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A pill to treat COVID can only be a few months away


By JoNel Aleccia, Kaiser Health News

Friday, September 24, 2021 (Kaiser News) -Within a day after testing positive for covid-19 in June, Miranda Kelly was sick enough to be scared. At 44, with diabetes and high blood pressure, Had Kelly, a Certified Nursing Assistant breathing problems, symptoms severe enough to send her to the emergency room.

When her husband, Joe (46), also fell ill with the virus, she became really worried, especially about their five teenagers at home: ‘I thought,’ I hope to God we do not stop fans. We have children. Who is going to raise these children? ”

But the Kellys, who live in Seattle, agreed to a diagnosis just after their diagnosis. clinical trial at the nearby Fred Hutch Cancer research center that is part of an international effort to test an antiviral treatment that can stop covid early in its course.

The next day, the couple drinks four pills twice a day. Although they do not know if they have received an active medication placeboThey said their symptoms improved within a week. Within two weeks, they recovered.

“I do not know if we got the treatment, but I feel like we did,” Miranda Kelly said. “Having all these underlying conditions, I felt the recovery was very quick.”

The Kellys play a role in the development of the world’s next chance to stop covid: a short-term daily pill that can fight the virus early after diagnosis and presumably prevent symptoms from developing after exposure.

“Oral antiviral drugs have the potential to not only limit the duration of your covid-19 syndrome, but can also limit the transmission to people in your household if you are ill,” said Timothy Sheahan, a virologist at the University. of North Carolina, said -Chapel Hill, who helped pioneer in these therapies.

Antiviral drugs are already essential treatments for others viral infections, including hepatitis C and HIV. One of the most famous is Tamiflu, the widely prescribed pill that lasts flu and reduces the risk of hospitalization if given quickly.

The drugs developed to treat and prevent viral infections in humans and animals work differently depending on the type. But they can be designed to Immune system Fighting infection blocks receptors so that viruses cannot enter healthy cells, or reduce the amount of active virus in the body.

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

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

The top contender is a medication from Merck & Co. and Ridgeback Biotherapeutics called molnupiravir, Dieffenbach said. This is the product tested in the Kellys Seattle trial. Two others include a candidate from Pfizer, known as PF-07321332, and AT-527, an antiviral drug manufactured by Roche and Atea Pharmaceuticals.

They work by inhibiting the virus’ ability to reproduce 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. This in turn reduces the viral load of the patient, shortens the infection time and prevents the dangerous immune response that can cause serious illness or death.

So far, only one antiviral agent, remdesivir, was approved to treat covid. However, it is given intravenously to patients who are sick enough to be admitted to hospital, and are not intended for early, widespread use. In contrast, the top contenders studied can be packaged as pills.

Sheahan, who also performed preclinical work on brake desivir, conducted an early study in mice that showed that molnupiravir can prevent early diseases caused by SARS-CoV-2, the virus that causes covid. The formula was discovered at Emory University and later obtained by Ridgeback and Merck.

Clinical trials followed, including an early trial of 202 participants last year that showed that molnupiravir rapidly reduced levels of infectious virus. Merck CEO Robert Davis said this month that the company expects data from its larger Phase 3 trials in the coming weeks, with the possibility of obtaining emergency use permission from the Food and Drug Administration “before the end of the year” . “

Pfizer launched a combined Phase 2 and 3 test of its product on September 1, and Atea officials said they expect results from Phase 2 and Phase 3 trials later this year.

If the results are positive and an emergency is granted for any product, Dieffenbach said: ‘can be distributed quickly.’

This would mean that millions of Americans would soon have access to a daily oral medication, preferably a single pill, that could be taken for five to ten days upon initial confirmation of the infection.

“When we get there, it’s the idea,” said Dr. Daniel Griffin, a specialist in infectious diseases and immunology at Columbia University, said. “To have it all over the country so that people get it the same day they are diagnosed.”

Once set aside due to lack of interest, oral antiviral drugs to treat coronavirus infections are now a subject of fierce competition and funding. In June, the Biden Administration announced that it had agreed to receive approximately 1.7 million treatment courses of Merck’s molnupiravir for $ 1.2 billion, if the product received authorization or full approval. In the same month, the administration said it would invest $ 3.2 billion in the antiviral program for pandemics, which aims to develop antiviral drugs for the covid crisis and beyond, Dieffenbach said.

The pandemic has begun a long-neglected effort to develop powerful antiviral treatments for coronavirus, Sheahan said. Although the original SARS virus frightened scientists in 2003 – followed by the Middle East Respiratory Syndrome, or MERS, in 2012 – research efforts slowed when outbreaks did not continue.

“The commercial drive to develop products has just fallen into the tubes,” Sheahan said.

Widely available antiviral drugs join the monoclonal antibodies already used to treat and prevent serious diseases and hospitalizations caused by covid. The laboratory manufactures monoclonal antibodies, which mimics the body’s natural response to infection, was easier to develop, but should be administered mainly by intravenous infusions.

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

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

A challenge to develop antiviral drugs quickly is to acquire enough participants for the clinical trials, each of which has to enroll many hundreds of people, said Dr. Elizabeth Duke, a research fellow from Fred Hutch who oversees the molnupiravir trial, said.

Participants must be vaccinated within five days after a positive covid test and be registered for the trial. On any given day, interns make 100 calls to patients with Covid-positive people in the Seattle area — and most say no.

“Just generally, there is a lot of mistrust about the scientific process,” Duke said. ‘And some of the people say some nasty things to the interns.

If the antiviral pills prove to be effective, the next challenge is to build a distribution system that can rush them to people once they test positive. Griffin said it requires something similar to the program UnitedHealthcare set up last year, which accelerated Tamiflu packages to 200,000 at-risk patients enrolled in the insurer’s Medicare Advantage plans.

Merck officials predicted the company could produce more than 10 million treatments by the end of the year. Atea and Pfizer did not release similar estimates.

Even more promising? Studies determining whether antiviral infections may occur after exposure.

“Think about it,” said Duke, who also oversees a prophylactic trial. ‘You can give it to everyone in a household or to everyone in a school. Then we talk about a return to a normal life. “



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