This week’s COVID-19 podcast by the Infectious Disease Society of America focused on the critical information that physicians – and the public – need to understand about Monoclonal Antibody therapeutics now available from Pfizer and Regeneron.
How do monoclonal antibody treatments help combat COVID-19? In this episode, we discuss the latest information on monoclonal antibodies with Dr. Eric Daar of UCLA Medical Center, Dr. Alyssa Letourneau of Massachusetts General Hospital and Dr. Roger Bedimo of the VA North Texas Health Care System.
Here are a few notes from the speakers. Dr. Eric Daar of UCLA Medical Center explained the fine points of the EUA and NIH guidance.
This population group – of high risk individuals – has been understudied . . . Intervening early in the population of individuals could have a huge impact on both their morbidity and mortality, and also importantly right now, the number of people requiring medical services . . . When they really focused on the highest risk group for ER visits or hospitalizations, they found that they both reduced the requirement by about 65% to 70%.Dr. Eric Daar of UCLA Medical Center, in IDSA Podcast: COVID-19: The Latest on Monoclonal Antibodies (Dec. 19, 2020)
Dr. Roger Bedimo of the VA North Texas Health Care System spoke to some of the challenges of identifying and rapidly treating people most likely to benefit.
Monoclonal Antibodies were found to be most beneficial in reducing death and disease . . . in people with high risk of progression . . . So the EUA has specified people that have a high body mass index (over 45), people with pre-existing conditions such as diabetes . . . or immunosuppressive diseases, or over 65 years of age.
Now, figuring out how to identify the population groups to get tested, and rapidly prioritizing them to receive Monoclonal Antibodies is a big challenge, but that is the first part of the answer. That is what should be done if you want to do them justice.
The second part is figuring out how to administer these products in the hospital . . . we need to have the locations either in the Emergency Department or Infusion Clinic where they can receive the antibodies for up to an hour, and another hour for follow up and monitoring.Dr. Roger Bedimo of the VA North Texas Health Care System in IDSA Podcast
Alyssa Letourneau of Massachusetts General Hospital went into more details on these challenges.
Things that need to be done that are challenging again are identifying patients quickly enough – ideally within 3 days of a test being sent and in patients who have had fewer than 10 days of symptoms.
Age is easy . . . BMI is more difficult – we don’t always have a height registered. Because it is not considered the ‘Standard of Care’ by the NIH and these products are issued under Emergency Use Authorization, we need to have a shared decision making approach with the patient, which is time consuming.
When patients come into get the infusion, they need to be examined when the arrived, because if they are too sick to get the therapy, obviously we need to send them to the Emergency Department to be evaluated. The infusion is an hour, they need to be monitored for an hour, and then they need to be followed to be sure there is no unexpected infusion related reaction or anaphylaxis.
It’s been difficult, especially with the amount of data that has been shared with us. If these work, this will be amazing. But in the sense of how much data we have, etc., it’s really hard to put in the resources to stand up these clinics quickly and to be able to do it equitably across our system.Alyssa Letourneau of Massachusetts General Hospital in IDSA Podcast.
These are all reasonable points. However, we would like to point out that if logistics, money & staff are the issues, those are problems political and public health leaders should be solving.
All of the doctor’s in the podcast noted that the NIH statement that these therapies are “not the standard of care” is an impediment. Hopefully, this can be clarified soon. They are not the standard of care for all patients, or for hospitalized patients. But that misses the critical point of the targeted patients for whom both the guidelines themselves and knowledgeable physicians indicate they should be the standard of care.
“So if this was a highly effective therapy that was considered the standard of care, then the onus would be on us to make sure that every single one of those people knew about this as an option.”
There are several major trials ongoing at over 80 sites across the country that will give us more data . . . In the interim, the best we can do right now is make sure that people are aware and make sure providers are aware . . .
The most important thing is that institutions that have access to this therapy . . . have put in a great deal of thought to make sure that any provider or patient that wants to take advantage of this opportunity through the EUA, that they do indeed have access to it.Dr. Eric Daar of UCLA Medical Center, in IDSA Podcast: COVID-19