“MONOCLONAL ANTIBODIES”

There’s a COVID-19 treatment available at Meadows Regional Hospital that may save lives, and many people haven’t heard about it. Here’s what you need to know.

Months into the nation’s COVID-19 crisis, news that President Trump and the first lady had tested positive for the virus shook America to its core. Within hours, a team of doctors held a press conference reassuring the public that he would be continually monitored and given the best possible care available.

“He’s on a routine regimen of COVID therapy,” physician Sean Conley reported in front of cameras in October.

For the most part, the treatment plan for the president was similar to the treatment regimens delivered to the hundreds of thousands of patients hospitalized for COVID-19, but with a couple of exceptions. President Trump also received a dose of REGNCOV2, an experimental drug made by Regeneron that had shown promise in small, preliminary research trials.

REGN-COV2 is one drug in a family of monoclonal antibodies (mAbs), laboratory-made proteins that mimic the immune system’s ability to fight

continued from page

off harmful antigens such as viruses, according to the U.S. Food & Drug Administration (FDA) website. REGN-COV2 combines two antibodies: casirivimab and imdevimab.

In November of last year, the FDA issued emergency use authorizations (EUA) for two monoclonal antibody pharmaceuticals. The first to be greenlighted was a drug produced by Eli Lilly — bamlanivimab. It was authorized for use to treat mild to moderate cases of COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 88 pounds) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes patients who are 65 years of age or older or who have certain chronic medical conditions.

Regeneron’s REGNCOV2 (casirivimab and imdevimab) was authorized a few days later.

“Though we’ve learned a lot about treating patients, we haven’t had a definitive treatment for the virus,” notes Geoff Conner, MD. “Right now, the monoclonal antibody treatment is as important as the vaccine, but it isn’t getting the publicity because everyone is focused on the vaccine.”

Conner remarks that many folks will have to wait weeks — maybe months — to be vaccinated. Since the virus’ mortality rate is much greater in patients who are 65 or older and/or have certain contributory health problems, there’s a high probability of someone in that group contracting the virus before they get vaccinated.

“If he or she contracts the virus and gets a positive COVID test, then their doctor can prescribe the monoclonal antibody treatment, and it may keep them out of the hospital, and it may save their life,” he says. “The sooner you get the treatment, the better. It’s an infusion that’s done at the hospital and takes a couple of hours to administer.”

However, patients who are hospitalized due to complications of the virus are not eligible to receive the mAbs treatment, as stated in the FDA’s guidelines.

“It’s an important tool in our toolbox,” Dr. Conner says. “Studies show that when given early, it may reduce the likelihood of a patient’s condition worsening. Monoclonal antibodies can possibly keep our hospitals from filling up, and that’s why it is critical for everyone to know it is available here.” The studies the FDA cites on their website are small but paint a hopeful picture. Among the study group, patients receiving the Regeneron infusion were three times less likely to visit a hospital or emergency room (9% of patients who did not receive the therapy compared to 3% who did). Four percent of patients treated with Eli Lilly’s infusion (bamlanivimab, which is available at Meadows Regional Medical Center) were hospitalized or visited the ER compared to 15% of the patients who did not receive the drug, according to a study published in the Journal of the American Medical Association ( JAMA) in December.

Dr. Conner has seen the results firsthand. He has prescribed the mAbs infusion to several patients who tested positive for COVID- 19 in the last month.

“Meadows has received several doses of Eli Lilly’s bamlanivimab, so that’s what my patients received,” he says. “I’m happy to report that all of my patients are doing well. Again, the monoclonal antibody treatment is available now and can be used to keep our hospitals from exceeding their capacity.”

It is important to note that hospitals can’t freely administer the drug. It has to be ordered by a physician.

THE ROLL OUT

According to a U.S. Department of Health and Human Services (HHS) Public Health Emergency webpage, mAbs pharmaceuticals are being allocated at the federal government level to states, territories, and federal entities on a two-week cycle. An online graphic presents the distribution process, often referred to as the “roll out.” According to their dashboard, 414,195 monoclonal antibody therapeutics have been delivered to the states as of January 5, 2021, and of those, 17,174 were delivered to Georgia.

“As of January 7, we’ve received 33 total doses,” says Jeffrey Harden, Chief Nursing Officer and VP of Patient Care Services at Meadows Regional Medical Center in Vidalia. “Of those, we’ve administered 27.”

Harden explains that the roll out has been an imperfect process and frustrations have run high, but they are committed to serving the community and making the best of a tough situation.

“For us, it’s been impossible to plan ahead because we don’t know when the treatments are coming in and how many treatments will be in individual shipments until the day before,” he says. “Even when we have vials of the monoclonal antibody available for patients, it’s challenging for us to administer the drug.”

Though the infusion itself takes an hour to administer, the total patient care window is about three hours including consultation prior to the infusion and a 1-hour post-infusion period where the patient is monitored by a trained professional to safeguard against life-threatening reactions. During the consultation, the patient is asked to read the mAbs fact sheets that explain its categorization as a non-FDAapproved pharmaceutical product. Patients sign a release before accepting the infusion. Harden notes that some patients who have had the medication ordered chose not to proceed with the treatment.

“Our nursing staff is already stretched thin,” Harden continues. “And just like everyone else, we have to deal with day-today staffing shortages when a nurse or two tests positive for COVID and can’t come to work for several days. As the cases in our area rise, hospitalizations rise, and we need more nurses to care for everyone. It’s hard to pull one away for three hours. We have managed to do it so far, but it hasn’t been easy.”

Another challenge is the strict requirements on where the monoclonal antibody infusion can be administered to patients. In a Lilly Playbook outlining the implementation and protocols of the mAbs program for hospitals across the United States, treatment sites are defined as existing hospital or community- based infusion centers, existing clinical spaces like urgent care facilities, and “hospitals without walls.” The Playbook also itemizes other requirements of mAbs infusion sites to manage patient flow and ensure HIPAA compliance.

Since infusion candidates have already tested positive for the virus, they can not be placed in areas near non-COVID patients. Fifty-four percent of hospital beds at Meadows are currently filled with patients who are struggling with the virus, and that number will likely rise in the upcoming weeks. It’s what hospital administrators across the country are referring to as a “logistical nightmare.” “Doctors in our area have offered to administer the treatment for us, but because the [monoclonal antibody] treatments were shipped directly to our pharmacy, we are not allowed to re-distribute the drugs to other entities,” Harden says. “Like everyone else, we are hoping that the treatment will gain FDA approval soon, and that will allow it to be administered in many other facilities.” The Lilly Playbook notes that “sites that would like to be considered for product allocation should contact their State or Territory Health Authority.” The state and territory health authorities allocate the mAbs products to individual infusion sites like Meadows. Harden’s understanding is that the state makes their allocation decisions based on “the number of patients presenting with the virus” in individual counties. If so, the allocation numbers would be greater for state “hot spots,” but again, capacity and staffing challenges may render an infusion site incapable of administering the mAbs product to more patients.

FOOD FOR THOUGHT

Geoff Conner’s concern is that only looking at positivity numbers or hospitalization trends doesn’t paint an adequate picture to base allocation decisions at the state level. He feels the state should also consider other factors before making decisions.

“Communities with higher percentages of elderly people in their population should get more,” he says. “We have a lot of older folks here, and they are more at risk than younger people. It only makes sense that we would receive more of the monoclonal antibody products here to have onhand.” U.S. Census numbers report that 17% of the Toombs County population are over 65 years of age (Tattnall County: 15%, Montgomery County: 17.5%, and Appling County: 17.7%). In comparison, Cobb County (north of Atlanta) reports that only 12.7% of their community members are over 65. “They should make adjustments,” he says.

And Conner feels that the state should consider the overall health profile of communities in their equation, as well. Community health is a little more difficult to determine. However, studies reveal that communities with greater percentages of people living at or below the poverty level have higher incidences of obesity, diabetes, COPD, and heart disease among its population. Checking the U.S. Census data finds a greater concentration of people living in poverty in Toombs (19.2%), Tattnall (26.5%), Montgomery (19.4%), and Appling (20.9%) Counties, compared to other areas of the state. In Cobb County, 8.3% are living at or below the poverty line (Houston County: 11% and Gwinnett County: 9.2%). There is a strong argument to be made that counties with higher poverty rates have populations with more health problems and need to be given more of the mAbs products to administer to COVID positive patients. Dr. Conner is also upset that many of the doses of the monoclonal antibodies are going unused. Like so many, he’s frustrated and wants to see improvements made to the system, problems solved quickly, and more efficiency and logic added into the process. “At the end of the day, my job is to help my patients and find effective treatments,” he says. “That’s what I am trying to do.”