FDA contradicts Pfizer on second cycle of Paxlovid for COVID

There is not “any evidence” that a second course of Paxlovid from Pfizer Inc. will help COVID-19 patients whose symptoms return after an initial course of the antiviral, a Food and Drug Administration (FDA) official said. from the United States a day after Pfizer executives defended the idea.

Doctors and virologists have been struggling to understand a number of reports of viral rebounds in patients after completing a five-day course of treatment.

In an interview given on Tuesday, the executive director of PfizerDr. Albert Bourla said that doctors could prescribe a second course of treatment for patients who relapse, and some doctors have suggested that a longer course of Paxlovid might prevent symptoms from returning.

In cases where virus levels spike, “then a second cycle is given, as is done with antibiotics, and that’s it,” Bourla said Tuesday.

There is no data to support a longer treatment course or two separate five-day courses to treat or prevent flare-ups, he said Wednesday. John Farleydirector of the Office of Infectious Diseases of the Center for Drug Evaluation and Research of the FDAin a post on the agency’s website.

“No evidence of benefit at this time” to repeat the dose or a longer course of treatment, he said Farley in the post. “We continue to review clinical trial data and will provide additional information as it becomes available.”.

Pfizer did not immediately respond to a request for comment.

In light of reports of viral rebound in some patients, the agency conducted further analysis of data from previous clinical trials to understand the phenomenon, it said. Farley.

These showed that about 1% to 2% of people from a previous trial tested positive for polymerase chain reaction, or PCRafter a cycle of Paxlovid and a negative initial test. However, some people who received a placebo also experienced viral rebound, she said.

“It is not clear at this time that this is related to drug treatmentFarley said in the post.

The Government considers Paxlovid the “Preferred therapy for management of non-hospitalized adults with COVID-19″ said on Wednesday the FDA in a statement, citing treatment guidelines from the National Institutes of Health.