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As extra docs prescribe Pfizer’s highly effective COVID-19 tablet, new questions are rising about its efficiency, together with why a small variety of sufferers seem to relapse after taking the drug.
Paxlovid has turn into the go-to possibility towards COVID-19 due to its at-home comfort and spectacular ends in heading off extreme illness. The U.S. authorities has spent greater than $10 billion to buy sufficient tablets to deal with 20 million individuals.
However consultants say there’s nonetheless a lot to be discovered in regards to the drug, which was approved in December for adults at excessive threat of extreme COVID-19 based mostly on a research during which 1,000 adults acquired the remedy.
WHY DO SOME PATIENTS SEEM TO RELAPSE?
Docs have began reporting uncommon circumstances of sufferers whose signs return a number of days after finishing Paxlovid’s five-day routine of tablets. That’s prompted questions on whether or not these sufferers are nonetheless contagious and may obtain a second course of Paxlovid.
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Final week, the Meals and Drug Administration weighed in. It suggested towards a second spherical as a result of there’s little threat of extreme illness or hospitalization amongst sufferers who relapse.
Dr. Michael Charness reported final month on a 71-year-old vaccinated affected person who noticed his signs subside however then return, together with a spike in virus ranges 9 days into his sickness.
Charness says Paxlovid stays a extremely efficient drug, however he wonders if it is perhaps much less potent towards the present omicron variant. The $500 drug therapy was examined and OK’d based mostly on its efficiency towards the delta model of the coronavirus.
“The ability to clear the virus after it’s suppressed may be different from omicron to delta, especially for vaccinated people,” mentioned Charness, who works for Boston’s VA well being system.
May some individuals simply be vulnerable to a relapse? Each the FDA and Pfizer level out that 1% to 2% of individuals in Pfizer’s authentic research noticed their virus ranges rebound after 10 days. The speed was about the identical amongst individuals taking the drug or dummy tablets, “so it is unclear at this point that this is related to drug treatment,” the FDA acknowledged.
Some consultants level to a different risk: The Paxlovid dose isn’t robust sufficient to totally suppress the virus. Andy Pekosz of Johns Hopkins College worries that might spur mutations which might be proof against the drug.
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“We should really make sure we’re dosing Paxlovid appropriately because I would hate to lose it right now,” mentioned Pekosz, a virologist. “This is one of the essential tools we have to help us turn the corner on the pandemic.”
HOW WELL DOES PAXLOVID WORK IN VACCINATED PEOPLE?
Pfizer examined Paxlovid within the highest-risk sufferers: unvaccinated adults with no prior COVID-19 an infection and different well being issues, reminiscent of coronary heart illness and diabetes. The drug decreased their threat of hospitalization and dying from 7% to 1%.
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However that doesn’t replicate the overwhelming majority of Individuals at the moment, the place 89% of adults have had no less than one shot. And roughly 60% of Individuals have been contaminated with the virus sooner or later.
“That’s the population I care about in 2022 because that’s who we’re seeing — vaccinated people with COVID — so do they benefit?” requested Dr. David Boulware, a College of Minnesota researcher and doctor.
There’s no clear reply but for vaccinated Individuals, who have already got a hospitalization charge far under 1%.
That will come from a big, ongoing Pfizer research that features high-risk vaccinated individuals. No outcomes have been printed; the research is anticipated to wrap up within the fall.
Pfizer mentioned final yr that preliminary outcomes confirmed Paxlovid failed to fulfill the research’s targets of considerably resolving signs and decreasing hospitalizations. It just lately stopped enrolling anybody who’s acquired a vaccination or booster prior to now yr, a change Boulware says suggests these sufferers aren’t benefitting.
At a minimal, the preliminary knowledge ought to be launched to federal officers, Boulware mentioned. “If the U.S. government is spending billions of dollars on this medicine, what’s the obligation to release that data so that they can formulate a good policy?”
CAN PAXLOVID BE USED TO HELP PREVENT COVID-19 INFECTION?
Pfizer just lately reported that proactively giving Paxlovid to relations of individuals contaminated with COVID-19 didn’t considerably cut back their probabilities of catching it. However that’s not the top of the story. Pfizer is learning a number of different potential advantages of early use, together with whether or not Paxlovid reduces the size and severity of COVID-19 amongst households.
“It’s a high bar to protect against infection but I’d love to see data on how Paxlovid did against severe disease because it may be more effective there,” mentioned Pekosz.