New COVID-19 pills may keep recently diagnosed patients out of hospital, company says

October 1, 2021

(File photo) – Pixelimage/iStock

(NEW YORK) — 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.

“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.

Other companies, including Pfizer and Roche, are also working on antiviral pills 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.

“More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world,” Robert M. Davis, the chief executive officer and president of Merck, said.

“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.”