First-Ever Oral Antiviral Pill To Treat COVID-19

First oral pill to treat high-risk COVID-19 patients has been approved for the first time in the UK to subdue the pandemic.

Highlights:

Britain approves the first Merck's oral anti-viral pill to treat COVID-19
The drug – molnupiravir is found to have greater efficacy against COVID-19 if initiated early
Further deployment plans are to be confirmed by UK and NHS in due course

Symptomatic COVID-19 can be now treated using the first-ever approved Merck's COVID-19 pill in the world by the UK medicines regulator.

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‘Molnupiravir – the first oral pill to treat high-risk COVID-19 patients is deemed as a “gamechanger” in containing the spread of the COVID-19 pandemic in the UK.’
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About the Drug

The US drug companies Merck, Sharp, and Dohme (MSD), and Ridgeback Biotherapeutics, have developed the first antiviral drug for COVID-19– Molnupiravir. One of the added benefits is that the drug can be consumed as a pill rather than being injected (intravenously).

This allows the easy administration of the drug even outside the hospital premises to reduce the severity.

The pill that was initially formulated to treat flu has been shown to cut down the hospitalization or death risk by about half in clinical trials. The UK and NHS are yet to confirm their further deployment plans in due course.

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Rising Rate of Infections

Although there is a dip in pandemic rates, the number of daily COVID-19 cases is still as high as 40,000 as per the latest seven-day average report in the UK. The country has recorded nearly 41,242 COVID cases on Thursday with 214 deaths within 28 days after testing positive.

England's deputy chief medical officer, Prof Jonathan Van-Tam warns of “some "hard months to come" in the pandemic. He further added that while COVID cases appeared to have stabilised, deaths were rising and there were signs infections were starting to "penetrate" older age groups”.

Hence, bearing in mind the constant struggle faced by the UK to contain the alarming infection rate, the drug was finally approved for COVID-19 treatment.

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Mechanism of the Drug

The drug targets aspecific enzyme that is used by the SARS-CoV-2 virus to make its copies. This allows the introduction of errors into its genetic code, thereby preventing further multiplication.

As the virus ceases to multiply, the drug maintains a lower viral level in the body and thereby reducing the disease severity. Following this phenomenal discovery, Merck supposed that the treatment should likewise hold the efficacy even against new variants of the virus in the future.

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Evidence from Clinical Trials

The clinical trials of molnupiravir have been conducted previously in 775 COVID-19 patients. It was found that only 7.3% of those who had been given the drug were hospitalized as compared to 14.1% of patients with placebo or dummy pills.

In addition, there was no death among the molnupiravir group when compared to eight deaths from COVID-19 under the placebo in the trial. However, the trial results are yet to be peer-reviewed and were published in a press release. Moreover, other study data propose that molnupiravir might not be effective in cases where patients have already been hospitalized with severe COVID-19. The drug requires immediate initiation. Further late-stage trials are yet to be conducted to authenticate the use of the drug for preventing infection.

"If these outcomes are replicated in the UK population, then the number of cases requiring hospital admission could be halved and the number of deaths greatly reduced”,says Prof Penny Ward, from King's College London, who was not involved in the study.

How to Use?

Molnupiravir is authorized for treatment – twice a day for five days among higher risk COVID-19 patients. This includes patients with mild to moderate COVID-19 with at least one risk factor like diabetes, obesity, advanced age, or heart disease, for developing severity of infection.

Further to this, the MHRA recommends initiation of the drug within five days after the onset of symptoms and immediately "as soon as possible" after a positive COVID-19 test for its benefits.

Merck also intends to extend the manufacturing licenses for surplus supply through generic drugmakers.

"With no compromises on quality, safety and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data (on molnupiravir)," says MHRA chief June Raine in a statement.

Revolutionary Drug Formulation

The treatment was a "gamechanger" for the most frail and immunosuppressed. "Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for Covid," says Health Secretary Sajid Javid.

Other companies (apart from Merck) have also reported being working on similar treatments for COVID-19. The US rival of Merck’s – Pfizer has also joined the race by initiating the trials of two different antiviral tablets, while Roche – another Swiss company is operational on a similar medication.

Roll out of the Drug

The first delivery of the drug is predicted in November following which 480,000 courses are confirmed for purchase by the UK. The drug is to be branded as Lagevrio in Britain.

The drug is planned to be rolled out for both vaccinated and unvaccinated patients initially through a national study for reinforcing the added efficacy of the drug.

However, it is uncertain as to how the NHS plans to distribute the drug so quickly. Sources anticipate the initial supplies to some care homes for elderly or vulnerable patients.

Cost to be Anticipated

Although the UK government has not disclosed the cost for its initial contract of 480,000 courses of molnupiravir, US authorities have made an advance purchase of 1.7 million courses. That is roughly $1.2 billion, or $700 (£513) cost for each patient.

The purchase agreements have also been addressed by other countries like Australia, Singapore, and South Korea.

Merck affirmed that it was foreseeing to formulate 10 million treatment courses by the year-end and a minimum of 20 million sets to be produced in 2022. Before the market opened, the shares of the US-based drugmakers escalated up to 2.1% at $90.54.

Source-Medindia