Drug remdesivir shows promise in treatment of virus patients
Study: Those who took the drug had a 31% faster time to recovery
A government-run study of Gilead Science’s remdesivir, the most promising experimental drug to treat COVID-19, shows that it helps patients with advanced disease, shortening their illness and slightly reducing death rates.
The drug is expected to be approved for emergency use.
In long-awaited news, the National Institute of Allergy and Infectious Diseases an
nounced Wednesday that hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received an inactive placebo, according to a preliminary analysis of data.
Although not a cure, it represents the first treatment shown to improve outcomes in patients infected with a virus that has paralyzed the global economy and killed at least 227,000 people worldwide.
“While we are waiting for a vaccine, this is something that allows us to better fight this disease. It is the first step,” said pulmonary and critical care specialist Dr. Sharon Chinthrajah of Stanford Medicine, who led the hospital’s NIAID-sponsored trial. “It tells us: We may be able to make a change in the disease trajectory if you become hospitalized.”
In the study, patients who received the drug made by the Foster City-based company had a 31% faster time to recovery than those who received a placebo. The median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received a placebo.
Results also suggested
a modest survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group.
The U.S. Food and Drug Administration plans to announce an emergency use authorization for the drug, according to the New York Times. This is an easing of rules, due to the urgency of need, that would allow the drug to be used without formal and time-consuming federal review or approval.
Meeting with reporters at the White House on Wednesday, NIAID Director Dr. Anthony S. Fauci, the federal government’s leading infectious diseases scientist, cautioned that the results still need to be properly peer reviewed.
But he expressed optimism that it could help make a difference in speeding up the recovery of some patients.
“Although a 31% improvement doesn’t seem like a knockout 100%, it is a very important proof of concept because what it has proven is that a drug can block this virus,” Fauci told reporters.
Until now, information about the drug has been leaked out in drips, with conflicting reports about the drug’s potential benefit. Many of the trials have been uncontrolled or poorly controlled. A Chinese study was stopped early due to too few patients.
But the U.S. government’s
randomized, controlled trial involving 1,063 patients, which began Feb. 21, is considered the gold standard of research. The trial, known as the Adaptive COVID-19 Treatment Trial, or ACTT, is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19.
A total of 68 sites, including Stanford University and UC San Francisco, joined the study.
An independent data and safety monitoring board overseeing the trial met on Monday to review the results and shared their interim analysis with the study team, according to NIAID. The trial closed to new enrollments on April 19.
Based upon their review of the data, they noted that remdesivir was better than a placebo from the perspective of the primary endpoint, time to recovery, a metric often used in influenza trials. Recovery in the study was defined as being well enough for hospital discharge or returning to normal activity level.
More detailed information about the trial results, including more comprehensive data, will be available in a forthcoming report, according to NIAID.
“It’s a good direction. It’s an early finding. We need a closer view of the data, for a better roadmap,” said UC San Francisco infectious
disease expert Dr. Peter Chin-Hong, who led the university’s trial.
Viral treatment is just part of the picture, he said. Often what kills patients is an overaggressive immune response, which triggers massive inflammation in what’s called a “cytokine storm.” Immune cells are overproduced and flood into the lungs, making it hard to breathe and leading to often fatal Acute Respiratory Distress Syndrome.
“A viral medicine is not going to help with organ damage,” he said.
Other drugs will be needed to prevent or treat the devastating inflammation.
“But it stops viral reproduction while organs have time to heal,” he said,
Reducing a patient’s levels of virus could also reduce the risk that they will transmit it to others, he said.
Remdesivir patient Monica Yeung-Arima of Palo Alto received the drug while hospitalized for 13 days at Stanford Hospital in early March. Yeung-Arima received intravenous infusions for five days. Three days later, she began to feel better.
“I am so glad that I could be one of the guinea pigs,” she said. “Even if it’s not a 100% cure, it will put many people at ease to have a solution. I’m so glad that there’s positive news and the drug can possibly be used in
many patients soon.”
Nearly two months after becoming infected on a Nile River cruise, she is back to her normal routine, although she still has chest congestion and an intermittent cough.
Also on Wednesday, Gilead said that a different trial showed that patients who were given the drug earlier showed a faster response to treatment.
That study involved 397 patients with severe cases of COVID-19 who were divided into two groups and given remdesivir in fiveand 10-day dosage regimens.
While patients in both groups showed improvements in symptoms, those who were given the drug sooner exhibited a quicker response to the treatments. Gilead said 64.5% of patients who were given the five-day treatment were discharged from the hospital within 14 days, compared to 53.8% of patients on the 10day remdesivir course.
Of all the drugs now under investigation for COVID-19 treatment, remdesivir is one that makes the most biological sense.
It incorporates itself into the viral genetic code, interrupting reproduction. In animals and cell cultures, it has killed the pathogens MERS and SARS, which are genetically similar to the new virus.
Gilead, which specializes in antiviral drugs,
found it by screening the company’s vast library of chemical compounds, an approach that is revolutionizing drug discovery. Companies spend a lot of money building these libraries, then test promising compounds on different cells or molecules to see if they are a hit for a certain disease target. Most hits go nowhere.
The company hoped it would work during the West African Ebola outbreak of 2013 to 2016. But as an Ebola drug, it was a flop.
Now the drug has been repositioned as a treatment for coronaviruses.
The reason that repurposed drugs such as remdesivir could be a good tool for fighting the virus is because they have already been through safety trials, which confirm that taking the medicine is not going to cause death on its own.
The other important factor is that these drugs are already in production. There may be challenges in scaling up the manufacturing to meet the demand, but at least the basic infrastructure is there.
“Is it perfect? No,” Stanford’s Chinthrajahr said. “But it offers hope after all the heartbreak of people hospitalized with COVID-19.”