Last year, the US government spent more than $ 18 billion funding pharmaceutical companies to produce the Covid vaccine. This is an effort that will lead to at least five highly effective injections at record speed. We are currently investing more than $ 3 billion in neglected research areas. Developing tablets to fight the virus in the early stages of infection has the potential to save many lives in the coming years.
A new program announced by the Department of Health and Human Services on Thursday will speed up clinical trials of some promising candidate drugs. If all goes well, some of those first pills may be ready by the end of the year. Antiviral programs against pandemics support the research of entirely new drugs not only for coronaviruses, but also for viruses that may cause future pandemics.
Many other viruses, such as influenza, HIV, and hepatitis C, can be treated with simple tablets. However, despite more than a year of research, there is no such pill to treat a person infected with the coronavirus before it causes havoc. Operation Warp Speed, a program of the Trump administration to accelerate Covid-19 research Invested much more money in vaccine development The gap that new programs try to fill, rather than treatment.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a key supporter of the program, looks forward to receiving antivirals from pharmacies as soon as Covid-19 patients test positive. He said he was doing it. It develops symptoms due to coronavirus or Covid-19.
“I get up in the morning and feel sick, lose my senses of smell and taste, and have a sore throat,” Dr. Forch said in an interview. “I call a doctor and say,’I have a covid and I need a prescription.'”
Dr. Fauci’s support for antiviral research stems from his own experience in the fight against AIDS 30 years ago. In the 1990s, his laboratory conducted research that led to the first antiviral drug for HIV, a “protease inhibitor” that blocks essential viral proteins and keeps the virus out for life.
In the early 2000s, researchers discovered that an antiviral drug called sofosbuvir could cure hepatitis C almost 100%. Tamiflu, an over-the-counter drug for influenza, Save time It is needed to recover from the infection and reduce the chances of a flu attack landing someone in the hospital.
At the beginning of the pandemic, researchers began testing existing antiviral drugs in people hospitalized with severe Covid-19. However, many of those trials failed to show any benefit from antivirals. In retrospect, the choice to work in a hospital was a mistake. Scientists know that the best time to try to block the coronavirus is in the first few days of the disease, when the virus replicates rapidly and the immune system has not yet begun to defend. ..
Many people crush and recover from the infection, while others start to misfire the immune system and damage tissues rather than viruses. It is this self-harm that sends many people using Covid-19 to the hospital, as coronavirus replication is declining. Therefore, drugs that block replication in the early stages of infection are very likely to fail in trials in patients who have progressed late in the disease.
So far, only one antiviral drug, remdesivir, has shown obvious benefits to hospital people. Originally investigated as a potential treatment for Ebola, the drug appears to shorten the course of Covid-19 when given intravenously to patients. In October, it came to get the first-and so far only-antiviral drug Full FDA approval To cure the illness.
Remdesivir may work more effectively if taken as a tablet in the early stages of Covid-19. However, in the approved formulation, the compound does not work orally. It cannot survive the passage from the mouth to the stomach and circulatory system.
Researchers around the world are testing other antiviral drugs that are already known to act in the form of tablets.One such compound called molnupiravir Developed In 2003, researchers at Emory University tested it against viruses such as influenza and dengue.
In collaboration with Miami’s Ridgeback Biotherapeutics, the Emory team conducted experiments on so impressive mice that Merck approached them to bring the drug to Covid-19’s human clinical trials.
Dalia Hazda, Merck’s Vice President of Infectious Diseases and Vaccines Research, said:
However, in inpatient trials, molnupiravir did not appear to affect the disease. In April, the company Announcement They were abandoning the trial.
Dr. Tim Sheehan, a virologist at the University of North Carolina, said: “It’s not surprising to me that these kinds of drugs don’t dramatically improve someone’s results when they’re sick for a few days.”
The company started Second study Last fall, this time we will test the drug in people who have recently been diagnosed with Covid-19. The trial is ongoing, and Merck is looking for volunteers at high risk of infection, such as the elderly with obesity and diabetes. Dr. Wada said the trial should give clear results by October.
Last year, government funding for Covid-19 treatment focused on a small number of candidates, including monoclonal antibodies and remdesivir.Many other studies on antiviral drugs Small and lack of funds.. In January, the next Biden administration began designing a new program dedicated to antiviral drugs.
Last week we saw the first results of this plan.Ministry of Health and Social Welfare Announcement Purchasing 1.7 million molnupiravirs from Merck at a cost of $ 1.2 billion, provided that the current trial leads to approval by the Food and Drug Administration. According to Dr. David Kessler, chief scientific officer of the Biden administration’s Covid-19 response team, the government may seek similar deals on two other antiviral drugs that are far more advanced in clinical trials.
“By the end of the fall, we hope to have antiviral drugs available to help end this chapter of the epidemic,” Dr. Kessler said in an interview.
One of the medicines the government is considering AT-527, Developed by Atea Pharmaceuticals. The compound has already proven to be safe and effective as a treatment for hepatitis C, and early studies suggest that it may also be effective against Covid-19. .. Roche has partnered with Atea to test people, and both companies are currently conducting late-stage clinical trials.
Another drug on government radar is an application of a molecule created by Pfizer scientists and first designed as a potential drug for SARS in the early 2000s. The drug had been on the shelves for years, but last spring scientists decided to modify its structure to act on the new coronavirus protease. More than 200 Pfizer researchers have joined forces on a molecule now known as PF-07321332.
The drug was designed to be given intravenously, but Pfizer researchers have succeeded in modifying its structure to function as a pill.when mouse Oral administration of the drug has reached levels sufficient to block the coronavirus.Pfizer Release It is a clinical trial in March to study people’s safety, and will move to a late trial next month.
Dr. Kessler acknowledged the challenges of using such tablets to reduce hospitalization and mortality from Covid-19. People need access to the drug as soon as the test is positive. “Your testing program will have to be linked to your treatment,” he said.
And if the history of antiviral research is a guide, the first drug for Covid-19 will probably only provide modest benefits to the disease, Dr. Forch said. But that would be a good start.
“With all these medicines we’ve been dealing with for years, we’ve never hit a home run for the first time at bat,” said Dr. Forch. “It’s really good to start a line drive from the left wing wall.”
The government will also spend up to $ 1.2 billion on research centers where scientists carry out early-stage research on drugs that otherwise block the coronavirus. Some drugs can interfere with other essential viral proteins, while others can make it impossible to copy the viral genes.
Many scientists say the study will be a good investment, even if the next-generation pills don’t arrive in the next few years. Mark Namchuk, director of therapeutic translation at Harvard Medical School, said:
The program not only studies tablets that act against coronavirus, but also other high-risk pathogens such as flavivirus, which causes diseases such as dengue and West Nile fever, and togaviridae, which causes mosquito-borne diseases such as chikungunya. We also support research on. And eastern equine encephalitis.
“There is always a threat,” said Dr. Forch. “I think there will be a long-term need for drugs.”
Tablets to treat Covid-19? The United States is betting on it.
Source link Tablets to treat Covid-19? The United States is betting on it.