Despite some declarations to the contrary, the pandemic is not over. Fortunately, there are now several effective treatments available to help lower the fatality rate. Chief among these is paxlovid, which significantly reduces the risk of hospitalization and death, and will be available in December 2021. was granted an initial Emergency Use Authorization by the Food and Drug Administration. And SARS-CoV-2, the virus that causes COVID, may evolve resistance to it. The world desperately needs more options to stay ahead of the virus.
New antiviral treatments are now showing promise. Clinical trial results show that a single injection of a substance called pegylated interferon lambda (PEG-lambda) is highly effective in preventing her severe COVID. In a cohort of mostly vaccinated patients, participants who received this drug within 7 days of showing symptoms were more likely to go to hospital or emergency room compared to those who received placebo. Those who received PEG lambda within 3 days had a 58% reduction in risk. Treatment may also reduce the risk of death, but the numbers were too small to be significant.Findings on Wednesday New England Journal of Medicine.
The drug was even more effective in unvaccinated patients. Side effects are minimal and PEG-lambda has other advantages. It is a “broad-spectrum” antiviral agent useful against many diseases. The researchers hope the new data will lead to FDA approval so doctors can administer her PEG-lambda to patients. “The tragedy is that millions of lives could have been saved if we had been able to use this early in the pandemic,” said Jeffrey S. Stanford, senior author of the study. says Glenn. “You can still do it.”
“This was a well-designed and well-controlled trial. Confounding factors such as age, race and comorbidities were all considered,” says Evangelos Andreakos, an immunologist at the Athens Academy who was not involved in the study. says Mr. “The findings are compelling.” One caveat is the large number of people who had to undergo a small number of treatments to benefit, but this is not unique to PEG-Lambda. Antivirals need to be given early before we know if these individuals will develop severe disease,” says Andreacos. “This will be solved by identifying high-risk patients and improving targeted therapy.”
PEG-lambda is a synthetic version of a naturally occurring protein called interferon, attached to a molecule that slows its clearance from the blood. It is administered as a single subcutaneous injection. In comparison, Pax Lovid takes her 3 tablets twice a day for 5 days.
Interferons are signaling molecules that are part of the innate immune response, the body’s first line of defense against invaders. Type I interferons (such as alpha and beta) have been studied for decades as antiviral agents, but can cause serious side effects such as fever, nausea, vomiting, and muscle aches. This is because the receptors they bind to are found on many tissues as well as immune cells, so boosting type I interferons can overdrive the immune response. type interferon) binds only to receptors on epithelial cells located in the lungs, airways, intestines, and liver, where SARS-CoV-2 primarily acts. Researchers believe this is why lambda has minimal side effects. This wasn’t a big surprise as it has been safely administered to over 3,000 patients in clinical trials as a treatment for hepatitis.
The reputation for unpleasant and sometimes fatal side effects of type I interferons, and the lack of efficacy of interferons in inpatient trials, may have slowed progress in interferon lambda research. was encouraging enough to justify the current phase 3 trial. His Eiger BioPharmaceuticals, the company developing PEG-lambda, announced the results of this trial in his press release last year, but researchers have yet to wait to see the data themselves. I didn’t.
Interferons are produced by cells that sense intruders as a signal to activate cellular defenses. However, many viruses have evolved methods to suppress cellular interferon production or evade detection. “SARS-CoV-2 is very good at hiding from immune responses. . However, interferon receptors cannot be blocked, so injecting interferon into the body sets off an alarm, readying the cells to fight the virus. process, ”she says Prokunina-Olsson.
Glenn founded Eiger in 2008, owns the company’s stock and sits on its board of directors. Eiger began developing interferon lambda for viral hepatitis. When the pandemic hit, Glenn and his colleagues turned their attention to SARS-CoV-2. He recruited independent researchers from the TOGETHER Trial network to test the drugs Eiger provided. The trial was conducted in Canada and Brazil and included approximately 2,000 participants. Of these, 931 received treatment and 1,018 received placebo. Participants had to first show symptoms within the past week and have had a positive rapid antigen test. At least one trait, such as, increased the risk of developing serious illness.
More than 80% of participants were vaccinated. However, among those who did not receive treatment, those who received treatment within three days were 89% less likely to be hospitalized. This is comparable to Paxlovid’s efficacy for hospitalization, Glenn says. “But with lambda, you can do it in one shot. By definition, you have 100% compliance.” The study spanned multiple waves of her COVID, so depending on the circumstances, the drug could be against several subspecies. tested. The Omicron variant had the best response to the drug, but “all variants worked,” he says, Glenn.
“This is not a ‘whack-a-mole’ fix for a specific virus variant,” Prokunina-Olsson said. “This is how we generally strengthen the first line of defense against viral infections.”
One of the limitations of paxlovid is that the active ingredient is administered with another drug that slows down the body’s metabolic rate. This may also affect other medications the patient is taking. Older patients, who are more at risk for COVID, are more likely to take additional medications that may not be interruptible. Additionally, the virus mutates to evade protease inhibitors, a class of drugs to which paxlovid belongs. You can, but researchers haven’t yet seen that happen with Paxlovid. “This is very interesting not only for COVID, but also for emerging infectious diseases with pandemic potential,” he says Andreakos.
Eiger plans to apply for Emergency Use Authorization with the FDA. Rumba interferon, if approved urgently, could be a “very powerful tool in the fight against COVID”. Ultimately, he believes the drug will be used more widely to fight other viruses. He said, “Hopefully we can do research to generate data on influenza. [respiratory syncytial virus]other coronaviruses, etc.,” he says.
