BIO member Pfizer Inc.’s antiviral drug Paxlovid, which has already been shown to reduce the risk of hospitalization and death from COVID-19, can also reduce the risk of symptoms of long COVID, which affects millions of people in the U.S. and around the world, according to a study published last week by the Department of Veterans Affairs.
FDA has already authorized Paxlovid’s two-drug treatment (nirmatrelvir and ritonavir) “for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients” who are “at high risk for progression to severe COVID-19, including hospitalization or death.”
Citing the results from their study “Nirmatrelvir and the risk of post-acute sequelae of COVID-19,” released on the pre-print server medRxiv before peer review, Veterans Affairs researchers said that patients taking Paxlovid within five days of testing positive for a SARS-CoV-2 infection had decreased risk of long COVID.
Long COVID or PASC (post-acute sequelae of SARS-CoV-2) refers to a spectrum of symptoms affecting the patient’s physical and mental health that persist, recur or appear four or more weeks after the initial SARS-CoV-2 infection, according to a RECOVER initiative factsheet.
“Paxlovid reduces the risk of severe COVID-19 in the acute phase, and now, we have evidence that it can help reduce the risk of long COVID,” said Dr. Ziyad Al-Aly, chief of research and development at the VA St. Louis Health Care System, who led the study.
The study, which used the healthcare databases of the U.S. Department of Veterans Affairs, included more than 56,000 veterans “who had a SARS-CoV-2 positive test between March 01, 2022, and June 30, 2022.”
All participants in the study “had at least 1 risk factor for progression to severe COVID-19 illness” and “survived the first 30 days after SARS-CoV-2 diagnosis.”
Patients “given the oral antiviral medication in the first 5 days of a COVID-19 infection had a 25% decreased risk of developing 10 of 12 different Long COVID conditions studied,” including heart disease, blood disorders, fatigue, liver disease, kidney disease, muscle pain, neurocognitive impairment, and shortness of breath, the study said.
The study notes that “Nirmatrelvir was also associated with reduced risk of post-acute death and post-acute hospitalization,” with “reduced risk of PASC in people who were unvaccinated, vaccinated, and boosted, and in people with primary SARS-CoV-2 infection and reinfection.”
NIH to test Paxlovid for long COVID treatment
The U.S. National Institutes of Health’s (NIH) RECOVER Initiative announced last week it “is preparing several clinical trials to evaluate treatments to improve symptoms related” to long COVID as described by the CDC.
The release pointed out a trial protocol that ClinicalTrials.gov posted recently for a randomized, placebo-controlled trial that will test Pfizer’s Paxlovid or a placebo in 1,700 volunteers with long COVID aged 18 and older.
The trial that will test the efficacy of antivirals and other therapeutics for the treatment of long COVID “is in the final stages of development and approvals and is expected to begin enrolling participants in early 2023” and has picked Pfizer’s antiviral drug as the first treatment it will study.
The study, which is scheduled to start on January 17, 2023, will be supervised by the Duke Clinical Research Institute, which has been named “the Clinical Trials Data Coordinating Center for large-scale national research studies aimed at understanding and improving the treatment of long COVID.”
In addition to the therapeutic trials, RECOVER also announced conducting “several longitudinal observational cohort studies and related sub-studies, more than 40 pathobiology studies, evaluation of potential PASC biomarkers, and analyses of more than 60 million electronic health records.”