Remdesivir did not cut COVID hospital stay or mortality

  • Remdesivir did not cut COVID hospital stay or mortality

Remdesivir did not cut COVID hospital stay or mortality

A World Health Organization (WHO) trial that concluded Gilead Sciences Inc's remdesivir did not significantly help Covid-19 patients is reliable, a scientist who evaluated the data said on Friday, as the United States company criticized its methodology.

Results from the WHO's highly anticipated Solidarity trial, which studied the effects of remdesivir and three other potential drug regimens in 11,266 hospitalized patients, found that none of the treatments "substantially affected mortality" or reduced the need to ventilate patients, according to a copy of the study seen by the Financial Times.

Gilead, which got the Solidarity data 10 days ago, questioned the findings, telling Reuters they appear "inconsistent with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir".

"These remdesivir, hydroxychloroquine, lopinavir and interferon regimens appeared to have little effect on in-hospital mortality", the study found.

Martin Landray, a professor of medicine and epidemiology at Oxford University, said the World Health Organization trial results for hydroxychloroquine and lopinavir were in line with a previous British study he co-led.

Earlier this month, data from a U.S. study of remdesivir by Gilead showed the treatment cut patients' COVID-19 recovery time by five days compared with patients who got a placebo in a trial comprised of 1,062 subjects. The European Union just agreed to a 1 billion euros (US$1.2 billion) deal for remdesivir.

Remdesivir was among the first to be used to treat coronavirus, and was recently given to US President Donald Trump when he was in hospital. The patients who were part of the trial were hospitalized with a diagnosis of COVID-19. 2,750 volunteers were give Remdesivir, 954 HCQ, 1,411 Lopinavir, 651 Interferon plus Lopinavir, 1,412 only Interferon, and 4,088 placebo (no drug).

The WHO's findings mean that the only drug proven to increase COVID-19 survival rates is dexamethasone, a cheap steroid that can be taken orally and is widely available around the world.

Solidarity continues to recruit about 2,000 patients a month in its search for more effective treatments for COVID-19 with many countries, especially in Europe, now experiencing a surge in new cases of coronavirus.

"We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design".

Remdesivir had received regulatory approvals or temporary authorisations to treat COVID-19 in approximately 50 countries including India. Almost 39 million people around the world have been diagnosed with COVID-19 and more than one million have died.

There is a bit of uncertainty in the data, but the study says it "absolutely excludes" the idea remdesivir can save a significant number of lives and says the findings are "comfortably compatible" with the drug having no life-saving effect at all.

The attention is now turning to new experimental therapies such as antibodies designed in the lab to fight the virus and new, untested, anti-viral drugs.

"We're looking at what's next".