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As more doctors prescribe Pfizer’s powerful COVID-19 pill, new questions are being raised about its performance, including why a small number of patients seem to relapse after taking the drug.
Paxlovid has become the preferred choice against COVID-19 due to its convenience in the home and its impressive results in preventing serious illness. The United States government has spent more than $10 billion to buy enough pills to treat 20 million people.
But experts say much remains to be learned about the drug, which was authorized in December for adults at high risk of severe COVID-19 based on a study in which 1,000 adults received the drug.
WHY DO SOME PATIENTS SEEM TO RELAPSE?
Doctors have begun to report rare cases of patients whose symptoms return several days after completing the five-day regimen of Paxlovid pills. That raised questions about whether those patients are still contagious and should receive a second cycle of Paxlovid.
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Last week, the Food and Drug Administration stepped in. He advised against a second round because there is little risk of serious illness or hospitalization among patients who relapse.
Dr. Michael Charness reported last month on a 71-year-old vaccinated patient who saw his symptoms diminish but then return, along with increased levels of the virus nine days after his illness.
Charness says that Paxlovid is still a very effective drug, but wonders if it might be less potent against the current omicron variant. The $500 drug treatment was tested and approved based on its performance against the delta version of the coronavirus.
“The ability to clear the virus after suppression may be different from omicron to delta, especially for vaccinated people,” said Charness, who works for the Boston VA health system.
Could some people be susceptible to a relapse? Both the FDA and Pfizer note that between 1% and 2% of people in the original Pfizer study saw their virus levels recover after 10 days. The rate was about the same between people who took the drug or the dummy pills, “so it’s not clear at this time if this is related to drug treatment,” the FDA said.
Some experts point to another possibility: the dose of Paxlovid is not strong enough to completely suppress the virus. Andy Pekosz of Johns Hopkins University worries that this could lead to drug-resistant mutations.
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“We really should make sure we’re dosing Paxlovid properly because I’d hate to lose it right now,” said Pekosz, a virologist. “This is one of the essential tools we have to help us get through the pandemic.”
HOW WELL DOES PAXLOVID WORK IN VACCINATED PEOPLE?
Pfizer tested Paxlovid in the highest-risk patients: unvaccinated adults without previous COVID-19 infection and other health problems, such as heart disease and diabetes. The drug reduced their risk of hospitalization and death from 7% to 1%.
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But that doesn’t reflect the vast majority of Americans today, where 89% of adults have received at least one injection. And about 60% of Americans have been infected with the virus at some point.
“That’s the population I care about in 2022 because that’s what we’re seeing, people vaccinated with COVID, so do they benefit?” asked Dr. David Boulware, a researcher and physician at the University of Minnesota.
There is no clear answer yet for vaccinated Americans, who already have a hospitalization rate well below 1%.
That may come from a large, ongoing Pfizer study that includes high-risk vaccinated people. No results have been published; the study is expected to conclude in the fall.
Pfizer said last year that initial results showed Paxlovid did not meet the study goals of significantly resolving symptoms and reducing hospitalizations. It recently stopped enrolling anyone who had received a vaccine or booster in the last year, a change that Boulware said suggests those patients aren’t benefiting.
At a minimum, preliminary data should be turned over to federal officials, Boulware said. “If the US government is spending billions of dollars on this drug, what is the obligation to release that data so they can make good policy?”
CAN PAXLOVID BE USED TO HELP PREVENT COVID-19 INFECTION?
Pfizer recently reported that proactively giving Paxlovid to family members of people infected with COVID-19 did not significantly reduce their chances of getting it. But that is not the end of the story. Pfizer is studying several other potential benefits of early use, including whether Paxlovid reduces the duration and severity of COVID-19 among households.
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“It’s a high bar for protection against infection, but I’d love to see data on how Paxlovid performs against severe disease because it may be more effective there,” Pekosz said.