Monoclonal antibody treatment

Reclining chairs and infusion equipment for administering monoclonal antibody treatment to COVID-19 patients are in the process of being set up inside a large enclosed tent on North Blvd., across the street from Entrance 3 of Baton Rouge General Hospital Mid City, Tuesday, Sept. 21, 2021. Administering of monoclonal antibody treatment to patients who have contracted COVID-19 is slated to start at that site on Thursday, run by teams contracted by the La. Dept. of Health. (Photo by Travis Spradling, The Advocate)

BATON ROUGE, La. - Louisiana’s supply of monoclonal antibody treatments, a drug the state has relied on heavily to try and keep COVID-19 patients from becoming critically ill, has dropped by roughly 30% as demand rises in other states struggling with the delta variant, according to public-health officials.

The drugs, produced by pharmaceutical companies Regeneron and Eli Lilly, are one of the few treatments studies show can prevent hospitalization when given to COVID patients early in the course of the disease.

They gained prominence in October, when former president Donald Trump received monoclonal antibodies experimentally to treat a COVID infection before vaccines were available. The Food and Drug Administration authorized it for emergency use in November and access has widened such that anyone over 65 or with a number of common medical conditions can get it.

Monoclonal treatment chart

Louisiana has relied heavily on the use of monoclonal antibody treatment during coronavirus surges, which can help keep COVID-19 patients out of the hospital. While demand is down in Louisiana, it’s growing among other states, which could strain supply in the future.

But in recent months, even as it has become much more common, its supply in the U.S. has still lagged. It is currently being apportioned to states by the federal government based on the number of cases.

With coronavirus cases continuing to drop in Louisiana, that's meant fewer doses arriving. In late August, the state consumed over 7,100 treatments in a week, about 7% of the nation’s weekly 100,000 dose distribution. But during the week ended Sept. 8, less than 4,400 doses were administered.

The flagging usage is a good sign as it indicates that Louisiana is likely past the peak of the fourth surge of the virus sparked by the highly-contagious delta variant. But rising use in other parts of the country now being hit by the delta variant may make it harder for people here to get it, particularly if another surge occurs.

“The new cutbacks really haven’t adversely affected us yet, but it might in the weeks to come,” said Dr. Joe Kanter, the state health officer. “Even though we’re on a downward trend, we still have a lot of COVID relative to other states.”

Dr. Joseph Kanter

Dr. Joseph Kanter during a press conference, Tuesday, September 7, 2021, in Baton Rouge, La. (Photo by Hilary Scheinuk, The Advocate)

When Louisiana's usage of monoclonal antibodies peaked in August, there wasn't a limit to how many doses of the treatment states could order from the federal government.

But low vaccination rates in many parts of the U.S., coupled with the delta variant, are creating supply constraints. There's been a 20-fold increase in monoclonal antibody use since mid-July, according to the U.S. Department of Health and Human Services, the federal agency that distributes the treatment.

Recently, states like Florida and Texas have pushed the monoclonal antibody treatment over prevention measures like masking or vaccine mandates even as delta’s deadly surge reached those areas. In response, HHS changed its formula for deciding how much each state gets.

Now the drug will be delivered based on a state’s share of coronavirus cases, and states will only receive a weekly shipment if they’ve used at least 70% of the supply on hand, said Kanter.

“Given this reality, we must work to ensure the federally purchased supply of these life-saving therapies remains available for all states and territories, not just some,” said an HHS spokesperson in an emailed statement.

Louisiana was one of seven southern states using 70% of the nation’s supply in recent weeks. At Ochsner Health, 13,000 of the system’s total 17,500 doses delivered were during the delta surge.

Though Louisiana’s COVID cases have tumbled from the all-time highs of the fourth surge, Louisiana remains in the top half of states for hospitalizations, with around 1,220 across the state, and the ninth-highest for deaths per capita over the last week, with an average of around 37 per day.

About 55% of the state's overall population remains unvaccinated. But despite hesitancy to receive what studies show are safe, effective, FDA-approved vaccines, health professionals said unvaccinated patients who have contracted COVID have largely accepted the treatment, which is still under an emergency use authorization.

“That’s what we see in the hospital: ‘Oh, sign me up, I’ll take the infusion.’ But they’re not willing to get the vaccine,” said Dr. Jennifer Avegno, director of the New Orleans Health Department. “It really is a little bit baffling.”

The drug costs around $2,100, which the federal government has covered. Comparatively, the vaccine costs less than $100 to make, deliver and administer, said Avegno.

To be effective, the monoclonal antibodies must be used during a “sweet spot” when people who might get severely ill are within 10 days of the first symptom, said Dr. Julio Figueroa, an infectious disease expert at LSU Health New Orleans. Patients cannot be sick enough to be on oxygen or need hospitalization, and a physician referral is required.

The drug, which is administered via intravenous infusion, is made up of synthetic antibodies that mimic the antibodies created by the body when someone fights off a virus after infection.

Those synthetic antibodies are more targeted than the antibodies the vaccine nudges the body into creating, however. So using the treatment is a bit like being defended by an army versus having an army, a navy and an air force. And it does not prevent infection or transmission the way the vaccine does.

“When we do the vaccination, what we induce is a polyclonal response — ‘poly’ meaning multiple,” said Figueroa. “You are able to create a number of antibodies that would protect you. One of those sets of antibodies, or multiple, would protect you against any different variants that would be out there.”

Giving the IV of antibodies also takes up a chunk of hospital resources, Figueroa said. It can take a few hours to administer, it’s only available in certain places, staff must monitor patients and hospitals have to create an area that can contain lots of COVID positive patients.

Patients with a positive PCR test can be referred for antibody treatment by a physician if they meet one of the following criteria:

  • Have a body mass index (BMI) greater than 25
  • Have chronic kidney disease, diabetes or immunosuppressive disease
  • Are currently receiving immunosuppressive treatment
  • Are 65 years of age or older
  • Are 55 years of age or older and have one or more of the following: cardiovascular disease, hypertension, chronic obstructive pulmonary disease/other chronic respiratory disease

Kids between 12 and 17 can also get the treatment if they are in the 85th percentile for BMI or have a number of diseases such as sickle cell disease, heart disease, cerebral palsy, asthma or other issues that require a ventilator, tracheostomy or gastrostomy.

Although Louisiana’s cases continue to trend downward, the state has plans to set up 13 federally supported sites before the end of the week. There are another 143 providers that can administer it.

There are no current plans in Louisiana to alter the criteria to receive it, but other states have sparked controversy after altering plans based on a person's vaccination status. Tennessee officials recently limited the treatment to unvaccinated people.

“It’s a very American approach to health care,” said Avegno of the broad willingness to take monoclonal antibodies versus the hesitancy surrounding vaccines. She compared the COVID response to the way people think about heart disease.

“We would much rather pay for the angiogram, stent, cath lab and heart surgery but not for vegetables that would have prevented all that in the first place," Avegno said. "We expect to be able to live as we please and then spend an awful lot of money dealing with the complications, rather than a little bit of prevention.”


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