This article is from the source 'nytimes' and was first published or seen on . It last changed over 40 days ago and won't be checked again for changes.

You can find the current article at its original source at https://www.nytimes.com/2020/04/29/health/gilead-remdesivir-coronavirus.html

The article has changed 36 times. There is an RSS feed of changes available.

Version 17 Version 18
Remdesivir Shows Modest Benefits in Coronavirus Trial Remdesivir Shows Modest Benefits in Coronavirus Trial
(about 16 hours later)
Modest results from a federal trial of an experimental drug helped send the stock market soaring on Wednesday, another sign of the desperation for a viable treatment against the coronavirus.Modest results from a federal trial of an experimental drug helped send the stock market soaring on Wednesday, another sign of the desperation for a viable treatment against the coronavirus.
Just before markets opened, Gilead, maker of the antiviral drug remdesivir, announced that it was “aware of positive data” about the drug’s performance in a federal trial, sending futures upward. Trading in the company’s shares was briefly halted.Just before markets opened, Gilead, maker of the antiviral drug remdesivir, announced that it was “aware of positive data” about the drug’s performance in a federal trial, sending futures upward. Trading in the company’s shares was briefly halted.
Later, in a briefing at the White House, Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said the trial had shown that treatment with the drug could modestly speed recovery in patients infected with the coronavirus.Later, in a briefing at the White House, Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said the trial had shown that treatment with the drug could modestly speed recovery in patients infected with the coronavirus.
The improvement in recovery times “doesn’t seem like a knockout 100 percent,” Dr. Fauci conceded, but “it is a very important proof of concept, because what it has proven is that a drug can block this virus.”The improvement in recovery times “doesn’t seem like a knockout 100 percent,” Dr. Fauci conceded, but “it is a very important proof of concept, because what it has proven is that a drug can block this virus.”
Sitting at Dr. Fauci’s side, President Trump said, “Certainly it’s positive, it’s a very positive event.” In past weeks, he has repeatedly hailed remdesivir as a potential “game changer,” despite spotty evidence.Sitting at Dr. Fauci’s side, President Trump said, “Certainly it’s positive, it’s a very positive event.” In past weeks, he has repeatedly hailed remdesivir as a potential “game changer,” despite spotty evidence.
Business leaders, scientists and politicians alike are scrambling to find ways to fight an insidious epidemic and to reopen a devastated economy. The virus has claimed at least 60,000 lives in the United States, and more than 200,000 worldwide. There have been precious few reasons for optimism, and the markets seized on the news.Business leaders, scientists and politicians alike are scrambling to find ways to fight an insidious epidemic and to reopen a devastated economy. The virus has claimed at least 60,000 lives in the United States, and more than 200,000 worldwide. There have been precious few reasons for optimism, and the markets seized on the news.
The trial sponsored by the National Institute of Allergy and Infectious Diseases enrolled 1,063 patients who were given remdesivir or a placebo. The time to recovery averaged 11 days among those who got the drug, compared with 15 days for those who got the placebo.The trial sponsored by the National Institute of Allergy and Infectious Diseases enrolled 1,063 patients who were given remdesivir or a placebo. The time to recovery averaged 11 days among those who got the drug, compared with 15 days for those who got the placebo.
There were fewer deaths in the remdesivir group, but the result did not reach statistical significance, Dr. Fauci said. Deaths were not a primary measure in the trial.There were fewer deaths in the remdesivir group, but the result did not reach statistical significance, Dr. Fauci said. Deaths were not a primary measure in the trial.
Dr. Fauci cautioned that the results of the study still needed to be properly peer-reviewed, but he was optimistic that remdesivir would become “the standard of care” for patients with Covid-19.Dr. Fauci cautioned that the results of the study still needed to be properly peer-reviewed, but he was optimistic that remdesivir would become “the standard of care” for patients with Covid-19.
Some scientists were unsettled by the way in which the findings were reported. The disclosure of trial results in a political setting, before peer review or publication, is very unusual, said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who has conducted dozens of clinical trials.Some scientists were unsettled by the way in which the findings were reported. The disclosure of trial results in a political setting, before peer review or publication, is very unusual, said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who has conducted dozens of clinical trials.
“Where are the data?” he asked. Scientists will need to see figures on harms associated with the drug in order to assess its benefits, he added.“Where are the data?” he asked. Scientists will need to see figures on harms associated with the drug in order to assess its benefits, he added.
“This is too important to be handled in such a sloppy fashion,” Dr. Nissen said.“This is too important to be handled in such a sloppy fashion,” Dr. Nissen said.
Dr. Michele Barry, a global health expert at Stanford University, said she had faith in Dr. Fauci’s assessment. Still, she added, “It is unusual to call a drug the ‘standard of care’ until peer review of data and publication, and before studies have shown benefit in mortality.”Dr. Michele Barry, a global health expert at Stanford University, said she had faith in Dr. Fauci’s assessment. Still, she added, “It is unusual to call a drug the ‘standard of care’ until peer review of data and publication, and before studies have shown benefit in mortality.”
The Food and Drug Administration is likely at some point to announce an emergency approval for remdesivir, a senior administration official told The New York Times. Another drug touted by the president, hydrochloroquine, also was granted such an approval, but results in patients have been disappointing.The Food and Drug Administration is likely at some point to announce an emergency approval for remdesivir, a senior administration official told The New York Times. Another drug touted by the president, hydrochloroquine, also was granted such an approval, but results in patients have been disappointing.
In one study of veterans with Covid-19, those receiving hydrochloroquine and an antibiotic died at higher rates than those given ordinary supportive care.In one study of veterans with Covid-19, those receiving hydrochloroquine and an antibiotic died at higher rates than those given ordinary supportive care.
Mr. Trump also hopes to put in place a crash program to develop a vaccine, an undertaking being seen with skepticism even inside the administration. The accelerated process, known internally as Operation Warp Speed, would aim to produce hundreds of millions of doses by the end of this year.Mr. Trump also hopes to put in place a crash program to develop a vaccine, an undertaking being seen with skepticism even inside the administration. The accelerated process, known internally as Operation Warp Speed, would aim to produce hundreds of millions of doses by the end of this year.
But medical experts, including Dr. Fauci, have warned that developing a vaccine will require a year to 18 months at the earliest, and that rushing the process could endanger public health.But medical experts, including Dr. Fauci, have warned that developing a vaccine will require a year to 18 months at the earliest, and that rushing the process could endanger public health.
For now, drug treatment seems a more attainable goal.For now, drug treatment seems a more attainable goal.
“Remdesivir is not a magic bullet, but it’s as good as we get right now,” said Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco, and one of the trial’s investigators.“Remdesivir is not a magic bullet, but it’s as good as we get right now,” said Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco, and one of the trial’s investigators.
“Patients come to the hospital thinking we have a treatment, and by treatment, they mean a drug,” he added. “We have been impotent in not having any options.”“Patients come to the hospital thinking we have a treatment, and by treatment, they mean a drug,” he added. “We have been impotent in not having any options.”
Remdesivir has never been approved as a treatment for any disease. It was developed to fight Ebola, but results from a clinical trial in Africa were disappointing.Remdesivir has never been approved as a treatment for any disease. It was developed to fight Ebola, but results from a clinical trial in Africa were disappointing.
But as the coronavirus pandemic took hold, the drug emerged as one of the more promising potential treatments. It interrupts the production of the virus in lab studies and seems safe in animals.But as the coronavirus pandemic took hold, the drug emerged as one of the more promising potential treatments. It interrupts the production of the virus in lab studies and seems safe in animals.
Until now, high expectations for remdesivir have been fueled largely by anecdotal reports of Covid-19 patients who took the drug and recovered.
[Like the Science Times page on Facebook. | Sign up for the Science Times newsletter.]
Two such reports were published in the prestigious New England Journal of Medicine, lending credibility to what researchers said were actually uncertain results.
Without trials comparing the drug to a placebo, it has been impossible to know whether the drug made a difference or patients got better on their own with normal supportive care.
Updated June 22, 2020Updated June 22, 2020
A commentary published this month on the website of the British Journal of Sports Medicine points out that covering your face during exercise “comes with issues of potential breathing restriction and discomfort” and requires “balancing benefits versus possible adverse events.” Masks do alter exercise, says Cedric X. Bryant, the president and chief science officer of the American Council on Exercise, a nonprofit organization that funds exercise research and certifies fitness professionals. “In my personal experience,” he says, “heart rates are higher at the same relative intensity when you wear a mask.” Some people also could experience lightheadedness during familiar workouts while masked, says Len Kravitz, a professor of exercise science at the University of New Mexico.A commentary published this month on the website of the British Journal of Sports Medicine points out that covering your face during exercise “comes with issues of potential breathing restriction and discomfort” and requires “balancing benefits versus possible adverse events.” Masks do alter exercise, says Cedric X. Bryant, the president and chief science officer of the American Council on Exercise, a nonprofit organization that funds exercise research and certifies fitness professionals. “In my personal experience,” he says, “heart rates are higher at the same relative intensity when you wear a mask.” Some people also could experience lightheadedness during familiar workouts while masked, says Len Kravitz, a professor of exercise science at the University of New Mexico.
The steroid, dexamethasone, is the first treatment shown to reduce mortality in severely ill patients, according to scientists in Britain. The drug appears to reduce inflammation caused by the immune system, protecting the tissues. In the study, dexamethasone reduced deaths of patients on ventilators by one-third, and deaths of patients on oxygen by one-fifth.The steroid, dexamethasone, is the first treatment shown to reduce mortality in severely ill patients, according to scientists in Britain. The drug appears to reduce inflammation caused by the immune system, protecting the tissues. In the study, dexamethasone reduced deaths of patients on ventilators by one-third, and deaths of patients on oxygen by one-fifth.
The coronavirus emergency relief package gives many American workers paid leave if they need to take time off because of the virus. It gives qualified workers two weeks of paid sick leave if they are ill, quarantined or seeking diagnosis or preventive care for coronavirus, or if they are caring for sick family members. It gives 12 weeks of paid leave to people caring for children whose schools are closed or whose child care provider is unavailable because of the coronavirus. It is the first time the United States has had widespread federally mandated paid leave, and includes people who don’t typically get such benefits, like part-time and gig economy workers. But the measure excludes at least half of private-sector workers, including those at the country’s largest employers, and gives small employers significant leeway to deny leave.The coronavirus emergency relief package gives many American workers paid leave if they need to take time off because of the virus. It gives qualified workers two weeks of paid sick leave if they are ill, quarantined or seeking diagnosis or preventive care for coronavirus, or if they are caring for sick family members. It gives 12 weeks of paid leave to people caring for children whose schools are closed or whose child care provider is unavailable because of the coronavirus. It is the first time the United States has had widespread federally mandated paid leave, and includes people who don’t typically get such benefits, like part-time and gig economy workers. But the measure excludes at least half of private-sector workers, including those at the country’s largest employers, and gives small employers significant leeway to deny leave.
So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.
Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.
A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.
The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.
States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.
Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.
If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)
If you’ve 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.If you’ve 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.
If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. 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.If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. 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.
Until now, high expectations for remdesivir have been fueled largely by anecdotal reports of Covid-19 patients who took the drug and recovered.
[Like the Science Times page on Facebook. | Sign up for the Science Times newsletter.]
Two such reports were published in the prestigious New England Journal of Medicine, lending credibility to what researchers said were actually uncertain results.
Without trials comparing the drug to a placebo, it has been impossible to know whether the drug made a difference or patients got better on their own with normal supportive care.
A separate study of remdesivir, published on Wednesday in The Lancet, found no benefit to the drug, compared with placebo.A separate study of remdesivir, published on Wednesday in The Lancet, found no benefit to the drug, compared with placebo.
“Unfortunately, our trial found that while safe and adequately tolerated, remdesivir did not provide significant benefits over placebo,” said the lead investigator of the new study, Dr. Bin Cao of the China-Japan Friendship Hospital and Capital Medical University in Beijing.“Unfortunately, our trial found that while safe and adequately tolerated, remdesivir did not provide significant benefits over placebo,” said the lead investigator of the new study, Dr. Bin Cao of the China-Japan Friendship Hospital and Capital Medical University in Beijing.
“This is not the outcome we hoped for,” he added.“This is not the outcome we hoped for,” he added.
The results are hard to interpret, because the study was far smaller than planned — enrolling 236 patients instead of the 453 that had been expected, because there were too few severely ill patients now in China.The results are hard to interpret, because the study was far smaller than planned — enrolling 236 patients instead of the 453 that had been expected, because there were too few severely ill patients now in China.
Dr. Eric Peterson, a clinical trials expert at Duke University, said that with too few patients, “all you can say is it doesn’t seem to work in this population.” If there had been a big effect of the drug, he added, that would have been seen.Dr. Eric Peterson, a clinical trials expert at Duke University, said that with too few patients, “all you can say is it doesn’t seem to work in this population.” If there had been a big effect of the drug, he added, that would have been seen.
He added that the trial should not be repeated with this population, but instead in those who are less severely ill.He added that the trial should not be repeated with this population, but instead in those who are less severely ill.
“This is a flawed study,” Dr. Barry said, but results might improve if the drug were given at a higher dose or earlier in the course of the disease.“This is a flawed study,” Dr. Barry said, but results might improve if the drug were given at a higher dose or earlier in the course of the disease.
Acceding to demands, Gilead has distributed the drug to hundreds of patients under so-called compassionate use, a regulatory exemption by which patients may receive a drug apart from a clinical trial.Acceding to demands, Gilead has distributed the drug to hundreds of patients under so-called compassionate use, a regulatory exemption by which patients may receive a drug apart from a clinical trial.
Gilead itself published reports of uncontrolled studies. On Wednesday, in another news release, the company announced that a study comparing a five- to 10-day course of treatment with the drug showed that those getting the shorter course of treatment did just as well.Gilead itself published reports of uncontrolled studies. On Wednesday, in another news release, the company announced that a study comparing a five- to 10-day course of treatment with the drug showed that those getting the shorter course of treatment did just as well.
That study had no control group and was “noninformative,” Dr. Peterson said.That study had no control group and was “noninformative,” Dr. Peterson said.
Sheila Kaplan contributed reporting.Sheila Kaplan contributed reporting.