[ad_1]
(CNN Spanish) – Remdesivir is an experimental drug produced by the company Gilead Sciences, which could be authorized by the United States Food and Drug Administration (FDA) for emergency use to treat the coronavirus, according to The New York Times, citing a senior government official. But some studies have cast doubt on the effectiveness of this drug in treating covid-19.
For starters, the FDA told CNN in a statement Wednesday that it is in talks with Gilead Sciences, the maker of remdesivir, to make the drug available to patients and that Gilead’s current supply of the drug could cover at least 140,000 treatments. ongoing for coronavirus patients, Chief Executive Daniel O’Day said Wednesday.
Dr. Anthony Fauci, the nation’s leading infectious disease doctor, announced optimistic results from a remdesivir trial that began on February 21.
“The data shows that remdesivir has a clear, significant, and positive effect in decreasing recovery time,” Fauci said in the Oval Office during a meeting with Louisiana President and Governor John Bel Edwards.
However, the researcher behind that trial told CNN that remdesivir “is not the end of the story” when it comes to treating the virus.
“We have work to do. We are looking for other therapies, this trial will continue, ”said Dr. Andre Kalil, principal investigator of the clinical trial, which was sponsored by the National Institutes of Health. “In medicine, it never ends. We can always do better. And we want to do better. “
The company that created the drug describes remdesivir as a “nucleotide analog with broad-spectrum antiviral activity.” The key word is experimental, because as the company clarifies, remdesivir has not been approved for any use by any country in the world.
Currently, there is no treatment for covid-19 approved by the United States Food and Drug Administration. While doctors are testing various treatments, it is not yet known whether they will work.
What do the studies say?
A study funded by the United States Government found that patients who took remdesivir recovered faster than patients who did not take it. It’s not a home run, but federal officials are willing to offer any hope they can in a pandemic that has infected more than 1 million Americans and killed more than 60,000.
The head of the National Institute of Allergy and Infectious Diseases (NIAID) was optimistic about the results.
However, last week, the pharmacist Gilead Sciences said that the results of a study investigating the effects of remdesivir in the treatment against covid-19, were inconclusive and were published prematurely on the WHO page of where it was removed.
Merdad Parsey, medical director at Gilead Sciences, said in a statement last week that while the data was inconclusive, “the trends in the data suggest a potential benefit for remdesivir, particularly among patients treated at an early stage of the disease.” .
This week, Gilead Sciences published its own findings from a different trial of the drug. The company said it found that patients taking remdesivir were just as good for five days as those taking it for 10 days.
For this study, remdesivir was not tested against a placebo to see if it was an effective treatment for the virus, so more evidence is needed to prove that. The study used 397 severe patients with covid-19.
The most common adverse events in more than 10% of patients in some of the groups in the Gilead trial were nausea and acute respiratory failure, the company said.
The Chinese Study
Although the product is being presented as a hope by the United States, in China, a small study found that the use of remdesivir did not help coronavirus patients.
The Chinese study’s findings are in conflict with other indications of the drug’s efficacy from other trials, two of them also on Wednesday.
Experts say it will take much more testing and a little longer before it becomes clear whether remdesivir can help patients recover from covid-19 infections.
The study in China was stopped early because there were not enough patients, but indicated that the drug did not work as expected, as reported in the Lancet medical journal on Wednesday. Some details of this study were published last week on the World Health Organization website, and then removed.
The Lancet study was randomized, placebo-controlled, meaning that patients randomly received the dummy medication or treatment and patients and doctors did not know who was receiving what.
The team from the China-Japan Friendship Hospital and Capital Medical University in China tested the drug on 237 coronavirus patients in Wuhan.
“Unfortunately, our trial found that while safe and adequately tolerated, remdesivir did not provide significant benefits over placebo,” said Bin Cao, the researcher who led the study, in a statement.
Gilead’s studies continue
Remdesivir is among several drugs that are in the testing stages for covid-19, but the NIAID trial is the first to be conducted under rules intended to obtain FDA approval.
About 1,090 people participated in the trial internationally, Dr. Fauci said, calling it “the first high-powered placebo-controlled randomized trial.”
But the World Health Organization said it is too early to comment on the results of the remdesivir trial released Wednesday.
“Usually you don’t have a study that will come out and change the game,” said Dr. Maria Van Kerkhove, WHO technical leader for the coronavirus response.
She said the agency generally gathers evidence from various studies before reviewing and criticizing the evidence.
“Sometimes it can take multiple publications to determine (what) is the ultimate impact of a drug,” said Dr. Mike Ryan, executive director of the WHO health emergencies program.
