Recently, Lise Liles had a wake-up call. Some very good friends of hers—a young, healthy couple in their thirties—were severely ill from COVID-19 infections. As a pharmacist for CSI Pharmacy, Lise was especially frustrated. She knew there were two new therapies available that could be used to treat early COVID-19 symptoms for non-hospitalized patients. At the time, however, her pharmacy was not able to provide these treatments.
These new therapies—Regeneron’s REGEN-CoV and GlaxoSmithKline’s Sotrovimab—are experimental monoclonal antibody treatments that have been granted emergency use authorization by the FDA. Fortunately, Lise’s friends were able to access one of these treatments elsewhere, and they both responded quickly.
“I’ve seen this firsthand,” Lise says. “If there had been an ICU bed available in Texarkana, my friend would have been in it. I feel wholeheartedly that REGEN-CoV is what helped her recover. I’m just thankful she was able to receive treatment.”
This near-miss experience changed Lise’s whole perspective on COVID-19 and how we treat it. It’s what drove her reach out to colleagues currently administering monoclonal antibody therapy elsewhere, in order to implement the program at CSI Pharmacy. In early August, the pharmacy did acquire a supply of REGEN-CoV and, like the other specialty products it provides, began infusing the treatment in patients’ homes.
Among the first people infused under CSI Pharmacy’s new REGEN-CoV protocol was one of their own employees. Caryn Gallagher is a commercial billing manager for the company and has lived with a number of autoimmune and other rare conditions for many years. Since the start of the pandemic, she has lived in fear of coming down with COVID-19.
“I don’t have an immune system,” she says. “I have avascular necrosis, I had my colon removed for ulcerative colitis, and my kidneys are failing. So I’m kind of in a tender state right now. I’ve been staying very safe, trying not to get COVID, because we knew it wouldn’t be good if I got it.”
Last month, however, her adult daughter was unknowingly exposed and developed symptoms. When Caryn’s COVID-19 test also came back positive, she immediately texted her boss, CSI Pharmacy CEO James Sheets. Caryn was infused with REGEN-CoV the following day.
The timeline for administering the infusion is short, Lise says. “Patients have to meet certain criteria. The drug should be administered within ten days of symptom onset. Patients have to have an active infection, and they can’t be using oxygen therapy or be hospitalized. So you want to get it to them before they get that sick.”
One of the challenges in accessing this life-saving treatment, however, is that it must be administered by infusion, either intravenously (IV) or subcutaneously (SC). But with hospitals filled beyond capacity with critically ill COVID-19 patients, there are fewer options where those with less critical symptoms can get the thirty-minute monoclonal antibody treatment.
In fact, when Caryn was diagnosed, her doctor was about to send her to the emergency room as he did the previous three patients for whom he prescribed REGEN-CoV, because he thought there was no other choice. He was surprised to learn that the home infusion company she works for could do the treatment in the home.
CSI Pharmacy also provides immune globulin (IG) therapy in the home to patients who often are immune compromised. The pharmacy’s director of nursing, Roxanne Marlar, wants to reassure those patients that their nurse will not be treating COVID-19 patients.
“We’re using dedicated nurses for the monoclonal antibody treatments,” she says. “We just hired two more nurses, and I will make sure that the agency staff we use for IVIG are not also seeing COVID patients.”
REGEN-CoV and Sotrovimab are experimental therapies that are authorized for the treatment of mild-to-moderate COVID-19 in adults and children 12 years of age and older. Patients must have a positive SARS-CoV-2 test and be at high risk for developing severe COVID-19, including hospitalization or death. Neither of these treatments is to be used to treat COVID-19 patients who have progressed in their symptoms to require hospitalization or oxygen therapy.
REGEN-CoV is also authorized as a preventative treatment that can be given after the patient has been exposed to the virus but before they have started to develop symptoms. It can only be used in this way, however, if the exposed individual is at high risk for developing severe COVID-19 (for example, they are 65 or older or have other complicating conditions), and they are not fully vaccinated.
Patients who are not expected to mount an adequate immune response to the vaccine, including those with immune compromising conditions such as primary immune deficiency diseases, patients undergoing cancer treatment, and those who take certain immune suppressing medications, are also eligible to receive prophylactic REGEN-CoV treatment.
REGEN-CoV can also be given to high-risk patients as a preventative if they are at greater risk of being exposed to an infected person because they live in an institutional setting, such as a nursing home or prison, in which an outbreak of COVID-19 is taking place.
The FDA expressly states that prophylaxis with REGEN-CoV is not a substitute for vaccination against COVID-19. Three vaccines are currently available that are very effective in preventing COVID-19 and the serious clinical outcomes it causes, including hospitalization and death. Everyone over the age of 12 is urged to get vaccinated. Vaccines are widely available in all communities and are free of charge.