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An effective antiviral drug may completely change COVID-19 pandemic.
COVID-19 oral medicine is coming soon. An effective antiviral drug will completely change the rules of the game.
In June of this year, Miranda Kelly (Miranda Kelly) tested positive for the COVID-19. The 44-year-old Kelly is a registered nurse assistant. She suffers from diabetes and high blood pressure. Her condition deteriorated rapidly on the day of diagnosis. Due to breathing difficulties, she Was taken to the emergency room.
Subsequently, her 46-year-old husband Joe was also diagnosed as positive. Kelly was really scared. She was especially worried about the five teenage children in the family. “I just wanted to ask God to bless us not to wear ventilators. We still have children. If we are gone, who will take care of the children?”
Anxiety and panic caused the Kellys, who live in Seattle, to agree to participate in a clinical trial shortly after the diagnosis. The trial happened to be held at the nearby Fred Hutchinson Cancer Research Center, which was in the midst of the COVID-19 pandemic. They have won the attention of the world with their excellent judgment. They participated in the organization of a multinational study to test an antiviral drug specifically for the COVID-19.
The Kellys began to take the medicine religiously from the second day of participating in the trial: taking four capsules twice a day. They were not told whether they received the active drug or the placebo, but they said that within a week, their symptoms improved. In less than two weeks, they recovered.
“I don’t know if we got the real medicine, but I feel that we should have been in the test group,” Miranda Kelly said. “Considering my various medical history, coupled with the fact that I was so ill when I was just diagnosed, I think I recovered very quickly.”
The Kellys may have contributed to the global fight against the COVID-19 epidemic. If last year’s anti-epidemic focus was on the development of vaccines, then the focus of many studies this year is to produce new antiviral drugs to combat this disease that has claimed the lives of more than 4.5 million people. The purpose of vaccines is to prevent infection, but they are only part of the weapons needed to fight the new coronavirus. And a pill that can reduce symptoms, speed up recovery and be taken at home will be a major advancement. It can reduce the burden on hospitals and is expected to further reduce the severity and mortality of the COVID-19.
As the northern hemisphere enters autumn, coupled with fears that cases will increase in the colder months, pharmaceutical companies are racing against time.
Carl Dieffenbach, director of the AIDS department of the National Institute of Allergy and Infectious Diseases, said that at least three antiviral drugs for the treatment of COVID-19s are undergoing clinical trials, and the results of these clinical trials are expected to be announced before the end of autumn or early winter. .
Dieffenbach said that the most powerful competitor is a drug called Molnupiravir developed by Merck and Ridgeback Biotherapy. The Kellys participated in the clinical trial of this drug in Seattle.
The other two drugs are Pfizer’s drug candidate PF-07321332, and Roche and Atea’s antiviral drug AT-527, which performed equally well in small trials. Pfizer announced today (September 27). Japan) just announced that the company’s drug candidates have entered the phase 2 and phase 3 joint trials.
According to Dieffenbacher, if things go well, humans may be only a few months away from an oral drug that can fight the virus early after diagnosis, and the advent of such drugs will make us a big step forward from truly returning to normal life. .
$3 billion plan
The COVID-19 pandemic has lasted for a year and a half. The US government has invested $18.5 billion in vaccines. This strategy has produced at least five effective products at a record rate. But the government’s investment in drugs is much smaller, only about 8.2 billion U.S. dollars.
Some other viruses, including influenza virus, HIV virus and hepatitis C virus, can be treated with a simple pill. But despite more than a year of research, there is currently no such drug that can treat patients before the new coronavirus infection rages.
In June of this year, the U.S. government launched a new project called the Epidemic Antiviral Project (APP), which invested more than US$3 billion in the development of antiviral drugs for the treatment of COVID-19. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), is a key supporter of the project. He said that he hopes that patients in the future can quickly get oral medications when they are infected with the COVID-19.
Fauci explained to the New York Times, “I woke up in the morning and felt bad, my sense of smell and taste disappeared, and my throat was sore. I called my family doctor and said,’I have the COVID-19, please give me a prescription. Prescriptions.'”
Fauci’s support for research on antiviral drugs stems from his personal experience in fighting the AIDS epidemic 30 years ago. In the 1990s, his research institute developed the first antiviral drugs to treat AIDS. “Protease inhibitors” can block an important viral protein and inhibit the virus for life.
At the beginning of the 21st century, researchers discovered that an antiviral drug called Sofosbuvir could cure hepatitis C almost 100%.
As for Tamiflu, it is a widely used prescription medicine for flu. If taken quickly, it can shorten the duration of flu and reduce the risk of hospitalization.
At the beginning of the pandemic, researchers began to test existing antiviral drugs in hospitalized patients with severe COVID-19. But many trials have not shown any benefits of antiviral drugs. In hindsight, choosing to experiment with hospitalized patients was a mistake.
Scientists now know that the best time to try to stop the new coronavirus is in the first few days of the disease, when the virus is rapidly replicating and the immune system has not yet established a defense. Therefore, the key is to target patients at an early stage of infection and block viral replication as early as possible through drugs.
So far, doctors have very few drugs to fight the new coronavirus. Several therapies such as remdesivir, monoclonal antibodies, and the steroid dexamethasone have improved the care of patients with COVID-19 disease, but these drugs are not a panacea, nor are they suitable for everyone.
For example, an antibody therapy produced by Regeneron Pharmaceuticals seems to reduce the risk of severe illness after the COVID-19, but it is expensive to produce and can only be administered by intravenous infusion.
Regeneron Pharmaceutical Company
Remdesivir has a similar problem, it also requires intravenous fluids, and the results of research have been mixed. Although the U.S. Food and Drug Administration (FDA) has approved remdesivir for the treatment of hospitalized patients with COVID-19, the World Health Organization is still holding a wait-and-see attitude towards its efficacy, saying “There is currently no evidence that remdesivir can improve the survival rate of these patients. And other results.”
If people can take remdesivir as a pill early in the course of the COVID-19 disease, it may be more effective. But in the approved formulation, this compound cannot be taken orally. It cannot survive the journey from the mouth to the stomach to the circulatory system.
Dozens of therapies began to cross the line
At present, dozens of new coronavirus antiviral treatments are being developed around the world. Merck and Pfizer are undoubtedly the largest pharmaceutical companies closest to the end point, and two oral antiviral drugs are undergoing human clinical trials.
Merck’s drug called Monopiravir comes from a laboratory at Emory University. In 2013, researchers here wanted to find an antiviral drug to treat equine encephalitis virus infection, which is a major threat to human and animal public health in the Americas.
Extensive testing confirmed that this broad-spectrum antiviral drug can inhibit the replication of a variety of RNA viruses, including influenza viruses, multiple coronaviruses, and respiratory syncytial viruses.
The Emory team collaborated with Ridgeback Biotherapy in Miami to conduct impressive experiments on mice, and Merck found them and began to use the drug in human clinical trials for the COVID-19.
Daria Hazuda, Merck’s vice president of infectious disease and vaccine research, said: “We think this drug is really amazing.”
A small trial observed the effect of Monopiravir on 202 COVID-19 patients who started to develop symptoms. The trial showed that when the treatment entered the fifth day, the virus was not detected in the nasopharyngeal swabs of the participants taking monopilav, but the virus was still found in 11% of the participants taking the placebo.
Therefore, the trial shows that Monopiravir can reduce and eliminate the infectivity of patients with mild COVID-19s and accelerate the clearance of the virus. This fact indicates that it may not only help treat the COVID-19, but also help reduce the chance of its spread. .
But to know how useful it is, you need to see what happens in further experiments. Currently, Monopiravir has a number of trials going on around the world. Researchers want to understand whether early monopiravir treatment can reduce the time for severely ill patients to clear the virus; whether it can better prevent the possibility of severe illness and death in unhospitalized patients than placebo.
There is also an interesting experiment to observe its blocking effect, to understand whether the early treatment of monopiravir in positive patients can prevent the family members living with the infection from being infected.
Previous studies have shown that Monopiravir can prevent the spread of the COVID-19 virus in ferrets. Some trials should yield clear results before this fall.
Pfizer’s new coronavirus antiviral drug is modified based on a molecule that may be used to treat SARS. The drug has been shelved for many years, but last spring, scientists decided to modify its structure to make it able to fight the protease of the new coronavirus. More than 200 Pfizer researchers have joined forces to study this molecule, and the drug is currently named PF-07321332.
The drug was originally designed to be injected intravenously, but Pfizer researchers successfully changed its structure to make it work as a pill. Pfizer said on September 27 that after determining that the oral antiviral drug candidate was “safe and well tolerated” in the first trial phase, the drug entered the phase 2/3 joint trial phase.
In addition, the government is also considering the AT-527 developed by Roche and Atea Pharmaceuticals.
This compound has been proven to be a safe and effective hepatitis C treatment, and early studies have shown that it may also be effective against the COVID-19.
Roche has partnered with Atea to conduct human trials, and the two companies are currently conducting late-stage clinical trials.
Of the three drugs, at least one may be on the market before the end of this year. Merck CEO Robert Davis said this month that the company hopes to obtain data from a larger phase 3 trial in the next few weeks and may seek emergency use authorization from the US FDA “before the end of the year.” . The other two drug candidates are also expected to receive results from Phase 2 and Phase 3 trials later this year.
The U.S. Department of Health and Human Services has announced that once Merck’s Monopilav is approved for emergency use, it will purchase 1.7 million courses of the drug for $1.2 billion. Dr. David Kessler, chief scientific officer of the Biden administration’s COVID-19 response team, said the government may seek similar deals for the other two antiviral drugs.
In an interview with CNN, Dr. Kessler said: “I hope we can get antiviral drugs before this fall to help us end this epidemic.”
If antiviral drugs prove to be effective, the next challenge will be to strengthen the distribution system so that the drug can be delivered to patients as soon as they test positive.
Merck said that production capacity is not a problem. By the end of this year, the company will produce more than 10 million treatment courses of drugs, and unlike vaccines, this drug does not require cold chain transportation; the key is to connect various testing centers with clinics.
It is best for the patient’s attending doctor to receive a positive result and issue a prescription immediately.
The first drugs to treat the COVID-19 may only have limited benefits for the disease. But this will be a good opportunity-humans should have concentrated on researching antiviral drugs long ago.
Timothy Sheahan, a virologist at the University of North Carolina at Chapel Hill, said: The epidemic has initiated a long-neglected effort to develop effective antiviral treatments against the coronavirus. The 2003 SARS epidemic panicked scientists — followed by the Middle East Respiratory Syndrome (MERS) in 2012 — but when these epidemics did not continue, research slowed down.
Sean said: “The commercial motivation to develop any product is just a flash in the pan. Pharmaceutical companies cannot accept your development of a drug for an infectious disease that has disappeared.”
It is precisely in accordance with this concept that the federal government has decided to spend 1.2 billion US dollars to establish research centers, where scientists will conduct drug research against coronavirus and other high-risk pathogens.
Even if the next generation of drugs will not come out in a few years, many scientists say this research will be a good investment. Mark Namchuk, director of transition medicine at Harvard Medical School, said: “The threat is always there. It may help to deal with this pandemic and may provide the first line of defense for the next pandemic.”
As for the moment? An effective antiviral drug will completely change the rules of the game. The medicine can be taken orally at home when the first symptoms of infection occur. This medicine not only relieves the condition of the infected person, but also prevents them from spreading to other people, which may save us from the epidemic.
Namchuk said: “Everyone in the family, or everyone in the school can take the medicine in time. This means that we may finally be able to return to a normal life.”
An effective antiviral drug may completely change COVID-19 pandemic.
(source:internet, reference only)