Dr. Michael Saag cannot get enough monoclonal antibodies to treat Covid-19.
They are not personal to him; he still has natural antibodies against the coronavirus since he recovered from the disease last March.
But Saag, an infectious disease physician at the University of Alabama at Birmingham, said he would take the monoclonal antibodies – made in a lab to reflect the body’s natural immune response to the virus – ‘in the blink of an eye’ if he had an infection. would receive. second time.
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“Monoclonal antibody products are a godsend for those patients who qualify and are seen by us early in the course of the disease,” said Saag. “The sooner the better.”
Unlike the antiviral drug remdesivir and the steroid dexamethasone – both of which are given to patients hospitalized with Covid-19 – monoclonal antibodies are the only therapy to date approved by the Food and Drug Administration and intended is to prevent patients from being admitted to the first hospital. place. The FDA has granted emergency use clearances to two drug manufacturers – Eli Lilly and Regeneron – for their monoclonal antibody products.
But many doses remain untouched in health care facilities across the country, and healthcare providers are reluctant to do so.
“Many of us with infectious diseases aren’t sure that the monoclonal antibodies are worth it,” says Dr. Christopher Ohl, a professor of infectious diseases at Wake Forest School of Medicine in Winston-Salem, North Carolina.
In fact, some doctors on the forefront of treating Covid-19 patients have turned down their allocation of the treatment, citing lack of evidence that it really works.
“This is not something ready for prime time,” said Dr. Pieter Cohen, associate professor at Harvard Medical School and physician at the Cambridge Health Alliance Respiratory Clinic near Boston.
In fact, the Infectious Diseases Society of America, which helps clinicians, recommends the routine use of monoclonal antibodies, citing insufficient evidence that they work. The National Institutes of Health’s treatment guidelines also indicate that there isn’t enough data to recommend its use.
There is some early evidence that monoclonal antibodies can reduce the amount of virus in a person’s system, known as viral load. Last week, drug company Regeneron published preliminary findings in the New England Journal of Medicine on 275 patients showing such a decrease, “with greater effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline.”
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?
President Donald Trump received the monoclonal antibodies made by Regeneron when he was hospitalized with Covid-19 and later claimed they were a “cure” – although it’s impossible to pinpoint exactly how much they helped amid the variety of treatments he received.
Meanwhile, Operation Warp Speed officials have almost begged doctors to use available doses of the monoclonal antibodies.
Moncef Slaoui, chief scientific advisor to Operation Warp Speed, said last week that the use of monoclonal antibodies has been “disappointing” so far. His data showed that between 5 and 20 percent of the national supply had been used.
“Many states have products available,” said Alex Azar, Secretary of Health and Human Services. “The best time to get those antibodies isn’t when you get to the emergency room, but soon after you’re diagnosed with Covid.”
Both Eli Lilly and Regeneron monoclonal antibodies are intended for the treatment of Covid-19 patients who are also at high risk of developing complications that could lead to hospitalization. But they must be given in the first four to seven days of their illness.
Eli Lilly said his preliminary analysis of his monoclonal antibody seemed to show a reduction in hospitalizations or emergency department visits. Those Phase 2 results were published in the New England Journal of Medicine in late October.
The idea of keeping hospital admissions to a minimum is tempting, especially as the country continues to log an astronomical number of cases. On December 18, more than 114,000 people were currently hospitalized with Covid-19, according to the Covid Tracking Project. That is the largest number of hospital admissions reported in the US since the start of the pandemic.
But administering the drugs can be costly and complicated for healthcare providers. Monoclonal antibodies are administered intravenously, in an infusion of one hour, with a full appointment lasting about three to four hours.
And because eligible Covid-19 patients are highly contagious, they must be kept separate from other vulnerable patients who need outpatient infusions, such as those receiving chemotherapy for cancer.
“You need a special infusion center for a certain amount of time,” said Ohl from Wake Forest. “Not many of us rush to give this stuff.”
We’ve been inundated trying to figure out how to make sure there’s enough room for everyone sick with Covid to get the right care.
The treatments, Cohen said, “are not making good use of our health care resources at this point. We are inundated with trying to figure out how to make sure there is enough room for everyone who is sick with Covid to get the right care. to get.”
“To free up those kinds of resources for experimental treatment is not what I would recommend,” he added.
Other facilities have also mentioned logistical complications for the infusions, forwarding their supplies of monoclonal antibodies to larger institutions, such as Vanderbilt University Medical Center in Nashville, Tennessee.
Dr. Karen Bloch, an infectious diseases physician at Vanderbilt, said her team has about 500 doses available. “We actively seek out patients who meet risky criteria and try to have them treated within the first seven days of disease onset,” she said.
Anecdotally, Bloch said that patients who received the monoclonal antibodies have had “fantastic reactions.”
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Saag, of the University of Alabama at Birmingham, said in his experience that the treatment “performed very well, much better than anything else we’ve used.”
Saag said a major problem hampering his use of the monoclonal antibodies is that most patients are either referred late, after seven days of illness, or they do not meet the criteria outlined in the FDA’s Emergency Approval for the treatment: age 65 or if you have serious underlying health problems.
Medicines authorized for emergency use must follow the strict guidelines set out in the EUA, as it is called, so that doctors don’t have the flexibility to try them in other groups.
All agree: Larger, more robust studies of monoclonal antibodies are needed. Some are already in full swing.
Dr. Raymund Razonable, a professor of medicine and principal investigator of monoclonal antibody studies at the Mayo Clinic in Rochester, Minnesota, has overseen more than 900 antibody infusions across Mayo’s nationwide centers.
Razonable’s research is not yet complete, but anecdotally, he and his colleagues have found that about 2.6 percent of high-risk patients who receive the monoclonal antibodies end up in the hospital, versus about 10 percent of such patients who don’t receive the treatment. .
“This is really important to us as an institution,” said Razonable, “as we’re seeing more and more hospital admissions, to the point that we’re expanding several wards in the hospital to accommodate Covid patients.”
One key may be effective communication and education in the public. If people who test positive for Covid-19 don’t know they can qualify for monoclonal antibodies, they won’t seek treatment until it’s too late.
“You want to catch them before they don’t really feel sick,” said Razonable, who acknowledged that doctors have a limited chance of using the treatment.
“If you catch them early, the hope is that it will not lead to hospitalization,” he said. “If we can prevent that, it will be useful.”
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