Demand increasing for infusion treatment to lessen COVID-19 hospitalizations


DETROIT—More than 4,000 people testing positive for COVID-19 in Michigan have been treated with one of the two approved monoclonal antibody infusion treatments at more than 100 hospitals, pharmacies and urgent care centers that are administering the Eli Lilly and Regeneron cocktail therapies.

Early results show hospitalization rates at about 5% compared to 10% to 15% rates in similar high-risk populations, according to the state Department of Health and Human Services.

While demand for the therapies has been lower than expected because of significant drops in positive COVID-19 tests the past three months and the increasing availability of coronavirus vaccinations, emergency and infectious disease doctors are recommending eligible people get the treatment.

As of March 7, Michigan has administered 2.6 million doses of COVID-19 vaccines, or about 17% of the population.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Monoclonal antibody infusion treatment is available for certain people who have tested positive for COVID-19 with mild or moderate symptoms and are at high risk for hospitalization or death.

Eligible people include those ages 65 and older, considered obese, or who have a chronic disease such as diabetes, kidney, lung or heart disease, hypertension or any immunosuppressive disease.

Made famous when former President Donald J. Trump, former Gov. Chris Christie and former HUD secretary Ben Carson took the antibody treatments late last fall, the Lilly and Regeneron treatments are showing positive results, although data is still being analyzed, said two doctors overseeing clinics at Ascension St. John Hospital in Detroit and 1st Choice Urgent Care in Dearborn.

Clinical trial data from Lilly and Regeneron project the treatments can reduce hospitalizations among high-risk COVID patients from 10% to 3%. The FDA gave emergency use authorization to Lilly and Regeneron in November.

In follow-up phone surveys of 301 Michigan monoclonal antibody recipients, 4.7% reported being hospitalized, 64% said they felt somewhat or considerably better within two days of treatment, said MDHHS spokesperson Lynn Sutfin in an email to Crain’s.

Some 14 days after the infusion treatment, 97.3% reported feeling somewhat or considerably better, the state said.

Dr. Leonard Johnson, St. John’s chief of infectious diseases, said he is recommending eligible people who may be at an elevated risk from being hospitalized or dying from COVID-19 get the infusion. He helped set up two antibody infusion sites at St. John Hospital in Detroit and Ascension Providence Hospital in Southfield.

“If you look at the clinical trials published on these antibodies, there is clearly a benefit” of up to a 6% reduction in hospitalizations, Johnson said. “We are tracking hospitalizations and ER visits. It’s too early to talk about results. But the reaction has been very rare.”

So far, Ascension’s metro Detroit’s sites have received more than 300 doses and administered 135 infusions, Johnson said.

COVID-19 positive patients can ask if they are eligible for the antibody treatment, or doctors and nurses in hospital emergency departments, urgent care centers or primary care physicians can refer them, Johnson said.

“Some people who schedule appointments have a particular concern and know that they’re a high-risk individual,” he said. “Some of the patients are definitely motivated to go get it because they’ve read about it. But sometimes it’s the provider who thinks they should have it.”

1st Choice Urgent Care clinic in Livonia is one of six clinics operated by 1st Choice where monoclonal antibody infusion treatments are given to eligible people with COVID-19.

1st Choice Urgent Care clinics have been offering the COVID-19 antibody infusion treatments since Feb. 25 at its six locations in Dearborn, Garden City, Taylor, Bloomfield, Southfield and Livonia, said Dr. Ali Hassan, medical director.

“We see patients at all the clinics, but because it is more of a specialty service, using IVs, we have specific days at each centers,” he said. “The quicker you can give treatments you can do better.”

The monoclonal antibody infusion itself takes about 30 minutes and then another hour in the waiting room to ensure there are no side effects, Hassan said.

So far, 1st Choice has infused more than 30 people with the Lilly therapeutic cocktail who fit the eligibility criteria established by the FDA, said Hassan, adding about 20% of the clinic’s patient population who test positive could receive the therapy.

“Last week I had a 75-year-old female who came in for an appointment. She was tearing up because her husband was sitting in an ICU” with COVID-19, Hassan said. “She said, ‘We both got sick with this. I’m not feeling that bad. But I don’t want to end up like him in the ICU after a couple of days. They are thinking of putting him on a ventilator.’ “

Hassan said people are hearing about the antibody treatments by word of mouth or from their doctor. He said the patient with the hospitalized husband heard about it from her neighbor.

“We are trying to get the word out but people need to know about this option,” Hassan said. “What we did was to send out emails or text notices to all our patients through our electronic medical record.”

Sutfin said smaller rural hospitals and those in the Upper Peninsula began dosing their patients sooner than larger, urban hospitals.

For example, among the first 1,500 patients to receive the therapies, more patients were treated at hospitals in the Upper Peninsula (157) than in Detroit (91), Sutfin said.

Hassan and Johnson said they set up clinics as soon as they could and are seeing demand increase.

“The focus has been on testing and vaccines. The state has not pushed antibodies as much with the effort on reducing positive cases and deaths,” Hassan said. “There is still a subset of the population benefits from this therapy. There is just not enough information out there.”

In Michigan, monoclonal antibody clinics can be found using a online locator offered by the U.S. Department of Health and Human Services.

“We know that many hospitals are overwhelmed with the recent rise in patients hospitalized with COVID-19, and hospital staff are exhausted after months of pandemic response,” said Dr. Robert Kadlec, the HHS assistant secretary for preparedness and response, in a statement.

Besides Ascension Michigan and 1st Choice, clinics are located at hospitals in systems that include Beaumont Health, Henry Ford Health System, Michigan Medicine, Spectrum Health and McLaren Healthcare Corp. Pharmacies include OneCare LTC, MIDC Northville and Omnicare LTC.

The therapy also is offered for specific groups of people, including patients in long-term care facilities, skilled nursing facilities, psychiatric facilities and prisons.

For example, only three of 120 patients, or 2.5%, treated by MDHHS-contracted nurses and emergency medical services in seven long-term care facilities during large outbreaks were admitted to a hospital, Sutfin said. There was one patient who died, she said.

“These are impressive outcomes in a very vulnerable population,” Sutfin said in an email to Crain’s.

Earlier this year, Michigan received 22,514 patient courses of Eli Lilly’s bamlanivimab and 4,216 doses of Regeneron (casirivimab and imdevimab drug cocktail).

Of those nearly 27,000 patient courses, nearly 21,000 (18,436 Elli Lilly and 2,412 Regeneron) have been allocated to infusion sites in Michigan.

But with 4,000 doses administered, only 20% of the total doses have been administered at infusion clinics.

“There are a variety of reasons why the state believes demand is low,” Sutfin said.

For example, only 20% to 30% of people who are COVID positive and symptomatic meet the high-risk criteria and qualify for monoclonal antibody therapy, she said.

“This is far below the amount of medication that is available,” Sutfin said.

Hassan agreed. He said demand is low because the numbers of people eligible for antibody treatment are shrinking.

“Your audience is already much smaller than the vaccine,” Hassan said. “You have to meet a bunch of criteria, a positive test within 10 days. The COVID positivity rate has declined to 3% from a high of 15%.”

Over the last several months, the percentage of younger people positive with COVID-19 has increased. “The younger people give to each other more, not the elderly, who are catching from their grandkid,” he said.

Another factor is that new positive COVID-19 cases have dropped from more than 7,000 a day in November to around 1,200 per day on March 9.

Since the pandemic began last March, more than 600,000 positive cases have been recorded with 15,670 deaths, a 2.6% fatality rate, according to the latest state data.

“We have an overall reduction in total cases and there will be a decrease in demand” for the COVID-19 antibody therapy, Johnson said.

“That’s kind of natural,” he said. “It’s just a reflection of a lot less cases. We’ve already vaccinated a lot of our elderly and higher-risk individuals across the state.”

Johnson said the overall number of admissions to St. John Hospital have gone down significantly. Currently, St. John has about 15 COVID-19 inpatients, a much lower number than last December, when the hospital averaged more than 65 COVID-19 patients per day in three specialized units.

At Beaumont Health, Dr. Paul Chittick, an infectious disease specialist, said the system has administered 579 doses across three hospital sites in Royal Oak, Dearborn and Troy. It is now just operating clinics in Royal Oak and Troy.

“Demand has picked up a bit in recent weeks,” Chittick said. “(We) suspect this is because more providers are aware of them (and) there was a new study published that suggested more benefit.”

Last week, the National Institutes of Health and the Infectious Diseases Society of America issued statements recommending their use among the eligible groups.

The Lilly and the Regeneron cocktails use lab-created molecules as a substitute for antibodies to trigger the patient’s immune system to attack coronavirus. The antibodies are designed to block coronavirus from entering cells.

However, at a certain point in the infection, believed to be about 10 days, they don’t work as well, experts say. They are also used to treat other illnesses, but were discovered to work well on COVID-19 patients.

Johnson said the main point for people to know about the antibody therapies is they are for people with high-risk conditions such as obesity or those over age 65.

“People really should interact with their physicians early in the course to let them know about it. If they’re not getting better after a few days, if they develop increasing shortness of breath, see your doctor because you could be considered for these therapies,” he said. “The key is not to wait too long because after 10 days, there’s no evidence that they offer benefits.”

This story first appeared in our sister publication, Crain’s Detroit Business.


Source: modernhealthcare.com

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