Economy

Blow to two drugs used in India to fight Covid

Blow to two drugs used in India to fight Covid”

A World Health Organisation (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 today, as the U.S. company criticised its methodology.

Gilead Sciences Inc., the US company that developed the drug, said the findings appeared inconsistent with evidence from other studies validating the clinical benefit of remdesivir, which was used to treat US President Donald Trump's coronavirus infection.

A World Health Organisation study of more than 2,750 Covid-19 patients suggested that antiviral drug Remdesivir has "little or no effect" on survival.

Gilead, which quickly repurposed what it had developed as an Ebola drug when the Covid-19 pandemic began, said that other, smaller remdesivir trials showed the treatment cut Covid-19 recovery time by five days and helped reduce the risk of death in some patients who were getting oxygen. The California-based company said that the benefits from Remdesivir for Covid-19 patients were demonstrated in three previous trials, the results of which were published in the New England Journal of Medicine last week.

The UN agency hired independent statistician and epidemiologist Richard Peto to evaluate its "Solidarity Therapeutics Trial" results after United States biopharmaceutical company Gilead criticized the WHO's methodology, saying the trial's findings appeared inconsistent with evidence from other studies.

Indian health authorities like their counterparts in other countries had approved remdesivir for emergency use on Covid-19 patients as an investigational therapy. It's since been authorized for use in several countries.

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In the trial, 2,750 participants received remdesivir, 954 received hydroxychloroquine, 1,411 received Lopinavir, 651 received Interferon plus Lopinavir, 1,412 Interferon and 4,088 received placebo.

The study looked at how each of these treatments affected mortality, ventilator use, and length of hospital stay in patients that were hospitalized with COVID-19.

Gilead questioned the findings, saying that Solidarity "prioritized broad access, resulting in significant heterogeneity in trial adoption, implementation, controls and patient populations and consequently, it is unclear if any conclusive findings can be drawn from the study results". For interferon and remdesivir, the authors note, this trial accounts for more than three-quarters of all patients who have been randomised to receive them so far.

However, whether the shot can safely protect people from COVID-19, which has killed more than 1 million people worldwide, will only become clear when final Phase III trials - which are going on outside China - are complete. "We are concerned that the data from this open-label global trial have not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design", drugmaker Gilead said in a statement on Friday. The trial researchers have posted their findings, which are yet to be peer-reviewed, on an online preprint archive. We need scalable, affordable and equitable treatments.

Until now, remdesivir has been the only drug that appeared to have specific effects for coronavirus.

Newer anti-viral drugs, immunomodulators and anti-SARS-CoV-2 monoclonal antibodies are now being considered for evaluation, the World Health Organization said.



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