An Underutilized Lifesaver
If given early in the illness, Paxlovid can prevent COVID hospitalizations and save lives. Why is this drug underused?
On February 13, 2024, National Geographic Press published a book I wrote called, TELL ME WHEN IT’S OVER: AN INSIDER’S GUIDE TO DECIPHERING COVID MYTHS AND NAVIGATING OUR POST-PANDEMIC WORLD. For the next few months, I will be writing about various issues discussed in that book.
Paxlovid is an antiviral drug that inhibits the growth of SARS-CoV-2 virus. If given in the first 5 days of illness, Paxlovid prevents hospitalizations and deaths. For example:
• In April 2022, researchers at Pfizer published a study of 2,200 unvaccinated adults who were randomized to receive Paxlovid or placebo within the first three days of illness. They found that the drug was 89 percent effective at preventing hospitalizations. This study was criticized because, at the time that it was published, most people in the United States had been vaccinated. Did Paxlovid also work in adults who were previously vaccinated?
• In December 2022, researchers at the CDC published a study of 700,000 adults with COVID who had been previously vaccinated, 28 percent of whom had received Paxlovid in the first 5 days of illness. Paxlovid decreased the incidence of hospitalization by 51 percent.
• In April 2023, researchers from Hong Kong published a study of 14,000 nursing home residents with COVID, only 1 in 4 of whom had received the antiviral drug. Paxlovid decreased the rate of hospitalization by about 50 percent.
• In June 2023, researchers at the National Institutes of Health published a study of 1,000,000 adults, 9.7 percent of whom were treated with Paxlovid in the first 5 days of illness. Paxlovid decreased mortality by 73 percent.
• In July 2023, researchers from the CDC published a study of 90,000 adults who were or were not treated with Paxlovid within 5 days of symptom onset, finding that the drug reduced hospitalization by 80 percent.
• Most recently, in April 2024, researchers at Pfizer published a multicenter, prospective, placebo-controlled study of Paxlovid in 1296 vaccinated or unvaccinated participants with COVID. They found that the time to sustained resolution of symptoms was 12 days in the Paxlovid group and 13 days in the placebo group. Several news outlets reporting on this study concluded that Paxlovid wasn’t of value in patients with COVID. However, 5 (0.8%) participants in the Paxlovid group and 10 (1.6%) in the placebo group were hospitalized for severe COVID—a 50% reduction. The goal of antiviral agents is to prevent high-risk patients from hospitalization or ICU admission or death. Paxlovid has consistently been shown to be effective in achieving that goal.
Supported by these studies, Paxlovid is recommended for groups at highest risk for severe COVID. These groups include the elderly, pregnant women, people who are immune compromised, or people with high-risk medical conditions such as chronic lung, heart, or kidney disease, obesity, or diabetes among others. Nonetheless, less than half of those in high-risk groups had taken Paxlovid. Paradoxically, one recent study of 20 million people enrolled in Medicare found that those at highest risk were less likely to receive the anti-viral drug. Why? Two reasons. One is legitimate, the other isn’t.
Some people choose to avoid Paxlovid for fear of “Paxlovid Rebound,” which as it turns out, isn’t a thing. People are not more likely to suffer a worsening of symptoms following administration of Paxlovid than those who didn’t take the drug. “Paxlovid Rebound” should be renamed “COVID Rebound”, which occurs as people move into the second stage of the illness, where the immune response causes a worsening of symptoms.
A legitimate reason to withhold Paxlovid is concern that it could interfere with the effects of other drugs, of which there is a long list. Sometimes drugs that should not be given at the same time as Paxlovid can be replaced with other drugs. Sometimes the drugs can be adjusted or withheld. It’s a matter of assigning the relative risks of stopping a drug for a few days versus the risk of being hospitalized or dying from COVID. There are no risk-free choices. Only the choice to take different risks. It is likely that in many instances doctors err wrongly on the side of withholding Paxlovid in a patient who likely could have withstood the effects of stopping other drugs for a few days.
Hundreds of people in the United States are currently dying from COVID every week. Many of these deaths are preventable with early treatment.
Dr. Offit is an excellent communicator of health information. I have read many of his books, support the Vaccine Education Center at his hospital, and appreciated his voice of reason during the height of the Covid pandemic.
However, Pfizer's April 2024 study of Paxlovid was NEGATIVE. There was no significant difference in hospitalization or deaths in the two groups: high risk unvaccinated or low risk vaccinated. There was one death from any cause in the 317 high risk unvaccinated people which does not meet statistical significance; it was chance. There were 10 (1.6%) placebo vs 5 (0.8%) Paxlovid hospitalization but this also was not shown, by the study, to have been due to Paxlovid. Statistically, it was as likely due to chance and the authors acknowledge this: "The results with respect to the number of Covid-19 related hospitalization and deaths from any cause, ALTHOUGH NOT SIGNIFICANT..."
This paper is an excellent example of the necessity of randomized controlled trials (RCT). Observational trials can suggest hypotheses but a RCT is essential as, well designed, it avoids bias.
Pfizer's April 2024 paper, try at they may to spin in their favor, was a NEGATIVE trial. It failed to show that Paxlovid decreases death, hospitalization, or duration of symptoms.
Thank you very much for showing the value of Paxlovid as an antiviral treatment !