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In a statement, the company said 7.3% of the 385 patients who received the antiviral were either hospitalized or died from Covid-19, compared with 14.1% of the 377 patients who received a placebo, which does not do nothing.
“This is the most impactful result that I can remember seeing from a drug available orally in the treatment of a respiratory pathogen, perhaps ever,” Dr Scott Gottlieb, former commissioner of the United States Food and Drug Administration, to Anderson Cooper of CNN. “I think getting an oral pill that can inhibit viral replication – which can inhibit this virus – is going to be a real game-changer.”
Antiviral treatments are a type of antimicrobial – treatments that kill or inhibit the growth of microorganisms such as bacteria (fought by antibiotics), fungi (fought by antifungals), or, in this case, a virus.
Some of the best-known antivirals are those developed to treat herpes, HIV, and the flu.
“Most people have heard of Tamiflu, and they’ve heard of acyclovir,” said Dr. Myron Cohen, professor of medicine, microbiology, immunology and epidemiology at the University of Carolina at the University of North Carolina. North. Acyclovir is a type of antiviral drug used to treat chickenpox, herpes, and shingles.
“We haven’t developed a ton of other antivirals,” he said.
What makes molnupiravir different
Another antiviral, remdesivir, is currently the only drug approved by the FDA for the treatment of Covid-19. Remdesivir, manufactured by Gilead Sciences and sold as Veklury, is given by intravenous infusion, so it’s not as easy as swallowing a pill.
Molnupiravir is said to be easier for patients – no IV is required – and it works differently, modifying the SARS-CoV-2 virus to inhibit replication.
“It is actually incorporated into the genetic material of the virus and introduces errors,” Dr Daria Hazuda, scientific director of MSD, Merck’s brand operating outside of the United States and Canada, said during a briefing. with the Science Media Center in the UK on Friday.
“So on a number of incorporations the errors make the virus less able to replicate itself.”
Dr Mark Denison, a virologist at the Vanderbilt Institute for Infection, Immunology and Inflammation, said that molnupiravir’s mode of action, called mutagenesis, is what separates it from remdesivir.
“The two basic mechanisms are either chain termination, which I call the delayed stop sign, or mutagenesis, which is like blowing up potholes in the road while the car is moving. just damages the genome, ”he told CNN.
What an antiviral pill could mean for Covid-19
Cohen, who previously worked on molnupiravir, said that when looking at the results of an antiviral drug like molnupiravir, he wanted to see three things.
“Stop the progression of the disease, so you take them and you forget about them, right?” ” he said. “The second thing we would like the pill to do, if you take it for a symptomatic illness, is to stop Covid for a long time, right? You have a persistent cough, persistent headaches.”
Cohen said his third goal would be for “treatment to serve as prevention,” so a person with Covid-19 is less likely to pass it on to others.
“We would like it to clear the replication of SARS-CoV-2 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 it was “crucial” to have an antiviral drug that could prevent Covid-19 infection to become serious.
“We already have monoclonal antibodies that do this and are actually quite effective. The problem is, they require an infusion or injections. It’s really heavy on the individual, it’s heavy on the health care system.” , she said, referring to Covid-19 treatments. produced by Regeneron, Eli Lilly and GlaxoSmithKline and Vir.
“It would be a total game changer if someone, when diagnosed with mild Covid, at the start of their treatment, is able to take a pill at home. It eases the burden on the health care system. It helps. also really the individual. ”
Yet an antiviral cannot replace a vaccine.
White House Covid-19 response coordinator Jeff Zients said in a briefing Friday that the best way to think about such a drug is as an additional tool, for use with vaccines.
“This is a potential additional tool in our toolkit to protect people from the worst consequences of Covid,” Zients said. “I think it’s really important to remember that vaccination, as we talked about today, remains by far our best tool against Covid-19. It can keep you from getting Covid in the first place. And we want to prevent infections, don’t just wait to treat them once they happen. “
What is the next step for molnupiravir
There is still a lot to be learned about the drug and who it might work for. The detailed trial on Friday focused on adult patients who were considered at high risk for severe Covid-19, most often due to obesity, advanced age, diabetes and heart disease. None had been vaccinated against Covid-19.
Molnupiravir is also under investigation as a post-exposure prophylaxis – researchers are examining whether it can prevent the virus from spreading in households, after a person has been exposed but has not yet tested positive.
Merck said Friday that it plans to submit an application to the FDA for emergency use authorization as soon as possible, and other regulators around the world.
Ahead of the trial’s results, the company said it was producing unsafe molnupiravir and expects 10 million treatments to be available by the end of the year.
Merck has already sold 1.7 million treatments to the US government, if it obtains clearance or approval from the FDA. The company said it will offer tiered pricing to provide worldwide access and that it will work with generic drug makers to accelerate availability in low- and middle-income countries.
CNN’s Lauren Mascarenhas contributed to this report.
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