A PILL A DAY KEEPS COVID AT BAY: Everything You Need To Know About The New Covid Cure

Source-FMT

KEY POINTS:

  • Molnupiravir is an antiviral that suppresses SARS-CoV-2 replication via a process known as “lethal mutagenesis" ; creating errors in the mechanism that replicates the virus’s genetic material, resulting in faulty copies. 
  • Malaysia agreed to purchase 150,000 courses to treat Covid-19 patients under the terms of the deal with Merck, according to Health Minister Khairy Jamaluddin.
  • According to an interim review of data from a randomised trial, it reduced the risk of hospitalisation by about 50%, according to a statement released by Merck on October 1st 2021. 
  • Merck anticipates producing 10 million treatment courses by the end of 2021, with further doses planned for 2022.

Source - Observer

A PILL A DAY KEEPS COVID AT BAY: Everything You Need To Know About The New Covid Cure

Molnupiravir, an antiviral medication in development by Merck & Co., has been praised as a prospective game changer in the war against Covid-19. In a late-stage trial of adults with mild-to-moderate cases, the experimental drug was found to significantly reduce the risk of hospitalisation or death by about half. The prospect of a treatment that patients can easily obtain and use at home has led several governments to place orders for supply even before authorities agree on its use.

150000 Doses Of Merck Covid Pill Enroute To Malaysia

Malaysia has signed a letter of undertaking to purchase Merck Sharp & Dohme’s antiviral drug Molnupiravir, according to Health Minister Khairy Jamaluddin.

The government agreed to purchase 150,000 full treatment packs (patient courses) to treat Covid-19 patients under the terms of the deal.

“This decision was made in preparation for us to begin the transition to the endemic phase of living with the Covid-19 virus by adding new innovative treatment options as a ‘weapon’ to fight Covid-19, in addition to the use of vaccines and other public health measures.”

Who Is Merck Sharp & Dohme?

Merck operates outside the United States and Canada as Merck Sharp & Dohme.

Merck Sharp & Dohme, not to be confused with Merck Group, which is a German multinational science and technology company, of which the American pharmaceutical giant was once a subsidiary of.

Merck Sharp & Dohme, a member of the prestigious Fortune 500, is renowned for its life-saving medicines, including Keytruda (cancer), Januvia (diabetes), and Gardasil (HPV vaccine).

Source-The-Conversation

What Is Molnupiravir?

The medication was discovered at Emory University in Atlanta, and is being developed by Kenilworth, New Jersey-based Merck and Miami-based Ridgeback Biotherapeutics LP.  Molnupiravir is the chemical name for a medication that was first developed to treat influenza and is administered orally in the form of a capsule. 

It suppresses SARS-CoV-2 replication, the coronavirus that causes Covid-19, via a process known as “lethal mutagenesis." In basic English, it creates errors in the mechanism that replicates the virus’s genetic material, resulting in faulty copies. 

source-reuters

But Does It Actually Work?

According to an interim review of data from a randomised trial, it reduced the risk of hospitalisation by about 50%, according to a statement released by Merck on October 1st 2021. 

28 (7.3%) of 385 patients who received the medication were hospitalised, compared to 53 (14.1%) of 377 patients who received a placebo. 

No fatalities were recorded in individuals receiving Molnupiravir through day 29, while eight people in the placebo group died. The study was small, and more research is necessary. 

However, the findings were so promising that Merck and Ridgeback decided to stop the trial and begin the process of obtaining regulatory approval in collaboration with independent trial monitors and the US Food and Drug Administration. 

The company said at a September conference that preliminary research indicated that Molnupiravir may neutralise the most prevalent SARS-CoV-2 variants, including delta and gamma variants.

Source - Observer

Molnupiravir Vs Other Treatments

An antiviral known as Remdesivir, by Gilead Sciences Inc., alongside other monoclonal antibodies, are given via an intravenous infusion. intravenous infusions need to be administered at medical facilities like clinics or hospitals, where other patients are present, increasing the risk of transmitting other illnesses to patients and medical staff alike.

One of the biggest advantages of Molnupiravir is that it is manufactured in pill form, easing administration of the drug. Due to its pill form, it will most likely be cheaper too, compared to intravenous monoclonal antibodies. 

According to the New York Times, it is estimated that a standard 5-day course of Molnupiravir will cost approximately USD $700 per patient, which is currently 33% the cost of monoclonal antibodies used in the treatment of covid-19.

The most ideal treatments are those that are affordable, easy to administer, safe and well tolerated. When these requirements are found in a drug that also directly combats the virus’ – it suppresses SARS-CoV-2 replication in a process called “lethal mutagenesis" – it has the advantage of becoming a revolutionary medication in the fight against covid-19. 

Other medications currently used in the treatment of covid-19 like steroids and blood thinners do not directly combat the virus, instead, they work through managing the symptoms of covid-19 like blood clots and inflammation. 

How Is Molnupiravir Administered 

Adults with mild-to-moderate Covid were given Molnupiravir orally every 12 hours for five days. The most effective protocol is still currently being studied. 

Molnupiravir had minimal effect on patients already hospitalised with severe illness, according to a research published earlier this year. One study is examining whether it can be used to limit the transmission of SARS-CoV-2 in homes with at least one person who has Covid.

source-drug target review

What Are The Side Effects Of Molnupiravir 

Interim studies revealed no evidence of an increased risk of adverse events. Only 1.3% of Molnupiravir treated individuals discontinued treatment owing to an adverse event, compared to 3.4% in the placebo group. 

Despite this, Molnupiravir’s safety will need to be shown in a much larger cohort of patients. Participants were advised to refrain from heterosexual intercourse or use contraception during the experiment. While this is standard procedure for certain other medications, such as cancer treatment, it indicates that Molnupiravir may cause birth defects in pregnant women.

Source-friends-of-UNFPA

Molnupiravir Supply Chain

Merck anticipates producing 10 million treatment courses by the end of 2021, with further doses planned for 2022.

In June, the pharmaceutical company agreed to a $1.2 billion supply deal with the US government under which it would provide 1.7 million courses of the treatment once the medication received emergency use authorization or clearance from the FDA. 

Merck said it will use a tiered pricing model based on World Bank country income criteria to reflect nations’ respective capacity to fund a pandemic-related health response. 

In April, the pharmaceutical company announced voluntary licence arrangements with generic drug makers in India to expedite the availability of Molnupiravir in more than 100 low-income and middle-income nations as soon as the medicine receives required clearances. Merck also has agreements with other countries that are awaiting regulatory approval. 

source - sinar harian

Other Countries Rushing To Order Molnupiravir

With news of Merck’s breakthrough Molnupiravir and its ability to revolutionise covid-19 treatment, many countries were in hot pursuit of it. 

In addition to Malaysia placing orders, other countries like Singapore, Thailand, USA, South Korea, Australia, New Zealand, England and Germany are also in a race to get their hands on Molnupiravir.

  • Malaysia – 150,000 courses
  • Singapore – declined to comment on the number of doses purchased
  • Thailand – 200,000 courses 
  • South Korea – 20,000 courses
  • Australia – 300,000 courses
  • New Zealand – 60,000 courses
  • USA – 1.7 million courses 

Merck anticipates producing 10 million treatment courses by the end of 2021, with further doses planned for 2022.

source-pharmaboardroom

Does This Mean Molnupiravir Will Negate The Need For Vaccines?

No. Vaccination continues to be the most effective method of protection against Covid-19. Even in highly vaccinated populations, Covid-19 cases continue to occur, indicating that antiviral treatments will be critical in reducing the disease’s severity, particularly in the elderly and those with weaker immune systems with whom vaccination is less effective. 

The best way to combat this disease is to prevent infection in the first place. Social and public health interventions, such as wearing face masks and maintaining social distance, are critical for limiting viral transmission and putting a stop to Covid outbreaks.

source - bbc

First Ivermectin, Now Molnupiravir … What’s The Hype?

The evidence supporting the safety and effectiveness of Molnupiravir was strong enough for the study’s independent board of medical experts to recommend that the clinical trials be stopped early, prior to enrolling and studying all 1,550 intended participants, allowing the drug to proceed with regulatory approval processes.

In comparison, there is presently no evidence that Ivermectin is beneficial against COVID-19, including a big trial that demonstrated no advantage over a placebo and another flawed study that was removed from a pre-print platform. Ivermectin is an anti-parasitic medication that is used to treat parasitic illnesses caused by roundworms, threadworms, and other types of parasites. The US Food and Drug Administration has cautioned against self-administering Ivermectin for COVID-19, especially from veterinary sources meant for animal usage rather than human use, since this reduces the drug’s availability for necessary uses and may pose safety concerns if administered improperly.

Health professionals suggest aiming to prevent COVID-19 first via preventative measures such as vaccination, hand washing, facial mask usage and social distance measures. If diagnosed with COVID-19, health experts suggest self-isolation to prevent infection of others and contacting healthcare professionals as necessary for treatment using approved medicines that have been shown to be safe and effective.

Source - NBC News

Molnupiravir Only Reserved For Symptomatic Or Category 3, 4, 5 Patients In Malaysia, Says KJ

According to Health Minister Khairy Jamaluddin, the antiviral tablet Molnupiravir will be provided free of charge to Covid-19 patients who have been symptomatic for at least five days or to patients in categories three, four, and five.

However, he said that the medications will only be administered on the advice of doctors.

“We need these treatment pills in addition to our vaccination programme. We found that with these pills, we give doctors the option to give them to those who have not been vaccinated and those who have. It will be given for free.

“Merck Sharp & Dohme clinical trials have shown its effectiveness in treating category three, four and five cases, especially those with symptoms for four to five days," he said after visiting the Kuala Lumpur Hospital here on Thursday (Oct 7).

The government agreed to acquire 150,000 complete treatment packages for Covid-19 patients through an agreement with the American multinational pharmaceutical firm Merck Sharp & Dohme.

Molnupiravir has also been shown to be effective against Covid-19 variants that are more aggressive, such as Gamma, Delta, and Mu.

Source - NBC News

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