The drug is given intravenously, costly and complex to administer, the panel concluded that it has no meaningful effect on death rates or other important outcomes for patients.
The World Health Organisation (WHO) had updated its guidelines on the usage of anti-viral drug Remdesivir to treat COVID-19 patients, no matter how severe their illness is, as it has “no important effect” on survival chances.
These new guidelines were based on the data from the WHO Solidarity Trial that tested patients’ responses to repurposed drugs including Remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon as an option for COVID-19 treatment. During the trial, 2,750 volunteers were given Remdesivir, 954 HCQ, 1,411 Lopinavir, 651 Interferon plus Lopinavir, 1,412 only Interferon, and 4,088 placeboes. it was found that there was little or no effect of these drugs on the outcome of COVID-19 over a 28-day period. The interim results from this trial was published on 15 October after which
The World Health Organization’s Solidarity trial is the world’s largest ongoing randomized control trial of potential COVID-19 therapeutics.
Initially developed as a treatment for the Ebola virus, Remdesivir was found in one study published in May to reduce the length of hospital stays for COVID-19 sufferers from 15 to 10 days on average.
After looking over the data from this trial and three other randomized trials which included data from 7,000 patients, the WHO Guideline Development Group (GDG) said there was “no evidence-based on currently available data that it does improve patient-important outcomes”. The international group of experts includes 28 clinical care experts, 4 patient-partners and one ethicist.
According to a WHO statement, the evidence suggested no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes. However, the group believes that more research is needed.
Since the drug has to be given intravenously and is costly and complex to administer, the panel concluded that it has no meaningful effect on death rates or other important outcomes for patients, a report by Reuters states.
“Especially given the costs and resource implications associated … the panel felt the responsibility should be on demonstrating evidence of efficacy, which is not established by the currently available data,” it added.
However, WHO’s recommendations are not binding and are part of its so-called “living guidelines” project. This project is designed to offer guidance to doctors to help them make decisions about patients in fast-moving situations such as the pandemic.
The US, EU, India and other countries, however, have granted temporary approval for the use of remdesivir after several trials and studies showed that it helped some coronavirus patients.
Doctors remain uncertain about when and when not to use the only drugs known to improve survival for the sickest COVID-19 patients: dexamethasone or similar steroids.
And things got murkier with the recent news that the anti-inflammatory drug tocilizumab could help. Like the key WHO study on Remdesivir, the preliminary results on tocilizumab have not yet been published or fully reviewed by independent scientists, leaving doctors unclear about what to do.
“It’s a genuine quandary,” said University of Pittsburgh researcher Dr Derek Angus, who is involved in a study testing many of these treatments. “We need to see the details.”
Dr Rochelle Walensky, infectious disease chief at Massachusetts General Hospital, agreed. “It’s really hard to practice medicine by press release,” she said on a podcast Thursday with a medical journal editor.
Gilead also spoke out on a previous occasion and said the WHO data is “inconsistent, with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of Remdesivir.” They believe that the WHO trial has not been as rigarous as the trials the company had conducted during the pandemic.
In a statement, Gilead said the drug is seen as a treatment for the virus by various other national organisations.
“We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with COVID-19 .”
Remdesivir is also known as Veklury.
With inputs from wires