FILE PHOTO: Paxlovid, Pfizer’s anti-viral medication to treat the coronavirus disease (COVID-19), is displayed in this picture illustration taken in Medford, Massachusetts, U.S., on May 12, 2022. REUTERS/Brian Snyder/Illustration/File Photo
CHICAGO — The United States-government-backed Recover study of long COVID will examine Pfizer Inc’s antiviral drug Paxlovid in a clinical trial of 1,700 patients, organizers said Thursday.
The U.S. Food and Drug Administration (FDA) said in July it had authorized state-licensed pharmacists to prescribe Pfizer Inc’s COVID-19 pill to eligible patients to help improve access to the treatment.
The antiviral drug, Paxlovid, had been cleared for use and available for free in the United States since December, but fewer than half of the nearly 4 million courses distributed to pharmacies by the government so far have been administered.
Use of the pill, authorized to treat newly infected, at-risk people to prevent severe illness, has, however, jumped as infections rise.
“Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, had said in a statement.
The agency said patients who tested positive for SARS-CoV-2, the virus that causes COVID-19, should bring their health records for the pharmacists to review for kidney and liver problems.
The American Medical Association had said in a statement prescribing decisions should be made by a doctor wherever possible.
The FDA also had said pharmacists should refer the patients to a healthcare professional licensed to prescribe drugs if there is not sufficient information to assess kidney or liver function, or if modifications are needed due to a potential drug reaction.
Patients with reduced kidney function may need a lower dose of the treatment, it added.
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