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How is the pill against COVID-19 that will hit the market in a few months

2021-09-25T23:57:06.397Z

The antiviral pill molnupiravir could stop the coronavirus in the early stage of infection. Experts hope they will help "return to normal life."



By

JoNel Aleccia

-

KHN

One day after testing positive for COVID-19 in June, Miranda Kelly was sick enough to freak out.

At 44 years old, with hypertension and diabetes, this nursing assistant had trouble breathing, a symptom so severe that she ended up in the emergency room.

When her husband, Joe, 46, also fell ill with the coronavirus, she became very concerned, especially for her five teenage children: “I thought, 'I pray to god we don't end up hooked up to a ventilator.

Who is going to raise these children?

I pray to god we don't end up hooked up to a fan.

Who is going to raise these children?

Miranda Kelly, Nursing Assistant

But the Kellys, who live in Seattle, Washington, agreed right after their diagnoses to join a clinical trial at nearby Fred Hutch Cancer Research Center, which is part of an international effort to test an antiviral treatment that could stop COVID. -19 in the early stage of infection.

The next day, the couple were taking four pills, twice a day.

Although they were not told whether they had received a drug or a placebo,

within a week, they said, their symptoms improved.

In two weeks, they had already recovered.

"I don't know if we got the treatment, but I feel like we did," said Miranda Kelly, "with all these underlying conditions, I felt like the recovery was very quick."

Experts assure that antivirals such as molnupiravir, which is being investigated, could change the course of the coronavirus pandemic.MERCK & CO.

The Kellys play a role in developing what could be the world's next opportunity to deal with COVID-19: a short-term regimen of daily pills that can fight the virus early after diagnosis and possibly, prevent the development of symptoms after exposure.

"Oral antivirals not only have the potential to reduce the duration of the COVID-19 syndrome, but also to limit transmission to people at home if you are sick," said Timothy Sheahan, a virologist at the University of North Carolina. Chapel Hill, who has helped promote this research.

When will the new antivirals be ready?

Antivirals are already essential treatments for other viral infections, including hepatitis C and HIV.

One of the best known is Tamiflu, a widely prescribed pill that can shorten the duration of the flu and reduce the risk of hospitalization, if given quickly.

These drugs, developed to treat and prevent viral infections in people and animals, work differently depending on the type.

But they can be designed to stimulate the immune system to fight infection,

block receptors so viruses cannot enter healthy cells,

or reduce the amount of active virus in the body.

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At least three promising antivirals are being tested for the coronavirus in clinical trials, with results expected in late fall or winter, said Carl Dieffenbach, director of the AIDS Division at the National Institute of Allergy and Infectious Diseases, which oversees the development of these drugs.

"I think we will have answers on what these pills are capable of in the coming months," Dieffenbach said.

The main contender in this race is a drug from Merck and Ridgeback Biotherapeutics called molnupiravir, Dieffenbach said.

This is the product that is being tested in the trial involving the Kelly family in Seattle.

Two others include a Pfizer candidate

, known as PF-07321332;

and AT-527,

an antiviral produced by Roche and Atea Pharmaceuticals.

These work by interfering with the virus's ability to replicate in human cells.

In the case of molnupiravir, the enzyme that copies the viral genetic material is forced to make so many mistakes that the virus cannot reproduce.

That, in turn, lowers the patient's viral load, shortens the time to infection, and prevents the kind of dangerous immune response that can cause serious illness or death.

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So far, only one antiviral drug, remdesivir, has been approved to treat COVID-19.

But it is given intravenously to patients sick enough to be hospitalized, and it is not intended for early and widespread use.

In contrast, the new contenders under study can be packaged in pill form.

Sheahan, who also did preclinical work on elremdesivir, led an initial study in mice that showed that molnupiravir could prevent early illness caused by SARS-CoV-2, the virus that causes COVID-19.

The formula was discovered at Emory University and later acquired by Ridgeback and Merck.

There have been clinical trials, including an initial trial of 202 participants last spring, which showed that molnupiravir rapidly reduced levels of infectious viruses.

Merck CEO Robert Davis said this month that the company expects data from its largest phase 3 trials in the coming weeks, with the potential to apply for emergency use authorization from the Food and Drug Administration (FDA ) "Before the end of the year."

Pfizer launched a combined phase 2 and 3 test of its product on September 1, and Atea executives said they expect results from the phase 2 and 3 tests later this year.

If the results are positive and emergency use is granted for any product, Dieffenbach said, "distribution could start quickly."

That would mean that millions of Americans could soon have access to a daily oral medication, ideally a single pill, that could be taken for five to 10 days as soon as COVID-19 infection is confirmed.

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"That's the idea," said Daniel Griffin, an expert in immunology and infectious diseases at Columbia University.

"Have this throughout the country, so that people receive it the same day they receive the diagnosis," he added.

Once sidelined for lack of interest, oral antivirals to treat coronavirus infections are now subject to fierce competition and funding.

Molnupiravir is being developed by Merck & Co. and Ridgeback Biotherapeutics, and is in phase 3 clinical trials, MERCK & CO.)

In June, the Joe Biden Administration announced that it had agreed to obtain about 1.7 million cycles of molnupiravir treatment from Merck, at a cost of $ 1.2 billion, if the product receives emergency authorization or full approval.

The same month, the Administration said it would invest $ 3.2 billion in the Pandemic Antiviral Program, which aims to develop antivirals for the coronavirus crisis and beyond, Dieffenbach said.

It will not be a substitute for vaccination

The pandemic reinvigorated the antiviral research effort.

Although the Severe Acute Respiratory Syndrome (SARS) virus gave scientists a scare in 2003, followed by the Middle East Respiratory Syndrome (MERS), in 2012, research efforts slowed when these outbreaks did not persist.

"The commercial drive to develop any product just disappeared," Sheahan said.

Widely available antiviral drugs would join monoclonal antibody therapies already used to treat and prevent serious illness and hospitalizations caused by COVID-19.

Laboratory-produced monoclonal antibodies, which mimic the body's natural response to infection, were easier to develop, but must be administered primarily intravenously.

The federal government is covering

the cost of most monoclonal products at $ 2,000 per dose

.

It is still too early to know the price of antivirals.

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Like monoclonal antibodies, antiviral pills are not a substitute for vaccination, Griffin said.

They would be another tool to fight the coronavirus.

A challenge in rapid antiviral drug development has been recruiting enough participants for clinical trials, which must recruit hundreds of people, explained Elizabeth Duke, a Fred Hutch researcher who is overseeing the molnupiravir trial.

Participants must not be vaccinated and must be enrolled in the trial within five days of a positive COVID-19 test.

Each day, recruiting staff make at least 100 calls to recently positive coronavirus individuals in the Seattle area, with most choosing not to participate.

"Generally speaking, there is a lot of mistrust about the scientific process

," Duke said, "some people say nasty things to recruiters."

If antiviral pills are effective, the next challenge will be to drive a delivery system where they can reach people as soon as they test positive for COVID-19.

Griffin said something similar to the program established last year by UnitedHealthcare will be needed, which accelerated Tamiflu kits to 200,000 at-risk patients enrolled in the insurer's Medicare Advantage plans.

Merck executives predicted that the company could produce more than 10 million therapy courses by the end of the year.

Atea and Pfizer have not released similar estimates.

How promising are these new treatments?

It is being studied whether antivirals can prevent infection after exposure.

"Let's think about it," said Duke, who also oversees a prophylactic trial.

“We could offer the medicine to everyone in a home or a school.

So, there we would perhaps be talking about a return to normal life ”.

KHN (Kaiser Health News) is the newsroom of KFF (Kaiser Family Foundation), which produces in-depth journalism on health issues.

Along with Policy Analysis and Surveys, KHN is one of KFF's top three programs.

KFF is a nonprofit organization that provides health information to the nation.

Source: telemundo

All news articles on 2021-09-25

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