A pill to treat COVID-19 cut the risk of hospitalization or death in half, according to early results from a phase 3 trial. Merck, the manufacturer, will now seek an emergency use authorization (EUA) for the drug.
If approved, it would be the first — and, so far, only — easy-to-administer COVID-19 treatment.
The challenge: The pill is an antiviral, a type of drug that interferes with a virus’ ability to replicate. Slowing down the virus makes it easier for the immune system to then clear the infection.
Antivirals are most effective when given soon after an infection starts, but the only FDA-approved COVID-19 antiviral — remdesivir — must be administered intravenously, in a hospital setting, over the course of several days.
Besides making it expensive and hard to access, that means most of the people who receive the treatment already have infections so severe that they’ve been hospitalized.
“This would allow us to treat many more people, much more quickly.”William Schaffner
A pill to treat COVID-19: Several groups have been developing oral antivirals for COVID-19, which would be far easier to give to people earlier in an infection — a doctor could write a prescription as soon as a patient tests positive, and they could take the pills at home.
“This would allow us to treat many more people, much more quickly, and, we trust, much less expensively,” William Schaffner, an infectious disease expert at Vanderbilt University, told the Associated Press.
Now, Merck and Ridgeback Biotherapeutics appear poised to be the first developers to cross the finish line with their pill to treat COVID-19, a drug called molnupiravir.
Testing time: The trial included about 760 unvaccinated adults with mild-to-moderate COVID-19. Besides being unvaccinated, volunteers had at least one other trait that put them at high risk of severe disease, such as obesity. All started treatment within five days of developing symptoms.
The participants were divided into two groups: the treatment group took antiviral pills twice a day for five days. The control group received placebo pills.
People in the treatment group were about 50% less likely to be hospitalized or die during the study’s 29-day period, according to the drugmakers: 14.1% of the placebo group died or were hospitalized, compared to about 7.3% of the treatment group.
While eight people died in the placebo group, no one died in the treatment group before the end of the study.
Adverse effects were comparable between the two groups.
A new COVID-19 treatment: The trial results have yet to be peer-reviewed, but Merck and Ridgeback plan to submit their data and an application for an EUA to the FDA as soon as possible.
It’s not clear what the pill to treat COVID-19 would cost in the U.S., but the federal government has agreed to buy 1.7 million courses of the drug if it is approved, according to the New York Times, for $700 per course.
“Antiviral treatments that can be taken at home … are critically needed.”Wendy Holman
The pill’s makers have committed to licensing the medication to generic drug manufacturers to make it available cheaply in low- and middle-income countries, too.
“Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Ridgeback CEO Wendy Holman said.
“We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic,” she continued.
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