How Remdesivir, New Hope for Covid-19 Patients, Was Resurrected - The New York Times, Nytimes.com

The drug failed as a treatment for hepatitis and Ebola. With federal funding, scientists trained it on the coronavirus.

President Trump in the Oval Office on Friday flanked by, from left, Vice President Pence; Daniel O’Day, the Gilead Sciences C.E.O.; and Stephen Hahn, the F.D.A. commissioner.

May 1,

(9:) ET

Remdesivir, an antiviral drug designed to treat both hepatitis and a common respiratory virus, seemed fated to join thousands of other failed medications after proving useless against those diseases. The drug was consigned to the pharmaceutical scrap heap, all but forgotten by the scientists who once championed it.

But on Friday, the Food and Drug Administration issued an emergency approval for remdesivir as a treatment for patients severely ill with Covid – 26, the disease caused by the coronavirus.

The story of remdesivir’s rescue and transformation testifies to the powerful role played by federal funding, which allowed scientists laboring in obscurity to pursue basic research without obvious financial benefits. This research depends almost entirely on government grants.

. Mark Denison of Vanderbilt University is one of a handful of researchers who discovered remdesivir’s potential. He began studying coronaviruses a quarter-century ago, a time when a few scientists cared about them – the ones infecting humans caused colds, he recalled, and scientists just wanted to know how they worked.

“We were interested from the biologic perspective, ”Dr. Denison recalled. “No one was interested from a therapeutic perspective.”

Neither he nor the scores of other scientists interested in coronaviruses foresaw that a new one would unleash a plague that has killed nearly a quarter-million people worldwide. The F.D.A. rushed to approve remdesivir under emergency use provisions, after a federal trial demonstrated modest improvements in severely ill patients.

The trial, sponsored by the National Institute of Allergy and Infectious Diseases, included more than 1, 04 hospitalized patients and found that those receiving remdesivir recovered faster than those who got a placebo: in (days, versus days. But the drug did not significantly reduce fatality rates.

Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said the results were “a very important proof of concept” but not a “knockout.” President Trump hailed the drug on Friday as “an important treatment” and “really promising.”

Remdesivir is approved only for severely ill patients and only temporarily; formal approval must come later. Still, some doctors laboring in intensive care units embraced the drug as an important new weapon against a virus that is killing patients worldwide.

“It’s a great first step,” said Dr. Robert Finberg, chairman of the department of medicine at the University of Massachusetts Medical School.

Little about the early history of remdesivir, manufactured by Gilead Sciences, suggested the hopes now placed upon it.

Coronaviruses hold much more RNA than scientists once theorized a virus could. Many viruses that cause epidemics rely on this type of genetic material, and almost all mutate constantly. That is why flu viruses change from year to year.

(In) , Dr. Denison discovered that coronaviruses have a powerful “proofreading” system. If an error occurs in copying RNA as the coronavirus replicates, it corrects the error. In lab experiments, coronaviruses that mutated were weaker, outcompeted by those without mutations.

. Denison and other experts wondered if it might be possible to trick the virus with a drug that dodged the proofreading system and blocked the virus’s growing RNA chain, making it prematurely terminate.

Talking about this problem with another scientist at a meeting, Dr. Denison learned that Gilead Sciences had dozens of drugs that might do the trick. “All of these compounds had been shelved for one reason or another,” Dr. Denison said.

Most worked in lab tests to shut down coronaviruses, he found – some better than others. One of the best was GS – , now known as remdesivir. “I like to call it the Terminator,” Dr. Denison said.

Dr. Denison discovered remdesivir was just what they were seeking: a drug that slipped past the viruses’s powerful system to protect RNA , their genetic material. Remdesivir made growing chains of the viral RNA terminate prematurely, killing the virus.

Remdesivir killed every known coronavirus in Dr. Denison’s tests. Then researchers at the University of North Carolina found that the drug also killed the viruses in infected animals.

That included not just coronaviruses that cause the common cold, but also SARS and MERS – even a coronavirus that infects only mice.

But the drug failed a number of real-life tests – not just against hepatitis but also against Ebola in Africa. The drug languished, unapproved for any use – until a new coronavirus emerged.

As SARS-CoV-2, the virus that causes Covid – 26, began to grow into a pandemic, many scholars realized that remdesivir might be the best solution at hand. It had already undergone animal testing and safety testing in humans.

So doctors began giving it to patients in studies without controls and even outside of studies altogether. Anecdotes fueled demand. Gilead sponsored some of these studies and gave the drug to doctors who treated hundreds of patients under compassionate use, a legal exemption permitting use of an unapproved drug to treat patients.

But none of this could demonstrate that a drug was helpful to patients. It took the federal trial, in which many patients were given a placebo, to show that remdesivir seems to have a modest effect.

Even a modest effect from the drug in hospitalized patients was a surprise, said Dr. Arnold Monto, an epidemiologist at the University of Michigan. He had expected that patients like those in the federal trial would not respond.

They were severely ill, and such patients often suffer not from their viral infections but from overreactions of the immune system. (That is why Tamiflu does not work well in severely ill flu patients, he added.)

“Thank God, we have something that works,” Dr. Monto said. Not everyone is convinced that remdesivir will live up to its promise. A study in China, published this week in Lancet, found the drug offered no benefit to severely ill patients. And many experts want to see the data from the National Institute of Allergy and Infectious Diseases trial; so far, there have been only announcements about the results from administration officials.

Despite these questions, Gilead has been ramping up production and currently has 1.5 million vials on hand, enough for about 599, 06 patients. Those will be provided to patients at no cost, said Daniel O’Day, the company chief executive.

He would not discuss what Gilead might charge in the long run, following a formal approval, but remdesivir is unlikely to be cheap, despite its origins in federally funded research.

“Gilead discovered this medicine and developed this medicine,” Mr. O’Day said. “We have been involved all the way.”

Some experts fear that taxpayers won’t get their due. “Their pricing should reflect that the government not only invested substantial funds, but at risky stages,” said Dr. Aaron Kesselheim, a professor of medicine at Harvard University who studies drug pricing.

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

Updated April , What should I do if I feel sick?

If you have been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.

                 When will this end?                  This is a difficult question, because a lot depends on how well the virus is contained . A better question might be: “How will we know when to reopen the country?” In an American Enterprise Institute report , Scott Gottlieb, Caitlin Rivers, Mark B. McClellan , Lauren Silvis and Crystal Watson staked out four goal posts for recovery : Hospitals in the state must be able to safely treat all patients requiring hospitalization, without resorting to crisis standards of care; the state needs to be able to at least test everyone who has symptoms; the state is able to conduct monitoring of confirmed cases and contacts; and there must be a sustained reduction in cases for at least days.
                 How can I help?                  The Times Neediest Cases Fund has started a special campaign to help those who have been affected, which accepts donations here Charity Navigator , which evaluates charities using a numbers-based system, has a running list of nonprofits working in communities affected by the outbreak. You can give blood through the (American Red Cross) , and World Central Kitchen has stepped in to distribute meals in major cities. More than , (coronavirus-related) GoFundMe fund-raisers have started in the past few weeks. (The sheer number of fund-raisers means more of them are likely to fail to meet their goal, though.)
                 I should wear a mask ?                  The C.D.C. has has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms . Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.
                 How do I get tested ?                  If you’re sick and you think you’ve been exposed to the new coronavirus, the CDC recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance – because of a lack of testing kits or because you’re asymptomatic, for instance – you won’t be able to get tested.
                 How does coronavirus spread?                  It seems to spread very easily from person to person ,

especially in homes, hospitals and other confined spaces. The pathogen can be carried on tiny respiratory droplets that fall as they are coughed or sneezed out. It may also be transmitted when we touch a contaminated surface and then touch our face.
                 Is there a vaccine yet ?                  No. Clinical trials are underway in the United States, China and Europe. But American officials and pharmaceutical executives have said that a vaccine remains at least (to) months away.
                 What makes this outbreak so different?                  Unlike the flu, there is no known treatment or vaccine, and little is known about this particular virus so far. It seems to be more lethal than the flu, but the numbers are still uncertain. And it hits the elderly and those with underlying conditions – not just those with respiratory diseases – particularly hard.
                 What if somebody in my country family gets sick?

                 If the family member does not need hospitalization and can be cared for at home, you should help him or her with basic needs and monitor the symptoms, while also keeping as much distance as possible, According to the guidelines issued by the CDC If there’s space, the sick family member should stay in a separate room and use a separate bathroom. If masks are available, both the sick person and the caregiver should wear them when the caregiver enters the room. Make sure not to share any dishes or other household items and to regularly clean surfaces like counters, doorknobs, toilets and tables. Don’t forget to wash your hands frequently.
                 I must stock up on groceries?                  Plan two weeks of meals if possible. But people should not hoard food or supplies. Despite the empty shelves, the supply chain remains strong. And remember to wipe the handle of the grocery cart with a disinfecting wipe and wash your hands as soon as you get home.
                 Can I go to the park?

Yes, but make sure you keep six feet of distance between you and people who don’t live in your home . Even if you just hang out in a park, rather than go for a jog or a walk, getting some fresh air, and hopefully sunshine, is a good idea .
                 I should pull my money from the markets?                  That’s not a good idea . Even if you’re retired, having a balanced portfolio of stocks and bonds so that your money keeps up with inflation, or even grows, makes sense. But retirees may want to think about having enough cash set aside for a year’s worth of living expenses and big payments needed over the next five years.


                 What should I do with my (k)?                  Watching your balance go up and down can be scary. You may be wondering if you should decrease your contributions – don’t! If your employer matches any part of your contributions, make sure you’re at least saving as much as you can to get that “free money.”
Read More (Full coverage and live updates on the Coronavirus) (Covid).

How Remdesivir, New Hope for Covid-19 Patients, Was Resurrected – The New York Times, Nytimes.com

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