Important COVID-19 Antibody Drugs Aren’t Being Used Enough

“Antibody drugs from Regeneron and Eli Lilly could reduce hospitalizations from Covid-19 by 50-70%,” as the article says.

When President Donald Trump got sick with Covid-19 in October, he credited an antibody drug from Regeneron with making him feel better “immediately.”

“I felt as good three days ago as I do now,” he said in a video shot in front of the White House after he left Walter Reed National Military Medical Center, promising medicines from Regeneron and Eli Lilly would soon be available to the American public to help stop the terrible effects of Covid-19.

The concern, as these drugs were cleared through the FDA and made it to market last month, was that there wouldn’t be enough supply. They’re complicated to manufacture, and Regeneron said there were only enough doses for 80,000 Americans by the end of November. Lilly has 250,000 doses available.

An average of more than 200,000 Americans are currently getting diagnosed with Covid-19 every day, according to data compiled by Johns Hopkins University. Policymakers expected to need to ration the antibody drugs.

But a month into their distribution, the opposite problem has emerged: the drugs are not getting used.

“We have a surplus of these monoclonal antibodies right now,” Health Secretary Alex Azar told CNBC’s Shepard Smith Tuesday night. “What’s happening is people are waiting too long to seek out the treatments.”

Moncef Slaoui, chief scientific adviser to the U.S. government’s Operation Warp Speed, told CNBC Tuesday that the federal government is distributing about 65,000 doses of the antibody drugs every week to states.

But, he said, only 5% to 20% of the doses are getting administered to patients.

“It should be used much more,” Slaoui said in a telephone interview, noting the drugs — which are indicated for patients at high risk for severe Covid-19 — could cut down on hospitalizations by 50% to 70%.

The drugs are not simple to administer. For one thing, they’re given by intravenous infusion, so patients must go to health centers where this can be done. But since they’re likely contagious, existing IV facilities, like where patients receive chemotherapy, can’t be used.

Another issue is that the drugs need to be given early in the course of the disease. The FDA’s guidance for health-care providers says they should be administered as soon as possible after diagnosis, and within 10 days of symptom onset. It recommends against use of the drugs once patients are so sick they’re hospitalized.

But many patients don’t feel sick right away, so the idea of an IV-infused drug doesn’t occur to them immediately after diagnosis, Slaoui and Azar suggested.

“If you are over 65 or at risk of serious complications or hospitalization due to co-morbidities, what have you, and you test positive, you need to seek out and get the Lilly or Regeneron monoclonal antibody,” Azar said on the “News With Shepard Smith.” “It can dramatically reduce the risk for us of hospitalizations at a time when hospitals are getting very crowded with people with Covid.”

But it’s a challenge for some health systems to set up the infrastructure to deliver these drugs. Some states are using 100% of their allocation, Slaoui said. Others, like in Georgia and Illinois, may not be using any, according to former FDA Commissioner Dr. Scott Gottlieb.

Georgia’s public health department didn’t immediately respond to questions about their antibody usage. A spokeswoman for Illinois’ Department of Public Health said providers aren’t yet required to report use of monoclonal antibodies, but that the U.S. Department of Health and Human Services will require hospitals to report the information starting Jan. 8.

[…]

He noted the data behind the medicines suggest “the number needed to treat in terms of keeping one patient out of the hospital … is 10.” Lilly has said it will have 950,000 doses available by the end of January, Gottlieb cited the effects if 900,000 doses were used: “That means if all of the drugs got distributed, we could avoid 90,000 hospitalizations or emergency room visits. That would be substantial.”

Lilly noted the IV administration of the antibody drugs “presents unique challenges to the healthcare system,” and said it’s working to address the challenges to ensure patients who need the drug can get it. The company is running a number of pilot programs through Operation Warp Speed, including one with CVS for in-home infusions, a company spokeswoman said.

Researchers Claim Oral Drug Blocks COVID-19 Transmission Within 24 Hours

This drug (MK-4482) is notable because it has the distinction of “MK,” as in, it was developed in part by the Merck pharmaceutical company. I’m one to often disparage the pharmaceutical companies but Merck has done notable things in its past drug research. The Merck development of MK-677 — an experimental growth hormone secretagogue that has been shown to increase hunger, increase bone density in the frail, and improve healing in humans — has shown significant potential in medicine. A former Head of the US Biomedical Advanced Research and Development Authority has said that drugs similar to MK-4482 cause birth defects, but the study authors claim that toxicity studies on MK-4482 have already been done, with the results already approved by regulators as a sign to continue with research into the drug in people.


Treatment of SARS-CoV-2 infection with a new antiviral drug, MK-4482/EIDD-2801 or Molnupiravir, completely suppresses virus transmission within 24 hours, researchers in the Institute for Biomedical Sciences at Georgia State University have discovered.

The group led by Dr. Richard Plemper, Distinguished University Professor at Georgia State, originally discovered that the drug is potent against influenza viruses.

“This is the first demonstration of an orally available drug to rapidly block SARS-CoV-2 transmission,” said Plemper. “MK-4482/EIDD-2801 could be game-changing.”

Interrupting widespread community transmission of SARS-CoV-2 until mass vaccination is available is paramount to managing COVID-19 and mitigating the catastrophic consequences of the pandemic.

Because the drug can be taken by mouth, treatment can be started early for a potentially three-fold benefit: inhibit patients’ progress to severe disease, shorten the infectious phase to ease the emotional and socioeconomic toll of prolonged patient isolation and rapidly silence local outbreaks.

“We noted early on that MK-4482/EIDD-2801 has broad-spectrum activity against respiratory RNA viruses and that treating infected animals by mouth with the drug lowers the amount of shed viral particles by several orders of magnitude, dramatically reducing transmission,” said Plemper. “These properties made MK-4482/EIDD/2801 a powerful candidate for pharmacologic control of COVID-19.”

In the study published in Nature Microbiology, Plemper’s team repurposed MK-4482/EIDD-2801 against SARS-CoV-2 and used a ferret model to test the effect of the drug on halting virus spread.

“We believe ferrets are a relevant transmission model because they readily spread SARS-CoV-2, but mostly do not develop severe disease, which closely resembles SARS-CoV-2 spread in young adults,” said Dr. Robert Cox, a postdoctoral fellow in the Plemper group and a co-lead author of the study.

The researchers infected ferrets with SARS-CoV-2 and initiated treatment with MK-4482/EIDD-2801 when the animals started to shed virus from the nose.

“When we co-housed those infected and then treated source animals with untreated contact ferrets in the same cage, none of the contacts became infected,” said Josef Wolf, a doctoral student in the Plemper lab and co-lead author of the study. By comparison, all contacts of source ferrets that had received placebo became infected.

If these ferret-based data translate to humans, COVID-19 patients treated with the drug could become non-infectious within 24 hours after the beginning of treatment.

MK-4482/EIDD-2801 is in advanced phase II/III clinical trials against SARS-CoV-2 infection.