How Covid-19 Patient’s New Hope, Rendescivir, Revived

Rendecibir, an antiviral drug designed to treat both hepatitis and common respiratory viruses, joins thousands of other failed drugs after proving to be useless against these diseases I was destined. The drug was commissioned to the pharmaceutical scrap heap, but was forgotten by the scientists who once defended it.

But on Friday, the Food and Drug Administration urgently approved lemdecivir for the treatment of severely ill patients with Covid-19, a disease caused by a coronavirus.

The story of Remdecivil’s salvation and transformation testifies to the powerful role federal funding played in enabling scientists, working in ambiguous situations, to undertake basic research without apparent economic gains. I was able to proceed. This study relies almost entirely on government subsidies.

Dr. Mark Denison at Vanderbilt University is one of the few researchers to discover the potential of lemdesibir. He started researching coronaviruses a quarter century ago, when few scientists were concerned.

“We were interested from a biological perspective,” recalls Denison. “No one was interested from a therapeutic perspective.”

Neither he nor the scores of other scientists interested in the coronavirus predicted that the new one would unleash a plague that killed nearly 250,000 people worldwide. After the F.D.A. federal trial showed modest improvement in critically ill patients, it rushed to approve lemdecivir under the Emergency Use Code.

This study, sponsored by the National Institute of Allergy and Infectious Diseases, included more than 1,000 inpatients, with patients receiving lemdecivir recovering faster than patients receiving placebo. However, the drug did not significantly reduce lethality.

Dr Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said the results are “a very important proof of concept”, not “knockouts.” President Trump welcomed the drug on Friday as “an important cure and” promising “.

Rendescivir is approved only temporarily in critically ill patients. Formal approval must be done later. Still, some doctors working in the intensive care unit have adopted the drug as a significant new weapon against the virus killing patients worldwide.

“This is a great first step,” said Dr. Robert Finberg of the Department of Medicine at the University of Massachusetts School of Medicine.

Little was expected about the early history of the lemdesibir manufactured by Gilead Sciences.

Coronaviruses hold much more RNA than scientists once the virus can be theorized. Many viruses that cause epidemics depend on this type of genetic material, and almost all are constantly mutated. That is why the influenza virus changes year by year.

In 2007, Dr. Denison discovered that the coronavirus had a powerful “proofreading” system. If an error occurs in the RNA copy during coronavirus replication, the error is corrected. In laboratory experiments, the mutated coronavirus was weak and lost to the unmutated one.

Dr. Denison and other experts wondered if it was possible to fool the virus with drugs that bypass the proof-reading system and block the growing RNA strands of the virus, causing it to terminate prematurely.

Talking about this issue with another scientist at the meeting, Dr. Denison found out that Gilead Sciences had dozens of drugs that might do the trick. “All of these compounds were shelved for some reason,” Dr. Denison said.

Many of them worked in the lab to block the coronavirus-turned out to be better than others. One of the best is the GS-5734, now called Rem Desibiru. “I want to call it a terminator,” said Dr. Denison.

Rendicivir killed all known coronaviruses in Dr. Denison’s test. Researchers at the University of North Carolina then discovered that the drug also killed the virus in infected animals.

This includes not only coronaviruses that cause common colds, but also SARS and MERS, and coronaviruses that only infect mice.

However, the drug has failed many actual tests, not only for hepatitis but also for Ebola in Africa. Until the advent of new coronaviruses, the drug has declined and is not approved for use.

When SARS-CoV-2, the virus that causes Covid-19, began to pandemicly grow, many scientists realized that lemdesibir might be the best solution at the moment. It had already undergone human animal testing and safety testing.

As such, doctors have begun to give it to patients in studies without controls, and even outside the study. Anecdotes fueled demand. Gilead sponsored some of these studies and gave medicines to doctors who treated hundreds of patients under sympathetic use, a law allowing the use of unapproved drugs to treat patients. Exemption.

But none of these proved that the drug could help the patient. A federal study in which a large number of patients received placebo has shown that the effects of lemdesibir are modest.

Dr Arnold Montd, an epidemiologist at the University of Michigan, was amazed at the slight effects of the drug on inpatients. He expected patients like federal exams would not respond.

They are a serious illness and such patients often suffer from an overreaction of the immune system rather than a viral infection. (That’s why Tamiflu doesn’t work well in patients with severe influenza, he added.)

“Thank God, we do something good,” Dr. Mont said.

Not everyone is convinced that Lemdesibir will keep its promise. A study in China published this week in Lancet found that the drug offered no benefit to critically ill patients. And many experts want to see data from the National Institute of Allergy and Infectious Diseases trials. So far, only announcements have been made by the authorities.

Despite these questions, Gilead is increasing production and now has 1.5 million vials on hand, enough to support around 150,000 patients. These will be provided to patients free of charge, said Daniel O’Day, CEO of the company.

With formal approval, we didn’t talk about what Gilead would charge in the long run, but despite coming from federally funded research, lemdesibir isn’t cheap.

“Gilliad discovered and developed this drug,” O’Day said. “We have been involved all the time.”

Some experts fear that taxpayers have no tax obligations.

“Their prices should reflect that the government is not only investing a lot of money but is in a dangerous stage,” said Dr. Aaron Kesselheim, a medical professor at Harvard University who studies drug prices.

If Gilead won all the rewards, he added, “It doesn’t seem fair.”