It’s been roughly two months since the Food and Drug Administration gave emergency use approval to a new COVID-19 treatment that had the potential to keep early symptoms from progressing, according to early studies.
The federal government has been shipping the monoclonal antibody drugs all over the country, but health officials — including in New Jersey — would like to see more patients getting the treatment.
“This is one of the few potential medications we can offer COVID patients who aren’t hospitalized,” said Dr. Martin Topiel, Virtua Health’s chief of infectious diseases, who runs the monoclonal antibody program there. He said it seems effective at preventing mild to moderate symptoms from progressing to the point where the person has to be hospitalized.
“It seems to be effective when we can reach patients early in their symptoms, because they haven’t yet produced their own native antibodies,” he said. “We’re supplying a lab-made antibody protein for them as a replacement, and that’s why catching them early is beneficial.”
Under the emergency use authorization, the monoclonal antibodies are only available to those at high risk for severe COVID-19 illness, including those over 65 or with underlying conditions like diabetes and hypertension.
Lots of people may qualify, but many haven’t received the treatment for a number of reasons, from just not knowing it’s available to the logistics of getting the drug via infusion.
At a press conference Wednesday, State Health Commissioner Judith Persichilli also urged people to contact their doctor if they think they qualify. She noted that Rep. Bonnie Watson Coleman, D-12th Dist., received the treatment after testing positive this week.
“If you test positive and only have mild to moderate symptoms, call your healthcare provider to see if you are a candidate for monoclonal antibodies,” Persichilli said. “Our hospitals are reporting over 100 patients a day are getting this treatment and it is improving their condition and they’re avoiding hospitalization.”
Virtua Health has a good supply of one of the two drugs, made by pharmaceutical companies Regeneron and Eli Lilly, and is trying to get the word out that eligible patients can get the treatment, Topiel said.
It’s also been reported that people who want the treatment are having a hard time finding a healthcare facility that has it — all within the short window of time it would be most effective. To deal with that issue, the U.S. Department of Health and Human Services and the National Infusion Center Association created locator websites. But the websites only include information from states that opted into providing it, and New Jersey is not among them.
The New Jersey Department of Health — which channels the drug from the federal government to hospitals — said all acute care facilities in New Jersey have been given doses of the drugs.
So far Virtua has given the treatment to approximately 200 people via a dedicated infusion center at Virtua Willingboro Hospital.
“Not every health system has been able to stand something up effectively, both in the state and around the country,” Topiel said. “Some places are just utilizing our emergency rooms. Some even have difficulty with that, because they’re overwhelmed with patients.”
The infusion and observation period take a total of two hours, and the patients are all COVID-19 positive, so they cannot be mingled with other patients. Topiel said the infusion center in Willingboro was not in-use and they had adequate staffing, so they were able to devote it to this treatment.
The hospital’s first patient to get monoclonal antibodies was Jay Siegmeister, 60, of Cherry Hill, who had pre-existing conditions and tested positive for COVID-19 Nov. 29. In a statement from Virtua, Siegmeister said he had a headache, sore throat and shortness of breath but “felt better the very next day” after his infusion Dec. 1.
The FDA based its emergency use approval on randomized, placebo-controlled clinical trials — in Regeneron’s case, involving 799 patients, and for Lilly, 452 patients. A review by the National Institutes of Health noted that those who got the monoclonal antibodies were less likely to visit an emergency room or be hospitalized, but said the relatively small sample size makes “it difficult to draw definitive conclusions about the clinical benefit” of the treatment.
Topiel said he believes it works and it makes good sense for Virtua to get as many high-risk patients treated as possible so they don’t end up hospitalized.
“While certainly we’re concerned about patient outcomes, we also want to preserve the hospital so that we can take care of our patients and not get overwhelmed,” he said.
To streamline the process of getting patients into its infusion center, Virtua Health has set up a hotline at 856-325-3150 that people can call if they think they qualify. It’s easiest if patients go through their doctor to set it up because of the need for medical records, Topiel said, but candidates can call themselves, too.
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