Paxlovid May Reduce Long-Term Covid Risk For Some Patients, VA Study Says

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Covid patients who were treated with Paxlovid, the oral antiviral that has been shown to be highly effective in preventing hospitalization and death among older and at-risk people, appeared less likely to suffer from several key symptoms associated with prolonged Covid, according to a new study. .

The report, which is based on databases from the Department of Veterans Affairs, looked at more than 9,000 people who took Paxlovid, along with a control group of nearly 50,000 people who tested positive but didn’t take the drug. It showed a reduction of about 25 percent in 10 of the 12 symptoms studied, including the common complaints of persistent fatigue and brain fog. The results were valid regardless of whether people had been vaccinated or had a previous infection.

“This study is very important,” said Akiko Iwasaki, a professor of immunobiology and molecular, cellular and developmental biology at Yale University. “It has public health implications that are quite relevant today.”

Although vaccines have reduced the risk of hospitalization and death from SARS-CoV-2 infection, researchers remain concerned about individual suffering and population-wide threats from prolonged covid.

Data released this summer by the Centers for Disease Control and Prevention’s Household Pulse Survey suggests that about 15 percent of adults have had covid for a long time, developing symptoms that last three or more months after contracting it. the virus. The CDC recently enhanced the web-based survey to assess how big of an impact those symptoms have on long-haul carriers’ ability to carry out daily activities.

Ziyad Al-Aly, chief of research and development for the St. Louis VA Health Care System and lead author of the new report, said it showed the importance of introducing an antiviral to reduce the severity of acute illness. He also lends credence to the idea that prolonged Covid symptoms may be driven, at least in part, by viral persistence, in which infected people don’t completely clear the virus.

“Suppressing viral load can reduce the problem of viral persistence,” said Al-Aly, a clinical epidemiologist at Washington University in St. Louis.

The new VA-funded study was published online as a preprint, meaning it has not yet been peer-reviewed as is standard protocol for academic journals. Publishing preprints has become more common in the urgent atmosphere of the pandemic, often leading to a form of near-instant online peer review. Several prominent virologists weighed in online quickly and positively.

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Eric Topol, professor of molecular medicine and executive vice president of Scripps Research, tweeted that the report is “a breakthrough” and reviewed the findings in an online publication that emphasizes the urgency of developing treatments for what is now widely recognized as a disease. massive. -disability condition.

“We do not have any treatment that has been validated to treat Long Covid,” Topol wrote. “Definitive, rigorous, randomized clinical trials are long overdue.”

There are plans to measure the impact of Pfizer’s drug (nirmatrelvir and ritonavir) next year as part of the National Institutes of Health’s $1.15 billion RECOVER program, the agency recently announced. The clinical trial will enroll 1,700 adults. Results are not expected until 2024.

Some researchers said it would be helpful to have access to data from Pfizer’s placebo-controlled clinical trials evaluating the antiviral’s impact on acute Covid in thousands of volunteers.

“We could do long-term follow-up to determine whether the two groups have the same or different rates of persistent symptoms,” said David Putrino, director of rehabilitation innovation at Mount Sinai Health System in New York.

Pfizer said the company is “working with multiple institutions toward the start of studies to evaluate Paxlovid for potential use in the treatment of long-term COVID.” In its financial guidance for 2022, the company reported Paxlovid revenue of $22 billion.

Clinicians have been hampered in developing specific treatments for prolonged covid largely because the mechanism, or mechanisms, behind the wide variety of reported symptoms have not been identified. Leading theories include viral persistence, microclot development, and acute inflammation, which other studies have shown can cause long-term damage.

Iwasaki speculates that using Paxlovid to stop virus replication might not only prevent viral persistence but also the other mechanisms, by containing the virus within the upper respiratory tract before it migrates to other organs.

“The virus is the trigger for all the other hypotheses,” Iwasaki said. “Nip it in the bud as quickly as possible, and some of these things could be preventable.” He said that he believes there may be advantages to taking Paxlovid as soon as possible after diagnosis.

The new study has inherent limitations.

The people who signed up qualified to receive the drug under the emergency use authorization issued last year by the Food and Drug Administration, which is for anyone over the age of 12 who is at risk of serious illness, including those over 65 years old As a result, the study did not include previously healthy young people, who represent the majority of patients seen in many long-time Covid clinics, according to Benjamin Abramoff, director of the Post-COVID Assessment and Recovery Clinic at Penn Medicine.

There is no data to show whether these previously healthy young people would reap the same benefits as people at risk of serious illness. Putrino cautioned that the promising results of the study may be related to the antiviral’s ability to reduce the severity of acute illness that can lead to persistent complications, such as pulmonary fibrosis from pneumonia, pericarditis from inflammation and what is known as post-ICU syndrome. , instead of the other symptoms you commonly see.

“Many, many others with long-term covid had non-hospitalized/mild acute illness, but went on to develop this debilitating, syndromic, long-term covid, ME/CFS type,” Putrino said, referring to chronic fatigue syndrome.

As a retrospective study rather than a randomized controlled trial, there may also be underlying differences not explained in the study between those taking Paxlovid and the control group, including greater engagement with their doctors, Abramoff said.

“The study provides further evidence for the importance of prospective controlled studies looking at Paxlovid as a means of preventing prolonged covid in the general population,” Abramoff said.

Al-Aly, the lead author, said the study also highlighted for him the notable underuse of effective therapy, with 85 percent of people who were qualified to be prescribed the antiviral not taking it. “Is it because they weren’t offered it or because they had concerns?” he asked him.

In the short time since the study was published online, Al-Aly said he has seen lay readers jump to the wrong conclusions.

“We are not saying that all people should take Paxlovid,” Al-Aly said. “Right now, we don’t know that. People need to understand that.”

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