Antibody cocktails to treat Covid take off as Delta surges

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Dr. Sandeep Jubbal, infectious disease specialist, UMass Memorial Health. Photo umassmemorial.org

Outside, in letters a foot tall, the wall of the trailer reads: “GET TESTED. GET TREATED. CRUSH COVID.” Inside, leathery recliners cradle patients as a freshly mixed concoction drips into their veins: a combination of two monoclonal antibodies once used so rarely that when President Donald Trump got it last October, it ignited accusations of special treatment.

Now, amid the delta variant surge, the cocktail is rapidly becoming a more common, even routine medical response to a positive coronavirus test in a high-risk patient. Federal and state officials are promoting it, particularly in hard-hit areas, and demand has exploded from a trickle to more than 120,000 doses a week by the latest count from its maker, Regeneron Pharmaceuticals Inc.

The company’s combination was bolstered by recent data showing that it cuts the risk of hospitalization or death by roughly 70% in high-risk patients, and can reduce the chance of infection among a patient’s household members by more than 80%. Further fueling its momentum: a recently added option to deliver it in quick shots as well as the slower, more logistically complex infusions.

“This is huge, I would say,” said Sandeep Jubbal, the infectious disease specialist who oversees the trailer-based “Crush covid” unit at UMass Memorial Health in Worcester, Massachusetts, that opened in mid-July. Though the cocktail still has only emergency use approval, it appears to be so effective that “patients have been calling and thanking us for giving it to them,” he said.

Among the unit’s patients on Friday was an abundantly tattooed man with miserable symptoms — body aches, headache, cough — who gave his name only as Jason. He said he was unvaccinated and blamed his condition on a weekend wedding that led to at least 15 cases. Once he tested positive on Wednesday, his primary-care doctor instantly referred him to the unit, he said, hopeful it will help him feel better: “It’s brutal. I can’t eat. I can’t sleep. I had chest pain. It’s a nightmare.”

Monoclonals are by no means a substitute for getting vaccinated, experts emphasize. The treatment is aimed mainly at patients whose health conditions, age or weight place them at especially high risk of severe disease. But eligibility includes so many more-moderate risk factors, including merely being overweight, that fully 70% of the U.S. population qualifies.

In delta-hit Florida, Gov. Ron DeSantis, R, last week opened a “rapid response” antibody treatment site in Jacksonville. He announced plans for more such sites and for “monoclonal antibody strike teams” to deliver the drugs to long-term care venues.

His medical enthusiasm has a political edge: The cocktails are increasingly the delta-fighting weapon of choice for him and others who oppose restrictions such as mask mandates despite the surge in the South.

Regeneron’s chief executive officer, Leonard Schleifer, decried the politicization of the REGEN-COV cocktail in an interview, referring not to DeSantis but to media coverage and health officials.

Initially, journalists covered it as a “promising, exciting, potential cure treatment,” he said. “Right after Trump touted it, it was ‘speculative, unproven, unknown.’ So yes, this got politicized. This became a political football. It should never have been a political football.”

The result has “been a deafening and deadly silence about the benefits,” Schleifer said, adding that top public health officials worried that if they promoted antibody treatments, it could detract from their message about the importance of vaccination.

“The bottom line message should be: Get vaccinated, and if you get sick, get treated,” he said. “Why is that a complicated message?”

In recent days, that very message could be heard coming from federal officials including White House adviser Marcella Nunez-Smith. Vaccination is most important, she told reporters on Thursday, “but if you get covid-19 and you’re at high risk, I want to assure you about these therapies. Monoclonal antibodies work. They are safe. They’re free. They keep people out of the hospital and help keep them alive.”

Medical experts attribute the previous lack of vocal enthusiasm for such antibodies in recent months not to politics but the wait for solid data to instill confidence.

“If I thought there were strong evidence for monoclonal antibodies, I would have been giving them as soon as that evidence was available,” said Pieter Cohen, a Cambridge Health Alliance physician who writes the covid outpatient treatment guidance for UpToDate, a popular service that digests research and recommendations for medical staffers.

He shifted to endorsing the Regeneron cocktail only after the April appearance of a major study in more than 4,000 high-risk patients. It found a roughly 70% reduction in death and hospitalization, and no serious safety signals.

After months of confusion and misinformation about monoclonals, Cohen said, “now is the time that we actually know what works. And it’s time to get it if you’re at high risk for complications and you’re newly diagnosed with covid.”

Timing is key. Patients are advised to get tested promptly, and “if you test positive contact your primary-care provider immediately to assess you for eligibility,” UMass Memorial’s Jubbal said, “because the antibody treatments are supposed to be given within 10 days of onset of symptoms.” Once a patient needs oxygen, it could be too late.

Often shortened to “mAbs,” monoclonal antibodies are custom-made proteins that fight covid by binding to the virus, keeping it from entering healthy cells and replicating.

Another monoclonal antibody — bamlanivimab — has been withdrawn from use because it lost potency against some later variants. But the Regeneron cocktail works against delta and other circulating variants, the company says. It reports skyrocketing demand for the cocktail.

As recently as June, orders for 1,000 doses “would have been a big week for us,” Schleifer said. “Two weeks ago, we were over 50,000 a week.” The following week it crossed the 100,000-orders mark, and this week topped 120,000.

Most of those doses have been going to states hit hard by the delta surge, including Florida, Louisiana and Texas, he said. Use of the cocktails is rising broadly around the country as well, from a mobile-health unit in Sumter County, Georgia, to added antibody access at McLeod Health in the Carolinas.

Nunez-Smith said that among patients treated by a federal antibody team in Arizona, “not one has required hospitalization after that treatment.”

The federal government, which has contracted with Regeneron for all its REGEN-COV output this year, distributes the doses — 108,000 of them in July, she said, a fivefold jump from June. Patients in the U.S. have received more than 600,000 doses of monoclonal antibodies overall, she said. The government pays $2,100 a dose to Regeneron; all antibody treatment is free to patients.

In Massachusetts, nonprofit health system Mass General Brigham is in the midst of an intensive planning process to “rapidly expand not just our capacity but the settings” where monoclonal antibodies can be delivered, said Inga Lennes, the physician and executive who has overseen their use throughout the pandemic.

The need to deliver the cocktails via an intravenous infusion has long been the major bottleneck, she said. Now, a different mode of delivery — four quick shots, one in each limb — is entering the picture, backed by emergency approval and some recent data.

Patients who get the shots still need to be observed afterward for an hour in case of allergic reaction. But the logistical challenges are fewer than with infusions, which require special staff, space and skills, as well as a half hour or so to drip.

The Mass General Brigham goal, Lennes said, is to have covid antibody shots available for anyone who’s eligible — at walk-in locations near home or work rather than a distant infusion center — by the end of the current delta surge.

“We’re working as fast as we can” to set that up, she said.

Late last month, the FDA gave Regeneron’s cocktail emergency approval to be used preventively in high-risk patients who have been exposed to covid or live in high-risk settings like nursing homes. That new preventive usage is something like a “morning-after” pill, Regeneron’s Schleifer said, but only to be given following a known, prolonged exposure — not after casual interactions at, say, a music festival.

At UMass Memorial, the “Crush covid” antibody unit — part of a federal string of such units around the country — is quickly doubling its capacity from eight to 16 patients a day, Jubbal said.

And word is spreading. Some who are offered the treatment still refuse, often citing fear of a novel drug. But “the biggest barrier is the lack of awareness about even the existence of such a medication,” he said.

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