Taking a course of a particular antiviral pill over five days, shortly after COVID-19 diagnosis, may slash the risk of being hospitalized or dying of the virus by 50%, according to preliminary results announced by pharmaceutical companies Merck and Ridgeback.
If this pill — called molnupiravir — is ultimately authorized by the Food and Drug Administration, it would be the first antiviral pill people can take at home to reduce their risk of winding up in the hospital from the coronavirus. The medication would require a prescription and likely be for people with mild or moderate symptoms of COVID-19.
“This is the first oral antiviral that will be available to combat COVID-19 and why that’s so important, if you think of it if you’re someone who is unfortunate enough to get the news that you’ve contracted COVID-19, this is the pill, you can take it home and will significantly reduce the risk that you either ultimately are hospitalized or more importantly that you would ever face the unfortunate outcome of death,” Robert M. Davis, the chief executive officer and president of Merck told “Good Morning America” Friday.
“It’s really exciting,” Dr. Carlos Del Rio, the executive associate dean and a global health expert at the Emory School of Medicine, said.
Right now, most COVID-19 patients are sent home and told to monitor their symptoms. Having an effective pill to offer them would “make a difference,” Del Rio added.
Merck Thursday morning announced the results of an ongoing Phase 3 study are so compelling that an independent monitoring board recommended, in consultation with the FDA, ending the trial early so the companies can swiftly seek authorization. The full set of data would become available to the public at that time.
“This is an oral antiviral. So it’s a pill. You take it. It’s a five-day course of therapy and by taking the pill it actually inserts into the RNA of the virus and stops it from working and that really is the magic of how this works and really allows you to significantly reduce the risk of hospitalization or death,” Davis said.
The vaccine status of the trial volunteers was not disclosed in the press release, but doctors say pills like this should never be taken as an alternative to vaccines, which have been tested in hundreds of thousands of people across massive clinical trials, and are the most powerful way to dramatically reduce the risk of being hospitalized or dying of COVID — and reduce the risk of becoming infected in the first place.
Other companies, including Pfizer and Roche, are also working on antiviral pills for patients already diagnosed with COVID-19 that could become available soon. Merck plans to seek emergency authorization in the U.S. “as soon as possible” so that it can start mass distributing its antiviral pill.
The company has started producing the pills with the goal of having 10 million courses of the medication by the end of the year. The U.S. has already asked for 1.7 million doses, at a cost of over $1 billion.
Currently, doctors have some treatments to help those who are already sick with the virus, but those treatments are cumbersome, as they’re typically administered via intravenous infusion and usually reserved for patients who are hospitalized or have a high risk of becoming so.
“What we really need is the Tamiflu, if you will, for COVID-19,” Dr. Todd Ellerin, the director of infectious diseases at South Shore Health and an ABC News Med Unit contributor, said. “It’s possible that molnupiravir could be the agent.”
Molnupiravir is an antiviral drug, meaning it works by slowing the replication of the virus that causes COVID-19.
In an early analysis of 775 volunteers in a late-stage clinical trial, people who tested positive for COVID-19 within the last five days were split into two groups. The first group got the drug and the second got a placebo pill.
About 14% of people who got the placebo were hospitalized or died, compared to just over 7% of those who got the real drug.
“I think this is exciting,” Ellerin said, “because we need an oral antiviral. We desperately need an oral antiviral that can be given early in the course.”