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Remdesivir: "A major clinical breakthrough looks different"
Photo: Zsolt Czegledi / EPA-EFE / Shutterstock
According to the first results of a large-scale study, the active ingredient Remdesivir has not brought the hoped-for success in the treatment of seriously ill Covid-19 patients.
According to the evaluation, the mortality rate has not fallen, nor has the drug delayed the point in time when patients had to be ventilated.
Remdesivir is approved for the treatment of Covid-19 in several countries.
The active ingredient is marketed by the US pharmaceutical company Gilead under the trade name Veklury.
US President Donald Trump also recently received it after his infection.
At the beginning of July, the EU Commission issued Remdesivir, the first conditional approval for a drug for the treatment of Covid-19.
It can also be used in Germany, but subject to conditions:
It is
only intended for seriously ill Covid-19 patients
who have pneumonia and need additional oxygen.
The agent may
only be used in clinical settings
where patients are closely monitored.
Remdesivir was originally developed to treat Ebola patients, but was never approved for this use.
The drug is given by infusion and inhibits an enzyme that viruses need to multiply.
Because of its antiviral effects, it is also traded as a possible drug against Covid-19.
All four active ingredients tested failed
The World Health Organization (WHO) therefore included it in the so-called Solidarity Trial - a large-scale study in which medical teams from all over the world take part, with as little bureaucratic effort as possible.
According to the first results that have now been published, none of the four tested active ingredients brought the hoped-for success, including Remdesivir.
The data from 11,000 patients from 400 hospitals were used for the analyzes.
The study is now to be reviewed by independent scientists and then appear in the "New England Journal of Medicine".
In addition to remdesivir, the study also tested the malaria drug hydroxychloroquine and a combination of the HIV drugs ritonavir and lopinavir.
However, the studies were discontinued after other research and initial results of the WHO analysis showed that they had no substantial impact on the recovery of Covid-19 patients.
With this, the hope was mainly directed towards Remdesivir.
However, the preliminary study results could not confirm this.
Of 2,743 patients treated with remdesivir, eleven percent died.
In the roughly equal comparison group that the patients were not treated with the agent, the figure was 11.2 percent.
The difference is so small that it could have arisen by chance.
The end for Remdesivir?
Manufacturer Gilead doubts the informative value of the results now published.
Since medical teams worldwide can participate in the study, deviations in the implementation, control and the selected patients are to be expected.
"As a result, it is unclear whether conclusive findings can be drawn from the study results," said an official statement.
Gilead refers to a study published in the New England Journal last week.
In the study with more than 1000 hospital patients, around half received remdesivir, the other half were treated with a placebo and served as a control group.
According to this, Covid 19 patients who had received Remdesivir recovered five days faster on average.
However, there is no evidence that remdesivir significantly reduces mortality.
The studies also do not indicate whether remdesivir might have a greater effect if it is given as early as possible, before patients have to be hospitalized.
"Treating Covid late is difficult," said Benjamin tenOever of the Icahn School of Medicine to the science magazine Science.
At an advanced stage, inflammation and coagulation disorders are more of a problem.
An antiviral drug like Remdesivir may do little to help.
It remains to be seen whether the new study results will affect the conditional approval in the EU.
"I suspect that the use of Remdesivir will not change quickly as a result of the Solidarity Study," said Bernd Salzberger, infectiologist at the University Clinic Regensburg, the Science Media Center.
All previous studies have shown that the condition of Covid-19 improved after they received Remdesivir - even if a lower mortality rate has not yet been proven.
2000 euros per treatment
In the EU, the approval for remdesivir is - unlike usual - only limited for one year.
A long-term approval should then be decided on the basis of further study results.
If there are indications that the agent does not have the desired effect, the approval can be withdrawn beforehand.
For example, the EU medicines agency Ema is currently investigating whether remdesivir could possibly trigger kidney damage in Covid 19 patients.
However, it is still completely unclear whether there is a connection.
The coronavirus can also affect the kidneys.
The EU is said to have secured the delivery of 500,000 doses of Remdesivir for the next six months for one billion euros, reports the Reuters news agency, citing an insider.
This means that the cost of a five-day treatment would be around 2000 euros.
Gilead had also called for this award in the USA.
"For the time being, Remdesivir is the only drug, besides dexamethasone, that is available to us on the clinical COVID-19 front," said Clemens Wendtner, infectiologist at the Munich Klinik Schwabing, the Science Media Center.
"But a major clinical breakthrough looks different and warns us that the fight against COVID-19 is far from over."
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