Explained: Why WHO vs Gilead on remdesivir matters

Grant Boone
October 16, 2020

The WHO trial was conducted in 11,266 adult patients in more than 30 countries, and also found that other medicines repurposed since the pandemic began - malaria drug hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir and interferon - also offered little or no benefit to Covid-19 patients.

After months of planning and testing a handful of repurposed drugs that studies from around the world have found useful in treating COVID-19, researchers in the largest scientific study for potential COVID-19 treatments has found many of them ineffective against the SARS-CoV-2 virus. "These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized Covid-19 patients, as indicated by overall mortality, initiation of ventilation and duration of hospital stay".

Gilead in a statement to the Financial Times said "the emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies validating the clinical benefit of remdesivir". A preprint is available at medRxiv.

The WHO Solidarity trial, one of the largest ongoing studies of COVID-19 drugs, examined the effects of remdesivir and three other treatment candidates in more than 11,000 patients in 30 countries.

World Health Organization began the Solidarity trial after a COVID-19 research forum in February recommended the evaluation of treatments for the disease and experts identified four repurposed antiviral drugs that could have at least a moderate effect on mortality. "This is real world evidence".

The drug's manufacturer Gilead rejected the findings of the trial. "Consequently, it is unclear if any conclusive findings can be drawn from the study results", the company said in a prepared statement.

The WHO declined to comment, saying the results of the study were not yet public.

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The remdesivir findings aren't terribly surprising based on previous findings, but they are "still impactful", especially given the dizzying size of the Solidarity trial, said Dr. Maricar Malinis, an infectious disease physician at Yale University.

Developed by the Beijing Institute of Biological Products, the vaccine has already been approved for an emergency inoculation programme in the country.

Washington authorised the emergency use of the medicine, made by USA pharmaceutical company Gilead Sciences and originally intended as a treatment for Ebola - on May 1, followed by a range of other countries and the European Union.

That study, too, did not find that remdesivir prevented deaths in patients with COVID-19. But they add to concerns about how much value the pricey drug gives because none of the studies have found it can improve survival.

More than five drugmakers here, including Dr Reddy's Laboratories, Cipla, and Hetero Healthcare, have signed agreements with Gilead to produce and supply generic versions of the patented drug in India as well as in several low- and middle-income countries. About 2,750 were randomly assigned to get remdesivir.

Remdesivir, the only antiviral drug authorized to treat COVID-19 in the U.S., did not stop patients from dying or shorten their hospital stays in a massive World Health Organization study.

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