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People no longer need a positive COVID-19 test to be prescribed the antiviral medications Paxlovid or Lagevrio.
The FDA announced the changes Wednesday in letters sent to the drugs' manufacturers, Pfizer and Merck.
Both medications are approved to treat mild to moderate COVID-19 in people with a high risk of developing severe disease, such as being older or having certain health conditions. Paxlovid remains approved for patients ages 12 and up; Lagevrio remains approved for patients ages 18 and older.
Antivirals can stop the replication of the virus in the body, thereby reducing a person's overall viral load. This reduces the chances of the illness having more serious symptoms and possibly requiring hospitalization.
People take the medications, which come in pill form, as soon as possible after a diagnosis for 5 days. Research shows Paxlovid can reduce the chance of hospitalization by 46% and the chance of death by 65%. For Lagevrio, research shows a 30% reduction in hospitalization, with even greater protection for people ages 75 and older.
In the letters, the FDA said it replaced the requirement for a positive test to instead require a current diagnosis of mild to moderate COVID-19.
FDA: Feb. 1, 2023, letter to Pfizer Inc.; Feb. 1, 2023, letter to Merck Sharp & Dohme LLC.
CDC: "Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for Healthcare Professionals."
U.S. Department of Health and Human Services: "Information Sheet – Paxlovid Eligibility and Effectiveness," "Information Sheet – Lagevrio Eligibility and Effectiveness."
Lead image: Pfizer
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Cite this: Positive Test No Longer Required to Get COVID Antivirals - Medscape - Feb 02, 2023.