The two approved Covid-19 antibody treatments that can help keep high-risk patients out of hospital are so few that doctors face a daunting question as cases increase in the United States: Which patient should be first in line?
Antibody treatments should be performed shortly after the patient shows a positive result before severe symptoms occur. Hourly IV infusions are considered to be one of the most promising treatments for the disease.
But the doses of the drugs, one made by Regeneron and the other by Eli Lilly, are extremely limited. Both companies have received emergency permits from the Food and Drug Administration in recent weeks.
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30,000 doses of Regeneron are expected to begin on Tuesday, Health and Human Resources Secretary Alex Azar told reporters on Monday, with an additional 50,000 doses available within a week. Eli Lilly distributed about 120,000 servings.
This barely covers the number of new cases diagnosed in the United States each day – the seven-day average of 170,000 new cases per day.
“It’s very challenging,” said Dr. Raymund Razonable, a specialist in infectious diseases at the Mayo Clinic in Rochester, Minnesota. “What we do is assess who of our patients are most likely to be the most at risk and then prioritize them.”
Antibody treatments do not cure Covid-19; instead, they work to reduce the amount of virus in the human body. If given early enough during the course of the disease, this may prevent patients from progressing to hospitalization.
While doctors are making difficult decisions about which patients to receive antibody infusions, several high-profile patients have already advertised the drugs incandescently. President Donald Trump received the Regeneron drug when he was hospitalized with Covid-19 in October and later praised it as a “cure.” Dr. Ben Carson, secretary of the Department of Housing and Urban Development, also received the treatment and wrote on Facebook that he was “convinced” that it had saved his life. And Chris Christie, the governor of New Jersey, received the drug Eli Lilly.
But Trump, Christie, and Carson were all hospitalized with Covid-19 and therefore do not meet the criteria for drug use listed in the FDA’s emergency licenses.
In fact, according to the FDA, Regeneron and Eli Lilly treatments should not be given to patients who are already in hospital or treated with oxygen.
Because some doses are already available and more are on the way, hospital systems across the country are developing protocols for which patients will receive treatments.
Northwell Health in New York focuses on the high risk of hospitalization. High-risk patients are anyone who is considered obese — more than 40 percent of American adults, according to the Centers for Disease Control and Prevention — and those with chronic kidney disease, diabetes, or any condition that damages their immune systems.
Another factor in health systems is equal distribution.
According to Razonable, the Mayo Clinic’s team of infectious disease experts determines which patients should be given the drug, belongs to a group of lawyers “to make sure the drugs are distributed without bias”.
Dr. Tara Vijayan, an infectious disease expert at UCLA Health, is developing a medical center distribution plan for monoclonal antibodies.
“We absolutely have to do our part to ensure that it is done in a fair way and reaches the high-risk population,” Vijayan said.
“In terms of ethical distribution, first-come, first-served individuals would go their way,” said Dr. Cameron Wolfe, an infectious disease expert and associate professor of medicine at the Duke University School of Medicine.
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Beyond the question of “who” is “where.”
Complicating matters is the fact that Eli Lilly and Regeneron treatments are given as an IV infusion shortly after patients receive a positive result. This means that patients must go to a specially equipped facility to receive the drug while they are still infected – excluding, for example, the possibility of outpatient chemotherapy centers, as cancer patients are severely deprived of immunodeficiency.
While emergency care clinics and emergency departments are usually where the patient could receive such treatment, “he doesn’t want to be admitted during the busiest time of the year,” Wolfe said.
And each infusion of monoclonal antibodies takes one hour, more time is needed to examine patients on arrival and then later for any monitoring for any side effects.
“The minimum duration of the entire process will be about three or four hours,” Vijayan said.
“You can’t use any old clinic to do that. You have to do it in a place that can handle Covid,” Wolfe said. “These places aren’t really as common as you might think.”
Regeneron expects about 200,000 patients to have enough of its treatment by the first week of January. Eli Lilly expects to produce up to 1 million batches by the end of 2020.
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