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Remdesivir: Argentina will test in 100 patients the promising drug against the coronavirus that the US and Europe have already authorized

2020-07-04T00:00:25.383Z


It will be in the framework of the "Solidarity" study, promoted by the WHO and being carried out in ten hospitals. What is this antiviral and what benefits has it shown so far.


Adriana Santagati

07/03/2020 - 16:07

  • Clarín.com
  • Society

This Friday, Europe announced the approval of remdesivir, the first drug authorized to treat coronavirus, the same drug for which the United States government has secured half a million doses. In Argentina, this antiviral will begin to be tested from next week on a hundred patients in ten hospitals.

Remdesivir is a drug that had been developed for Ebola, but since it was not very useful for this virus, it stopped investigating. But SARS-COV2 was found to be sensitive to this antiviral in vitro, and so it became one of the first drugs to be studied for the treatment of coronavirus. It slows down the production of new virus particles and this slows the infection and makes patients recover faster . In the clinical trials that have been carried out so far, it has shown promising results, which first led to its approval by the FDA, the US health agency, and now the European authority gave it a "conditional" authorization due to the exceptional nature of the pandemic.

The “Solidarity” trial is being carried out worldwide by the World Health Organization, where various therapeutic alternatives for covid-19 are being studied on a large scale of patients. In Argentina, it is implemented by the Ministry of Health of the Nation, and 10 hospitals in five districts of the country participate, representing a geographic diversity and showing the most complex indicators at the time the study began.

Bottles of remdesivir, the drug produced by the Gilead laboratory and which will be tested from next week in Argentina. (EFE)

The infectologist Gustavo Lopardo, local coordinator of "Solidarity", confirmed to Clarín that a first batch of 1,100 ampoules has already arrived in Argentina , which will be used in 100 patients in these 10 hospitals. The doses are in distribution, so it is expected to start using them early next week.

There is no certainty that remdesivir is "the" therapy against coronavirus, and in fact trials are also being done with other drugs and with the plasma of recovered patients, but Leopardo points out that it is "one of the most advanced". The US FDA and the European EMA - two of the heaviest health agencies in the world - approved it "not because it is nice, but because there are already a couple of studies that showed some clinical improvement, " says Lopardo. And it gives details of these previous investigations.

There was a first study of compassionate use in 61 patients, which is not taken into account, which was followed by a study with 237 that did not show benefits “probably because it was small” and a third study, larger, with 1,063 patients, which was on which the FDA and EMA were based. This trial did show a greater tendency to improvement among those who received it, and also lower mortality among patients who received remdesivir. Another study, with 397 patients, analyzed the application time and found that the results were similar in a five-day treatment than in one of ten, which is also a positive indicator because it reduces the time it should be administered. It is not a minor fact, because being intravenous, the patient must be hospitalized.

The coordinator of "Solidarity" explained how the study will continue from the incorporation of remdesivir. It will be distributed in the 10 participating centers: Hospital Italiano, Ramos Mejía and Muñiz (Capital), Posadas, Mariano and Luciano de la Vega, and Houssay (Buenos Aires), Perrando (Chaco), Cuyén and Centenario (Santa Fe) and Rawson (Cordova).

Being a randomized study, it is a computer that assigns which patient receives one of the therapies being tested. Because "Solidarity" began by analyzing the effectiveness and safety of the controversial hydroxychloroquine and lopinavir / ritonavir. Those lines did not obtain the expected results and were discontinued , since it is a study with "adaptive design". Therefore, at this stage patients are divided into three groups: those who receive interferon, those who will receive remdesivir and the control group, in which these drugs are not tested but are given all the treatment indicated for an infection of this kind.

Solidarity has already recruited 5,500 patients worldwide , of whom 50 are Argentines . The results of this global investigation will be key to define a therapeutic strategy against the virus .

However, there are countries that are already ensuring doses of the drug produced by the American pharmaceutical company Gilead , a laboratory with cutting-edge research that has important drugs for HIV and hepatitis C. This week, Gilead set the price per dose at $ 390 , and said that it reached agreements with producers of generic drugs in developing countries to be able to offer the treatment at a lower price and facilitate its access worldwide. The United States has already purchased 500,000 doses, equivalent to 100% of the company's production for July and 90% for August and September, and the European Union is also in negotiations.

In Argentina, official sources confirmed that there are no negotiations for now with the US pharmaceutical company. In fact, Gilead did not even make an application to ANMAT for the marketing of this drug . For this, laboratories must present the body with a series of documents, including the clinical studies that support their product. The authorizations of the FDA and the EMA are an important guarantee, but it is not automatic : the Argentine agency makes its own analysis before registering a drug to enable the marketing of the first batch.

ACE

Source: clarin

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