Antibody Drugs For COVID-19 Are A Cumbersome Tool Against Surges
Government officials are trying to figure out how to make better use of drugs that can keep people with COVID-19 out of the hospital. That's an urgent but daunting challenge in Michigan, where hospitals are struggling to keep up with a surge in new cases.
Monoclonal antibodies can hold the coronavirus in check by mimicking the body's natural immune defenses. The drugs, produced by Regeneron and Eli Lilly, can keep people with mild to moderate COVID-19 out of the hospital and have emergency authorization for people over 65, as well as others with certain underlying health conditions.
On Wednesday, Michigan Gov. Gretchen Whitmer urged people in her state who qualify for these drugs to seek them out, recalling that President Trump took the treatment after he fell ill with COVID-19.
"Regeneron's treatment very likely helped save the former president's life," the Democratic governor said at a news conference. "It could help save yours, too."
She said she's hoping to expand access to these drugs.
"We know, that as awareness increases, more people will take it, and we want to be sure we have the capacity to keep up with demand."
That will be a tall order. About 30% of the roughly 8,000 people in Michigan who are being diagnosed daily with COVID-19 are potentially eligible. That's more than 2,000 people a day.
Yet, the University of Michigan can provide this treatment for about 16 people a day, said Lindsay Petty, an infectious disease doctor who runs the program, which she added has administered more than any other facility in the state. Overall, she said her program has treated more than 700 people, out of a statewide total of 6,600 treatments since the drugs were authorized in November.
The challenge is these drugs must be given by intravenous infusion. That takes 21 minutes or an hour, depending on the manufacturer, and people need to be observed for at least an hour afterward. Petty said many nurses who perform these infusions are already working nights and weekends.
"We can only expand to a certain amount before it definitely starts to impact our non-COVID patient care," she said. "So, we are limited within the capacity of what we can do, and other sites are definitely limited in the same way."
The treatment could potentially be given in emergency rooms, she said, but the current surge makes that unrealistic. "All of our emergency departments in the state are overwhelmed."
The best option would be to set up whole new sites to infuse these drugs, she said.
At least there's plenty of the drugs to go around. That's because many hospitals and clinics around the country have not been aggressive in using monoclonal antibodies. And many people freshly diagnosed with COVID-19 haven't sought them out.
Treatment got off to a slow start in part because the early studies weren't convincing. The National Institutes of Health's COVID-19 treatment guidelines initially said there was not enough information to know whether to recommend them or not. The guidelines have gradually been strengthened to the point that the guidelines now recommend their use.
The challenge now is logistics. Dr. Peter Newcomer, chief clinical officer for University of Wisconsin Health, said the treatment never really took off at his facility. And now, with a low load of cases to begin with, his hospital is only treating a patient or two a day. Wisconsin hasn't seen the same surge as Michigan.
"It's just complicated," he said. "If you show up to a clinic in a county, first we need you to be aware there's a treatment." Your health care provider also needs to know about it, and "we need that provider to call. We need that call to go to the pharmacist who then reviews it. That pharmacist calls the patient back, convinces them to come in for an infusion. They've got to do that at the end of the day."
A few institutions have found a way to launch robust programs. The Mayo Clinic reports that it has treated more than 5,100 patients since November. MedStar Health in Washington, D.C., said it has treated more than 1,500.
The University of Michigan doesn't simply wait for people in need to ask for the treatment. Dr. Petty said the clinic identifies clients with positive COVID-19 tests and looks at their medical records to identify those who qualify. That includes people over 65, and those with underlying health conditions such as obesity, kidney disease and immune disorders. Treatment is most effective shortly after symptoms appear.
But Petty said that process has bogged down during the surge, starting with a testing system that's overwhelmed and running behind. And with a flood of positive test results, it's more work to identify people who would qualify for the treatment, and a challenge to reach out to them quickly.
Doctors need to treat 10 to 20 patients to keep one out of the hospital. In Michigan, for instance, Petty said 3.5% of people who get treated with the antibodies end up in the hospital, while she would expect about 7% of untreated people in similar circumstances to need hospital care.
Even so, there is potentially a growing role for this treatment. Regeneron reported in press releases this week that its product is effective in preventing COVID-19 among people at high risk for infection. A second study found that the treatment also helps people who test positive for COVID-19 but don't have symptoms.
These treatments involve injections instead of infusions, which would simplify administration of these drugs. The FDA would need to grant emergency use for these additional situations.
The use of vaccines has already substantially reduced the number of older people needing to be hospitalized, and as vaccination spreads, that should keep younger people out of the hospital as well.
"I wish I could tell you... that the need for treatment in the outpatient setting is going to go away sometime soon, but sadly I do not believe that," said Leah Lipsich, a vice president at Regeneron who oversees infectious disease medications. People with some health conditions such as immune system disorders may not be protected by vaccines, and not everyone will get vaccinated.
COVID-19 surges, such as the one in Michigan, won't be brought under control by these medications, either. Petty agrees with other public officials who say the tools for dealing with a surge are first and foremost personal actions, such as mask-wearing and social distancing.
You can contact NPR Science Correspondent Richard Harris at [email protected].
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