Effects of remdesivir evaluated in new manufacturer-funded studies

Two new manufacturer-sponsored studies examined the effectiveness of remdesivir in patients hospitalized with COVID-19.

The first study compared data from the extension phase of an open-label trial of 10 days of remdesivir plus standard of care (SOC) treatment with real-world, retrospective data from patients treated with SOC alone. Both studies enrolled patients who were treated in spring 2020 for COVID-19. All patients had oxygen saturation of 94% or less on room air or supplemental oxygen, and all patients had pulmonary infiltrates. Propensity score weighting was used to balance patient demographics and clinical characteristics across treatment groups. Results were published by Clinical Infectious Diseases on June 26.

A total of 1,974 patients treated with remdesivir plus SOC and 1,426 who received SOC alone were included after weighting. Remdesivir was found to significantly reduce mortality (hazard ratio [HR], 0.46; 95% CI, 0.39 to 0.54). This association was observed at each oxygen support level, with the greatest effect seen in patients on low-flow oxygen. Patients on remdesivir were also significantly more likely to be discharged at day 28 than those getting standard care (HR, 1.64; 95% CI, 1.43 to 1.87).

"The present analysis contributes to the growing evidence base, with data from one of the largest cohorts of patients exposed to remdesivir in a clinical trial," said the study authors, concluding that the results support "the potential benefits of remdesivir to reduce all-cause mortality and shorten hospital stays in patients hospitalized with COVID-19."

They noted that one limitation of the study is the lack of data on what other investigational agents, including corticosteroids, were given to the patients receiving standard of care and how that varied among study sites.

Another new study of remdesivir, also funded by Gilead and published by Clinical Infectious Diseases on June 24, focused on hospitalized COVID-19 patients with estimated glomerular filtration less than 30 ml/min/1.73 m² from acute kidney injury, chronic kidney disease, or kidney failure, including patients on dialysis. The 243 participating patients were randomized 2:1 to remdesivir or placebo. At day 29, the composite endpoint of all-cause mortality or need for mechanical ventilation was similar between groups, at 29.4% and 32.5% with remdesivir and placebo, respectively (P=0.61). Treatment-emergent adverse events were reported in 80.4% versus 77.5% and serious adverse events in 50.3% versus 50.0%, respectively.

Lowered than planned enrollment caused the trial not to be sufficiently powered to show an effect, but the results do indicate that remdesivir was safe in patients with COVID-19 and severe kidney impairment, the study authors concluded.