Why potentially life-saving monoclonal antibodies go unused

SAN DIEGO (KGTV) – There is only one authorized treatment designed to keep high-risk COVID-19 patients out of the hospital, but hundreds of thousands of doses of the same experimental therapy given to former President Donald Trump are stored .

Flooded hospitals have been slow to administer monoclonal antibodies because of what one infectious disease expert called a “perfect storm” of complicating factors. Some healthcare providers have refused the doses altogether.

These challenges include the limitation of staff and space as the number of cases increases, the time it takes to administer an IV, and the short window providers must reach patients who are eligible for treatment.

Still, federal and state health officials urged providers to expand access to the experimental therapy, which has shown promise in early-stage studies. A clinical trial of the cocktail of monoclonal antibodies made by Regeneron found that hospital admissions fell to 3 percent, compared with 9 percent in the group that received a placebo.

At San Diego’s Family Health Centers, they converted a dental office and part of the unused medical space into a monoclonal antibody infusion clinic.

“I feel we should do everything we can to keep our hospitals from becoming overwhelmed,” said Assistant Medical Director Dr. Christian Ramers.

Dr. Ramers said he and two assistants infuse about five patients a day with the lab-made antibodies four days a week. They plan to scale up the surgery to serve up to eight patients a day, but the low-income clinic is already doing more infusions than some large hospitals.

Interestingly enough, the supply is not the problem. This is another case where there are hundreds of doses of this drug in refrigerators all over San Diego County, ”he said.

Late last month, the Department of Health and Human Services said 378,000 doses of monoclonal antibodies had been distributed to hospitals and clinics in the province. Only 20 percent of the stock had been used.

Regeneron and a second company, Eli Lilly, were approved in November for emergency applications to treat people at high risk of serious illness on an outpatient basis before a person is admitted to hospital.

The drug itself is free, with thousands of doses paid for by the federal government.

Everyone thought it would be picked up as soon as they went to the centers. But unfortunately, because of a perfect storm of things. It hasn’t been picked up that much, ”said Dr. Peter Chin-Hong, infectious disease specialist at UC San Francisco.

Some hospitals have avoided treatment because of limited data. The National Institutes of Health says there is “insufficient data” to recommend for or against the drugs. Clinical trials are still underway.

The infusions take two hours for the patient, plus some additional preparation time to thaw and mix the solution. That is a challenge at a time when staff is tight.

“This is the middle of a wave right now and there aren’t that many people to walk around,” said Dr. Chin-Hong. He said UCSF does about two to four infusions a day.

There is also a limited time to administer the treatment. Under the FDA emergency use clearance, qualified patients must receive the antibodies within 10 days of their symptoms appearing.

Dr. Ramers said the average patient might wait a few days to get a test, and then a few more to get results. By then, “you’re already pushing the end of that window, so there’s a lot of work that needs to go into identifying people very quickly.”

Family Health Centers has developed an algorithm to scan the positive tests for the best candidates so that they can quickly contact those patients and try to make an appointment for the long-term treatment.

They are aimed at people over the age of 65 or with risk factors such as obesity, diabetes, lung disease and other conditions.

Because of the need to quickly analyze medical histories and test results, Family Health Centers can only offer monoclonal antibodies to existing patients who test positive at one of their clinics, said Dr. Ramers.

But he said other health care providers are offering the treatment. Patients just need to know to ask.

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