While several studies, including a final report from the National Institutes of Health (NIH), have concluded that remdesivir in infectious-disease patients can speed the recovery process, a new study published in JAMA says it may not shorten hospital stays for all.
The study, which focused on U.S. veterans who were hospitalized for COVID-19, concluded that remdesivir was not associated with improved survival, but was associated with longer hospital stays.
The drug was granted emergency use authorization by the FDA for the treatment of hospitalized COVID-19 patients in May 2020, and the Infectious Diseases Society of America and NIH currently recommend it for patients hospitalized with severe COVID-19. However, the drug’s effectiveness has been called into question previously after a World Health Organization (WHO) panel advised against using it.
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The advisory came after the drug was shown to have “little or no effect” during the agency’s multi-country Solidarity Trial.
The new study, which used data from the Veterans Health Administration on 5,898 patients who were admitted across 123 hospitals, suggests that remdesivir may actually prolong hospital stay for some patients.
Among the study participants, 2,374 received remdesivir, while 3,524 did not. Remdesivir recipients and matched controls were similar in age – around 66 years old – predominately male, and required similar levels of care. About 20.7% of those who had received remdesivir were admitted to the ICU versus 19.1% in the control group, and 5.9% needed ventilator support versus 3.8% who did not.
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The research team found that remdesivir was not associated with reduced mortality risk, and that those who had received it actually had a longer median time to discharge when compared with matched controls. The patients who received remdesivir averaged about six days in the hospital versus three days for those who had not.
“In this cohort study of U.S. veterans hospitalized with COVID-19, remdesivir treatment was not associated with improved survival but was associated with longer hospital stays,” the researchers concluded. “Routine use of remdesivir may be associated with increased use of hospital beds while not being associated with improvements in survival.”
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Researchers suggested that prolonged hospital stays could be the result of complications from treatment, such as kidney injury, or that clinicians were keeping patients in the hospital until completing the course of treatment, which could be up to 10 days.
In a statement provided to Axios, Gilead, maker of remdesivir, said the “modest-sized retrospective study looked at COVID-19 patient care very early in the pandemic, as treatment protocols for COVID-19 were still evolving,” and suggested that the patients who received the drug were more severely ill than those in the control group.
“Real-world evidence should be considered carefully in context of all available data, and randomized, double-blind, placebo-controlled trials remain the best tool for assessing the efficacy and safety of a medicine,” the statement said, according to Axios. “The efficacy and safety profile of Veklury has been established in the gold standard, double-blind, placebo-controlled ACTT-1 trial and is supported by results from two randomized, controlled Phase 3 studies.”
