The antiviral drug remdesivir has little or no effect on the survival chances of hospitalized patients with COVID-19, according to a preliminary study by the World Health Organization (WHO) released Thursday.
The WHO trial, dubbed “Solidarity”, evaluated four possible drugs to treat covid-19, including remdesivir and the hidroxicloroquina.
Remdesivir was one of the first drugs to be used to treat the new coronavirus and was recently administered to the President of the United States, Donald Trump, when he was admitted to the hospital because of this disease.
Gilead, the drug’s maker, rejected the study’s conclusions.
In a statement, the drugmaker said the WHO’s findings were “inconsistent” with other research, and that it was “concerned” that the results have not yet been reviewed by other scientists independent of the research.
What did the WHO study find?
For Solidaridad, the WHO evaluated the effects of four potential treatments:
- remdesivir, used against Ebola
- hydroxychloroquine, used against malaria
- interferon, used for autoimmune diseases
- combination of lopinavir and ritonavir, against HIV
The four drugs were tested with a total of 11,266 adult patients, admitted to 500 hospitals in more than 30 countries, over six months.
The results suggest that neither of these treatments has a substantial effect on patients.
In a statement released Thursday, the WHO said that “the provisional results […] indicate that remdesivir, hydroxychloroquine, lopinavir / ritonavir, and interferon regimens seem to have little or no effect“in mortality, the start of mechanical respiration or the time spent in hospital.
WHO chief scientist Soumya Swaminathan said Wednesday that the trials with hydroxychloroquine and lopinavir / ritonavir had already been stopped in June because they had been shown to be ineffective.
However, trials with interferon and remdesivir had continued.
The WHO results appear to contradict an early October study conducted by Gilead that concluded that remdesivir treatment reduced COVID-19 recovery time by five days compared to patients who received a placebo. Approximately 1,000 patients participated in that trial.
Dexamethasone, a low-cost steroid now widely used in COVID-19 patients in intensive care in the UK, was not included in the Solidaridad study.
What has been the reaction to the WHO results?
Gilead Sciences Inc. dismissed the findings.
“The data appears inconsistent with stronger evidence from multiple randomized controlled studies published in peer-reviewed journals that validate the clinical benefit of remdesivir,” the company said in a statement.
“We are concerned that the data from this global trial have not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design,” he added.
But Professor Martin Landray, who leads the large Recovery trial in the UK, said the study results were “important but sobering”, adding that there were already concerns about the cost and accessibility of remdesivir.
“Covid-19 affects millions of people and their families around the world,” he also said.
“It is not a rare disease. We need scalable, affordable and equitable treatments. The WHO Solidarity trial has done the world a great favor by producing clear, independent and robust results, once again showing the value of large randomized trials. to provide the knowledge we need to address the worst consequences of the pandemic, “he noted.
Remdesivir received US emergency use authorization from the Food and Drug Administration (FDA) on May 1.
Later that month, its use was approved in the UK and has since been licensed in several other countries.
Analysis by James Gallagher, Health and Science correspondent
Remdesivir has been touted as a potential therapy since the beginning of the pandemic and gained increased attention when it was part of Donald Trump’s cocktail of treatments.
But the WHO trial, published online, delivers a damning verdict.
There is some uncertainty in the data, but the study says it “absolutely excludes” the idea that remdesivir could save a significant number of lives.
The message is similar for the drug’s alleged potential to prevent people from needing mechanical respiration or to speed people’s recovery.
Until now, doctors have been raiding the medicine cabinet in search of existing drugs that can fight the new coronavirus.
Results have been disappointing with anti-malaria drugs, HIV drugs, multiple sclerosis drugs, and now an Ebola drug (remdesivir).
Only one ancient steroid, dexamethasone, has been shown to save lives.
The focus is now on new experimental therapies, such as antibodies designed in the laboratory to fight the virus and new, untested antiviral drugs.
We are still awaiting the results of these trials, but the concern is that “new” in medicine tends to mean “expensive”, and that will raise questions about who can access them.
What about other treatments against covid-19?
Following the results of the Solidarity trial, Dr Swaminathan said the WHO is now “looking at what’s next.”
“We are looking at monoclonal antibodies, immunomodulators, and some of the newer antiviral drugs that have been developed in recent months,” he said.
Meanwhile, in China, researchers say a vaccine in development has been found to be safe and elicits immune responses in combined early and mid-stage trials.
However, the researchers said it was not possible to say whether the vaccine-induced antibody responses were sufficient to protect against infection because the trial had not been designed to assess the efficacy of these antibodies.
Developed by the Beijing Institute of Biological Products, the vaccine has already been approved for use in an emergency inoculation program in the country.
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