According to scientists, daily pills to treat Covid may be just a few months away

Antiviral drugs, such as the investigational drug molnupiravir, can alter the progression of the pandemic, experts say. (MERCK & CO.)

The day the covid-19 test tested positive in June, Miranda Kelly became terrifyingly ill. At the age of 44, with diabetes and high blood pressure, Kelly, a certified nursing assistant, had breathing problems and her symptoms were severe enough to send her to the emergency room.

When my husband Joe, 46, was infected with the virus, he was really worried, especially about the five teenagers at home. I have children. Who intends to raise these children? “

However, Seattle-based Kellys agreed to participate in a clinical trial that was part of the nearby Fred Hutchin Cancer Research Center shortly after the diagnosis. International efforts Test antiviral treatments that may stop covid early in the process.

By the next day, the couple had taken 4 tablets twice a day. They weren’t told if they were taking an effective drug or a placebo, but they said their symptoms improved within a week. Within two weeks, they recovered.

“I don’t know if I’ve been treated, but I feel like I’ve been treated,” said Miranda Kelly. “To meet all these fundamental conditions, I felt the recovery was very quick.”

Kelly’s is responsible for developing what could be the next opportunity for the world to thwart Covid. A short-term regimen of daily tablets that can fight the virus early after diagnosis and possibly prevent the onset of post-exposure symptoms.

Timothy Sheehan, a virologist at the University of North Carolina, said: -Chapel Hill has helped develop these treatments.

Antivirals are already essential in the treatment of other viral infections, including hepatitis C and HIV. One of the most well-known is Tamiflu, a widely prescribed pill that can reduce the duration of the flu and reduce the risk of hospitalization if given quickly.

Drugs developed to treat and prevent viral infections in humans and animals vary in effectiveness. However, it can be designed to strengthen the immune system to fight infections, block receptors to prevent viruses from entering healthy cells, and reduce the amount of active virus in the body.

Karl Diffenbach, head of the AIDS division at the National Institute of Infectious Diseases, which oversees the development of antiviral drugs, said that at least three promising antiviral drugs from covid have been tested in clinical trials. Said that results are expected as soon as late fall or winter comes. ..

“I think we have an answer as to what these pills can do in the coming months,” said Deifenbach.

A leading candidate is a drug called molnupiravir from Merck and Ridgeback Biotherapeutics, Deifenbach said. This is a product that has been tested in Kelly’s Seattle trial. The other two include Pfizer’s candidate, known as PF-07321332, and AT-527, an antiviral agent manufactured by Roche and Atea Pharmaceuticals.

They work by blocking the ability of the virus to replicate in human cells. In the case of molnupiravir, the enzyme that copies the genetic material of the virus is forced to make so many mistakes that the virus cannot propagate. This reduces the patient’s viral load, shortens infection time, and prevents the types of dangerous immune responses that can cause serious illness and death.

So far, the only antiviral drug, remdesivir, Covid treatment approved.. However, it is administered intravenously to patients who are ill enough to be hospitalized and is not intended for early widespread use. In contrast, the top candidates under study can be packaged as tablets.

Sheahan, who also conducted a preclinical study of remdesivir, Early studies in mice It showed that molnupiravir can prevent early illnesses 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 including Early exam Of the 202 people who participated last spring, molnupiravir showed a rapid reduction in infectious virus levels. Merck CEO Robert Davis said this month that the company expects data from a larger Phase 3 trial in the coming weeks and grants an emergency use authorization to the Food and Drug Administration “by the end of the year.” He said he might ask.

Pfizer has started compounding Phase 2 and 3 trials of that product September 1st, And Athea authorities said they Expect results From Phase 2 and Phase 3 exams later this year.

If the results are good and one of the products is allowed for emergency use, Deifenbach said, “Distribution may start soon.”

This means that millions of Americans will soon have access to a drug that is orally administered daily, ideally a single pill, which can be taken for 5-10 days at the first confirmation of a covid infection. To do.

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

Oral antivirals to treat coronavirus infections have been the subject of fierce competition and funding after being left behind due to lack of interest. June, Biden Administrative announcement We have agreed to obtain approximately 1.7 million treatment courses at Merck’s Molnupiravir at a cost of $ 1.2 billion if the product is urgently licensed or fully approved.The same month, the administration said it Invest $ 3.2 billion According to Deifenbach, the pandemic antiviral program aims to develop antiviral drugs after a serious crisis.

The pandemic has embarked on a long-neglected effort to develop a powerful antiviral treatment for the coronavirus, Sheahan said. The original SARS virus in 2003 scared scientists, but in 2012 the Middle East Respiratory Syndrome (MERS) continued, but these outbreaks did not persist, slowing research efforts. ..

“The commercial motivation for developing a product is just down the pipe,” Sheahan said.

Widely available antiviral drugs join the monoclonal antibody therapies already in use to treat and prevent serious illnesses and hospitalizations caused by covid. Laboratory-produced monoclonal antibodies that mimic the body’s natural response to infection were easy to develop, but should be administered primarily by intravenous injection.

The federal government pays for most monoclonal products at $ 2,000 each time. It’s too early to know how antiviral prices are compared.

Like monoclonal antibodies, antiviral drugs will not be a substitute for vaccination, Griffin said. They will be another tool for fighting covid. “It’s nice to have another option,” he said.

One of the challenges in developing antiviral drugs rapidly was to recruit enough participants for clinical trials. Each participant needs to enroll hundreds, said Dr. Elizabeth Duke, a Fred Hutchin researcher and director of the Molnupiravir trial.

Participants must be unvaccinated and enroll in the study within 5 days after a positive covid test. One day, the intern makes 100 new covid-positive people in the Seattle area, but most say no.

“Generally speaking, there is a lot of distrust about the scientific process,” Duke said. “And some people are saying some sort of annoyance to the intern.”

If antiviral drugs prove to be effective, the next challenge is to strengthen the distribution system that allows people to rush them as soon as the test is positive.Griffin said something similar was needed Program established last year By UnitedHealthcare, we provided the Tamiflu kit to 200,000 at-risk patients enrolled in the insurer’s Medicare Advantage Plan.

Merck officials Predicted the company By the end of the year, it has the potential to produce more than 10 million courses of treatment. Atea and Pfizer have not released similar quotes.

Is it even more promising? A study assessing whether antiviral drugs can prevent post-exposure infections.

“Think about it,” said Duke, who oversees preventive trials. “You can give it to everyone in your home, or to everyone in school. Then we’re probably talking about returning to normal life.”

This story was originally published on September 24, 2021 Kaiser Health News..