Paxlovid, once hailed as a "game-changer" for its ability to treat COVID infections at home, is becoming one of the pandemic's biggest enigmas.
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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, Jill Biden and Anthony Fauci have each relapsed.
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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.
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Paxlovid use surged over the summer, with as many as 1/3 of reported COVID cases treated with it. But uncertainty over what's causing the relapses, and whether the drug helps younger patients, is making some people wary of the treatment, physicians say.
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At least part of the problem is that people are not routinely tested after taking Paxlovid, which makes it hard to establish how often rebound happens or why the virus lingers in some people, Leana Wen, a physician and a professor, told CNN.
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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.
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The prospect of reinfection shouldn't discourage older or high-risk patients from taking the pills, said Yale infectious diseases specialist Scott Roberts. "Rebound is almost always more mild than initial course," Roberts told Axios.
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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.
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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.
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The CDC recommends Paxlovid for those over the age of 50, and for those with medical conditions like lung or heart disease that makes them high-risk, although the drug's emergency authorization covers anyone 12 years old and up.
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Research in Clinical Infectious Diseases found the drug remains effective for vaccinated people who contract COVID-19, reducing emergency room visits by lowering the risk of complications like lower respiratory tract infection and cardiac arrhythmia.
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Beyond the Pfizer study requested by the FDA, a clinical trial of immunocompromised people is evaluating if Paxlovid should be used for five, 10 or 15 days.
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Paxlovid remains an important tool to keep some people out of the hospitals, especially with the highly contagious Omicron variant still circulating and many people not staying current on boosters, experts said.
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