Remdesivir drug authorized COVID-19 fight revealed but it may not be so miraculous, according to a study - Remdesivir is everything famous, popular and celebrated that can become a medicine.
The drug is the only one that has obtained FDA emergency authorization as a treatment for coronavirus, although its origins date back to a drug (failed) to fight Ebola in 2009.
In May, a study published in the New England Journal of Medicine found that COVID-19 patients treated with remdesivir had an average recovery time of 11 days, compared to 15 days for patients who had received a placebo.
But new research published in the Journal of the American Medical Association has found evidence that remdesivir did not significantly improve patient outcomes. Patients who took a 10-day treatment of remdesivir did not improve more than the rest and died in the same proportions.
Remdesivir works by inhibiting enzymes that replicate viruses, preventing their spread to the body; although it was not too effective against Ebola, it also did not cause negative side effects and proved to be safe.
So, starting in 2014, Gilead began investigating the use of remdesivir as a treatment for coronavirus such as SARS and MERS. Then, after COVID-19 emerged, the company began clinical trials to determine if the drug was effective against it.
The FDA issued an emergency authorization for remdesivir on May 1, to which Gilead responded by donating his drug supply for 2 months. At the same time, in June, the company announced that it would charge governments in developed countries $ 2,340 for each 5-day treatment.
The new study raises questions about whether it is worth paying that price.
The researchers observed a group of 584 people with confirmed cases of COVID-19, all at least 12 years of age and hospitalized with moderate pneumonia by COVID-19. The patients were divided into three groups: one received a 10-day treatment of remdesivir, the second received a 5-day treatment and the third was treated without remdesivir.
Remdesivir drug authorized COVID-19 fight revealed
The researchers compared patient outcomes in 2 ways: recording how many side effects patients had-fatal outcomes and negative symptoms - and measuring how much they had improved after treatment. They also recorded the length of hospital stays, recovery times and the length of time patients needed respiratory assistance.
After 11 days, patients in the 10-day group did not appear to be significantly better than patients treated without the drug for the same period of time. In fact, groups treated with remdesivir had more side effects and mild to moderate symptoms than those who did not take the medicine, although they had less severe symptoms in general. They were also more likely to have nausea, headaches, and hypokalaemia.
In turn, the results showed little difference in the time that the three groups spent in the hospital or in oxygen therapy. After 28 Days, 2% of patients in both the 10-day remdesivir and non-remdesivir groups had died.
In the 5-day group, however, only 1% died after 28 days. However, the study authors considered this finding to be of "uncertain clinical significance", as most people in the 10-day group left the hospital before completing the full course of their treatment (the average duration of their treatment was only 6 days).
Taison Bell, an infectious disease physician at the University of Virginia who participated in the May study, believes the new study does not necessarily show that remdesivir is ineffective.
Instead, he suggests that more work should be done to understand which patients could benefit from the drug. The May study found that remdesivir worked best for those requiring moderate to low amounts of complementary oxygen, Bell said.
"We need to target patients who are sick enough, but not too much, although we need to do more studies to determine what this population is," he says.
Bell also noted that the study provides evidence that longer remdesivir treatments may not be more effective than shorter ones-" certainly good news when considering the challenges of their manufacture and distribution—"
However, in a commentary accompanying the new study, Erin McCreary and Derek Angus, two researchers at the University of Pittsburgh Medical Center, mentioned that the new findings raise a question about " whether the drug is less effective than expected."
First, McCreary and Angus point out, the May study was larger than the recent one, so it may have been better equipped to find small differences between the participants. Second, the previous study compared remdesivir with placebo, while this new study compared remdesivir with a range of less specific treatments such as hydroxychloroquine, without remdesivir.
The patient groups were also different: as Bell pointed out, those recruited for the mayo study had more severe respiratory symptoms than those in the new JAMA study; however, since the first study found that people who benefited most from remdesivir tended to require low amounts of supplemental oxygen, that difference might not matter.
Ultimately, McCreary and Angus concluded, it is still unclear whether remdesivir will be more effective than other cheaper and more widely available options, such as the steroid dexamethasone, which has proven promising in early clinical trials.
"It is not known whether remdesivir offers an incremental benefit over corticosteroids, which are widely available and cheap," they wrote.
Remdesivir drug authorized COVID-19 fight revealed