What impact would Merck’s experimental pill have on the fight against covid-19? Dr. Huerta explains to us

(CNN Spanish) – On October 1, the US laboratory Merck and Ridgeback Biotherapeutics announced that their experimental antiviral pill molnupiravir cut the probability of hospitalization and death from COVID-19 by half.

If the results are confirmed, molnupiravir would be the first antiviral pill against SARS CoV2. Dr. Elmer Huerta analyzes in this episode the repercussion that this advance would have in the fight against the pandemic.

You can listen to this episode on Spotify or your favorite podcast platform or read the transcript below.

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Hello, I am Dr. Elmer Huerta and this is your dose of information about the new coronavirus, information that we hope will be useful to take care of your health and that of your family.

Today we will see how important the news is that an antiviral drug has been discovered to fight the new coronavirus.

The American laboratory Merck, known as MSD outside the United States and Canada, together with Ridgeback Biotherapeutics made the announcement through a statement.

The companies reported that their experimental pill molnupiravir cut the likelihood of hospitalization and death from COVID-19 in people infected by half.

Therefore, they would soon request the officials of the United States Food and Drug Administration (FDA) to authorize its emergency use.

Without a doubt, this is excellent news in the fight against the pandemic. If the results of the press release are confirmed, molnupiravir would be the first antiviral pill against SARS CoV2. At the moment, there are two more in development by the laboratories Pfizer and Roche.

Molnupiravir: what is it

As we heard in the April 11, 2020 episode, molnupiravir is an antiviral that is very active in causing a biological situation called “bug catastrophe” in the SARS CoV2 genome.

Described in 2002, the error catastrophe is the phenomenon in which an antiviral drug affects the genome of a virus so much that it suffers a huge amount of genetic errors or mutations, making it unable to replicate effectively, with which infection does not occur.

In the phase 1 and phase 2 studies described in last year’s episode, we said that compared to placebo, those who received molnupiravir were less likely to have respiratory viruses. And as the dose of the drug was increased, so did the negativity of the virus samples in the participants.

We concluded the episode by saying that it was very hopeful, and that we expected phase 3 studies, which demonstrate or deny the results obtained up to that date.

What was the study of the new pill

This is precisely the news today, in which the preliminary results of a phase 3, double-blind and randomized study of 1,550 volunteers from Latin America, Europe, Africa and the United States are released. In it, he pitted molnupiravir against a placebo. More than half of the volunteers were from Latin America.

The study began on August 5, 2021 and was open to patients with mild to moderate COVID-19 confirmed by laboratory test, with onset of symptoms within 5 days after the draw.

In addition, it required that patients have at least one of the following conditions, all of which are considered a risk factor for complications from covid-19:

• Obesity
• Over 60 years old
• Mellitus diabetes
• Heart diseases

What happened was that an independent data monitoring board advised that the study be stopped early. This happened because an interim analysis of data from the first 775 volunteers showed that molnupiravir reduced the risk of hospitalization or death by approximately 50%, an important benefit.

Of the 385 volunteers who received the medicine, 28 or 7.3% were hospitalized or died until the 29th day after the draw. While 53 of the 377 volunteers received placebo, or 14.1%.

As of day 29, no deaths were reported in patients receiving molnupiravir, compared with 8 deaths in patients receiving placebo.

Side effects and the possible future of this treatment

The regimen consisted of taking 4 tablets of molnupiravir twice daily for 5 days, and molnupiravir demonstrated consistent efficacy against the gamma, delta, and mu variants.

The incidence of side effects was comparable in the molnupiravir and placebo groups, and interestingly, 1.3% of the volunteers had to discontinue the study due to an adverse effect, compared with 3.4% of those using the placebo.

The US government has pledged to purchase 1.7 million full courses of treatment for the drug if it is cleared by the FDA.

Merck and Ridgeback have said it can produce 10 million complete courses of treatment by the end of the year, while negotiating contracts with governments around the world.

Although the company has not announced prices, The New York Times says the cost would be $ 700 per patient, which is understood to be for the five-day course of treatment in the United States.

The communiqué of the pharmaceutical companies clarifies that for other countries they plan to implement a system of tiered prices based on the World Bank criteria to measure the income of the countries according to their purchasing power.

Differences between antiviral, vaccine and monoclonal antibodies

Finally, and for the sake of commenting on concepts, it is important to differentiate between antivirals such as molnupiravir, the vaccines that we are using, and the monoclonal antibodies that are also being used in the United States.

We have already described that antivirals act by interfering with the genetic replication of the virus, thereby preventing the progression of the disease.

For its part, the difference between vaccines and monoclonal antibody treatments is the difference between active and passive immunity.

With vaccines or active immunity, structures of the new coronavirus or the whole but inactive virus are injected. This serves so that, by acting as antigens, it is the body’s own defense system that produces the neutralizing antibodies that can fight the virus.

Meanwhile, monoclonal antibodies or passive immunity, as we heard in the episode of October 5, 2020, are selected neutralizing antibodies that are produced in large quantities in the laboratory.

These are administered intravenously to the same group of patients who benefit from antivirals. That is, to those who are more likely to be complicated by the infection.

The effectiveness of monoclonal antibodies in preventing the infection from worsening is greater than that of molnupiravir. In figures, it has been estimated that it prevents 70 to 85% of hospitalizations.

In summary, the publication of the peer-reviewed scientific studies and evaluation by the FDA is awaited so that a new weapon is available in the fight against the pandemic.

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Do you have questions about the coronavirus?

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If you have any questions you can send it to doctor Elmer Huerta via Twitter. You can also go to CNNE.com/coronaviruspodcast for all episodes of our “Coronavirus: Fact vs. Fiction” podcast.