Gilead's slumping COVID-19 drug takes another hit with study showing no real benefit

Last fall, Gilead Sciences was riding high with its sudden blockbuster Veklury, a failed Ebola drug repurposed for hospitalized COVID-19 patients.

But less than a year later, doctors have increasingly turned away from Veklury, as evidence has mounted about its ineffectiveness. This week came more research, as a study from Europe published in The Lancet Infectious Diseases shows that Veklury has no real benefit.

The DisCoVeRy study enrolled people at 48 sites in five European countries who had shown symptoms for seven days and required oxygen. The 429 patients who received Veklury plus standard of care fared no better than the 428 patients who received standard of care only. The study was performed from March of last year to January 2021.  

After 15 days of starting treatment, 46% of those on Veklury had recovered enough to return home compared to 49% of those who received standard of care only. While 5% of those on Veklury had died by day 15, the control group had a 6% fatality rate.

Of those who remained hospitalized, 37% of Veklury recipients required supplemental oxygen compared to 38% in the control group. In the Veklury group, 12% remained in the hospital and did not require supplemental oxygen compared to 7% in the control group.

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"Given the strength of existing clinical evidence supporting Veklury, Gilead does not believe this data alter the demonstrated benefit risk profile of Veklury," Gilead said in a statement. "In an acute disease such as COVID-19, clinical outcomes are the most important measures of treatment efficacy."

The EU results reinforce the findings of the World Health Organization, which concluded last year that Veklury “appeared to have little or no effect” on hospitalized COVID-19 patients. That study, which included 11,266 patients in 30 countries, measured the length of hospital stay, the need for ventilation and overall mortality.

The infused drug gained FDA emergency use approval in May of 2020 based on a study that showed it cut recovery time for hospitalized patients by 31%. Despite this, scientists had serious doubts about the value of Veklury, pointing to other data that showed no reduction in mortality.

There also were questions about the regulatory process as the FDA never consulted a group of outside experts that it often relies on before approval. 

Aided by a ringing endorsement from then-president Donald Trump, Veklury rang up sales of $2.8 billion in 2020, including $1.9 billion in the final quarter. But those sales slid this year to $1.5 billion in the first quarter followed by $829 million in the second quarter.

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Despite the tumble, Gilead has stood by Veklury and did so again on Friday.

"The clinical benefits of Veklury were established in the gold standard, randomized, double-blind, placebo-controlled ACTT-1 trial and were supported by consistent results from Gilead’s SIMPLE-Moderate and SIMPLE-Severe studies," the company said. "Data from these trials as well as real-world patient and physician experience underline the critical role that Veklury is playing as a standard of care for the treatment of appropriate hospitalized patients with COVID-19."