A drug that could protect high-risk Covid-19 patients from developing severe illness is sitting on shelves unused as a record number of people are hospitalized in the U.S.
Thursday, public health officials at the federal and state levels plead with the country to take advantage of its vast supply of monoclonal antibody treatments, the only available therapy that can potentially keep patients out of the hospital.
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“This is the first time during the pandemic that I can recall when our resources far exceed demand,” Dr. William Fales, medical director for the Michigan Department of Health and Human Services, said Thursday during a media briefing organized by the U.S. Department of Health and Human Services. Fales estimated that just 10 percent of Covid-19 patients in the state who are eligible for the therapy had received it.
Monoclonal antibodies are lab-made drugs meant to mimic natural antibodies to SARS-CoV-2, the virus that causes Covid-19. They’re recommended for people who are at high risk of getting very sick from the virus, including anyone over age 65 and people with underlying health conditions.
At least one study showed that the therapy can lower the amount of virus in a person’s system. But no gold standard research proves that monoclonal antibodies do, indeed, provide this benefit. Most reports are anecdotal.
Fales said his team observed that hospitalization rates during the two weeks after monoclonal antibody therapy seems to be around 5 percent. That’s about half the rate of patients who received placebos in studies of the drugmaker Regeneron’s monoclonal antibody treatment, according to the Food and Drug Administration’s emergency authorization of the drug.
Dr. Andrew Thomas, chief clinical officer at the Ohio State University Wexner Medical Center, suggested Wednesday during a media call that use of monoclonal antibodies has eased strains on the hospital system.
Thomas said his system “ramped up” use of monoclonal antibodies quickly. “I’d like to think it’s why our hospitalizations have come down,” he said.
Dr. Jonathan Parsons, head of the monoclonal antibody treatment efforts at the Ohio State center, said, “Anyone who gets tested through our swabbing program is entered into an electronic medical record.” Parsons’ staff then contacts the primary care providers for patients who test positive, asking whether they’d like to refer patients for monoclonal antibodies.
New Jersey’s state epidemiologist, Dr. Eddy Bresnitz, said monoclonal antibodies may have played a role in a recent leveling off of the state’s Covid-19 hospitalizations. “It’s worth the effort to get it,” Bresnitz said during a media briefing Thursday.
So why aren’t people getting it?
Simply put, a lack of time, resources and awareness.
Obstacles to administration
Monoclonal antibodies must be given soon after a person has tested positive. “These medications work best when given early,” Surgeon General Jerome Adams said during Thursday’s briefing.
The two monoclonal antibody products that have been authorized for emergency use by the FDA, from the drugmakers Eli Lilly and Regeneron, must be given within the first week of illness.
But with testing still lagging across much of the country, many patients must wait several days to find out whether, in fact, they have been infected. Simply waiting for the test results can push patients past time they might qualify for treatment.
That barrier, however, shouldn’t be a factor in getting monoclonal antibodies, said Dr. John Redd, the chief medical officer for the office of the assistant secretary of health and human services for preparedness and response.
“Getting these therapeutics does not require having a PCR test,” Redd said during Thursday’s briefing. (A PCR, or polymerase chain reaction, test is considered the gold standard, but it can take days to get a result.)
Instead, Redd said, “a rapid test is quite appropriate.” Rapid tests can return results within minutes, but they have higher rates of false negatives.
Those on the front lines of treating Covid-19 patients say it’s not that easy.
Monoclonal antibodies are given intravenously, in an hourlong infusion, with an appointment lasting three to four hours. Because Covid-19 patients are contagious, they must be separated from other vulnerable patients who need outpatient infusions, such as those receiving chemotherapy for cancer.
Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco, said some patients might decline the treatment simply because they’re feeling better. But that might be a mistake. It has become clear that some patients may feel better before they abruptly get worse.
For many others, logistical problems get in the way.
Public transportation and ride-shares, such as Uber, are out of the question for those with active Covid-19. In addition, Chin-Hong said, some patients simply can’t afford three hours out of their day away from work or family obligations.
Chin-Hong estimates that his health system has used less than 20 percent of the monoclonal antibodies in stock.
What’s more, special infusion centers must be set up and staffed. Some say it’s an unreasonable demand on health systems that are already stretched.
“If we had this pandemic under control, we could set up infusion centers. We could set up rapid testing. But we don’t have those resources,” said Dr. Pieter Cohen, who is an associate professor at Harvard Medical School and a physician with the Cambridge Health Alliance Respiratory Clinic near Boston.
“We’re completely swamped with sick patients,” Cohen said.
Chin-Hong agreed. “These patients are generally well, and you want to focus on the sick patients,” he said.
“I think that’s where people’s mindsets are — particularly in California right now,” he said. The state has had a surge in Covid-19 cases of late. In the state’s most populous county, Los Angeles, 10 people on average test positive for the virus every minute.
The hurdles aren’t lost on at least some of those leading the federal response. “We recognize the health care system is very stressed,” Dr. Janet Woodcock, therapeutics lead for Operation Warp Speed, said during Thursday’s media call.
“On the other hand, if we don’t do this, the likelihood is that we’ll have even more overwhelmed hospitals and health care workers,” Woodcock said, adding that her team feels that efforts to set up such infusion centers are “worth it” to reduce the burdens on health care systems.
Some standalone kidney dialysis centers across the country have announced that they will begin administering monoclonal antibodies to Covid-19 patients during shifts set up for only those patients. Covid-19 has been shown to be especially dire for patients with kidney disease.
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Another factor may be lack of awareness, among both patients and providers, that the treatments are available.
During a media briefing Tuesday, Health and Human Services Secretary Alex Azar put the onus for pursuing monoclonal antibodies on patients, who “should be asking their doctors or health care providers why they aren’t being offered these antibody therapies.”
However, HHS’ online tool provides little assistance to those trying to find monoclonal antibody resources. The site has no data for people in at least 31 states, including Alabama, Kansas, Michigan, New Jersey, New York, North Carolina and Washington.
A spokesperson for HHS said Thursday that the team is working “as rapidly as possible” to update the site and that it expects more resources to be available by next week.
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