COVID-19 Resource Center

COVID-19 Resource Center

Perspective from Amesh A. Adalja, MD
Source:

Pfizer’s novel COVID-19 oral antiviral treatment candidate reduced risk of hospitalization or death by 89% in interim analysis of phase2/3 EPIC-HR study. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate. Accessed Nov. 5, 2021.

Disclosures: Bourla is employed by Pfizer.
November 05, 2021
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Pfizer says antiviral reduces risk for hospitalization, death from COVID-19 by 89%

Perspective from Amesh A. Adalja, MD
Source:

Pfizer’s novel COVID-19 oral antiviral treatment candidate reduced risk of hospitalization or death by 89% in interim analysis of phase2/3 EPIC-HR study. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate. Accessed Nov. 5, 2021.

Disclosures: Bourla is employed by Pfizer.
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Pfizer said Friday that its investigational oral antiviral Paxlovid reduced COVID-19-related hospitalizations and deaths by 89% in phase 2/3 study of nonhospitalized adults at high risk for severe disease.

Because of the “overwhelming efficacy” of the treatment, Pfizer said it would stop enrolling participants in the study and submit data to the FDA as part of an ongoing submission for emergency use authorization.

Sars-cov-2 rendering
Source: NIAID.

Paxlovid contains the protease inhibitor PF-07321332 and a low dose of ritonavir, which “helps slow the metabolism, or breakdown, of PF-07321332 in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus,” Pfizer said.

The interim data announced Friday are from 1,219 participants who were enrolled as of Sept. 29 in a randomized, double-blind study titled Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR).

According to Pfizer, three of 389 patients (0.8%) who received Paxlovid within 3 days of symptom onset were hospitalized through day 28 and none died. Comparatively, among 385 patients who received a placebo within 3 days, 27 were hospitalized and seven died (7%).

The company reported similar reductions in hospitalizations and deaths among those treated within 5 days of symptom onset — six of 607 patients (1%) who received Paxlovid were hospitalized through day 28 compared with 41 of 612 (6.7%) patients in the placebo arm, with no deaths reported in the treatment arm compared with 10 deaths among those who received the placebo.

Overall, through day 28, no deaths were reported in either group who received Paxlovid compared with 10 deaths (1.6%) among those who received the placebo.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” Pfizer Chairman and CEO Albert Bourla DVM, PhD, said in a news release. “These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of 10 hospitalizations.”

If approved, Paxlovid would be the first oral antiviral of its kind — a specifically designed SARS-CoV-2-3CL protease inhibitor — Pfizer said.

Additionally, the company said the antiviral could be prescribed for at-home use and could reduce the probability of infection after exposure.

According to Pfizer, the antiviral has demonstrated potent antiviral in vitro activity against variants of concern and other known coronaviruses, which suggests its potential as a therapeutic for multiple types of coronavirus infections.