A pill to treat Covid-19: ‘We’re talking about a return to, perhaps, normal life’
A pill to treat Covid-19: ‘We’re talking about a return to, perhaps, normal life’

A pill to treat Covid-19: ‘We’re talking about a return to, perhaps, normal life’

When her husband, Joe, 46, also became ill with the virus, she became really worried, especially about their five teenagers at home: “I thought, ‘I hope for God we do not end up with fans. We have children Who will raise these children?”

The next day, the couple took four pills twice a day. Although they were not told if they had been given an active medication or placebo, they said their symptoms were better within a week. Within two weeks, they had recovered.

“I do not know if we got the treatment, but I feel a little like we did,” Miranda Kelly said. “To have all these underlying conditions, I felt that recovery was very fast.”

The Kelly family has a role to play in developing what could be the world’s next chance to counteract covid: a short-term regimen of daily pills that can fight the virus early after diagnosis and possibly prevent symptoms from developing after exposure.

“Oral antivirals have the potential to not only limit the duration of one’s covid-19 syndrome, but also have the potential to limit transmission to people in your household if you are ill,” said Timothy Sheahan, a virologist at the University of North Carolina -Chapel Hill, which has pioneered these therapies.

Antiviral drugs are already essential treatments for other viral infections, including hepatitis C and HIV. One of the best known is Tamiflu, the commonly prescribed pill that can shorten the duration of flu and reduce the risk of hospitalization if given quickly.

The medicine, which is designed to treat and prevent viral infections in humans and animals, works differently depending on the type. However, they can be designed to boost the immune system to fight infections, block receptors so that viruses can not enter healthy cells, or lower the amount of active virus in the body.

At least three promising antiviral drugs against covid are being tested in clinical trials, with results expected as soon as late fall or winter, said Carl Dieffenbach, director of the AIDS department at the National Institute of Allergy and Infectious Diseases, which oversees antiviral development. .

“I think we will have answers on what these pills are capable of within the next few months,” Dieffenbach said.

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The best candidate is a medicine from Merck & Co. and Ridgeback Biotherapeutics called molnupiravir, Dieffenbach said. This is the product being tested in Kelly’s Seattle trial. Two others include a candidate from Pfizer, known as PF-07321332, and AT-527, an antiviral agent manufactured by Roche and Atea Pharmaceuticals.

They work by interfering with the virus’ 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 errors that the virus cannot multiply. In turn, it reduces the patient’s viral load, shortens the infection time and prevents the kind of dangerous immune response that can cause serious illness or death.

So far, only one antiviral drug, remdesivir, is approved to treat covid. However, it is given intravenously to patients who are sick enough to be admitted and are not intended for early, widespread use. In contrast, the best candidates examined can be packaged as pills.
Sheahan, who also performed preclinical work with belt straps, led one early study in mice which showed that molnupiravir could prevent early disease caused by SARS-CoV-2, the virus that causes covid. The formula was discovered at Emory University and later acquired by Ridgeback and Merck.
Clinical trials have been followed, including one early trial of 202 participants last spring who showed that molnupiravir rapidly reduced the level of infectious virus. Merck CEO Robert Davis said this month that the company expects data from its larger Phase 3 trial in the coming weeks, with the potential to apply for an emergency use permit from the Food and Drug Administration “before the end of the year.”
Pfizer launched a combined phase 2 and 3 trials with its product September 1stand Atea officials, they said expect results from Phase 2 and Phase 3 trials later in the year.

If the results are positive and emergency use is given for any product, Dieffenbach said, “distribution can begin quickly.”

This would mean that millions of Americans would soon be able to access a daily orally administered drug, ideally a single pill, which could be taken for five to 10 days at the first confirmation of covid infection.

“When we get there, that’s the idea,” said Dr. Daniel Griffin, an expert in infectious diseases and immunology at Columbia University. “To have this around the country so people get the same day they get the diagnosis.”

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Once put on the sidelines due to lack of interest, oral antiviral drugs for the treatment of coronavirus infections are now subject to fierce competition and funding. In June, Biden administration announced it had agreed to obtain about 1.7 million courses of treatment with Merck’s molnupiravir at a cost of $ 1.2 billion if the product receives emergency authorization or full approval. That same month, the administration said so would invest 3.2 billion in the Antiviral Program for Pandemics, which aims to develop antiviral agents for the covid crisis and beyond, Dieffenbach said.

The pandemic kickstarted a long-neglected effort to develop potent antiviral treatments for coronavirus, Sheahan said. Although the original SARS virus in 2003 gave scientists a fright – followed by the Middle East Respiratory Syndrome or MERS in 2012 – research efforts slowed as these outbreaks did not last.

“The commercial drive to develop any product just went down in the pipes,” Sheahan said.

Widely available antiviral drugs will join the monoclonal antibody therapies already used to treat and prevent serious illness and hospitalizations caused by covid. The laboratory-produced monoclonal antibodies, which mimic the body’s natural response to infection, were easier to develop, but should be given primarily through intravenous infusions.

The federal government covers the cost of most monoclonal products at $ 2,000 per tonne. dosage. It is still too early to know how the price of antiviral drugs can be compared.

Like the monoclonal antibodies, antiviral pills would be no substitute for vaccination, Griffin said. They would be another tool to combat covid. “It’s nice to have another option,” he said.

A challenge in developing antiviral drugs quickly has been to recruit enough participants for the clinical trials, each of which must enroll many hundreds of people, said Dr. Elizabeth Duke, a research fellow at Fred Hutch, overseeing its molnupiravir trial.

Participants must be unvaccinated and enroll in the trial within five days of a positive covid test. Every day, interns make 100 calls to newly covid-positive people in the Seattle area – and most say no.

“Just generally speaking, there’s a lot of mistrust about the scientific process,” Duke said. “And some of the folks are saying some ugly things to the interns.”

If the antiviral pills prove to be effective, the next challenge will be to increase a distribution system that can rush them to people as soon as they test positive. Griffin said it requires something similar the program created last year by UnitedHealthcare, which accelerated Tamiflu kits for 200,000 at-risk patients enrolled in the insurance company’s Medicare Advantage plans.
Merck officials predicted the company could produce more than 10 million courses before the end of the year. Atea and Pfizer have not published similar estimates.

Even more promising? Studies assessing whether antiviral agents can prevent infection after exposure.

“Think about it,” said Duke, who is also monitoring a prophylactic trial. “You could give it to everyone in a household, or everyone in a school. Then we’re talking about a return to, perhaps, normal life.”

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