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Anvisa (National Health Surveillance Agency) announced on Friday (12) the authorization to use the antiviral drug rendesivir for the treatment of covid-19.
The drug had been studied in Brazil since June 2020, when the agency authorized a clinical study in hospitalized patients with severe pneumonia caused by the new coronavirus (Sars-CoV-2) infection.
Both the request for authorization for the study and its use were made by the company PPD do Brasil Suporte a Pesquisa Clínica Ltda. Currently, the drug is approved or authorized for temporary use to treat patients with covid-19 in more than 50 countries , including the US, Australia, Canada, EU, Hong Kong, India, Israel, Japan, Singapore, South Korea, Taiwan, and the United Arab Emirates.
What are the results of rendesivir?
Developed to combat Ebola, rendesivir is an antiviral that has already shown good results in treating patients infected with the other coronaviruses that cause Sars and Mers.
The drug was already being used in the US to treat critically ill patients with COVID-19. There, the substance has been authorized by the FDA (the country’s regulatory body) for this purpose since May 1, 2020.
According to Gilead Brazil, manufacturer of the drug, studies such as research conducted by the American National Institute of Health (NIH, with 1,063 patients in the US, Europe and Asia, showed that hospitalized rendesivir patients recovered five days faster, on average, and critically ill patients seven days faster.
The researchers further concluded that the drug reduced the likelihood that patients receiving low-flow oxygen would progress to more severe stages, requiring mechanical ventilation or dying. In the largest group of patients in the study, those with low oxygen requirements, there was a significant reduction in mortality, from 9.9% to 2.6%. The data also point to a reduction in the progression (or evolution) of the disease.
At a press conference, Anvisa representatives declared that “the data provided by the laboratory showed that the use of the drug reduced both the time of use of oxygen support and the days of hospitalization. Given the worsening of the pandemic in Brazil, these data they were decisive for the agency to authorize the use of rendesivir, with a view to alleviating the health system. “
The WHO has already advised against the use of the drug
But not all scientists in the world have come to the same conclusion. In another study, conducted by Chinese doctors and published by the journal The lancet, the antiviral had few results among the patients evaluated.
In November last year, the WHO (World Health Organization) advised against the use of rendesivir for the treatment of covid-19. At that time, specialists from the institution pointed out in an article published in the British medical journal no there was evidence that the drug would increase the chances of survival or decrease the risk of mechanical ventilation.
In October, the Solidarity study, carried out with the support of the WHO and developed to test possible drugs against the disease, had already concluded that rendesivir, hydroxychloroquine and two other antivirals had little or almost no effect on hospitalization times or rates. chances of survival of patients with covid. -19.
But the organization emphasized that, although there is no solid evidence of the drug’s effectiveness, this does not mean that it cannot have benefits for some patients. However, given the lack of evidence, the possible risks associated with the use of the drug and its high cost, the experts considered it appropriate not to recommend the use, mHe supported them to conduct further clinical trials on the subject.
Rendesivir will not be sold in pharmacies.
Anvisa has already reported that the use of the drug is restricted to hospitals and that the drug will not be sold in pharmacies. This information will even come in both the package and the rendesivir package. Its recommended use is only for hospitalized patients in serious condition, who need oxygen support through the nose (but not intubated patients).
Only Gilead’s laboratory will be able to market the drug in Brazil and Anvisa is still waiting for information on the number of doses available for purchase.
According to Eric Bassetti, Gilead’s associate medical director in Brazil who spoke with Live well, the laboratory can meet the global demand for drug doses. “More than three million patients have already used rendesivir in the world to treat covid-19 and we have increased our production capacity to supply this demand,” he explains.
In addition, he explains that the drug must be used once a day for five days via an intravenous infusion, hence the need to use it only in a hospital setting. “It is recommended that the drug be administered to patients who are on oxygen support, but still without intubation,” he says. “There is a window of opportunity that must be respected to prevent the disease from progressing to its most serious form.”
The director, however, says that the drug is not a “lifesaver.” “It will serve to reduce deaths, but we still have a long way to go and we must maintain preventive measures such as social distance, hand hygiene and the use of masks,” he says.
When asked about the spelling of the drug’s name, Gilead’s press office said it has changed here in Brazil, from remdesivir – as it is used around the world – to giving way. According to them, “it was a requirement of Anvisa.”
* With information from reports published on 06/25/2020 and 11/21/2020.
