According to a preprint study by researchers in the US and at the Francis Crick Institute, Imperial College London, and other UK universities, the Merck Covid pill Lagevrio was linked to new virus mutations.
According to a study that highlights the danger of attempting to purposely alter the genetic coding of the pathogen, Merck & Co.’s Covid-19 tablet is causing the virus to evolve into new variants in some people.
Some researchers are concerned that the medication might produce more contagious or deadly forms of Covid, which has killed more than 6.8 million people worldwide in the last three years.
According to a preprint study by researchers in the US and at the Francis Crick Institute, Imperial College London, and other UK universities, mutations connected to the use of Merck’s medication, Lagevrio, have been found in viral samples taken from dozens of patients.
According to the study posted on the medRxiv website on Friday without peer review, it has not yet been established that the drug-linked mutations of the virus are more immune-evasive or lethal. However, the fact that they exist shows what some scientists believe to be possible hazards in the drug’s widespread use. The drug was recently approved in China.
By inducing changes in the Covid genome, Lagevrio helps to lessen the likelihood that the virus would cause severe sickness by preventing the virus from multiplying in the body. Before it was approved in late 2021, some scientists had expressed concern that the drug’s mode of action would result in mutations that could be troublesome. These concerns regarding Merck medicine have been rekindled by the preprint study.
“There’s always been this underlying concern that it could contribute to a problem generating new variants,” said Jonathan Li, a virologist at Harvard Medical School and Brigham and Women’s Hospital in Boston. “This has largely been hypothetical, but this preprint validates a lot of those concerns.”
Merck Response
Merck contests the claim that its medicine leads to harmful variants.
“There is no evidence to indicate that any antiviral agent has contributed to the emergence of circulating variants,” Merck spokesman Robert Josephson said in an email in response to questions about the study. “Based on available data we do not believe that Lagevrio (molnupiravir) is likely to contribute to the development of new meaningful coronavirus variants.”
He claimed that new mutations have appeared throughout the pandemic as a result of the virus’s unchecked spread, and Lagevrio can play a significant role in the cure. Merck cited animal studies that demonstrated its medication didn’t result in mutations.
According to Josephson in a follow-up email, the study authors make the assumption that the mutations were brought on by the use of molnupiravir but lack concrete evidence to support this. Instead, according to Josephson, “circumstantial associations between viral sequence origin and timeframe of sequence collection in countries where molnupiravir is available” led the researchers to their results.
Merck dropped as much as 1.2% in New York on Wednesday before cutting its losses to 0.4%.
The US Food and Drug Administration said it doesn’t comment on third-party studies and collaborates with Covid drugmakers to evaluate their products’ activity against variations. The FDA authorized Lagevrio in late 2021.
Preprint
Up until the conclusion of a “peer review” procedure, in which the research is examined by outside specialists, major scientific publications do not publish studies. In an effort to progress science more swiftly and disseminate crucial results, scientists began publishing their data on so-called “preprint servers” more frequently throughout the pandemic.
Small patient clusters with lagevrio-induced mutations were discovered by researchers, indicating that new versions were circulating among them. Although 21 people made up the largest group they discovered to have similar mutations, Ryan Hisner, an independent researcher from Indiana who contributed to the publication, believes that this number may not accurately reflect the problem’s severity because many patients’ viral samples weren’t examined.
About 13 million viral genomes from databases all over the world were analyzed by the researchers. In nations and populations where Lagevrio was likely to be used, especially the US and Australia where it was first launched, the drug-linked mutations were proportionally more prevalent. In nations where the medicine is not utilized, such as Canada, France, and others, the signature mutations are less common.
“These effects are visible in these databases,” said Theo Sanderson, a Crick Institute geneticist who led the study. “It appears that people are being treated, some of them aren’t clearing their infections, and some are passing them on.”
Hisner added that utilizing the medication from Merck would be risky due to the possibility of drug-linked mutations. According to Michael Lin, a Stanford University antiviral drug researcher who claimed to have spoken with the authors but not been involved in the study, the US should consider approving medications used in other countries to treat Covid, such as Xocova from Japan’s Shionogi & Co., and stop using Lagevrio. Late last year, China approved Lagevrio, and Shionogi stated that it is currently in the final phases of negotiations with China’s regulators over its Covid medication.
“It’s a very distressing situation,” said Lin. “There’s no evidence that any of these mutants is worse in any way — not yet — but it’s well agreed that you’re playing with fire if you’re creating random mutations and hoping nothing bad will come of it.”
Sanderson declined to comment on whether medical professionals should keep prescribing Merck’s medication, claiming the study doesn’t deal with the matter.
Lingering concerns
There have long been issues with Lagevrio’s effectiveness and safety. Health professionals advise against using it when pregnant. The US National Institutes of Health advise against using the medication when alternatives are available.
Former Warp Speed scientific czar Moncef Slaoui urged Merck to collaborate with Ridgeback Biotherapeutics LP to develop the urgently required oral Covid tablet for wider use. Early findings indicated that it reduced the incidence of hospitalization and death in non-immunized individuals by roughly 50%.
It’s actually less effective than those initial trials suggested, according to later studies. According to research published in December, although the length of time it took for symptoms to subside by several days, adding Lagevrio to conventional therapy did not decrease hospitalizations or fatalities in high-risk patients.
However, the number of Covid treatments is decreasing. To circumvent Covid antibodies produced by Regeneron Pharmaceuticals Inc., Eli Lilly & Co., and Vir Biotechnology Inc., variations have evolved. The final one to remain effective, Evusheld by AstraZeneca Plc, was recently taken off the US market. The only options left for Americans are Paxlovid and remdesivir from Gilead Sciences Inc., which must be administered in three daily sessions as soon as a person is diagnosed.
Because Paxlovid contains a substance called ritonavir, which interacts negatively with medications for other disorders like heart disease, which are common in those who are susceptible to severe Covid, some patients are not eligible to take it.
Early on in the development of medicine, Raymond Schinazi, a researcher at Emory University, voiced his reservations about Merck’s product. Years earlier, he had conducted his own investigation on it before giving up.
After learning about the new study, he demanded more observation to look into whether the viruses with drug-linked mutations are having any effect.
According to Schinazi, the preprint study raises “an orange flag, not a red flag yet.” “Proceed with caution.”
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