The World Health Organization has provided new guidance regarding the drug remdesivir that recently was given FDA emergency approval to treat hospitalized coronavirus patients. The health organization recommended against the use to treat coronavirus patients with the said antiviral.
The drug over the last few months has generated a lot of interest among scientists and public health experts. It was the first coronavirus treatment ever given approval in the United States. However, a panel at WHO recommended that “remdesivir has no meaningful effect on mortality or on other important outcomes for patients”.
Remdesivir is not suggested for patients admitted to hospital with covid-19, regardless of how severely ill they are, because there is currently no evidence that it improves survival or the need for ventilation, say a @WHO Guideline Development Group panel https://t.co/a55cB9wuH9
— The BMJ (@bmj_latest) November 20, 2020
According to the new recommendations the drug does not provide any benefits like reducing the need for mechanical ventilation or time for clinical improvement. The new review was published in the journal The BMJ.
One thing to note here is that the report by WHO did not say that the drug can still be a good therapeutic intervention, but in fact that data is lacking to recommend it use for now.
In response to this review, the company which makes this drug; Gilead Sciences said in a statement that its drug “is recognized as a standard of care for the treatment of hospitalized patients with Covid-19 in guidelines from numerous credible national organizations, including the U.S. National Institutes of Health and Infectious Diseases Society of America, Japan, U.K., and Germany.”
We released the following statement today related to the WHO COVID-19 treatment guidelines: https://t.co/vb8TG4CxYL.
— Gilead Sciences (@GileadSciences) November 20, 2020
The company also defended the drug use in coronavirus patients by explaining that multiple randomized, controlled studies published in peer-reviewed journals that found that Veklury (brand name for remdesivir) provided clinical benefits to COVID-19 patients.
In one of these studies, funded by the National Institutes of Health, it was seen that the drug reduced recovery time in hospitalized patients from 15 to 11 days. Two other separate trials without a placebo control group, sponsored by Gilead, also showed benefit in giving the antiviral to hospitalized patients.
President Trump was also given remdesivir along with other treatments last month when he was hospitalized with COVID-19.
However, in the current study the WHO panel reviewed four studies in total. These included the one conducted by the NIH, the other sponsored by WHO and another, which is the largest study conducted till date. The new study is not peer-reviewed yet and had 5000 study subjects.
Hospitalized patients with moderate #COVID19 randomized to a 5-day course of #remdesivir had a statistically significantly better clinical status vs those randomized to standard care at 11 days after initiation of treatment https://t.co/pT81pSCzKO
— JAMA (@JAMA_current) August 21, 2020
The WHO review of all these studies found that the approval for the drug might have been pre-emptive. According to
The results from that trial “Dr. Bram Rochwerg, an associate professor of medicine at McMaster University in Hamilton, Ontario, and a co-chair of the W.H.O. panel, the latest study “brought into question some of the benefit that had been seen earlier, in the N.I.H. study”.
He further explained that the new review still calls for continued remdesivir trials to see if “specific populations that could benefit.”
The FDA approved Remdesivir for COVID-19 treatment, but HHS's bad deal means the drug costs an obscene price. I want to know why the US is paying the highest prices in the world & when HHS will use its authority to keep prices down. https://t.co/3xLGktKMYf
— Elizabeth Warren (@SenWarren) November 20, 2020
Right now, the drug does not provide any clear benefit and is expensive and administered intravenously. All these resources can perhaps be diverted to treatments options that might help, according to Dr. Rochwerg said.
Since getting approval in October for remdesivir, Gilead reported $873 million in revenue this year till now.