By Erika Edwards - NBC News
The drug Remdesivir should not be used to treat hospitalized patients for COVID-19
, the World Health Organization ruled on Thursday, just a month after the Food and Drug Administration (FDA) approved its use in the United States for patients older than 12 years who are hospitalized with this disease.
Remdesivir, also known as Veklury, and the steroid dexamethasone are the only drugs licensed to treat COVID-19 patients.
But a recent massive global study of Remdesivir's efficacy, conducted by the WHO,
showed it had little to no impact on hospitalized patients
, contradicting previous research.
"Remdesivir does not have a significant effect on mortality or other conditions important to patients, such as the need for mechanical ventilation or time to clinical recovery," experts from the WHO Guidelines Development Group wrote in a statement. .
The research was published in The BMJ, a medical journal.
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Taking into account interim data from the WHO trial, which included data from more than 11,200 people in 30 countries,
"Remdesivir is now classified as a drug that should not be used routinely in patients with COVID-19
," Jozef said. Kesecioglu, president of the European Society for Intensive Care, in an interview with the Reuters news agency.
Gilead Sciences, the drugmaker that makes Remdesivir, has disputed the WHO's findings.
In an emailed statement, the drug manufacturer said: "We are confident that front-line physicians will recognize the clinical benefit of Veklury based on strong evidence from multiple randomized controlled studies."
Although doctors and hospitals are not required to follow WHO advice, the recommendation could slow down the use of Remdesivir.
However, the drug is still widely used in hospitals because it is licensed or approved in more than 50 countries
, including the United States, and it was one of the drugs that was administered to President Donald Trump when he tested positive for the coronavirus in October. .
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A previous study by the National Institutes of Health found that Remdesivir reduced the length of hospital stays for patients with moderate symptoms of the disease by about four days, from 15 to 11.
Because Remdesivir is believed to work to stop the virus from replicating, it
is likely to have a greater impact earlier in the disease
, said Hugh Cassiere, a pulmonologist at Northwell Health in New York.
"If you started remdesivir very early, you would expect to have better results," he said.
Ken Lyn-Kew, a medical specialist at National Jewish Health in Denver, agrees that it is important to continue studying Remdesivir, but is not as enthusiastic about using the drug in patients in advanced stages of the disease.
"The data shows that it really doesn't work very well in hospitalized patients
,
" he
said.
Kesecioglu said there were not enough data on when remdesivir might be effective or for which patients, leading to the decision to discourage its routine use in intensive care units.
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That means doctors should only use that drug occasionally, not as a standard treatment for COVID-19 patients.
Ten months after the onset of the pandemic, the debate continues in the medical industry about which drugs are the best to treat hospitalized patients with COVID-19.
Remdesivir has potential side effects on the kidneys,
according to data Gilead shared with the European Medicines Agency, which is evaluating its potential toxicity.
Meanwhile, the FDA on Thursday issued an emergency use authorization for Remdesivir in combination with Baricitinib, from the company Eli Lilly, a drug used to treat rheumatoid arthritis.
In a clinical trial of hospitalized patients with COVID-19,
combination therapy
was
shown to reduce recovery time
within 29 days of starting the drugs, compared to patients who received a placebo with remdesivir, the FDA said. it's a statement.
The agency cautioned that investigations must be conducted to confirm those results.
With information from Reuters