situation. I am a (68 year old) W&W CLL patient (a former patient of Dr. Coutre, and thus have no CLL Dr at the moment). While I have a PCP, they are essentially clueless as to CLL, monoclonals for COVID, and CLL impaired immunity. I have had 3 vaccinations (Pfizer), but was advised a while back by Dr. Coutre not to bother testing antibody levels — as it’s meaning is not really known.

My wife and I live together in the San Francisco Bay Area. We have no living relatives that could or would help us if one of us was infected with COVID. Also, my wife is orthopedically disabled and could not even take care of her own needs , much less mine should I become ill. Basically, should COVID strike - we are in deep trouble.

To put it another way ... neither my wife or I cannot get COVID without it turning our lives upside down. To date, we have been heavily sheltering - but it is taking a huge toll on us psychologically as the alternative (i.e. - to risk COVID) is unthinkable — as even a mild case would put us in an untenable situation. A severe case would Just be unmanageable.

Simply put — does anyone know of a way to get monoclonal infusions (one or both of us) so that we can safely live our lives without hiding from the “war”? I was going to ask Dr. Coutre this very question when we had our appointment in December, but clearly that is not an option.

I’d try to join the study mentioned above, but cannot risk ending up in a placebo arm. A compassionate use application might be helpful, but I have no one able to follow through on the CLL aspects of my situation.

Does anyone have any ideas? Thanks.

Jon

[cajunjeff in reply to Jonquiljo]

Jon, under the current emergency use authorization for regeneron, you are entitled to a mab infusion if you can report an exposure to covid.

Some doctors don’t understand this but it’s clearly written in the emergency use authorization you can find online.

Get a copy of that authorization and a medical record showing you have cll. Take that to a doctor you know and report an exposure. If you think hard enough, you can come up with an exposure where you were exposed. If you can bring a copy of the study showing people with cll have a more than 30% mortality risk with covid and explain to the doctor you do not create antibodies and consider this a matter of life and death for you.

If your doctor won’t do it, find another doctor who will. Go to walk in clinics if you have to. There is no clear guideline on what proof you need of an exposure. I had 2 different drs prescribe mabs for me and didn’t require anything other from me to prove an exposure other than me saying I had one. When I explained my plan to get mabs to the young doctor who treats me, once he understood the danger of covid he told me he would do the exact thing I am doing to protect himself.

Private message me if you need links to the study showing our mortality risk with covid or a link to the emergency use order for regeneron which doesn’t require we actually be diagnosed with covid to get the infusion.

There is no shortage of regeneron in my state and zero reason for any reasonable doctor to deny me access.

[Jonquiljo in reply to cajunjeff]

Thanks Jeff,

I think your strategy for getting Regen-Covid is a good one. I do wish that the people over here in California didn't have their head so far from the sunshine that they would make it easier. This is the most arrogant, self centered and ageist state that I have ever seen. And I live in one of the most arrogant and annoying counties in the state. It is also a medical wasteland.

I took my wife to her Dr. today (PCP) and tried to ask the office manager how they managed Regeneron infusions. The office had never even heard of Regeneron infusions - though I am sure they had many over 65 patients - and all over 65 patients qualify. CLL isn't required and it would just confuse them!

I've tried working with my PCP's office (also relatively local) and it took them 3 months to figure out how to even set someone up with a Regeneron infusion (with me harassing them) if they had COVID. It is complicated and not a proven path to getting an infusion. Perhaps because there is such a high vaccination rate around here (about 87% 5 yr. + have double shots), they don't want to think about actually protecting people from Covid. They just want people to get shots. But the requirements for Regeneron infusions here are that I have a positive Covid test if I have COVID and a negative PCR test if I was only exposed.

I had gotten all this straightened out with Dr. Coutre in September - when it was about getting an infusion if I came down with COVID. Stanford is about 60 miles away. Dr. Coutre was wonderful - especially since I now realize he was e-mailing me from his iPhone because he was out of the office with a severe illness. Dr. Coutre was that kind of guy! When I heard that antibody infusions were looking good for prevention, I was going to bring it up with Dr. Coutre at my appointment with him in December.

I don't know if I am going to find that locally - and I don't know when (or whether) Stanford will assign me another CLL physician. No one will ever replace Dr. Coutre - but perhaps they can help with this situation (and CLL).

So I guess I have to look around up here for a while. I didn't want to grab a single infusion without a plan - as it looks like even monoclonal protection is not a one time affair. That means I need to find someone who I can work with on an ongoing basis. I just wonder, who that might be?

For that matter, I will be 4 months out from my (immunocompromised) vaccine booster in December. My first booster was 4 months from my original vaccine series. Who will be able to ensure that this is something to pay attention to? Do we need shot #4 at that time?

[cajunjeff in reply to Jonquiljo]

Jon, with the news that a regeneron infusion might get us 8 months or more protection, I hope you will consider a strategy that focuses on getting that first infusion. If it’s true we get long term protection from the infusion, then getting one now buys you at least 8 months to develop a longer term plan.

I think the evidence is so compelling that we should get infusions to protect us, that if you are persistent you will find an understanding doctor. Good luck to you.

[Jonquiljo in reply to cajunjeff]

Perhaps I will. Our bureaucrats have bungled up this aspect of our pandemic response in a very large way. Our politicians have been totally uninterested as well. The only realistic approach is to game the system much as people did earlier in the pandemic to get third doses. So that is what I guess I will do. It will be a little hard to do with without a CLL Dr. and w/o a proactive PCP, but not impossible.

If only there was a proactive country like Israel that used monoclonal preparations in such a way to protect it's immunocompromised. They would make all the paper pushers in the US look like clowns again. I guess in the US we let the "alphabet agencies" rule the show (CDC and FDA). Logic does not thrive there.

[Smac29 in reply to Jonquiljo]

Hi Jon,

I would email Dr Coutres nurse. She is very helpful. And Dr Beth Ann Martin is filling in for the short term for Dr Coutre’s patients. You can always make a video appointment with her before December. Maybe she would have some advice on Regen-Cov.

I hope this helps a little. I also feel a little lost without Dr Coutre.

Sheryl

[Jonquiljo in reply to Smac29]

Do you know if Dr Martin is going to be handling Dr. Coutre’s appointments that have already been scheduled? I am sure that he had many patients scheduled on the books. I noticed that my appointment is still there. Not sure what Stanford plans to do. Thx. Jon

[Smac29 in reply to Jonquiljo]

Hi Jon,

When I talked to his nurse the other day she said Stanford is planning on hiring someone because Dr Coutre has many many patients. My appointment in February is still there also. But I did make appointment with Dr Martin for next week to meet her. I wanted to meet her because I have a few questions and I’m traveling for the holidays and if anything happens I’d like to still have a contact there.

I hope this helps.

Sheryl

[Jonquiljo in reply to Smac29]

Thanks. Hiring someone could take a very very long time. You’re talking about filling a position for senior research faculty. Dr Coutre could never be replaced, but even to find someone to fill his vacant position could take years.

Hmmm. I’m w&w. My PCP knows nothing about CLL. I live in Marin and as far as I know —there is no one around here that can even be trusted. And you’re an O&V alumnus. I’m sure they want to keep track of you.

[Smac29 in reply to Jonquiljo]

Well, I’m hopeful that they will find someone.

Sheryl

[bkoffman CLL CURE Hero in reply to Jonquiljo]

Please email or call me.

[Jonquiljo in reply to bkoffman]

I just sent you an e-mail. Thx.

[bkoffman CLL CURE Hero]

Most doctors are unaware or unable or unwilling to arrange the infusions on an ongoing basis. Jeff's situation is the exception, but shows it's possible. If we get the EUA for PrEP soon as I am convinced will happen, there will be more options.

[Jonquiljo in reply to bkoffman]

I wonder if the problem is simply monetary - that the US government will pay for the material, but makes the hospitals and infusion centers scramble for paltry reimbursement payments. It's got to be about money - it always seems to be the stumbling block here.

There is a large prejudice against the elderly and sick in this country. It's easy to line people up for mass administered $40 vaccines. It's another to put together the systems to give $2K-$3K monoclonal infusions - not to a bunch of immunocompromised people who likely will cost the system more than they are worth.

It's not just us - but rather everyone for whom the vaccines are likely not a solid defense against Covid. We are eager for our vaccines when they become available for us. When it becomes a case of vaccines being "not good enough." we are told to go home and hide.

[Palmetto in reply to bkoffman]

Here in Florida it does not require a doctors order after my husband was exposed I took him to a local testing area park where he got the injectable version of Regeneron that did not require an infusion. All you have to do is say that you were exposed to someone who has Covid and that you are immunocompromised and I’m sure it must work similarly in California.

[bkoffman CLL CURE Hero]

I think it's more about the docs being overworked and not supported in these efforts by admin for some of the reasons you state. They certainly are not paid to do all the paperwork that involved in CUP so they have to have big heart and a strong backbone to push on. Please email me open this matter.

[2016Longevity]

so to make certain that we understand this all correctly: eventually, down the road, in 2022 and beyond, CLL'ers, in W&W/treatment/remission with or w/o antibodies will be getting the Regen-Cov once in the 8 months or so by their hematologist/oncologist or CLL specialist, as a prophylaxis to prevent catching the disease during the pandemic and POST-pandemic ??

[bkoffman CLL CURE Hero]

What I hope for is that mAbs like Regen-Cov and AZD7442 soon will be widely available for pre-exposure and with a quick EUA for PAXLOVID™ (PF-07321332; ritonavir), we should feel safer with more levels of protection. No guarantees.