Some of the most promising COVID therapies are in short supply: Who will get them?

By: - December 23, 2020 7:00 am

Dr. Andrew Myers, director of inpatient COVID care at Tampa General Hospital, meets with TGH team members and University of South Florida infectious disease doctors in the 2D COVID unit. Credit: Daniel Wallace/TGH 2020

While COVID-19 vaccines trickle into Florida, COVID medicine is still top of mind for millions of Florida residents, visitors and medical personnel who are sick or trying to cure the sick.

But which sick people get the most promising drug cocktails? It’s been a mystery of sorts, but here is what we know:

The key hindrance until recently was that pharmaceutical companies had not completed enough studies on their drug candidates to merit authorization by the U.S. Food and Drug Administration. That has changed, with one drug, Remdesivir, an antiviral, gaining approval and widely used in Florida, and others coming along.

Even the experimental monoclonal antibodies cocktail used to treat President Donald Trump for COVID in October is now authorized nationally under an FDA Emergency Use Authorization, or EUA (which is not a full FDA approval).

Trump received that treatment in October via a “compassionate use” authorization, which is rare but set no precedent, according to Stat News, a leading health journal, and other reputable media.

Likewise, Trump colleagues Chris Christie, Rudy Giuliani and Ben Carson are believed to have been treated with monoclonal antibodies under compassionate-use authorizations in the fall, before the therapy was approved for others in late November.

Now that monoclonal antibodies therapy has Emergency Use Authorization, the question becomes about quantity. The supply of Regeneron’s drug cocktail through the end of January is limited to 300,000 doses, according to the manufacturer’s detail sheet. It hopes to pair with another manufacturer in 2021 to make 2 million more doses for the United States and elsewhere.

Those are low numbers considering more than 300 million people live in the United States and more than 21 million live in Florida alone — even counting the fact that not every COVID patient would qualify for the monoclonal antibodies.

Two Florida doctors told the Florida Phoenix they need not only a reliable supply but more data to help them figure out which patients, in what stage of the disease, with various underlying medical conditions, would benefit most from which drugs, in what dosages, administered for how long.

Dr. Nicole Iovine, chief epidemiology officer at UF Health Shands, in Gainesville. Credit: UF Health

“I wish we had more data. Not everyone is eligible for every treatment,” said Dr. Nicole Iovine, chief epidemiology officer at University of Florida Health Shands Hospital, in Gainesville. She said the best approach for now is to have a variety of options at hand.

“It would be nice to fast-forward on the research being done, to know which populations will benefit most,” said Dr. Andrew Myers, director of inpatient COVID care at Tampa General Hospital.

Dr. Myers said Tampa General is pretty well stocked with all top COVID therapeutics right now, but he was dubious about how supplies of promising monoclonal antibody therapies — like the ones Trump and other VIPS received in the fall — will look in January and February, especially if there is another holiday surge in cases.

“That’s a better question. If there’s an increase in the number of patients, I don’t know if they can keep pace,” Dr. Myers said.

Dr. Andrew Myers, director of COVID-19 care at Tampa General Hospital. Credit: Daniel Wallace/TGH

Dr. Iovine said she and other infectious-disease doctors are hoping manufacturers will scale up production of those therapies.

“Monoclonal antibodies are very, very promising,” she said. Those include bamlanivimab, produced by Eli Lilly, and the combination of casirivimab and imdevimab, made by Regeneron. They are EUA-approved to treat outpatients who are not yet severely sick but are at risk of becoming so.

Illustrating the potential surge in demand, AdventHealth Orlando opened a clinic at its flagship hospital last week to treat qualified outpatients with monoclonal antibody therapies, and it plans to open more such clinics in January, a spokesman said.

Eligibility for monoclonal antibody therapy was initially limited to patients at least 55 years old but has been expanded to include ages 12 and older in patients with elevated risk of developing severe symptoms, according to the FDA.

Antibody therapy combined with Remdesivir and possibly other drugs recently approved under Emergency Use Authorizations succeeded in healing Trump and his allies and they are succeeding in Florida, but there are many more challenges ahead than solutions, say some of Florida’s top epidemiologists.

Meanwhile, Remdesivir, the first and still only fully FDA-approved therapeutic drug, is the backbone of UF’s COVID treatment program, Dr. Iovine said.

“A combination of Remdesivir (antiviral drug)and dexamethasone (a steroid) are our workhorse at UF,” she said.  The combination can only be given to hospitalized patients in part because Remdesivir is administered by intravenous infusion, according to the FDA.

Pharmacist Michael Jackson, CEO of Florida Pharmacy Association. Credit: FPA

Michael Jackson, executive vice president and CEO of the Florida Pharmacy Association, said the association is not in a position to predict whether Remdesivir supplies will reliably meet future demand, but he advised patients to discuss back-up plans with their doctors.

“More demand is coming. You might find a deficit there,” Jackson said. “Patients might work closer with their primary care physicians … should there not be supplies readily available.”

Likewise, Jackson said he had seen “spot shortages” of dexamethasone even before the coronavirus pandemic.

The supply chains break at the source – manufacturers unable to keep up with demand for the drugs – or in distribution, when healthcare providers try to predict exactly how much they need but don’t always nail it. Ordering too much leaves an oversupply that may go to waste; ordering too little leaves them undersupplied.

AdventHealth Orlando also relies on Remdesivir and dexamethasone to treat COVID patients, and it is participating in clinical trials for treating hospitalized patients with Regeneron (the combined monoclonal antibodies therapy), said Dr. Victor Herrera, infectious-disease specialist and associate chief medical officer at AdventHealth Orlando.

Dr. Victor Herrera, infectious disease specialist at AdventHealth Orlando. Credit: AdventHealth Orlando

AdventHealth’s Scientific Review Committee also is reviewing possible use of baricitinib, which “moderates” a body’s immune-system response, cleared for use under an FDA Emergency Use Authorization to shorten recovery times for people sick enough to be hospitalized.

Baricitinib may be combined with Remdesivir, but it is not widely available, said Dr. Iovine, who is leading a UF clinical trial on the use of the combination. UF also conducted clinical trials on other drug combinations involving Remdesivir.

Convalescent plasma can be helpful but not to a wide spectrum of patients with various conditions in addition to COVID, Iovine said.

Asked what they most wish they had more of, the doctors were unanimous: More vaccines for their teams and in general, more data on which medicines work best for which patients, and more diligent effort on the part of the public to slow the spread of the disease.

Dr. Myers, who spent a year in Sierra Leone treating Ebola patients, said health care workers combatting COVID are stretched as far as they can go and are yearning for relief.

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Laura Cassels
Laura Cassels

Laura Cassels is a reporter, former statehouse bureau chief, and former city editor. She is a classical pianist, a Florida State University graduate and proud alum of the Florida Flambeau, an independent college newspaper.