First oral antiviral approved for early treatment of COVID-19

The United States Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) in December 2021 for the first oral antiviral, a pill containing two protease inhibitors – nirmatrelvir and ritonavir (Paxlovid, Pfizer) – for early treatment of COVID-19. This drug was approved for adults ages 18 and older with acute COVID-19, for having a pre-specified risk factor for progression to severe disease or for those age 60 or older regardless of chronic medical conditions.

Among 2,085 randomized subjects, there was a highly significant 88 percent reduction in deaths. Specifically, the primary outcome of death occurred in 1 of 1,039 who received the active drug and 10 of 1,046 given placebo.

With respect to early preemptive antiviral therapy, the new oral antiviral drug can be taken at home. To enhance access, the U.S. government already has purchased 10 million courses of treatment from Pfizer for $5 billion.

In a commentary published in the American Journal of Medicine, researchers from Florida Atlantic University's Schmidt College of Medicine and a collaborator note that health care providers are now able to add to their armamentarium against COVID-19 their prescription of this new antiviral drug for high-risk, newly-infected patients as soon as possible following diagnosis or within five days of the onset of symptoms.

Health care providers are among the most trusted professionals by the U.S. general public for reliable information about COVID-19. Health care providers already have and will continue to play crucial roles in reducing preventable morbidity and mortality from COVID-19."

Jennifer W. Caceres, M.D., first author and senior associate dean for admissions and student affairs, FAU Schmidt College of Medicine

To preserve antiviral efficacy for as long as possible, the authors say that these drugs should be prescribed by health care providers to patients within five days or less from the onset of COVID-19 symptoms as well as obtaining proof of a positive standardized diagnostic test. They stress that these drugs should not be prescribed for worried but uninfected patients.

"The U.S. has experienced nearly 1 million or about 16 percent of worldwide deaths from COVID-19 in approximately 5 percent of the world's population," said Charles H. Hennekens, M.D., Dr.PH, senior author, first Sir Richard Doll Professor of Medicine and senior academic advisor to the dean, FAU Schmidt College of Medicine. "This new, unique and easily administered prescribed oral antiviral drug for early COVID-19 treatment as well as more widespread vaccinations in prevention provide cautious optimism for U.S. health care providers and their patients."