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Molnupiravir vs COVID-19: Will the drug live up to the hype?

In the search for effective COVID-19 treatments, many drugs have failed to live up to their early promise. In a recent trial, seen as an important advance, the oral antiviral drug molnupiravir halved the risk of hospital admissions and deaths from COVID-19. Medical News Today explored the evidence to see whether this optimism is justified.
The experimental drug molnupiravir has brought fresh hope in the fight against COVID-19. But what do we know about it so far? Image credit: Jordan Lye/Getty Images.However, what do we are familiar it up until now?

A global trial

led by the pharmaceutical company Merck — known as MSD outside the United States and Canada — and Ridgeback Therapeutics, has found that the companies’ experimental antiviral drug molnupiravir reduces the risk of hospital admission or death from COVID-19 by approximately 50%.

Although this was a small-scale trial, so these positive results have led to countries rushing to sign up for supplies of the drug.

In the randomized, phase 3 trial, scientists gave molnupiravir or a placebo to 775 people. All the participants had tested positive for SARS-CoV-2 infections and experienced mild to moderate COVID-19 symptoms that had begun no more than 5 days earlier.

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Every participant

Every participant had at least one risk factor for severe COVID-19 but had not been admitted to a hospital. Risk factors included obesity, an age of over 60 years, diabetes, and heart disease.

The scientists allocated each of the 775 participants randomly to one of two groups so One group received molnupiravir and the other a placebo. The participants took the capsules twice a day for 5 days.

Of the 385 patients taking molnupiravir, 28 were admitted to a hospital, compared with 53 of those in the placebo group. Eight of the placebo group participants died, while all those receiving the antiviral were alive at the end of the 29-day study period.

Recruitment into the study has now been halted because of these overwhelmingly positive results. The manufacturer, Merck, is applying for emergency use authorization from the Food and Drug Administration (FDA).

The Singapore health ministry has signed a purchase agreement for molnupiravir, and the European Medicines Agency is considering a rolling review of the drug.

“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight and the pandemic.”

– Robert M. Davis, chief executive officer and president of Merck

Merck plans to produce 10 million courses of the treatment in 2021 and more in 2022.

the study results have been greeted with optimism. Prof. Tim Spector, a professor of genetic epidemiology at King’s College London, told MNT: “This is an exciting result from a randomized study of 775 patients, showing major effects in reducing severity and death from a simple pill given at the onset of infection.”

What is molnupiravir?

Molnupiravir belongs to a class of antivirals called mutagenic ribonucleosides. These change the viral genetic material and introduce errors to prevent replication and transcription of the viral genome.

Inside the host cell, molnupiravir is converted to molnupiravir triphosphate. When the virus tries to replicate, molnupiravir triphosphate is incorporate into the viral RNA of the nucleoside cytidine, causing a mutation.

The mutation stops the virus from replicatingTrusted Source. This keeps numbers of the virus in the body low and should reduce the severity of the disease.

Other drugs that interfere with viral RNA have shown potential as COVID-19 treatments. Remdesivir, an intravenously administered drug that interferes with an enzyme essential for replicating viral RNA, showed early promiseTrusted Source.

Although the FDA has granted approval to remdesivir, the World Health Organization (WHO)Trusted Source no longer recommends it as a COVID-19 treatment, due to insufficient evidence to support its use.

The advantage of molnupiravir is that, unlike all the other potential treatments so far, it is an oral tablet that a person can take outside a clinical setting. At a projected cost of around $700 per person for a 5-day course, it is also more affordable than other drugs. However, this cost is still likely to limit its use.

“Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed. We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic.”

– Wendy Holman, chief executive officer of Ridgeback Biotherapeutics

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‘Not a magic pill’

Prof. Sir Peter Horby, a professor of emerging infectious diseases and global health at the University of Oxford, is largely optimistic: “A safe, affordable, and effective antiviral would be a huge advance in the fight against COVID.”

However, he retain a note of caution: “It is important to remember that the absolute risks were 14% reduce to 7%, so quite a lot of people need to be treate to prevent one hospitalization or death. This means the drug needs to be very safe and affordable.”

By and by, there is normally a lower achievement rate than in clinical preliminaries.

William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, who said: “In the studies in very high risk patients, it reduced the level of serious disease by only half. It’s not a magic pill.”

He added: “In research settings, you can ensure that people take the pill as directed. In practice, there is usually a lower success rate than in clinical trials.”

Dr. Peter English, a retire consultant in communicable disease and a past chair of the British Medical Association Public Health Medicine Committee, has also expresse doubts: “The problem for antivirals like Merck’s molnupiravir is that they to use before people are (usually) deemed ill enough to need anything other than symptomatic self-care treatment.”

“Unless an antiviral medication could be made so cheap and so safe that it can be used ‘on spec’ by people who might have COVID-19, [it is] unlikely to be widely useful,” he adds.

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Safety concerns

Despite widespread optimism following the study results, some experts have raised concerns about the safety of a drug that works by causing mutations.

As molnupiravir causes viral RNA to mutate, there are concerns that it might cause mutations in host cells, as well. One study in animal cell cultures found mutations in cells treated with molnupiravir.

This has led to worries that the drug might cause cancers or birth abnormalities. The authors of the animal cell study that this mutagenic potential be asses in vivo, focusing on rapidly dividing cells. Additionally, they recommend monitoring to assess potential genotoxicTrusted Source side effects.

– Dr. Simon Clarke, associate professor of cellular microbiology at the University of Reading

Furthermore, they prescribe checking to evaluate potential genotoxicTrusted Source incidental effects.

Furthermore, they prescribe checking to evaluate potential genotoxicTrusted Source incidental effects.

Prof. Schaffner was less concerned about the possible genetic implications: “The FDA would certainly not have permitted clinical trials in humans if they thought there were any reasonable danger. […] Animal studies showed no adverse effects.”

Cautious optimism

These positive outcomes applied to individuals who had gotten molnupiravir before long the beginning of gentle to direct side effects

These positive results applied to people who had received molnupiravir soon after the onset of mild to moderate symptoms. A previous trial showed no benefit in giving the drug to patients already in hospital with COVID-19.

As an early treatment, molnupiravir could, Prof. Schaffner agrees, “offer another opportunity to prevent serious disease.”

All things considered, is molnupiravir the medicine and we have been holding on for to oversee COVID-19?

“Although [this trial] had relatively small numbers analysed (fewer than 400 per group), it had much better results than the study done in hospitalized patients. It approximately halved the rate of hospitalization and notably reduced the number of deaths. Preventing the virus from replicating at an early stage seems very beneficial.”

All in all, is molnupiravir the medication and we have been sitting tight for to manage COVID-19? Maybe, yet the proof isn’t yet definitive.

– Prof. Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine

So, is molnupiravir the drug and we have been waiting for to bring COVID-19 under control? Perhaps, but the evidence is not yet conclusive.

Furthermore, they prescribe checking to evaluate potential genotoxicTrusted Source incidental effects.

All things considered, is molnupiravir the drug and we have been holding on for to oversee COVID-19?

Prof. Spector is among those keen to see more trial results. . “But if this pans out, it will be a major game-changer for [COVID-19] treatment and possibly other viruses.”

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