The U.S. has shipped over half a million doses of antibody treatments that have the potential to keep high-risk Covid patients out of hospitals if given early enough in their infection.
This would help already overburdened hospitals avoid additional strain, but the drugs are still being underutilized despite their promising results, Trump administration health officials said Thursday. That’s because many patients don’t know how to access them, and hospitals aren’t prescribing the medications or arranging the infusion sites necessary to administer the drugs, they said.
“I want my colleagues to hear me,” U.S. Surgeon General Dr. Jerome Adams told reporters. “You need to think about and be willing to prescribe these medications much more frequently as a way to protect your patients, preserve your hospital capacity and to support your exhausted colleagues.”
The Food and Drug Administration in November issued emergency authorizations for antibody drugs from Eli Lilly and Regeneron. The latter’s drug was given to President Donald Trump, who said it made him feel better “immediately” when he was hospitalized with the coronavirus in October.
However, hospitals have listed a number of problems that come with prescribing the drugs. The treatments have the biggest benefit when delivered to someone early on in their infection. But Covid test results may be delayed and people might not seek care until they’re already displaying symptoms, diminishing the effectiveness of the antibody treatments.
The drugs are also difficult to administer. Hospitals have to assemble infusion centers with dedicated staff to dispense them, but some patients may have a hard time getting to those sites, and providing the drugs at someone’s home is labor intensive. It can also take more than an hour to give them to people through an IV infusion and requires an additional hour of monitoring afterward.
Despite the difficulties, it’s still worthwhile for hospitals to build the infusion centers and prevent more people from falling seriously ill with the virus, said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. The treatments are helpful for people 65 years old or over or those with underlying health conditions, the FDA says.
“Some of these may be unusual sites, not in hospitals but at other places, in order to take those high-risk people who have a high probability of getting hospitalized getting very sick, going into the ICU and so forth, to infuse them with antibodies as early as possible in the disease,” Woodcock told reporters.
The U.S. has doubled down on its efforts to use the treatments. The Department on Health and Human Services on Monday launched a “treatment locator” that allows health-care providers and patients to find potential locations to receive the antibody treatments. As of Jan. 6, more than 641,000 doses of the treatment courses had been administered but 75% remained unused, HHS said.
The federal government said Tuesday it purchased more than 1.2 million additional treatment courses of the Regeneron drug that will be delivered in the first half of 2021. That brings its supply of both antibody drugs to nearly 5 million courses, if needed.
The additional supply and the push from the Trump administration come as an average of 245,306 people test positive for Covid every day, according to a CNBC analysis of Johns Hopkins University data. There are more than 130,300 people hospitalized with Covid across the U.S., double the amount of patients since mid-November before the winter holiday season, according to data from the COVID Tracking Project, which is run by journalists at The Atlantic.
“So we hope the changes that we’re making, better public awareness and better provider awareness, will drive more administration of these antibodies,” Woodcock said.
Covid variants and efficacy
Early trial studies have shown the antibody drugs decrease the viral load in patients, shortens symptoms and, most importantly, keeps people out of the hospital, Woodcock said.
However, some medical experts are concerned that there’s not enough evidence the drugs work. The Infectious Diseases Society of America has recommended against routine use of Eli Lilly’s treatment, citing a lack of data. And the National Institutes of Health, citing “insufficient data,” said the drug “should not be considered the standard of care.”
New and more infectious variants of the coronavirus, especially a strain found in South Africa known as 501Y.V2, could be more resistant to monoclonal antibody treatments, White House health advisor Dr. Anthony Fauci said Tuesday. Unlike vaccines, which trigger an immune response that attacks different parts of the virus, monoclonal antibodies target a very specific component, Fauci told California Gov. Gavin Newsom in late December.
Woodcock said trials underway should give a better picture of how effective the drugs are, but there’s also “real world” evidence from health-care systems that have found the antibodies helpful. She added that researchers are “actively looking” to determine whether the new Covid mutations will have any impact on the treatments.
“It is possible that any variant, some variant at some point, could escape neutralization by any of these antibodies,” Woodcock said. “That’s also why we’re aiming toward combinations, or so-called cocktails, of monoclonals, because it’s much less likely that any given variant would escape both of them at once.”
— CNBC’s Will Feuer contributed to this report.
Source: Business - cnbc.com
