WHO says remdesivir has little effect in hospitalized Covid-19 — but Gilead calls new data 'inconsistent' with previous findings
A new WHO study is throwing cold water on the effectiveness on remdesivir in Covid-19 patients.
After conducting a large clinical trial looking into remdesivir and three other treatments, the WHO has found that none had any substantial effect on improving mortality rates, reducing the amount of patients needing ventilators or shortening hospital stays. The other therapies in the study were hydroxychloroquine, lopinavir and interferon.
The study first came to light following a Financial Times report Thursday afternoon. Within the preprint, WHO researchers said the trial was designed to see how the drugs affected in-hospital mortality.
With remdesivir, their findings didn’t confirm what the NIH had reported from ACTT-1: that the drug had “moderately reduced time to recovery.” In SOLIDARITY, it had no material effects on ventilation initiation or time to discharge.
Perhaps more importantly, the new results shattered any hopes of mortality benefits — where the previous study saw a slight numerical improvement that’s not statisically significant — anyone may have held:
This absolutely excludes the suggestion that Remdesivir can prevent a substantial fraction of all deaths. The confidence interval is comfortably compatible with prevention of a small fraction of all deaths, but is also comfortably compatible with prevention of no deaths (which would be consistent with the apparent lack of any reduction by Remdesivir in the initiation of ventilation or the durationof hospitalization in Solidarity).
In a statement emailed to Endpoints News, Gilead said it is aware of the report and “concerned” that the study hasn’t undergone peer review.
“The emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of Veklury,” the statement read, referring to the commercial name of remdesivir. “The trial design 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.”
The WHO’s trial is one of the biggest ongoing studies into Covid-19 treatments, and drugs can be added or removed at any time. The remdesivir arm enrolled 2,750 patients who were treated for 10 days, with a 200 mg dose administered on the first day and 100 mg doses given each of the following days. The paper only showed results covering the period from March to October.
Baird’s Brian Skorney took a grim view of Thursday’s news, all but declaring an end to the potential full FDA approval that’s currently under review. Skorney stopped short of saying the FDA would pull its emergency use authorization, but said Gilead will likely see much more limited use of remdesivir outside the US.
“Given the substantial size of this study and absence of even a hint of an effect, it’s hard to see these results as anything but extraordinarily negative for the outlook that remdesivir could have any real impact on the pandemic,” Skorney wrote to investors.
Remdesivir has had a long and bumpy road throughout the pandemic, and it’s currently not approved in any indication. Originally developed as a treatment for Ebola, remdesivir won orphan drug status in late March only for Gilead to give it up two days later following criticism that the company had rushed to obtain the designation, which comes with 7 years of market exclusivity among other regulatory benefits.
Then in May, the agency granted it a partial EUA to treat severe Covid-19 cases after the trial conducted by the NIAID suggested that the drug cut the average time to recovery to 11 days in the drug arm of a trial, compared to 15 in the control group. Remdesivir’s EUA was expanded in August to include the treatment of all hospitalized adults and children, thanks to another Gilead-led trial that showed modest efficacy.
That study garnered mixed reactions, however, as a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care. That result came in spite of the therapy meeting its primary endpoint, as patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement.”
Gilead has also drawn scrutiny over its pricing of the treatment, charging governments outside the US $2,340 for a 5-day course and $3,120 for American insurers.
When President Donald Trump was diagnosed with Covid-19 a few weeks ago, remdesivir was one of three treatments he received alongside Regeneron’s experimental antibody cocktail and dexamethasone, a cheap steroid that’s reduced mortality in the UK RECOVERY trial.
Remdesivir is one of only three treatments to have received an EUA from the FDA, alongside hydroxychloroquine and convalescent plasma, which were authorized in March and August, respectively. The former, an anti-malarial, had its EUA revoked in June.