/arc-anglerfish-arc2-prod-infobae.s3.amazonaws.com/public/TAUR4GUY3FDL3EGLQ3GAP7ZNFI.jpg?fit=%2C&ssl=1)
Currently there various clinical trials underway to check the efficacy and safety of the antiviral remdesivir to treat the new infection coronavirus. And before the end of April, the results of the first will be announced.
– –
While facing much criticism for having limited availability of compassionate doses —Since remdesivir is not approved to treat COVID-19, patients can only request it when they do not respond to other therapy and if their doctors guarantee it— Gilead, the biotech company that produces it, announced that accelerated manufacturing processes everything he could to have lists 1.5 million doses in case the clinical trial gives positive results. The provision of this antiviral originally intended for Ebola, which could be enough to 140,000 patientswill be donated free of charge.
– –
“Providing our existing supplies for free is the right thing to do to facilitate access to patients as quickly as possible and recognize the public emergency of this pandemic“he wrote on April 4 Daniel O’Day, CEO of Gilead, in a letter he wanted at the same time anticipate the result imminent first clinical trial and respond to criticism stemming from the frustration of many families when they see that their sick could not enter the compassionate use list.
– –
“These doses are for the treatment of patients with severe symptoms, through infusions intravenous daily in an environment hospitable. Having a potential treatment on our hands involves a significant responsibility“O’Day continued.
– –
With this batch, Gilead will deplete its raw material reserves, but as it recovers its supply, it has set an “ambitious goal”, according to the CEO: to produce more than 500,000 treatment cycles by October and more than a million by the end of the year. To achieve this, the bio-tech from California has reduced its production process from one year to six months and is currently building a provider network “Geographically diverse” to be able to manufacture remdesivir without interruptions.
– –
What results will the first clinical trial? The financial publication Barron’s, which analyzed the movements of Gilead’s public listing, gave it a 20% chance that the conclusions of the experiment in China be positive, and therefore generate the possibility of immediate approval of remdesivir to stop the pandemic of COVID-19, for which there is no treatment so far.
– –
According to Stat, the first scientific verification of the efficacy or ineffectiveness of this drug – the one with a most advanced development, at this time, among all the trials against him SARS-CoV-2– will only talk about seriously ill, the only ones that were accepted in the first group of tests in China.
– –
“The main objective is to demonstrate that the drug is better than placebo for improve symptoms in 28 days”, Explained the publication of medicine and science. “That improvement is measured with a scoring system that goes from the hospital discharge (one point) until death (six points). To count among those who responded to the drug, a patient must improve at least two points. Patients may remain hospitalized at the end of the 28-day clinical trial period, but still improve clinically enough — they no longer need intubation or supplemental oxygen, for example — to count as someone who responded. “
– –
Bloomberg He cited Umer Raffat, a financial analyst for medicinal companies at Evercore ISI, who estimated that the Study in Serious Patients “Could Disappoint”although he added that remdesivir could help those who received the drug with Sufficient advance in your course of treatment. And even if Gilead started increasing production, It is not because I already know that the drug works.
– –
Stat explained, also quoting Raffat: “The researchers conducting the serious case study of COVID-19 in China they have already done a provisional review of the data but did not stop the trial early. This suggests that the remdesivir is not working as well as expected, and the optimism of a positive overall result diminishes. “
– –
But according to the expert detailed in Bloomberg, with antivirals “it is not about the general result of the trial”, but a more difficult nuance to grasp. “All that matters is power identify the post-infection time point up to which an antiviral can be started and hope that it will be effective. ”
– –
For example, if the patients who received the placebo showed improvements by day 16 of the trial, it would be necessary to see how were those infused with remdesivir the previous days, until the 13th, to demonstrate superiority with statistical impact. “That would be described as the ‘Risk rate’, as the researchers call it. The magic number would be 1,2, which would imply that patients respond 20% better with remdesivir that with the placebo ”.
– –
There is also the possibility that results are inconclusiveStat warned.
– –
If the data shows that the antiviral had no visible benefits, but patients improved, the researchers will have to continue searching “what kind of impact did it have on the patients treated in the early stages Of his sickness”. That’s because antivirals tend to be more effective when given soon after a person becomes infected — because that’s how inhibit virus replication when it still has a reduced number of copies– but in this study, severe patients with COVID.19 were admitted “until 12 days later that they started showing symptom“
– –
Although Gilead assured that the million and a half doses (equivalent to treatment for 140,000 patients) will be distributed at no cost, nothing said yet about the price that remdesivir will have in case of being approved. “There will be immense pressure on the company to make the drug widely available, particularly if the pandemic begins to trigger health crises in least developed countries that cannot afford expensive drugs”, Analyzed Stat.
– –
More of 150 international organizations linked to health, they requested in a letter that Gilead won’t do a traditional patent, exclusive rights until 2031, in case the effectiveness of remdesivir for COVID-19 is proven, since numerous public resources from multiple countries participated, due to the pandemic emergency, in the investigation. They also suggested that the biotech company publish all of its available data on the drug, sample products and the information needed to produce generics, among other things.
– –
At the same time, a committee of the European Medicines Agency – Another Stat article denounced – issued a statement requesting that Gilead facilitate the availability of remdesivir “so fair and transparent”After the company cut its supply of the drug for compassionate use.
– –
“The company changed strategy and — except for pregnant women and children — he began offering the medication only through an expanded access program, as he called it. The goal of this program is to allow hospitals and doctors to request emergency use for ‘multiple critically ill patients at once’ such as part of clinical trials And what is more important- collect patient data. So far, Gilead has treated about 1,700 patients. ” But many others were left out of the new rules, and that caused complaints from families.
– –
That is why O’Day, the company’s chief executive, said in his statement: “We know from the heartbreaking letters we receive, the images we see in the news and the gloomy statistics, that the urgency to find comprehensive and effective solutions [al COVID-19] it becomes more intense every day. In the ways we believe it appropriate for Gilead to play a role today today – primarily through clinical trials, as well as expanded access and compassionate use – we are doing whatever it takes to fulfill the great responsibility that remdesivir gives us. ”
– –
