In a press release, the company said that 7.3% of the 385 patients who received the antiviral either were hospitalized or died of Covid-19, compared with 14.1% of the 377 patients who received a placebo. which does nothing.
“This is the most potent result I can remember having seen an orally available drug treating a respiratory pathogen, perhaps ever,” said Dr. Scott Gottlieb, former commissioner for the US Food and Drug Administration, told CNN’s Anderson Cooper on Friday. “I think getting an oral pill that can stop virus replication – that can stop this virus – is going to be a real game changer.”
Antiviral treatments are a type of antimicrobial treatment – treatments that kill or otherwise inhibit microorganisms such as bacteria (fought by antibiotics), fungi (fought by antifungal drugs), or in this case viruses.
Some of the more popular antivirals are those that are designed to treat herpes, HIV, and the flu.
“Most people have heard of Tamiflu and they have heard of acyclovir,” said Dr. Myron Cohen, Professor of Medicine, Microbiology, Immunology, and Epidemiology at the University of North Carolina. Acyclovir is a type of antiviral used to treat chickenpox, herpes, and shingles.
“We haven’t developed many other antivirals,” he said.
What is the difference between molnupiravir?
Another antiviral, remdesivir, is currently the only FDA-approved drug used to treat Covid-19. Remdesivir, which is made by Gilead Sciences and sold under the name Veklury, is given by intravenous infusion so it is not that easy to swallow a pill.
Molnupiravir would be easier for patients – no IV needed – and it works differently by modifying the SARS-CoV-2 virus to inhibit replication.
“It actually gets built into the genetic material of the virus and creates errors,” said Dr. Daria Hazuda, Chief Science Officer at MSD, Merck’s non-US and Canadian label, in a briefing with the Science Media Center in the UK on Friday.
“With a series of incorporations, the errors mean that the virus is less able to replicate.”
Dr. Mark Denison, a virologist at the Vanderbilt Institute for Infection, Immunology, and Inflammation, said the way molnupiravir works, called mutagenesis, differentiates it from remdesivir.
“The two basic mechanisms are either chain breaking, which I call the delayed stop sign, or mutagenesis, which is like pounding potholes in the road while the car is moving. It just damages the genome, ”he told CNN.
What an antiviral pill could mean for Covid-19
Cohen, who previously worked on molnupiravir, said if he looks at the results of an antiviral drug like molnupiravir, he wants to see three things.
“Stop the progression of the disease so you take it and forget about it, right?” he said. “The second thing we want the pill to be, if you’re taking it for symptomatic illness, is to stop Covid, right? It’s not just ‘don’t let me progress and die – don’t let me’ have a persistent cough, persistent headache. ‘ ”
Cohen said his third goal is “preventative treatment” so that someone with Covid-19 is less likely to pass it on to others.
“We want it to wipe out the SARS-CoV-2 replication in the nose so quickly that your nose is no longer a danger to me,” he said.
Former Baltimore City health commissioner and CNN medical analyst Dr. Leana Wen told CNN on Friday that it was “crucial” to have an antiviral drug that could prevent a Covid-19 infection from becoming serious.
“We already have monoclonal antibodies that do this and are actually quite effective. The problem is that they require an infusion or injections. This is really stressful for the individual, it is a burden on the health system, “she said, referring to the Covid-19 treatments made by Regeneron, Eli Lilly and GlaxoSmithKline and Vir.
“It would be a total game changer if someone with a mild Covid diagnosis could take a pill at home early in treatment. That relieves the health system. That really helps the individual too. “.”
However, an antiviral cannot replace a vaccine.
White House Covid-19 Response Coordinator Jeff Zients said during a briefing Friday that such a drug is best thought of as an additional tool to be used alongside vaccines.
“This is a potential additional tool in our toolbox to help protect people from the worst effects of Covid,” said Zients. “I think it’s really important to remember that vaccination, as we discussed today, remains by far our best drug against Covid-19. It can prevent you from getting Covid in the first place. And we want to prevent infections. “Don’t just wait to treat them as soon as they happen.”
What’s next for molnupiravir
There is still a lot to learn about the drug and who it might work for. The study detailed on Friday focused on adult patients who were considered to be at high risk for severe Covid-19, most commonly due to obesity, old age, diabetes and heart disease. Nobody was vaccinated against Covid-19.
Molnupiravir is also being studied as a post-exposure prophylaxis – researchers are investigating whether it can prevent the virus from spreading in households after someone has been exposed but hasn’t tested positive.
Merck said it planned on Friday to file an application for emergency approval with the FDA and other regulatory agencies around the world as soon as possible.
In anticipation of the study results, the company announced that it produces vulnerable molnupiravir and expects to have 10 million courses of treatment by the end of the year.
Merck has already sold 1.7 million treatment courses to the US government upon approval or approval from the FDA. The company said it will offer tiered pricing to allow access around the world and work with generic drug companies to accelerate availability in low and middle income countries.
CNN’s Lauren Mascaren contributed to this report.