Gilead Sciences released a statement to refute the World Health Organization’s claim that a recent trial on remdesivir showed “little or no effect” against Covid-19.
Earlier on Thursday, the WHO released the interim results of the Solidarity Therapeutics Trial on four drugs – remdesivir, hydroxychloroquine, lopinavir/ritonavir, and interferon.
The study concluded that remdesivir had little or no effect on hospitalized Covid-19 patients, as measured by mortality on Day 28, the need for ventilation, and hospital stay length.
WHO evaluated the four drugs’ efficacy and safety in 11,266 hospitalized Covid-19 patients at 405 institutions in 30 countries. The study results were posted on medRvix, a site that pre-releases a journal.
“These remdesivir, hydroxychloroquine, lopinavir and interferon regimens appeared to have little or no effect on hospitalized Covid-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” the research team said. “The mortality findings contain most of the randomized evidence on remdesivir and interferon, and are consistent with meta-analyses of mortality in all major trials.”
The WHO also announced that it planned to increase the number of research institutes to about 500 to quickly evaluate other promising treatment options such as new antiviral agents and monoclonal antibodies against Covid-19.
Gilead released a statement on WHO’s study results shortly after the WHO’s announcement.
The company said it was aware that initial data from the WHO’s Solidarity trial had been made public before publication in a peer-reviewed journal. “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 (remdesivir),” Gilead said in the statement.
Gilead argued that the WHO’s Solidary study had limitations in the trial design, questioning the results' credibility. The company said the study was an open-label, global one that provided early access to remdesivir for patients, particularly in countries where ongoing trials of treatment candidates were not available.
“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,” Gilead said.
The company went on to say that Veklury proved its clinical benefit in three randomized, controlled trials, including the ACTT-1 study, which was randomized, double-blind, and placebo-controlled.
The ACTT-1 trial, conducted by the National Institute for Allergy and Infectious Diseases (NIAID), primarily in the U.S. and Europe, showed that Veklury treatment provided clinically meaningful improvement for hospitalized Covid-19 patients, the company emphasized.
These data, which were peer-reviewed and published in the New England Journal of Medicine, supported the inclusion of Veklury in various treatment guidelines and led to the drug’s winning of approval or temporary nod as a Covid-19 treatment in approximately 50 countries, the company added.