indica News Bureau-
In an open letter on Friday, the CEO of Gilead Sciences’ said that COVID-19 patients treated with their antiviral medicine Remdesivir have responded well to the treatment and the clinical trial is seeing rapid recoveries in fever and respiratory symptoms, both symptoms of coronavirus infection. The team said that almost all the patients who participated in the trial have been discharged within a week, paving a bright future for the treatment of the novel coronavirus.
The hospital in Chicago that undertook the clinical trial also reported that patients who volunteered for the trial were showing signs of recovery. The University of Chicago Medicine recruited 125 people with Covid-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of Remdesivir.
During a video discussion about the trial results with other University of Chicago faculty members Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the Remdesivir studies for the hospital said, “The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish”, reported STAT news.
In the open letter published on April 10, the CEO of Gilead Sciences’ Daniel O’Day wrote that the New England Journal of Medicine (NEJM) published an analysis of the effects of our investigational medicine Remdesivir on a small group of patients with severe symptoms of COVID-19.
“These are patients who received treatment through the compassionate use program for Remdesivir, which is for critically ill patients who are unable to take part in a clinical trial. The results, which cover 53 of the first patients to have been treated in the program, show that the majority demonstrated clinical improvement after taking Remdesivir…. These early data from 53 patients have not been generated in a clinical trial and cover only a small portion of the critically ill patients who have been treated with Remdesivir,” the letter read.
The outcomes offer only a snapshot of Remdesivir’s effectiveness. The same trials are being run concurrently at other institutions, and it’s impossible to determine the full study results with any certainty.
O’Day further said that Remdesivir is an investigational treatment and has not been approved for use anywhere in the world and to determine if whether it is a safe and effective treatment, a lot more needs to be done.
“Multiple clinical trials are underway across the world to build a complete picture of how Remdesivir works in various contexts. These studies cover a range of patient populations across different demographics and with varying types of symptoms: moderate, severe where patients need oxygen support, and critical where medical ventilation is required. These patients all receive Remdesivir through intravenous infusions in a hospital setting.
“In studying Remdesivir, the question is not just whether it is safe and effective against COVID-19 but in which patients it shows activity, how long should they receive treatment and at what stage of their disease would treatment be most beneficial. Many answers are needed, which is why we need multiple types of studies involving many types of patients,” he wrote.
Throwing light on the clinical trials being undertaken at Gilead, he wrote, “Seven clinical trials have been initiated to determine whether Remdesivir is a safe and effective treatment for COVID-19. Each of these was set up with unprecedented speed thanks to the remarkable efforts of the various groups involved, as well as the level of knowledge we had on Remdesivir.
“The order in which the trials were initiated mirrors the path of the pandemic. China initiated the first two studies in early February for patients with severe and moderate symptoms of the disease. Since then, an additional five trials have been initiated around the world.
“Two Phase 3 studies are being run by Gilead in areas with a high prevalence of COVID-19 in the United States, Asia and Europe. One of these is for patients with severe disease and the other studies Remdesivir in patients with more moderate symptoms. One of the many questions that these studies aim to answer is whether treatment duration can be shortened from 10 days to 5 days. The severe arm fully enrolled the number of patients it was originally designed for and we have now expanded the study so that thousands more patients can participate, including those on mechanical ventilation.
“The U.S National Institute of Allergy and Infectious Disease (NIAID) began a global trial on February 21. This trial randomly assigns patients to treatment with either Remdesivir or with a placebo to enable a controlled comparison of outcomes. The trial is enrolling approximately 800 patients with a broad spectrum of symptoms. The World Health Organization is also conducting a global trial, Solidarity, and the Inserm DisCoVeRy trial recently began in Europe.”
The CEO further expressed his hopefulness at getting the results from all the clinical trials by the end of April and said the team will work quickly to interpret the findings.
“We expect that we will have preliminary data from the study of Remdesivir in severe patients at the end of April…. In May, we anticipate the initial data from the placebo-controlled NIAID trial as well as data from the Gilead study of patients with moderate symptoms of COVID-19,” he wrote.
Remdesivir was one of the first medicines identified as having the potential to impact SARS-CoV-2, the novel coronavirus that causes Covid-19, in lab tests. The entire world has been waiting for results from Gilead’s clinical trials, and positive results would likely lead to fast approvals by the Food and Drug Administration and other regulatory agencies. If safe and effective, it could become the first approved treatment against the disease.
Mullen however said it was too early to draw any conclusions as the results from the placebo group were not in yet.
“It’s always hard. But certainly, when we start [the] drug, we see fever curves falling,” she said.
“Fever is now not a requirement for people to go on trial, we do see when patients do come in with high fevers, they do [reduce] quite quickly. We have seen people come off ventilators a day after starting therapy. So, in that realm, overall, our patients have done very well.”
She added, “Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three,” STAT news reported.
In a statement Thursday, Gilead said: “What we can say at this stage is that we look forward to data from ongoing studies becoming available.”
