Gilead’s remdesivir hailed as COVID-19 standard of care after trial success

It’s official – Gilead’s remdesivir helps severely ill patients recover faster from COVID-19, according to results from a phase 3 placebo-controlled trial.

Results from the international ACTT trial involving more than 1,090 patients were published yesterday by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the government-funded National Institutes of Health.

This is the first big success in the effort to find treatments that work against the COVID-19 coronavirus, and while remdesivir won’t be used to stop people getting infected, results of the study show it could play an important role in relieving pressure on healthcare systems.

Its effects have probably been noticed in the countries where it is being trialled – aside from the US remdesivir has already been used in trials in China and Europe to help patients recover and leave hospital.

Preliminary results showed the trial met its endpoint after showing patients who received remdesivir had a 31% faster time to recovery than those who received placebo.

Median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo.

Results also suggested a survival benefit, although this was not statistically significant, with a mortality rate of 8% for those receiving remdesivir versus 11.6% for those receiving placebo.

Comprehensive data will be published in a forthcoming report, but Gilead’s CEO Daniel O’Day thanked everyone who had worked on this and other remdesivir trials in an open letter.

O’Day said: “Since January, our teams have been working day and night to determine whether remdesivir might work in patients with COVID-19.

“These efforts include collaboration with study investigators and governments on the various clinical trials. Today’s news, that remdesivir might play a role in easing the burden of the pandemic, is the outcome we all hoped would be possible.”

Remdesivir is an antiviral drug that was originally intended as a treatment for Ebola, which has shown promise against the SARS-CoV-2 coronavirus that causes COVID-19. 

Dr Anthony Fauci, director of NIAID, said that results proved the drug could block the virus. “This will be the standard of care,” he said in an interview with NBC news.

SIMPLE trial

The data from ACTT followed the phase 3 SIMPLE trial, which tested five day and 10day dosing regimens of remdesivir in 397 patients hospitalised with severe COVID-19.

It showed that the time to clinical improvement for 50% of patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group. 

More than half of patients in both treatment groups were discharged from the hospital by Day 14. 

At day 14, 64.5% of patients in the 5-day treatment group and 53.8% of patients in the 10-day treatment group achieved clinical recovery. 

Gilead also said that an exploratory analysis showed patients who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated with more than 10 days of symptoms. 

At the end of last week Gilead contested findings of a smaller trial that were accidentally posted online by the World Health Organization. 

The results were interpreted as a failure by some reports, but the findings had not been peer-reviewed. 

Gilead has also tweaked endpoints of its phase 3 remdesivir trial, changing endpoints and adding extra arms. 

(Updated to include new data from ACTT)

 

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