Paxlovid, once hailed as a "game-changer" for its ability to treat COVID-19 infections at home, is becoming one of the pandemic's biggest enigmas, Axios' Arielle Dreher writes. The intrigue: There's growing concern about the link between Pfizer's antiviral pill and COVID rebound, in which patients test positive or have symptoms days after a course of the drug is completed. - President Biden, First Lady Jill Biden and NIAID director Anthony Fauci have each relapsed.
Zoom in: The FDA has asked Pfizer to investigate whether a second five-day course of the drug will prevent the virus from returning. - Pfizer executives in May suggested patients who can't clear the virus with the first course should take more, Bloomberg reported.
- A large study of more than 109,000 people in the New England Journal of Medicine concluded the drug significantly reduced hospitalizations and deaths among patients aged 65 and older but that there was no evidence of benefit in younger adults.
- Paxlovid could have the added benefit of warding off long COVID, or symptoms that linger beyond the first 30 days after testing positive, and studies to determine this are underway.
But availability of the drug could change before clear answers emerge. - The Biden administration has only bought enough pills to supply Paxlovid through the middle of next year, after which it will transition to the commercial market, HHS Assistant Secretary for Preparedness and Response Dawn O'Connell wrote in a blog post on Tuesday.
Between the lines: COVID rebound has also been observed in people who have not taken Paxlovid, and some experts believe it might be a natural course of the infection to see symptoms ebb, then return. What they're saying: "The consensus by the vast majority of people caring for COVID patients is that the rebound is not really a side effect of Paxlovid, it is more that are we really treating people for long enough or not?" Sarju Ganatra, a cardiologist at Lahey Hospital and co-author of the Clinical Infectious Diseases study, told Axios. Yes, but: "This is where having a well-designed, well-controlled study helps us understand disease better, and this is the challenge of anecdotal reports. Without a control, it's really hard to know what's actually happening," said Kara Chew, an infectious disease physician at the University of California Los Angeles. Read the rest. |
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