Hospitals scramble as antibody treatments fail against Omicron
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Hospitals, drug companies, and Biden administration officials are rushing to face one of the Omicron variant’s biggest threats: two of three monoclonal antibody treatments doctors have relied on to keep patients from getting sick. Covid-19 to become seriously ill do not appear to thwart the latest version of the coronavirus.
The only such treatment that is still likely to work against Omicron is now so rare that many doctors and hospitals have already run out of supplies.
Monoclonal antibodies have become a mainstay of Covid treatment, proven to be very effective in preventing hospitalization of high risk patients. But even as infections increase and Omicron becomes the dominant form of new cases in the United States, some hospitals have started to cut back on treatments, fearing they might suddenly become unnecessary.
In New York City, administrators at NewYork-Presbyterian, NYU Langone and Mount Sinai hospitals have all said in recent days that they will stop giving patients the two most commonly used antibody treatments, made by Eli Lilly and Regeneron, according to scores obtained by The Times and responsible for health systems.
“This is a dramatic change over the past week or so,” said Dr. Daniel Griffin, infectious disease specialist at Columbia University in New York City. “And I think that makes sense.”
The Omicron variant accounted for about 73 percent of new cases in the United States last week, according to the Centers for Disease Control and Prevention. This is up from just over 12% the week before.
(Some researchers think the percentage is not that high yet, although they also find that Omicron infections are doubling every two or three days.)
Federal health officials plan to assess later this week whether to suspend shipments of Eli Lilly and Regeneron products to individual states, based on Omicron’s dominance in different parts of the country, according to a senior administration official who spoke on condition of anonymity.
The only monoclonal antibody treatment that has worked well against Omicron in lab experiments is also the most recently licensed: sotrovimab, made by GlaxoSmithKline and Vir Biotechnology and licensed in May.
Already in high demand even before the appearance of Omicron, the supply of sotrovimab is currently very limited. But the situation should improve somewhat in the coming weeks. The Biden administration is in talks with GlaxoSmithKline to get more doses to be delivered by early next year, the administration official said.
Regulators are also expected to approve this week’s antiviral pills from Pfizer and Merck, the first two in a new class of Covid treatments, according to two senior administration officials.
Both pills can prevent serious illness in high-risk patients who until now may have received antibody treatments. Particularly promising is Pfizer’s treatment, known as Paxlovid, as it has been shown to be very effective and likely to work against Omicron.
Supplies of these antivirals will be limited at first, but even modest amounts can help ease the pressure on doctors who have so far relied on monoclonal antibodies to treat Covid patients.
Still, Dr Bob Wachter, chairman of the Department of Medicine at the University of California at San Francisco, warned that the limited availability of antibody treatments could come as a shock to patients who thought it was a reliable and powerful processing.
“If you have chosen to be less sure than you could have been, either because of your choice of vaccines or your choice of mask, this is a riskier proposition than it would have been. a few weeks ago, “said Dr Wachter.
Late last year, Regeneron and Eli Lilly received clearances for monoclonal antibody treatments performed by testing the blood of people who had recovered from the disease at the start of the pandemic.
Each patient produced a large number of different antibodies. Companies have focused on one or two that have been shown to be particularly effective in stopping earlier versions of the coronavirus.
Clinical trials have shown that these antibodies are effective in preventing hospitalization if given to people at the onset of their illness. President Trump received monoclonal antibodies made by Regeneron during his fight against Covid.
At first, doctors struggled to get rare doses. The drugs were usually given as an infusion in hospitals or clinics, with sessions sometimes lasting several hours. Despite the downside, monoclonal antibodies have become widely used to treat Covid.
Some hospitals have made them more accessible by setting up drive-thru monoclonal antibody clinics. Doctors have even started giving the drugs to people simply exposed to the coronavirus, in order to prevent them from getting sick.
Nearly 68,000 doses of monoclonal antibodies were administered across the country last week, according to the Department of Health and Human Services. Most of the patients received Regeneron treatment followed by Eli Lilly.
When the coronavirus variants began to emerge a year ago, researchers found that some had acquired resistance to monoclonal antibodies. A mutation in their surface proteins prevented the antibodies from sticking to the viruses, a step necessary to neutralize them.
For several months, the government suspended nationwide distribution of Eli Lilly’s antibody treatment, as it was found to be ineffective against variants such as Gamma, which emerged in Brazil and spread to many countries. many countries last spring.
Fortunately, doctors could still dispense the Regeneron treatment, which was still effective against the variants and was abundant. Other variations have largely disappeared from the United States as Delta has become dominant this summer.
Delta has been shown to be sensitive to all authorized antibody treatments. The Biden administration has once again given the green light for Eli Lilly’s treatment and ordered hundreds of thousands of doses.
But Omicron changed everything.
When the new variant was identified last month in southern Africa, researchers began lab studies testing monoclonal antibodies to see how well they worked against it. Scientists found that the antibodies to Regeneron and Lilly had failed to prevent the variant virus from invading cells. Sotrovimab, on the other hand, remained potent.
George Scangos, CEO of Vir, attributed the resilience of sotrovimab to the strategy researchers used to find it. Rather than looking into the blood of Covid survivors, the researchers examined the blood of people who had survived the 2003 SARS outbreak, caused by a related coronavirus.
They identified an antibody from a SARS survivor that also protected against the coronavirus that caused Covid. This double action suggested that the sotrovimab antibody attached itself to a part of the virus which changed very little during its evolution. And new variants would be unlikely to change, the researchers said.
“I think we didn’t get here by luck, but through a thoughtful process,” Dr Scangos said.
At New York Community Hospital in Brooklyn, clinicians administer Regeneron and Eli Lilly treatments to approximately 100 Covid patients daily. The hospital ran out of GSK-Vir treatment stocks several weeks ago.
“If I had a choice, I would give GSK,” said Dr. Ralph Madeb, the hospital’s co-medical director.
The federal government has ordered approximately 450,000 doses of sotrovimab, at a cost of approximately $ 2,100 per person. The expeditions began in the fall. But as Omicron emerged, authorities halted shipments of GSK-Vir’s still effective sotrovimab to states, in a bid to preserve supply as scientists determined how bad the news was. variant would pose a threat.
When it became clear that Omicron was gaining a foothold, the government allocated 55,000 doses of sotrovimab to states, with deliveries arriving as early as this week. GSK is expected to deliver 300,000 additional doses to the United States in January.
“What matters most is the supply we can have in January, February and March, and we are doing everything we can to increase it,” said Dr Scangos.
Kathleen Quinn, spokesperson for GSK, said the companies “are actively working to expand our capacity,” adding another production facility and speeding up production plans.
Expansion plans might not come soon enough for places like the upper Midwest, which is already lacking in monoclonal antibodies amid a wave of Covid.
Dr Bruce Muma, president of the Henry Ford Health System in Michigan, said the health system and state officials are bracing for a reduction in monoclonal antibodies Regeneron and Eli Lilly, while anticipating only a meager supply of sotrovimab.
Dr Muma said demand for the treatment is already outstripping supply. He expects frontline staff to encounter angry patients.
“They’re going to be dealing with a fearful population of patients who aren’t able to get what they think they need to get,” he said.
“We can’t even afford the slightest surge, and with Omicron, it looks like it’s coming,” said Dr Muma.
Dr Griffin, who sees patients in New York City, said he expects some tough conversations now that major healthcare systems have stopped using them until the most effective treatment arrives.
Vaccinated patients should always be well, he said. But the most likely to be upset will be patients who “didn’t want to get the shot but thought, ‘I can trust monoclonal drugs. If I need them, they will be there for me.
The sudden appearance of Omicron prompted the Food and Drug Administration to quickly figure out how to regulate monoclonal antibodies in this new chapter of the pandemic.
The agency “works with the sponsors of all currently licensed therapies to assess activity against any global SARS-CoV-2 variant of interest and is committed to communicating with the public as we learn more. “, according to agency spokesperson Chanapa Tantibanchachai.
Dr Lindsay Petty, an infectious disease specialist at the University of Michigan School of Medicine, said she and her colleagues were wondering when and whether to switch abundant monoclonal antibodies to the rarer sotrovimab.
“Once we decide to change, we predict that we will run out of medication every week,” she said.
Both Regeneron and Eli Lilly say they are developing monoclonal antibodies for Omicron, but it will be months before they’re ready to use.
Noah Weiland contributed reporting.
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