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AAn experimental antiviral pill reduced the chances of patients newly diagnosed with Covid-19 being hospitalized by about 50%, a finding that could give doctors a desperately needed new way to treat the sick, drugmaker Merck said on Friday. .
A five-day cycle of molnupiravir, developed by Merck and Ridgeback Biotherapeutics, reduced both hospitalizations and deaths compared to a placebo. In the placebo group, 53 patients, or 14.1%, were hospitalized or died. Of those who received the drug, 28, or 7.3%, were hospitalized or died.
Simple oral medication to help treat Covid-19 has been an elusive goal since the start of the pandemic. Other drugs, including Gilead’s Remdesivir, have also been shown to reduce hospitalizations if given at the onset of illness, but must be administered intravenously.
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“If this comes to pass, it will change the landscape,” said Andy Pavia, chief of the pediatric infectious disease division at the University of Utah. “There is still a lot we need to know. What does the side effect profile look like? Do we know how to dose it in different populations like children and the obese? But as a frontline result, it’s really exciting. “
If approved, molnupiravir could have a dramatic impact on efforts to fight the pandemic. Merck and Ridgeback said they would seek emergency use authorization from the Food and Drug Administration “as soon as possible” and submit it to regulators around the world.
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Data from the study was made public in a press release and has yet to be peer reviewed. But even the highest numbers were encouraging. During the first 29 days of the study, no deaths were reported in the molnupiravir group and eight deaths were reported in patients given the placebo.
Patients in the study had mild to moderate Covid-19, were within five days of symptom onset when administered, and had at least one risk factor associated with poor disease outcomes.
The study was terminated prematurely on the recommendation of an independent data monitoring committee and in consultation with the FDA, Merck said. These committees are responsible for ensuring that studies are in the best interests of patients and recommend their discontinuation if it is clear that a drug is working.
Only limited information on side effects was made public in the press release, but the companies said the rates were similar between the placebo group and the treated group. An adverse event, or poor outcome, occurred in 35% of those who received molnupiravir and 40% of those who received placebo. Only 1.3% of subjects treated with molnupiravir stopped the drug because of an adverse event, compared with 3.4% who stopped the placebo.
“When people talk about endemic Covid and the future of Covid, they don’t spend as much time talking about the value of intervening early to reduce the severity of the disease and it is a very valuable tool,” said Natalie Dean, assistant professor of biostatistics. at Emory University which studies infectious diseases. “The more accessible it can be, the more effective it can be. “
In an interview, Dean Li, head of research and development at Merck, said that no particular side effects stood out as being more common with the drug, but more complete data will be available at a later date.
Molnupiravir works in a different way from other antiviral drugs, creating multiple errors in the virus’s RNA and interfering with its ability to replicate. Since there isn’t a lot of experience with this mechanism, Pavia said, the safety data will need to be looked at closely. He also said he doubted the drug would be used in pregnant people. None were included in the study.
DNA sequencing data on the SARS-CoV-2 variant that causes Covid-19 was available in 40% of the 81 cases. The drug appeared to be effective against so-called worrying variants, including Gamma, Delta, and Mu variants of the virus.
“As you well know, it is likely that we will see a continued evolution of these variants,” Li said. “Our prediction from our in vitro studies and now with these data is that molnupiravir is named after the right – you know it’s named after Thor’s hammer [Mjollnir], it is a hammer against SARS-CoV-2 regardless of the variant.
The study had recruited 90% of the 1,500 volunteers it planned to include, but the decision to stop it was based on data from 762 patients. A breakdown on the participants’ origin, ethnicity and gender was not immediately available, but the trial was conducted in countries around the world, including Argentina, Italy, Japan, UK. United and United States.
Li said the data monitoring committee met on Tuesday. He said he was in his kitchen when he got a text from Roy Baynes, Merck’s chief medical officer. He said the results immediately impressed him.
“You think of all the people who could benefit from it and all the people who are in your life that you wish they could benefit from,” Li said.
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