Continued Confusion & Hesitancy in Appropriate Use of Monoclonal Antibodies is Costing Lives

There was great news over the last few weeks with the Pfizer and Moderna vaccine roll-outs.  On the other hand, there is still tragic confusion and hesitation on the appropriate and focused use of Monoclonal Antibodies.   As both our national health leaders with the most insight and experience with these therapeutics, and knowledgeable physicians point out:

  • The single most important factor is effective communication to and education of the public. If people who test positive for Covid-19 are unaware they could qualify for monoclonal antibodies, they will not seek treatment until it’s too late.

As physicians become better informed on the history of antibodies, the actual clinical trial results, and talk to other physicians who are familiar with them, we are seeing progress. But literally each day counts!

FDA Commissioner Hahn and HHS Commissioner Azar have been communicating in strong and clear terms on this:

“We’ve got to get the therapeutics used. We need patients who test positive, who are at risk of hospitalization, to get on these monoclonal antibodies. We actually have more right now than there are getting used. We’ve got to get them earlier, so we keep people out of hospitals,” Health and Human Services Secretary Alex Azar told CNN’s Jake Tapper Monday. An HHS spokesperson confirmed that a new report showed only 5%-20% of the available supply of monoclonal antibodies are actually being used — an ironic statistic considering one big concern was that there would not be enough supply to meet demand. It is the first time HHS had requested utilization information from facilities and providers administering the drugs.

CNN Health: Monoclonal antibodies: A Covid-19 treatment people might not know about

Much of the confusion seems to come from the summaries at the Infectious Disease Society of America, where they do not clearly communicate benefits. For example, here is their Headline:  “Article published in the New England Journal of Medicine with interim analysis of phase 2 outpatient data showing a slight reduction in viral load.”

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And here is what the NEJM article actually reports.

SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19

Results

At the time of the interim analysis, the observed mean decrease from baseline in the log viral load for the entire population was −3.81, for an elimination of more than 99.97% of viral RNA. For patients who received the 2800-mg dose of LY-CoV555, the difference from placebo in the decrease from baseline was −0.53 (95% confidence interval [CI], −0.98 to −0.08; P=0.02), for a viral load that was lower by a factor of 3.4. Smaller differences from placebo in the change from baseline were observed among the patients who received the 700-mg dose (−0.20; 95% CI, −0.66 to 0.25; P=0.38) or the 7000-mg dose (0.09; 95% CI, −0.37 to 0.55; P=0.70). On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo. The percentage of patients who had a Covid-19–related hospitalization or visit to an emergency department was 1.6% in the LY-CoV555 group and 6.3% in the placebo group.

NEJM: SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19; Oct. 28, 2020; DOI: 10.1056/NEJMoa2029849

We understand some degree of prudence in not making definitive statements, but to characterize these findings as a “slight reduction in viral load” or that there is no evidence to show a correlation to clinical benefit in disease outcomes is directly contradicted by both the data and the long history of antibody therapeutics. This must be weighed against the real world risk assessments of severe disease or death in vulnerable population groups in the massive third wave of COVID-19 that require clear decision making and urgent action by the medical community. The effect of IDSA’s phrasing and positioning of these therapeutics which can and should be keeping high risk patients out of hospitals and saving lives right now, has been to cause confusion and hesitation. 

Meanwhile, those physicians who are being proactive are seeing “fantastic results.”   

A ‘godsend’ or not ‘worth the effort’? Monoclonal antibodies divide overwhelmed Covid doctors. Some doctors are clamoring for the treatment, which, officials say, in some places is sitting unused.

Some physicians, citing the IDSA, show exactly how this confusion plays out.

Cohen acknowledged the findings, but added, “We have no idea what viral load means in terms of outcomes for patients with Covid.” That is, will reducing the amount of virus in a person’s body change the course of their illness?  

The treatments, Cohen said, “are not a good use of our health care resources right now. We’re swamped just trying to figure out how to make sure there’s enough room for everyone who’s sick with Covid to get proper care.  

Dr. Pieter Cohen, an associate professor at Harvard Medical School and physician with the Cambridge Health Alliance Respiratory Clinic near Boston

Others, who focus on the demonstrated benefits and understand how antibodies can keep patients out of hospitals, have embraced them with very positive results.

Dr. Karen Bloch, an infectious disease physician at Vanderbilt, said her team has about 500 doses available. “We are actively reaching out to patients who meet high-risk criteria and trying to get them treated within the first seven days after onset of illness,” she said. Anecdotally, Bloch said patients who’ve received the monoclonal antibodies have had “fantastic responses.”

Saag, of the University of Alabama at Birmingham, said in his experience, the treatment “has performed very well, much better by far than anything else we have used.” Saag said a main problem hindering his use of the monoclonal antibodies is that most patients are either referred to him too late, after seven days of illness, or they don’t meet criteria outlined in the FDA’s emergency use authorization for the treatment: over age 65 or have significant underlying health problems.

One key may be effective communication and education in the public. If people who test positive for Covid-19 are unaware they could qualify for monoclonal antibodies, they will not seek treatment until it’s too late.

MSNBC News, Dec. 5, 2020: A ‘godsend’ or not ‘worth the effort’? Monoclonal antibodies divide overwhelmed Covid doctors.

Sanford Health in South Dakota established a proactive program that is saving lives.

Sanford Health, the largest provider of rural health care in the U.S., may have an answer to keep people with COVID-19 out of the hospital before a vaccine becomes available: monoclonal antibodies, the same therapy given to President Trump. NBC’s Dasha Burns gets an exclusive look for Weekend TODAY.

So, while we are happy to see the progress in awareness, it is still far too spotty, with overworked physicians not getting clear information and guidance on a uniform, national basis. Just as crucially, the public generally and the population groups most vulnerable to death or severe disease from COVID-19 must be engaged with the utmost urgency.

Immunoprevention.org will continue to bang the drum and reach out to our political and public health leaders to change that! Please review and spread the word on our plan for Focused Protection with Antibodies!.

Click to learn how Focused Protection with Monoclonal Antibodies can save lives now and protect the most vulnerable as we re-open America.
Continued Confusion & Hesitancy in Appropriate Use of Monoclonal Antibodies is Costing Lives
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