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

When her husband, Joe, 46, also fell ill with the virus, she really worried, especially about her five teenagers at home: “I thought, ‘I hope to God we don’t end up with fans. We have kids. Who’s going to raise these children? “

The next day, the couple were taking four pills, twice a day. Although they weren’t told whether they had received an active drug or a placebo, within a week, they said, their symptoms improved. In two weeks, they had recovered.

“I don’t know if we got the treatment, but I feel like we did,” Miranda Kelly said. “Having all these underlying conditions, I felt that the recovery was very fast.”

In a matter of days, the CEO of Pfizer says they will be ready to apply for approval of a Covid-19 vaccine for children.

The Kellys have a role in developing what could be the world’s next chance to thwart COVID: a short-term regimen of daily pills that can fight the virus early after diagnosis and possibly prevent the development of symptoms after diagnosis. exposition.

“Oral antivirals have the potential to not only reduce the duration of COVID-19 syndrome, but also limit transmission to people in your home if you are sick,” said Timothy Sheahan, a virologist at the University of North Carolina. -Chapel Hill, who has helped pioneer these therapies.

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

The 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.

At least three promising antivirals for COVID are being tested 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 antivirals. .

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

Covid-19 vaccine boosters may begin for some American adults, as CDC partially diverges from its advisers' recommendations

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

They 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.

So far only one antiviral drug, remdesivir, has been approved to treat covid. But it is given intravenously to patients sick enough to be hospitalized and is not intended for early and widespread use. In contrast, the top contenders under study can be packaged in pill form.
Sheahan, who also did preclinical work on remdesivir, led a early study in mice which showed that molnupiravir could prevent early illness 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 conducted, including a early judgment out of 202 participants last spring that showed molnupiravir rapidly lowered infectious virus levels. 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 “sooner. end of the year”.
Pfizer launched a combination phase 2 and 3 testing of your product September 1, and Atea officials said that wait for results Phase 2 and Phase 3 trials 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 drug administered daily by mouth, ideally a single pill, which could be taken for five to 10 days on the first confirmation of covid infection.

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

5 Things You Should Know About Coronavirus Booster Vaccines
Once sidelined for lack of interest, oral antivirals to treat coronavirus infections are now subject to fierce competition and funding. In June, the Biden announced administration 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 so would invest $ 3.2 billion in the Antiviral Program for Pandemics, which aims to develop antivirals for the covid crisis and beyond, Dieffenbach said.

The pandemic launched a long-neglected effort to develop powerful antiviral treatments for coronaviruses, Sheahan said. Although the original SARS virus in 2003 gave scientists a scare, followed by Middle East respiratory syndrome, or MERS, in 2012, research efforts slowed down when those outbreaks did not persist.

“The business push to develop any product just fell apart,” Sheahan said.

Widely available antiviral drugs would join monoclonal antibody therapies already used to treat and prevent serious illness and hospitalizations caused by COVID. Monoclonal antibodies produced in the laboratory, which mimic the body’s natural response to infection, were easier to develop, but must be administered primarily through intravenous infusions.

The federal government is covering the cost of most monoclonal products at $ 2,000 per dose. It is still too early to know how the price of antivirals would compare.

Like monoclonal antibodies, antiviral pills are not a substitute for vaccination, Griffin said. They would be another tool to fight the covid. “It’s good to have another option,” he said.

A challenge in rapid antiviral drug development has been recruiting enough participants for clinical trials, each of which must enroll hundreds of people, said Dr. Elizabeth Duke, a Fred Hutch research associate who oversees their molnupiravir trial.

Participants must be unvaccinated and enrolled in the trial within five days of a positive COVID test. On any given day, interns make 100 calls to recently covid-positive people in the Seattle area, and most say no.

“Generally speaking, there is a lot of mistrust about the scientific process,” Duke said. “And some people are saying nasty things to the inmates.”

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

Even more promising? Studies evaluating whether antivirals can prevent infection after exposure.

“Think about it,” said Duke, who also oversees a prophylactic trial. “You could give it to everyone in a home or everyone in a school. So we are talking about a return, perhaps, to normal life.”

Leave a Comment