Most of us are fairly adept by now at managing COVID-19, with an armor of previous infections, vaccinations, self-tests, and antiviral medicines like Paxlovid.
Within the newest examine, nonetheless, researchers report that taking Paxlovid might not present as a lot profit as docs initially thought—notably for older people who find themselves vaccinated.
In a analysis letter printed in JAMA on Feb. 20, Dr. John Mafi, affiliate professor of drugs on the David Geffen Faculty of Drugs at UCLA, and his colleagues used Canadian information to discover what occurred when folks took Paxlovid. A Canadian well being coverage in 2022 allowed prescriptions for Paxlovid just for symptomatic folks round age 70 as a way to reserve the medicine for individuals who wanted it most. Older individuals are at greater danger of creating problems from COVID-19. The coverage allowed the scientists to check folks on this age group who took Paxlovid to those that didn’t.
Among the many almost 1.5 million folks they studied, those that obtained prescriptions for the drug didn’t have considerably totally different charges of being hospitalized or dying from COVID-19 than those that didn’t get the drug. Most people studied had been vaccinated.
“Our essential discovering was that amongst vaccinated older adults, Paxlovid confirmed no statistically vital discount in COVID-19 hospitalizations or on mortality,” says Mafi, the examine’s lead creator.
That’s very totally different from the outcomes that Paxlovid’s maker, Pfizer, first reported in 2022. In that examine, Pfizer discovered that the drug decreased hospitalizations and deaths from COVID-19 by 89% in comparison with folks receiving placebo. However the group they studied was largely middle-aged and unvaccinated, which is a a lot totally different inhabitants than exists at present. “But that 2022 Pfizer examine was and continues for use to help the belief that the advantages of Paxlovid in unvaccinated adults additionally apply to vaccinated adults,” says Mafi. “That’s what’s getting used to justify its perceived effectiveness—and its checklist value at $1,650 per remedy course.”
In a press release, Pfizer mentioned it couldn’t touch upon a examine wherein it didn’t take part, however that the corporate “stay[s] assured in Paxlovid’s scientific effectiveness at stopping extreme outcomes, together with hospitalization and demise, from COVID-19 in sufferers at excessive danger of extreme sickness.”
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Paxlovid is supposed to assist these at excessive danger of creating problems from COVID-19, together with the aged, folks with compromised immune techniques, and people with a number of underlying well being circumstances. That is still a major criterion for prescribing the medicine, which is now obtainable for anybody age 12 or older and who’s at excessive danger of extreme illness.
Nonetheless, Mafi says there aren’t sturdy information on how Paxlovid impacts the illness course in people who find themselves vaccinated. His findings counsel that the advantages are about 4 occasions smaller than these reported by Pfizer.
“We aren’t saying that Paxlovid is ineffective,” says Mafi. “What this analysis is saying is that its effectiveness in older teams who’re most susceptible to COVID-19, however who’re vaccinated, is much decrease than what the sooner proof from unvaccinated teams confirmed.”
Extra analysis is required, however docs can contemplate this new info when deciding whether or not to advocate a affected person take Paxlovid. Different essential elements embody an individual’s medical historical past, the medicine’s danger of comparatively gentle negative effects, and Paxlovid rebound, wherein folks taking Paxlovid might check constructive once more after testing damaging.
Dr. Katherine Kahn, distinguished professor of drugs at UCLA and the examine’s senior creator, says that she’s going to talk about the most recent outcomes together with her sufferers, and “for typically well being folks, I’m not encouraging or discouraging [Paxlovid] in the event that they meet the standards for taking it,” she says. “However for folks with greater danger of morbidity or mortality, we’re extra prone to say we’d contemplate [Paxlovid] right now, though we don’t know 100% if you’ll profit.”
The brand new examine raises questions for future analysis. It doesn’t take into consideration, as an example, how previous infections may trigger the physique to answer Paxlovid. Mafi and Kahn say that they had been additionally not in a position to delve extra deeply into contributors’ vaccination historical past—what number of and which doses they obtained—or affirm whether or not they took Paxlovid inside 5 days of their first signs, when the drug is simplest. However they’re planning to entry the individual-level information and do a extra in-depth evaluation of different elements that will affect how efficient the drug is at decreasing hospitalizations and deaths.
“One of many conclusions of this examine is the advice for extra research, of each older people and those that are vaccinated, of the effectiveness of Paxlovid,” says Kahn.
