Thursday, August 26, 2021

After slow start, demand for COVID monoclonal antibodies treatment skyrockets

 


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https://www.usatoday.com/story/news/health/2021/08/25/monoclonal-antibodies-treatment-demand-skyrockets-covid-cases-climb/5579505001/

After slow start, demand for COVID monoclonal antibodies treatment skyrockets

For most of this year, the drugs President Donald Trump credited for his quick recovery from COVID-19 have sat unused on government shelves.

In a typical week in June, monoclonal antibodies were given to only 10 people across the entire Houston metropolitan area.

Now, though, demand is skyrocketing.

This week, about 1,200 Houston-area patients will receive REGN-COV, a monoclonal antibody made by the drug company Regeneron of Tarrytown, New York.

"We've seen an exponential rise in demand," said Dr. Howard Huang, who has led Houston Methodist Hospital's monoclonal antibody effort.

Regeneron sent out fewer than 25,000 doses a week nationwide in mid-July. Now, the Health and Human Services department is shipping about 168,000 doses a week, with 78% of the orders going regions of the country with low vaccination rates.

And demand for sotrovimab, another monoclonal antibody authorized for use against COVID-19, has spiked almost 300% over the past month.

Residents make their way down the sidewalk outside the main library after the doors to the Regeneron clinic opened Friday morning. About 50 people were in line outside the downtown Jacksonville, Florida main library Friday, August 20, 2021, as they waited for the 9 am opening of the clinic inside that gives Regeneron's Monoclonal Antibody treatment to mitigate the symptoms of COVID-19.

The push, Huang said, probably comes from the surge of COVID-19 cases, better public awareness of the drugs and doctors' successful experiences with them earlier in the pandemic.

"The biggest change is the delta variant and the surge in infection rates that's happening all over the country," said Alexandra Bowie, a spokesperson for Regeneron. 

Still, more people could benefit from them, presidential adviser Dr. Anthony Fauci said in a White House news conference on Tuesday.

He described monoclonal antibodies as "a much-underutilized intervention" in the fight against COVID-19 and said he wants people "to realize the advantage of this very effective way of treating early infection.

Less than half of the doses paid for by the federal government have been used so far, according to HHS.

Virus surge:Florida’s summer COVID wave leaves Jacksonville gasping. 'It’s like the floodgates broke open.'

Monoclonal antibodies, which are produced by cloning immune cells that have been shown effective against COVID-19, can reduce the risk of hospitalization or death by at least 70%, he said. 

But they need to be given early in the course of the disease – ideally within three to four days of diagnosis or first symptoms, Huang said. 

That is when the virus is multiplying quickly in the body and when sending an arsenal of fighters against it can make the biggest difference.

The treatment involves getting four injections, two in the abdomen and two in the arm.

The antibodies should be given to people 12 and older at high risk for a severe COVID-19 infection. That includes those who are pregnant, over 65, have a suppressed immune system because of disease or medication, who have conditions such as cerebral palsy, sickle cell disease, cardiovascular disease or chronic kidney or lung disease, or who have had a tracheostomy or gastrostomy.

REGN-COV also has been authorized for use in people who have been exposed to COVID-19, even if they have not yet tested positive for the coronavirus such as an at-risk person whose spouse is infected, or the resident of a nursing home or prison where there has been an outbreak.

Despite the surge in use of monoclonals, "we are still only reaching about 20% of the the people who could benefit," said Dr. Daniel Griffin, chief of the division of infectious disease for ProHEALTH, a New York-based health care provider. "Monoclonals never did seem to get the press that their effectiveness should warrant."

News reports are pouring in now. 

Texas Gov. Gregg Abbott, newly diagnosed with COVID-19 despite being vaccinated, announced last week that he had been given Regeneron's monoclonal antibodies. 

Florida Gov. Ron DeSantis has been touting the treatment as he opened treatment sites across the state. 

And a photo of a Florida patient lying on a library floor while awaiting the drug went viral last week. 

Florida Gov. Ron DeSantis discusses a free monoclonal antibody treatment site opening at the Havert L. Fenn Center and several others across the state during a news conference at the Fenn Center on Monday, Aug. 23, 2021, in Fort Pierce. "The monoclonal antibody treatments are free of charge to the (COVID-19) patients. Whatever they cost the federal government paid for that a long time ago, so if you're somebody that qualifies, and can benefit by that, you come in and you're not going to be charged for it," DeSantis said.

Last fall, Trump began touting monoclonal antibodies as miracle drugs. Not yet approved for the general public, he promised to make them available to any American who needed them.

The government has since issued two purchase agreements for Regeneron's drug, totaling about 1.5 million doses.

In the second agreement, which includes the vast majority of doses, the government agreed to pay $2,100 a dose, and patients would receive the drug at no cost. Some private insurance companies will add charges for delivering the drug.

The distribution of a monoclonal antibody made by Lilly was paused earlier this summer after it was shown not to be effective against some coronavirus variants.

Sotrovimab, made jointly by GlaxoSmithKline and Vir Biotechnology, received authorization only in late May, so it has not been used as frequently as the other two. It now has contracts with Indian Health Services and some military health systems as well as hospitals and health care centers in 26 states.

The drug, which also runs $2,100 a dose, should also come at no cost to the patient because of a combination of government upfront payments, reimbursements and the company's co-pay program, company spokesperson Lyndsay Meyer said.

Both monoclonal antibodies work similarly, but Regeneron's is a combination of two antibodies designed to address a broader range of variants.

GSK-Vir's is a single antibody derived from a patient who recovered from SARS-COV, the coronavirus that tore through Asia and parts of Canada in 2003. Research showed that sotrovimab reduces risk of death or hospitalization by 79% and that its effectiveness held up against variants such as delta.

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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