New COVID-19 Monoclonal Antibody Data Could Shift Clinical Practice

Medscape Critical Care ^ | February 2, 2021 | Eleanor Cummins

[gas_dr]

New data from phase 3 trials of monoclonal antibodies for patients with recent COVID-19 diagnoses, or at high risk for SARS-CoV-2 infection, could move the needle on clinician acceptance of the treatments, experts say.

Two monoclonal antibody formulations, Eli Lilly's bamlanivimab and Regeneron's cocktail of two antibodies, casirivimab and imdevimab, received emergency use authorizations from the US Food and Drug Administration in November to treat mild to moderate COVID-19 in outpatients. But current recommendations from the Infectious Diseases Society of America's COVID-19 treatment and guideline panel, based on data from a phase 2 trial of bamlanivimab, suggest against the routine use of the drug.

Data from phase 3 trials, for which the companies announced topline results in press releases last week, could result in a revision of the IDSA guidelines when published more formally and the committee convenes on the issue again, said Jason C. Gallagher, PharmD, a clinical professor at Temple University's School of Pharmacy and a member of the IDSA panel. It already appears to be encouraging clinician acceptance throughout the country, physicians said. The new data from Regeneron indicate that people who were recently exposed to SARS-CoV-2 and received its monoclonal antibodies had fewer confirmed infections than people in the trial who received placebo. In Lilly's trial, high-risk patients newly diagnosed with COVID-19 who received a combination of its monoclonal antibodies bamlanivimab and etesevimab had fewer COVID-related hospitalizations and deaths than those who got a placebo.

"It's validating what already looked to be going that way," said Gallagher. "It makes sense that if you give someone passive immunity, it's going to keep them from being admitted." However, he did not want to speak for the IDSA committee before they meet, and noted it would need more information than was provided in the press releases.

[gas_dr]

I know there is a lot of disagreement and a lot of people advocating certing treatments. From Quercetin, HCQ, Ivermectin, Vaccines and a lot of very passionate people dispensing opinion posing as fact.

I have posted this (I am not great at posting articles) for two reasons. So all can see what the state of the art is, and understand what treatment options we have. But more importantly to show what treatment really works. In my professional judgment...

IF YOU KNOW SOMEONE WHO IS SICK, OVER 65 OR WITH COMORBIDITIES, GET THEM ASAP TO AN OUTPATIENT INFUSION CENTER...for either Bamlanivimab OR Regeneron cocktail. I have seen this work in a close family member who has the whole shooting match of co-morbidities, was rapidly declining but not yet at severe disease. This member received Bamlanivimab and 36 hours was vastly improving.

THIS IS better than anything that partially helps such as ivermectin (40 - 50% effective at treatment) and HCQ (20 - 25% effective). By the time I see you in a critical care unit with SARS - CoVID - 2, there is little we can offer and death sky rockets.

Further it stands to reasons that between THIS EFFECTIVE treatment for high risk for progression and EFFECTIVE VACCINATION, we can declare this issue OVER and get back to normal rapidly.

I implore everyone who debates CoVID, read this, understand this, it is not from a fringe group or of questionable data. This is the solution on the treatment side, and the vaccinations are the treatment on the prophylaxis side.

[xzins]

Can you please comment on mRNA?

[gas_dr]

That is a broad based question, what specifically are you asking.

[goodnesswins]

Thx...have healthy 97 yr old cousin getting vax in next couple weeks...will keep this at the ready.

[Chickensoup]

Are these the treatments president Trump received.

[gas_dr]

Yes, President Trump received the Regeneron (the cocktail of monoclonal antibodies mentioned second in the article). The Lily product - Bamlanivimab is a single monoclonal antibody.

[FreedomForce]

I’m under 65 with no comorbidities. Will Bamlanivimab and the Regeneron cocktail eventually be available for everyone? Any possible negative effects of them for people who might be able to get by without them?

[gas_dr]

Yes, right now there are an abundance of doses secondary to lack of knowledge. This Phase III trial as the article says will likely move the needle. At this time, I would recommend anyone who has moderate disease get this. If you have comorbidities and mild disease, get this ASAP

[Candor7]

Big Ping.

Thanks gas_dr, will save info.

Thank you for sharing your opinion.

[DugwayDuke]

xzins wrote: “Can you please comment on mRNA?”

There is a lot of anti-vaccine propaganda out there. You might find this article useful.

https://www.mayoclinichealthsystem.org/hometown-health/featured-topic/covid-19-vaccine-myths-debunked

Or this one:

https://health.clevelandclinic.org/8-common-covid-19-vaccine-myths-explained/

Or this one:

https://www.mskcc.org/coronavirus/8-myths-about-covid-19-vaccines-debunked

Or, even this one:

https://www.yahoo.com/lifestyle/6-dangerous-covid-19-vaccine-myths-debunked-190229451.html

And, here’s one more:

https://www.henryford.com/blog/2020/12/vaccine-myths

Please note this are all very credible sources. You can place much more confidence in them than some youtube video.

[FreedomForce]

I’m puzzled how there can be a lack knowledge with something like this. Doctors just too busy to stay informed?

[RummyChick]

It’s not just age.

If your BMI is over 35 you qualify

if you are over 55 and have high blood pressure as many do you qualify

this article hacks me off. it just shows the problem with this disease and getting care. how many people might have been saved if they would have just been prescribed the infusion..and how many would now not be long haulers if they had the infusion

right now B-map is free
but when it starts costing 10 grand you are going to have to get approval with many insurance companies. time is of the essence with this..people are going to have to ask for expedited review

[HereInTheHeartland]

Really appreciate you sharing your expertise!
Lots of info out there, most of it is from non experts .
Great to hear from a real doc!

[gas_dr]

You are correct, I share your anger. This comes from an excellent clinical trial. I think a lot were waiting on the sidelines for this trial to publish

[Flick Lives]

Further it stands to reasons that between THIS EFFECTIVE treatment for high risk for progression and EFFECTIVE VACCINATION, we can declare this issue OVER and get back to normal rapidly.

—

The government will never let this go. Their drunk on power.

[Billthedrill]

Bump for later. When I am named head of the FDA my first action will be to prohibit unpronounceable medicine names.

[gas_dr]

It took me a while to learn how to say it — however there is a method to the madness, the designation -mab shows it is a biological (in this case, antibody)

[nutmeg]

Thanks for the info, Dr.!

[ReaganGeneration2]

Note this is for people with covid symptoms, not a preventative. Must be within 10 days of symptoms appearing. Not critical symptoms.