FDA: 'No evidence' 2nd Paxlovid course stops recurring symptoms

An FDA official said there is currently no evidence a longer course of Pfizer's COVID-19 antiviral treatment would benefit patients experiencing a rebound in symptoms.

The FDA's director of the office of infectious diseases, John Farley, MD, in a May 4 interview addressed reports of patients experiencing recurring symptoms after completing a five-day course of Pfizer's Paxlovid treatment. 

"There is no evidence of benefit at this time for a longer course of treatment … or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symtpoms following completion of a treatment course," Dr. Farley said.  

This is in contradiction to Pfizer's CEO, Albert Bourla, who told Bloomberg in a May 3 report a second course of Paxlovid can be given for rare cases in which people experience a relapse in symptoms, "like you do with antibiotics, and that's it," he said. 

The conflicting comments come as reports of people experiencing a symptom rebound after treatment with Paxlovid have recently garnered attention. Between 1 percent and 2 percent of participants in the Paxlovid clinical trial experienced a rebound in viral levels, Dr. Farley said.  This figure, however, was comparable to the control group, suggesting the phenomenon is not caused by the medication. "Most importantly, there was no increased occurrence of hospitalization or death or development of drug resistance" among these patients, Dr. Farley said. 

"These reports, then, do not change the conclusions from the Paxlovid clinical trial, which demonstrated a marked reduction in hospitalization and death," he said. 

 

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars