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Remdesivir accelerates recovery times in patients with coronavirus, says a major US-led trial. So far, the drug is the first with demonstrable positive results in treating people who have contracted the disease.
The world’s scientific community is debating the effects of its use. This is what you need to know about this drug.
What is it?
Remdesivir is a broad-spectrum experimental antiviral made by the American pharmacist Gilead Sciences, which was first developed to treat Ebola, a viral hemorrhagic fever.
It enthused the researchers in a 2016 primate study and was then used in a major trial in the Republic of the Congo, comparing it to three other drugs.
That study ended in 2019 because it failed to increase survival rates like two other monoclonal antibodies, laboratory-designed immune system proteins.
In February, the United States National Institute of Allergy and Infectious Diseases (NIAID) announced that remdesivir would once again jump on the scene in an investigation into SARS-CoV-2, the pathogen that causes Covid-19, because it was promising in tests. in animals against the SARS and MERS coronaviruses.
Read also: Laboratory in China has already produced a possible vaccine against Covid-19
How effective is it?
NIAID announced the results of its trial Wednesday, which included 1,000 people and concluded that hospitalized patients with Covid-19 respiratory problems treated with the drug improved faster than cases who received a placebo.
Patients who took the drug recovered 31% faster.
“Although the results were clearly positive, from a statistically significant point of view they were modest,” Anthony Fauci, NIAID chief scientist, said Thursday.
In other words, it works but it is not a miracle cure.
However, it is considered a “proof of concept” that could pave the way for better treatments, much like the first drugs developed to treat HIV in the 1980s, much less effective than those currently used.
The results suggested that remdesivir could reduce mortality rates from 11.7% to 8.0%, but these data are considered less statistically reliable.
Why are there mixed results?
The findings from the U.S.-led trial were announced the same day that The Lancet published the results of a study with the same drug but smaller that found no statistical benefit in remdesivir.
This study involved just over 200 people from Wuhan, China, and was a randomized controlled trial, considered the highest standard in treatment evaluation.
But it is also noteworthy that this study had to be stopped for not recruiting enough patients and its size was approximately five smaller than the study led by the United States.
“The trial numbers are too small to draw firm conclusions,” said Stephen Evans, medical statistics expert at the London School of Hygiene & Tropical Medicine.
When could it be available?
Remdesivir has already been given to patients around the world, in clinical trials and also outside of them, in response to Gilead’s “compassionate use requests” for access in some emergencies.
In the United States, the Food and Drug Administration (FDA) is expected to issue an “emergency use authorization” shortly, which would further expand its use, prior to its formal approval.
“I was talking to the FDA commissioner yesterday afternoon, last night, and he’s moving very fast,” Fauci said.
“They have not yet made a final decision, they have not announced it, but I would say that we will see it reasonably soon,” he said.
Since the drug is complex to manufacture and is given by injection rather than by pills, there are questions about whether the supply will be limited in the first phase.
In an open letter released Wednesday, Daniel O’Day, the president of Gilead, reported that the company has 1.5 million doses ready or nearly finished.
“We had estimated that this would be 140,000 treatments based on a treatment duration of 10 days,” he said, but another trial showed that five days is as effective as using it in 10 days.
This means that “we can significantly increase the number of treatments available, which Gilead is committed to donating,” O’Day said.
Read also: Laboratory in China has already produced a possible vaccine against Covid-19
How does it work?
Remdesivir belongs to a class of medication that directly attacks viruses.
It is what is called a “nucleotide analog” that mimics adenosine, one of the four basic components of RNA and DNA.
“The virus is not very careful with what it incorporates,” said virologist Benjamin Neuman of Texas A&M University.
“Viruses normally try to go fast and change speed as a precaution,” he warned.
Remdesivir is stealthily incorporated into the virus genome instead of adenosine, causing a short circuit in its reproduction process.
During a conference call, Gilead medical director Merdad Parsey said that while patients who had symptoms for less time seemed to respond better to the drug, there also appeared to be some benefit to those who were at more critical levels.
This is because the virus triggers an abnormal immune reaction called a cytokine storm responsible for lung injury.
“By limiting viral replication, it will limit inflammation, reduce the number of people who develop lung injury, and get them out of the respirator faster,” Parsey explained.
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