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According to the first results of a large-scale study, the active ingredient Remdesivir has not achieved the expected success in treating seriously ill patients with Covid-19. According to the evaluation, the mortality rate has not decreased nor has the drug delayed the time when patients needed to be ventilated.
Remdesivir is approved for the treatment of Covid-19 in several countries. The active ingredient is marketed by the American pharmaceutical company Gilead under the trade name Veklury. The president of the United States, Donald Trump, also received it recently after his infection.
In early July, the EU Commission issued Remdesivir, the first conditional approval of a drug for the treatment of Covid-19. It can also be used in Germany, but subject to conditions:
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Is only intended for seriously ill Covid-19 patientswho have pneumonia and need extra oxygen.
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The media can can only be used in clinical settingsin which 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. Due to its antiviral effects, it is also marketed as a possible drug against Covid-19.
All four tested active ingredients failed
For this reason, the World Health Organization (WHO) included it in the so-called Solidarity Trial, a large-scale study in which medical teams from all over the world participate, with the least possible bureaucratic effort. According to the first results that have now been published, none of the four active ingredients tested achieved the expected success, including Remdesivir.
Data from 11,000 patients from 400 hospitals were used for the analyzes. The study will now be reviewed by independent scientists and will later appear in the “New England Journal of Medicine.”
In addition to remdesivir, the study also tested the antimalarial drug hydroxychloroquine and a combination of the HIV drugs ritonavir and lopinavir. However, the studies were discontinued after further research and the initial results of the WHO analysis showed that they did not have a substantial impact on the recovery of Covid-19 patients.
With this, hope was mainly directed towards Remdesivir. However, the results of the preliminary study could not confirm this. Of 2,743 patients treated with remdesivir, eleven percent died. In the roughly equal comparison group in which patients were not treated with the agent, the figure was 11.2 percent. The difference is so small that it could have happened by chance.
The end of Remdesivir?
The manufacturer Gilead doubts the informative value of the results now published. Since medical teams from around the world can participate in the study, deviations in implementation, control and selected patients are expected. “As a result, it is unclear whether conclusive findings can be drawn from the study results,” an official statement said.
Gilead is referring to a study published in the New England Journal last week. In the study with more than 1000 hospital patients, about half received remdesivir, the other half were treated with a placebo and served as a control group. Consequently, Covid 19 patients who had received Remdesivir recovered on average five days faster. However, there is no evidence that remdesivir significantly reduces mortality.
Studies also do not indicate whether remdesivir might have a greater effect if given as soon as possible, before patients have to be hospitalized. “Treating Covid late is difficult,” Benjamin tenOever of the Icahn School of Medicine told the scientific journal Science. At an advanced stage, inflammation and clotting disorders are a bigger problem. An antiviral drug like Remdesivir may help little.
It remains to be seen whether the results of the new study will affect conditional approval in the EU. “I suspect that the use of Remdesivir will not change rapidly as a result of the Solidarity Study,” said Bernd Salzberger, an infectious agent at Regensburg University Hospital, the Science Media Center. All previous studies have shown that the Covid-19 condition improved after they received remdesivir, even if a lower death rate has yet to be shown.
2000 euros per treatment
In the EU, Remdesivir approval, unlike usual, is initially only valid for a limited period of one year. Then, a long-term approval should be decided based on the results of additional studies. If there are indications that the agent is not having the desired effect, approval can be withdrawn beforehand.
For example, the EU drug agency Ema is investigating whether remdesivir could trigger kidney damage in Covid 19 patients. However, it is not yet clear if 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 over the next six months for a billion euros, Reuters news agency reports, citing an insider source. This means that the cost of a five-day treatment would be around 2,000 euros. Gilead also requested this award in the United States.
“At the moment, Remdesivir is the only drug, other than dexamethasone, that is available to us on the clinical front of COVID-19,” said Clemens Wendtner, infectologist at Munich’s Klinik Schwabing, the Science Media Center. “But a major clinical breakthrough looks different and is warning us that the fight against COVID-19 is far from over.”
