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Why potentially life-saving monoclonal antibodies are not used



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

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

These challenges include staffing constraints and space during the increase in cases where it takes a long time to administer an infusion and short-window providers need to reach patients qualified for treatment.

Still, federal and state health officials urged providers to expand access to experimental therapy, which has shown promise in early trials. A clinical trial of the Regeneron monoclonal antibody cocktail showed that admissions decreased to 3 percent compared with 9 percent in the placebo group.

At the family̵

7;s health centers in San Diego, they have turned a dental house and some unused medical room into a monoclonal antibody infusion clinic.

“My feeling is that we need to do everything we can to prevent our hospitals from being overwhelmed,” said medical director Dr. Christian Ramers.

Dr. Ramers said he and two assistants add approx. five patients a day laboratory-produced antibodies four days a week. They plan to scale up the surgery to serve up to eight patients a day, but the low-income patient clinic is already making more infusions than some large hospitals.

“Interestingly enough, supply is not the problem. “This is another case where there are hundreds of doses of this drug sitting in refrigerators throughout 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 around the county. Only 20 percent of the supply was used.

Regeneron and another company, Eli Lilly, were granted emergency use permits in November to treat people at high risk for serious illness in an outpatient setting before a person is hospitalized.

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

“Everyone thought it would be snapped up as soon as they went to the centers. But unfortunately due to a perfect storm of things. It hasn’t really taken up that much, “said Dr. Peter Chin-Hong, a specialist in infectious diseases at UC San Francisco.

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

The infusions take two hours for the patient plus additional preparation time for thawing and mixing the solution. It is a challenge in a moment when staffing is tight.

“This is in the middle of an increase right now, and there are not that many people moving around,” said Dr. Chin-Hong. He said the UCSF makes about two to four infusions a day.

There is also a narrow time window for administering the treatment. Under FDA approval for emergency use, 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 wait a few more to get results. At that point, “you’re already pushing the end of the window, so there’s a lot of work that needs to go very quickly in identifying people.”

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

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

Due to 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 its clinics, said Dr. Ramers.

But he said other providers offer the treatment. Patients just need to know how to ask.




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