One day after testing positive for COVID-19 in June, Miranda Kelly was sick enough to be scared. At 44 years old, with hypertension and diabetes, the nursing assistant had trouble breathing, a symptom serious enough to end up in the emergency room.
When her husband, Joe, 46, was also got sick with the virus, she really cared, especially for her five teenage children: “I thought, ‘I hope to God we don’t end up with ventilators. Who is going to raise these kids? ”
But the Kellys, who live in Seattle, Washington, agreed right after their diagnoses to join a clinical trial at the nearby cancer research center. Fred Hutch who is part of an international effort to test an antiviral treatment that could stop covid at an early stage of infection.
Al 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.
Within two weeks, they had recovered.
“I don’t know if we got the treatment, but I feel like we did,” Miranda Kelly said. “By having all these underlying conditions, I felt like the recovery was very quick.”
The Kellys play a role in developing what could be the world’s next opportunity 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 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.
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.
These drugs, developed to treat and prevent viral infections. in people and animals, they 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.
They are being tested at At least three promising antivirals for COVID in clinical trials, and results are 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 about what these pills are capable of in the coming months,” said Dieffenbach.
The main contender in this race is a drug from Merck & Co. and Ridgeback Biotherapeutics called molnupiravir, Dieffenbach said. This is the product being tested at the Kelly trial in Seattle. Two others include a Pfizer candidate, known as PF-07321332; and AT-527, an antiviral produced by Roche and Atea Pharmaceuticals.
They act 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, reduces 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 it is not intended for early and widespread use.
On the contrary, new contenders under study can be packaged in form of pills.
Sheahan, who also did preclinical work on remdesivir, conducted a initial 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 an initial trial 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 (FDA ) “Before the end of the year.”
Pfizer launched a phase 2 and 3 combined trial of their product on September 1, and Atea executives said they expect test results phase 2 and 3 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, which could be taken for five to 10 days as soon as covid infection is confirmed.
“That’s the idea,” said the scholar r Daniel Griffin, an expert in immunology and infectious diseases at Columbia University. “Have this all over the country, so that people receive it the same day they receive the diagnosis.”
Once marginalized for lack of interest, oral antivirals to treat coronavirus infections are now subject to fierce competition and funding.
In June, the Biden administration announced that it had agreed to obtain about 1.7 million treatment cycles of molnupiravir 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 Antiviral Program for Pandemics , whose goal is to develop antivirals for the covid crisis and beyond, Dieffenbach said.
The pandemic reinvigorated the effort in antiviral research. Although scientists were scared by the Severe Acute Respiratory Syndrome (SARS) virus in 2003, followed by the Middle East Respiratory Syndrome (MERS), in 2012, research efforts slowed when these outbreaks did not persist.
“The commercial push to develop any product just disappeared,” Sheahan said.
Widely available antiviral drugs would join monoclonal antibody therapies already used to treat and prevent serious illnesses and hospitalizations caused by covid. 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 the most monoclonal products at $ 2,000 per dose. It is still too early to know the price of antivirals.
Like monoclonal antibodies, antiviral pills are not a substitute for vaccination, Griffin said. They would be another tool to fight covid.
A challenge in the rapid development of antiviral drugs has been to recruit enough participants for clinical trials, which must recruit hundreds of people, explained Dr. Elizabeth Duke, associate researcher at Fred Hutch overseeing the molnupiravir trial.
Participants must not be vaccinated and must be enrolled in the trial within five days of a positive COVID test. In just any one, 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. “Some people say nasty things to interns.”
If antiviral pills are effective, the next challenge will be to drive a distribution system where they can reach people as soon as they test positive for covid. Griffin said it will take something similar to the program established last year by UnitedHealthcare , which accelerated the kits from Tamiflu 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.
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 to everyone in a school. So, maybe there we would be talking about a return to normal life. ”
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