Pfizer: Paxlovid not effective in reducing symptoms in standard risk patients

America, Coronavirus, Elderly, Health, Healthcare, Hospitalization, Infection, Paxlovid, Testing, Treatment, USA

Pfizer: “An updated analysis from 1,153 patients showed a non-significant 51% relative risk reduction”.

Pfizer today shared data from the Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) study evaluating the use of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) in patients who are at standard risk for developing severe COVID-19.

In previously reported interim analyses, the company disclosed that the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met, and a non-significant 70% relative risk reduction was observed in the key secondary endpoint of hospitalization or death (treatment arm: 3/428; placebo: 10/426). An updated analysis from 1,153 patients enrolled through December 2021 showed a non-significant 51% relative risk reduction (treatment arm: 5/576; placebo: 10/569). A sub-group analysis of 721 vaccinated adults with at least one risk factor for progression to severe COVID-19 showed a non-significant 57% relative risk reduction in hospitalization or death (treatment arm: 3/361; placebo: 7/360).

Pfizer Reports Additional Data on PAXLOVID™ Supporting Upcoming New Drug Application Submission to U.S. FDA


Pfizer said on Tuesday it would halt enrollment in a trial for its COVID-19 antiviral drug, Paxlovid, in standard-risk patients after a study revealed the treatment was not effective in reducing symptoms in that group.

The drug has emergency use authorization for high-risk groups in which it has been effective in reducing hospitalizations and deaths.

The new data, however, showed a 51% relative risk reduction in standard-risk groups, which the company said was not statistically significant.

Reuters report: Pfizer stops enrollment in Paxlovid trial in standard-risk population




Paxlovid: Covid-19 infections rebounding a few days after treatment *4 UPDATES*





** This post was originally published on June 15, 2022 **