Doctors warn: Don't count on getting outpatient omicron treatments
When given early, lab-engineered antibody infusions have reduced COVID-19 hospitalizations among persons at high risk. Previous versions of these treatments do not appear to work against the omicron variant, however. Replacement products are in short supply, with providers given a few dozen treatments weekly while managing hundreds of new patients.
ROCHESTER — Three weeks ago, a person with underlying health conditions who tested positive for COVID-19 could count on quick access to monoclonal antibodies.
Lost in the confusion over ever-changing advisories about the virus has been the unexpected collapse in accessible outpatient treatment options for the newly diagnosed at risk.
In a scarcity economy reminiscent of the earliest days of the pandemic, the effective, once-plentiful monoclonal antibodies manufactured by Eli Lilly and Regeneron appear to no longer to work when pitted against omicron, and the products recently authorized to replace them are in short supply.
"If you're not vaccinated and you're hoping these outpatient treatments will be enough for you, don't be under the impression that they are readily available," said Dr. Avish Nagpal, director of infection prevention for Sanford Health Fargo. "They are not. There is a very high demand and we are struggling to meet that demand."
Nagpal distinguishes current shortages from a different situation last fall, when "pretty much anyone who wanted that medication were able to get it."
"They just had to meet any criteria listed in the emergency use authorization" he said. "We didn't have to turn away anybody unless they were out of the 10-day period."
From irreplaceable to seemingly obsolete
Prior to the emergence of the omicron variant, hypertensive, elderly or metabolically unhealthy persons with COVID-19 could lessen their risk by undergoing an hour-long infusion of monoclonal antibodies (or mABs).
When taken early, mAB treatments had a 70% effectiveness at preventing severe infection, and were aggressively promoted by governors in states such as Florida and Texas .
But the products themselves, cocktails of lab-engineered proteins with compound names such as bamlanivimab plus etesevimab by Eli Lilly, and casirivimab plus imdevimab by Regeneron, were tailored to combat delta alone.
With omicron having pushed delta off the stage, those infusions are believed to be no longer effective.
In their place, drug maker GlaxoSmithKline has delivered an omicron-recognizing mAB called Sotrovimab.
Additionally, Pfizer has received approval for an effective course of antiviral pills sold under the name Paxlovid.
Both are intended to help reduce the risk of hospitalization faced by those with preexisting conditions.
But they are shipped only intermittently to state health departments at the present time. Area providers say patients should not expect easy access to either treatment, given the mismatch of supply and demand.
"We don't have enough supply that we can operate on a daily basis," says Nagpal of Sanford's monoclonal antibody infusion center in Fargo. "Whenever we get the supply, we open it, but typically the supply is gone within the day."
HHS publishes the amounts each state gets of new outpatient COVID-19 medications, with shipments updated weekly. A table published on Monday, Jan. 17, shows that the federal government recently shipped just 594 doses of Sotrovimab to Minnesota, and 90 to North Dakota.
In total, MDH has recorded just 2,240 courses of Paxlovid shipped into Minnesota.
The numbers then apportioned to individual health systems are even smaller. Though facing hundreds of eligible patients, the Sanford Fargo facility is getting twice-weekly shipments of just 10-20 Sotrovimab treatments, doses it must then ration to those with qualifying conditions.
"I was just going through our list," Nagpal said of who best to provide the 10-20 antibody treatments, "going down from the highest- to lowest-risk patients. Even focusing on the highest-risk patients, we had 114 to work with today."
Mayo Clinic infectious disease specialist Dr. Raymund Razonable says Mayo also gets just "a few dozen" doses of Sotrovimab weekly. It then has to decide who to treat from over 200 patients in need each day.
"We have scoring system we have developed to identify" those with the greatest need, says Razonable, one prioritizing multiple medical comorbidities. "Those are the ones we reach out to and give the treatment as soon as we can."
Paxlovid is given as an alternative to mABs by participating providers, but supplies are similarly "also very low" Nagpal says. "We get one to two shipments a week. Today we got about 26 courses." Mayo receives a similar amount of the antiviral pills.
For those most in need, providers are advised to offer Paxlovid first. If that is unavailable, Sotrovimab is to be offered second. If that is unavailable, a three-day course can be offered of intravenous Remdesivir, an advanced illness drug recently approved for outpatient use. Logistical challenges complicate all of these treatments as well.
The recent narrowing of outpatient COVID-19 treatment options is so new, the Minnesota Department of Health monoclonal antibody treatment connector webpage has yet to update its copy to convey that legacy drug cocktails have effectively been shelved.
"With the omicron variant causing widespread infections sweeping across Minnesota, as across the nation, we are seeing unprecedented demand for treatments and therapies pressing against a limited supply," Doug Schultz of the Minnesota Department of Health said in an email.
"While the Department of Health and Human Services is still shipping bamlanivimab plus etesevimab, and casirivimab plus imdevimab, those are ineffective against omicron, so we are down to one monoclonal (Sotrovimab)."
The U.S government recently purchased 600,000 doses of Sotrovimab, but those will be delivered through the first quarter of this year.
"Do everything in the next two to three weeks to avoid getting COVID-19," Nagpal said. "Whether that's working from home, getting vaccinated or a booster if possible, or avoiding crowded spaces."
"Do that now, because unfortunately we are not in a position to tell you that if you need outpatient treatment, we will have one readily available."