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WHO recommends against Gilead’s Veklury, in break with US guidelines

Dive Brief:

  • The World Health Organization on Thursday recommended against the use of Gilead’s Veklury in hospitalized COVID-19 patients, saying there is no evidence the drug prevents death and calling data showing it improves outcomes “weak.” The WHO cited the SOLIDARITY study, which, in contrast to a major U.S. government-sponsored trial, found no clear difference in patients’ recovery time.

 

  • Veklury, also known as remdesivir, has been approved or otherwise authorized for use in roughly 50 countries. Its uptake has exceeded Wall Street analysts’ expectations, with Gilead reporting $873 million in sales in the third quarter.

 

  • The WHO’s advice could add uncertainty for nurses and doctors treating COVID-19 patients, as repurposed drugs like dexamethasone and newer antivirals like Eli Lilly’s bamlanivimab have data of varying quality supporting their use. Researchers have struggled to keep up with emerging science, especially on which patients benefit the most and the use of drugs in combination.

 

Dive Insight:

Veklury, an antiviral developed first for hepatitis C and then Ebola, was one of the first experimental drugs to be tested in COVID-19 patients. Though debated, the evidence that eventually led to an emergency use authorization and, later, full approval by the Food and Drug Administration showed the drug could help people hospitalized with COVID-19 recover faster.

However, studies haven’t conclusively demonstrated that Veklury prevents patients from dying, fueling some skepticism of the drug’s benefit. More recently, the WHO’s SOLIDARITY study showed treatment did not help improve survival.

SOLIDARITY also found Veklury didn’t prevent patients from going on mechanical ventilation nor did it seem to help them recover faster. The latter point is contrast to the National Institutes of Health ACTT-1 study, which showed patients taking Veklury were discharged or no longer needed medical care five days sooner, at the median, than those given placebo.

The conflicting results further fueled debate over the drug’s clinical benefit, although both Gilead and the FDA have said the SOLIDARITY data do not refute the findings of benefit in the U.S.-run trial.

WHO characterizes its recommendation as part of a “living guideline” on Veklury, and urges further research.

In a press release, Gilead stated that because the full SOLIDARITY data have not been released or peer reviewed, clinicians can’t evaluate their quality.

“The results released to date are inconsistent with more robust evidence from the [ACTT-1] trial and Gilead’s open-label trials, whose results have validated the clinical benefit of Veklury,” Gilead said.

Steven Seedhouse, an analyst at Raymond James, challenged Gilead’s assertions regarding peer review in a note to clients on Friday. He pointed to the WHO’s internal review of data, which included 28 clinical care experts, that took place before its recommendation Friday.

Seedhouse also noted inconsistencies in the data from Gilead’s own trials and ACTT-1, relating to their own measurement of recovery time.

“The acknowledgement that ‘clinical recovery’ is a subjective endpoint and based on physician discretion regarding oxygen support and discharge is precisely why we believe ACTT-1 shouldn’t be viewed as a definitive result that overrides any other trial, like SOLIDARITY,” he wrote.