In its latest guidelines, dated August 8, 2022, the US National Institutes of Health (NIH) gave one of its strongest recommendations to Paxlovid for patients at high risk of progressing to severe COVID-19, regardless of vaccination status. The list of underlying medical Conditions that increase the risk of severe COVID-19 are longstanding, accounting for more than four in 10 adults (138 million Americans, including 54 million who are age 65 and older). Nearly 4 million prescriptions have been filled since Paxlovid was licensed.
However, the results of a new retrospective observational study to study outside of Israel published in the New England Journal of Medicine (NEJM) seem to cast a question mark over the strength of these recommendations, particularly with the Omicron subvariant.
The report’s authors found that Pfizer’s antiviral drug Paxlovid offered little or no benefit to younger adults. However, it reduced the risk of hospitalization for high-risk older people. In particular, the supplementary material to the original study by paxlovid in high-risk non-hospitalized adults with COVID-19 during the Delta wave had shown benefits in those under 65 years of age, although the difference compared to placebo was much smaller than in those over 65 years of age.
The study authors used the electronic medical records of nearly 110,000 patients enrolled in Clalit Health Services, Israel’s largest state-mandated health services organization. Almost 4 percent, or 3,900 of the patients, had taken Paxlovid (nirmatrelvir) after contracting COVID-19.
Among those over 65, there was a 73 percent decrease in the rate of hospitalization and a 79 percent reduction in the risk of death. However, patients between the ages of 40 and 65 saw no benefit from taking the antiviral drug in either category, regardless of prior immunity status.
One of the main limitations of the study is that it was not randomized, which may introduce bias in its conclusions. The authors commented: “Our study showed that only a minority of patients who were identified as high-risk and eligible for nirmatrelvir [Paxlovid] therapy received antiviral therapy. We do not know why other eligible patients did not receive treatment, and there may be some selection mechanism that is not explained by the observed confounders.”
These findings have significant implications as Paxlovid use is on the rise amid repeated waves of infections trampling the population as COVID-19 is allowed free reign as a matter of policy. People turn to these medications to reduce the risk of serious illness and lessen symptoms, without a clear understanding by patients, medical providers, and pharmacies of the indication for these medications. This has consequences for the availability and access to these drugs and raises additional issues, such as the possible development of a Paxlovid-resistant variant.
In the context of the potential misuse of Paxlovid, the recent announcement to the US Chamber of Commerce Foundation by White House COVID-19 Response Coordinator Dr. Ashish Jha that the Biden administration will soon transfer responsibility for procuring tests and therapies to the commercial sector with dire consequences for the working class.
On the near horizon is the lifting of the pandemic emergency measures that cover COVID-related care for all Americans. The implications of going back to business as usual business of medicine is that those who are uninsured or underinsured will forgo these life-saving measures when they contract COVID-19 to save money for groceries and fuel or to pay rent. Even the new bivalent vaccines will come with a price. Meanwhile, the wealthiest will have no qualms about accessing them, further deepening class distinctions exposed by the pandemic.
However, the results of the recent study from Israel are not surprising. In June, Pfizer announced that it would suspend enrollment in its EPIC-SR [Evaluation of Protease Inhibition for COVID-19 in Standard-Risk] Test. Preliminary results indicated no significant benefit for unvaccinated adults without any risk factors or for previously vaccinated people with at least a risk of progressing to severe disease.
another reviewer to study from Hong Kong published in Lancet Infectious Diseases the same day as the Israeli study, but which was not mentioned in the press, offered further evidence of Paxlovid’s limited therapeutic role. The authors reviewed their clinical experience with Paxlovid and Lagevrio, Merck’s antiviral pill Molnupiravir, in hospitalized patients. They compared them to hospitalized patients who did not receive those drugs during the horrific wave of infections that slammed into the semi-autonomous region in February and March.
Though Lagevrio has been essentially ruled out for its comparatively lower efficacy (30 percent vs. 90 percent in early trials) compared to Paxlovid, it has never been directly tested. However the Lancet The study found that hospitalized patients who received any of the oral antiviral drugs had a reduced chance of dying compared to those who did not receive them.
The mortality risk reduction for Lagevrio was 52 percent and for Paxlovid it was 66 percent. Those who received antivirals had a lower risk of their disease progressing, but the drugs did not significantly affect their need for mechanical ventilation or ICU admission. The patients in the study had an average age of 70 to 80 years.
The authors wrote: “The results of our subgroup analyzes suggested a possible lack of significant benefit in younger patients (aged ≤ 65 years) and those who had been fully vaccinated, which would support prioritization of prescribing oral antivirals to older people and those who were not adequately vaccinated. vaccinated, who are also likely to be at increased risk of progression to severe COVID-19.”
Given the results of these studies, it is worth mentioning that the Centers for Disease Control and Prevention (CDC) recently estimated that approximately 95 percent of Americans over the age of 16 have some level of immunity against COVID-19. .
Dr. David Boulware, a physician and researcher at the University of Minnesota, said market clock, “Paxlovid will continue to be important for people at higher risk of severe COVID-19, such as the elderly and those with compromised immune systems. But for the vast majority of Americans who are now eligible, there really aren’t many benefits to this.”
These studies add to recent reports that First Lady Jill Biden, who recently became infected with COVID-19, was confirmed to be reinfected, having suffered a rebound infection after completing her course of Paxlovid. She is isolated again. Meanwhile, President Joe Biden is donning his mask during the 10 days banned as close contact, according to new CDC guidelines.
Although rebounding was supposed to be a rare phenomenon, the repetition of the phenomenon first in Dr. Anthony Fauci, then in President Joe Biden, and now in his wife Jill Biden highlights the question of whether rebound it is far more common than most had anticipated in an Omicron-dominant pandemic.
The US Food and Drug Administration (FDA) has commissioned Pfizer to conduct a trial to be completed by September 30 next year to see if a second five-day course of the drug would help. to prevent the “rare” phenomenon. The official request was sent by letter on August 5 during Biden’s second convalescence.
Pfizer responded in an email confirming the assignment, saying: “We are working with the FDA to finalize a protocol to study patients who may need a new treatment. We will share updates in due course.” However, as experts have pointed out, there does not appear to be any additional benefit from the second cycle of Paxlovid with regard to the prevention of serious illness and hospitalization.
In April, Bloomberg reported that the Biden administration was “under an obligation to pay Pfizer nearly $5 billion for the pills it has already ordered to treat COVID-19.” The White House planned to use the $10 billion in COVID-19 funding from the Senate to cover the cost of 20 million courses of COVID-19 antiviral pills. The other half has been used to purchase the bivalent COVID-19 boosters. However, as funding has dried up, there has been a decisive shift towards commercializing these treatments, leaving millions in the lurch as the fall and winter seasons fast approach.
Meanwhile, Pfizer is partnering with the Chinese pharmaceutical firm Zhejianghuahai in a five-year agreement to manufacture and sell Paxlovid exclusively in China. Huahai announced the deal on August 17, though Pfizer has publicly remained silent.
In February, the drug received emergency use. authorization in China, where a large part of the elderly population has remained unvaccinated and at risk of a severe outbreak of COVID-19 should an outbreak resurface in the only remaining country that has maintained a zero-COVID policy .
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