Sep. 24—As millions of Americans remain unvaccinated against the coronavirus, health experts hope potential approvals of a number of different oral anti-viral pills — to be taken daily to treat coronavirus — become the final puzzle pieces for ending the pandemic.
Three anti-viral medicines are currently being tested for efficacy in clinical trials as first reported by Kaiser Health News, and a decision on approval from the U.S. Food and Drug Administration could come within the next few months, according to Carl Dieffenbach, who is overseeing the medicines' development as the director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases.
One of those three drugs, molnupiravir, developed by Merck & Co. Inc. and Ridgeback Biotherapeutics, was tested on a family in Seattle who recovered from the virus in two weeks and could be the first approved, according to KHN. Other antiviral medicines under development by Pfizer and Roche and Atea Pharmaceuticals are also being tested in trials.
The approval of an oral antiviral medicine in the form of a pill could go a long way toward alleviating stress on hospitals and health systems, said Dr. Michael Ellis, chief medical officer of the University of Toledo Medical Center.
"It would help prevent people from having to be hospitalized in the first place," the infectious-disease expert from the former Medical College of Ohio Hospital said, "especially older people and nursing home folks."
Therapies such as Remdesivir, the only antiviral drug that is FDA approved to treat the virus, and antibody treatment REGN-COV2, which has been given emergency-use approval from the FDA and has been recommended by the World Health Organization, have proven to be effective in treating the novel virus.
But an oral medication, unlike the intravenously administered Remdesivir, would become a game-changer from the health-care system perspective, Dr. Ellis said.
"The big part is the logistics and the convenience," he said. "Obviously when it doesn't require an intravenous site, that makes a world of difference. People could be given this medication at home, or wherever they might be."
An early trial of 202 patients who used molnupiravir showed that the drug was effective in treating coronavirus. If approved under emergency-use authorization, the daily-dose pill could be distributed rather quickly, Mr. Dieffenbach said.
President Biden's administration committed in June to procuring 1.7 million treatment courses of molnupiravir pending an EUA from the FDA. In a statement announcing the partnership, Merck president Rob Davis said his company was "pleased to collaborate" with the U.S. government, and committed to making the drug available globally.
Dr. Johnathon Ross, an internal-medicine specialist who is president of the Toledo-Lucas County Health Department's Board of Health, said it would be "wonderful" news if an antiviral pill become approved to treat the virus, as it would give sick Americans another tool for combating the virus. But as with other medications, such as anti-parasite drugs ivermectin and hydroxychloroquine, that are effective in treating certain ailments but haven't yet proven to treat coronavirus, he said, the proof must be in the pudding.
"Nothing could make me happier than if Merck actually has something that will work," he said. "...But show me the controlled randomized trial that says the benefit is worth the risk of side effects and cost."
As of Friday, nearly 55 percent of Americans have been vaccinated. But 18 states — including Ohio — have yet to vaccinate half of their populations. Close to 54 percent of Lucas County's population is now fully vaccinated or has started the process.
Dr. Ross said the development and approval of antiviral pills could be huge for ending the pandemic, specifically among unvaccinated populations — in large part because of many people's reluctance to receive vaccines or injections.
"Who wants a shot?" he said. "Nobody wants to take a shot. So they probably would be more likely to take a pill."
Merck, Pfizer, and Atea have predicted they could each produce around 10 million courses of therapy by the end of the year. The benefits, Dr. Ellis said, would be extraordinary.
"I think some people would probably prefer to take a pill," he said. "The other thing is that some therapies require an infusion, and if there was no need for an IV infusion, then that would be a very good alternative."
First Published September 24, 2021, 5:32pm