Rare cases of COVID comeback pose questions for the Pfizer pill

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As more doctors prescribe Pfizer’s powerful COVID-19 pillNew questions about its performance are emerging, including why a small number of patients seem to relapse after taking the drug.

Paxlovid has become the go-to option against COVID-19 thanks to its convenience at home and impressive results in preventing serious illness. The US government has spent more than $ 10 billion to buy enough pills to cure 20 million people.

But experts say there’s still a lot to learn about the drug, which was cleared 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 APPEAR TO CUT OFF?

Doctors have begun reporting rare cases of patients whose symptoms recur several days after completing the five-day regimen of Paxlovid pills. This has raised questions about whether those patients are still contagious and should receive a second Paxlovid course.

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Last week, the Food and Drug Administration took over. He advised against a second round because there is little risk of serious illness or hospitalization among relapsing patients.

Dr Michael Charness reported last month of a 71-year-old vaccinated patient who saw his symptoms diminish but then returned, along with a spike in virus levels nine days after his illness.

Charness says Paxlovid remains a highly effective drug, but wonders if it might be less potent against the current omicron variant. The $ 500 drug treatment has been tested and approved based on its performance against the delta version of the coronavirus.

“The ability to clear the virus after it is suppressed may differ from omcron to delta, especially for vaccinated people,” said Charness, who works for the VA health system in Boston.

FILE - In this photo provided by Pfizer, a lab technician visually inspects samples of COVID-19 Paxlovid tablets in Freiburg, Germany in December 2021. As more doctors prescribe Pfizer's powerful COVID-19 pill, new questions emerge performance, including why a small number of patients seem to relapse after taking the drug.

FILE – In this photo provided by Pfizer, a lab technician visually inspects samples of COVID-19 Paxlovid tablets in Freiburg, Germany in December 2021. As more doctors prescribe Pfizer’s powerful COVID-19 pill, new questions emerge performance, including why a small number of patients seem to relapse after taking the drug.
(Pfizer via AP, file)

Could some people be susceptible to a relapse? Both the FDA and Pfizer point out that 1% to 2% of people in Pfizer’s original study saw their virus levels rebound after 10 days. The rate was roughly the same among people taking the drug or the dummy pills, “so it’s not clear at this point that 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. Johns Hopkins University’s Andy Pekosz fears they may be tracking drug-resistant mutations.

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“We should really make sure we dose Paxlovid appropriately because I would hate to lose it right now,” said Pekosz, a virologist. “This is one of the essential tools we have to help us turn the corner on the pandemic.”

HOW DOES PAXLOVID WORK IN VACCINATED PEOPLE?

Pfizer tested Paxlovid in patients at highest risk: unprecedented unvaccinated adults Covid-19 infection and other health problems, such as heart disease and diabetes. The drug reduced the 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 percent of adults have had at least one chance. And about 60% of Americans have been infected with the virus at some point.

“This is the population I care about in 2022 because that’s the one we’re seeing – people vaccinated with COVID – so do they benefit from it?” asked Dr David Boulware, a researcher and physician at the University of Minnesota.

There is still no clear answer for vaccinated Americans, who already have a hospitalization rate of far less than 1%.

This could stem from an ongoing large Pfizer study that includes high-risk vaccinated people. No results have been published; the study is expected to end in the fall.

FILE – A syringe with the Pfizer COVID-19 vaccine is prepared at a vaccination clinic at the Keystone First Wellness Center in Chester, Pennsylvania on December 21, 15, 2021. Pfizer is expected to apply for authorization for an additional booster dose of COVID -19 for the elderly.
(AP Photo / Matt Rourke, File)

Pfizer said last year that initial results showed Paxlovid failed to achieve the study’s goals in any meaningful way. resolution of symptoms and reduction of hospitalizations. It recently stopped enrolling anyone who has received a vaccination or booster in the past year, a change that Boulware says suggests those patients are not benefiting from it.

At a minimum, preliminary data should be released 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 formulate good policy?”

CAN PAXLOVID BE USED TO PREVENT COVID-19 INFECTION?

Pfizer recently reported that giving Paxlovid proactively to family members of people infected with COVID-19 did not significantly reduce their chances of taking it. But that’s 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 families.

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“It’s a high level to protect against infections, but I’d like to see the data on how Paxlovid did against serious illness because it might be more effective there,” Pekosz said.