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Results from a phase III trial of a new COVID-19 treatment showed it reduced the risk of hospitalization or long ER visits by half.
"The data look quite promising and other treatments have now fallen by the wayside," Paul Sax, MD, of Brigham and Women's Hospital in Boston, told USA Today. Sax was not involved in the research.
Most treatments for COVID-19 have become ineffective as the virus has evolved, leaving just a few antivirals such as Paxlovid as the remaining available treatments.
The new treatment is called pegylated interferon lambda and is made by California-based Eiger BioPharmaceutical. It is given as a single injection.
The study was published today in The New England Journal of Medicine. Researchers evaluated the treatment compared to placebo in 1,949 adults in Canada and Brazil who were at high risk of severe COVID-19. Those in the treatment group got the shot within 7 days of symptom onset.
The treatment worked best when taken within 3 days of symptoms appearing. Results also showed it was effective for both vaccinated and unvaccinated individuals, as well as against varying COVID variants.
"Peginterferon lambda has tremendous therapeutic potential, and we continue to see the emergence of aggressive variants of the virus spreading around the globe which are less sensitive to both vaccines and treatment with antibodies," said researcher Jordan Feld, MD, MPH, associate professor of medicine at the University of Toronto, in a news release. "Resistance due to variants or new strains of the virus could be an issue with some therapies, but this may not be a concern with peginterferon lambda due to its mechanism of action that involves activation of multiple virus-killing pathways."
Eiger BioPharmaceutical said it has 100,000 doses available and the capability to manufacture 10 million more.
The New York Times reported that the company may seek authorization for the treatment to be used outside the U.S. because of hurdles with the FDA.
"Regulators at the Food and Drug Administration late last year told the drug's maker, Eiger Biopharmaceuticals, that they were not prepared to authorize it for emergency use," the Times reported. "Eiger executives said part of the problem seemed to be that the clinical trial did not include an American site, but rather only sites in Brazil and Canada, and that it was initiated and run by academic researchers, rather than the company itself."
The New England Journal of Medicine: "Early Treatment with Pegylated Interferon Lambda for Covid-19."
USA Today: "An experimental COVID treatment could be a promising alternative to Paxlovid, study finds."
Eiger BioPharmaceutical: "New England Journal of Medicine Publishes Positive Phase 3 TOGETHER Results with Peginterferon Lambda in COVID-19."
The New York Times: "Why the Odds Are Stacked Against a Promising New Covid Drug."
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Cite this: Phase 3 Trial Reports Promising Results for New COVID Treatment - Medscape - Feb 09, 2023.