Demand for drugs to keep COVID-19 patients out of hospitals increases in the Triangle
The night that Ky Williams was diagnosed with COVID-19 she found it so hard to breath that relatives called every two hours to check on her.
“I slept on the couch, sitting up, with the television on rather loud, just to make sure I would wake up,” Williams said. “Because my breathing was so labored.”
The next day, someone from WakeMed, where Williams had tested positive, called to see if she would be interested in a new treatment for patients recently diagnosed with COVID-19. Studies suggest that an intravenous infusion of monoclonal antibodies can help keep people infected with the coronavirus from needing to be hospitalized.
Williams, 49, a construction engineer who lives in Raleigh, talked it over with her doctor who said she should try it.
“I literally felt like there was an elephant sitting on my chest,” she said. “So anything that was going to help me, especially if it was something that my doctor supported, I was all in.”
Williams is one of hundreds of COVID-19 patients in the Triangle who have been given monoclonal antibodies before they get sick enough to be hospitalized. All three of the Triangle’s large hospital systems — Duke, UNC and WakeMed — offer monoclonal antibody therapy to COVID-19 patients, with the understanding that the effectiveness of the drugs is still uncertain.
Monoclonal antibodies are lab-grown proteins that attack viruses and other pathogens. They got widespread attention last fall after an infusion was credited with helping President Donald Trump recover from COVID-19 in October.
The Food and Drug Administration allows use of monoclonals under an emergency use authorization, or EUA. That means studies suggest they may work and are safe but the extensive testing the agency normally requires has not been done yet. The FDA allows their use only with patients with a high risk of developing severe COVID-19, including those age 65 or older or who have certain chronic medical conditions such as diabetes or a weakened immune system.
The data that supported the EUA was limited and showed only moderate impact on patients, said Dr. David Wohl, an infectious disease specialist at UNC Health.
Still, UNC has given monoclonal antibodies to more than 1,200 patients across its 12-hospital system, including a dozen people a day at an infusion clinic in Pittsboro and up to 10 a day at a clinic that opened at Rex hospital in Raleigh this week.
“We are spending a lot of time, energy and resources to make this available. I wish I knew more about how effective it is,” Wohl said. “I just wish we had more data. That would make me feel more enthusiastic.”
But at a time when thousands of North Carolinians are testing positive for the coronavirus each day and hospitals are stretched to near capacity, doctors and their patients are embracing monoclonal antibody treatments. Dr. David Kirk, a pulmonary and critical care specialist at WakeMed, said until now primary care physicians have felt helpless watching their COVID-19 patients get sicker until they end up in the hospital.
“They were so freaking excited to say, ‘Wow, we finally have something that can be impactful for this high-risk population,’” Kirk said. “And we actually have patients weeping as they’re getting it because they’re so excited and so hopeful.”
Keeping people out of the hospital
WakeMed has given monoclonal antibodies to more than 580 patients. Based on the odds that a person with COVID-19 will end up being hospitalized, Kirk estimates that more than 50 of those patients did not need to be admitted because of the therapies.
“Keeping 50 people out of the hospital, for us that’s huge,” Kirk said.
Duke and UNC aren’t willing to put a number to how many people they think have avoided hospitalization because of monoclonal antibodies; the patients who receive the drugs are not chosen at random, and it’s hard to know what other factors might be at work. But they assume some people are benefiting.
Dr. David Weber, medical director for infection prevention at UNC Hospitals, told members of the UNC board of directors this week that monoclonal antibody therapy lowers the chance that a high-risk COVID-19 patient will need hospitalization from about 8% to about 3%.
“Certainly during the surge, they’re not only good for patients, keeping them healthier, but they’re also good for us, keeping people out of the hospital,” Weber said.
Williams, the WakeMed patient, says she didn’t feel any different immediately after her infusion on Dec. 9. But the next day, the tightness in her chest began to lift and breathing became easier. She never needed to be hospitalized.
Williams understood that monoclonal antibodies are thought to reduce symptoms of COVID-19 but are not a cure. In fact, the fatigue she felt from the disease lasted another month and she still has a lingering cough.
“I’m not back to normal,” she said.
Monoclonal antibody therapies slow to catch on
In November, the FDA issued emergency use authorization for two monoclonal antibody therapies — from Regeneron and Eli Lilly. The federal government, through Operation Warp Speed, has agreed to buy 1.5 million doses of the Regeneron cocktail of two antibodies and 950,000 doses of the Eli Lilly drug.
But monoclonal antibodies for COVID-19 were slow to catch on nationwide. In his final days in office, outgoing U.S. Secretary of Health and Human Services Alex Azar urged people who test positive for the virus and are 65 and older or have underlying health problems to ask their doctors why they are not receiving them.
“We have products sitting on the shelves that can help keep people out of the hospital,” Azar said at a press conference. “That is just as unacceptable as vaccines sitting on shelves unused.”
Doctors say there are several reasons why monoclonal antibodies aren’t used more frequently. For starters, the drugs are most effective within a few days of a patient developing symptoms. Some patients don’t learn about the drug until that window is closed, while others aren’t sick enough at that point that they see the benefit of trying an EUA drug, Kirk said.
Some patients are also put off by the way the drugs are administered, said Wohl at UNC. Rather than a pill or a shot, the drugs are given through an IV infusion that requires a visit to a special clinic that may last up to three hours.
In addition, infusions limit the availability of monoclonal antibodies, said Dr. Susanna Naggie, vice dean for clinical research at the Duke University School of Medicine. It takes a dedicated space and specially trained staff to administer them.
“Some clinics, health systems, smaller hospitals just don’t have the resources to stand something like that up,” Naggie said.
Duke Health has treated more than 100 patients with monoclonal antibodies under the FDA’s EUA, Naggie said. She said Duke provides the option but that doctors explain that scientists still don’t know for sure how well the therapies work and under what circumstances.
“When you have that transparent conversation with the patient, we have certainly had a number of patients say, ‘You know what, I don’t think that’s something I’m interested in,’” she said.
Like UNC’s Wohl, Naggie would like to see more research done on monoclonal antibody therapies and fears that making them so widely available now means patients won’t take part in the necessary clinical trials where they may get a placebo instead of the drug.
UNC and Duke are among dozens of sites across the country helping to test various therapies for treating COVID-19 patients before they require hospitalization. Some are new types of monoclonal antibodies, some are other types of drugs. Most are designed to be taken orally, eliminating the need for infusion centers.
The goal, said Naggie, is to come up with something like Tamiflu, an antiviral drug that reduces the severity of flu symptoms and shortens the recovery time.
For now, places that offer monoclonal antibodies are busy, handling the post-holidays spike in coronavirus cases. WakeMed has had patients from as far away as Wilmington and Virginia come to its infusion clinic. And UNC, which calls all of its patients who test positive for the coronavirus to let them know about the therapies, is having trouble keeping up with demand, Wohl said.
“We are swamped,” he said. “There’s a lot of people who are very, very excited about these compounds.”
This story was originally published January 28, 2021 at 6:00 AM.
