A comparison study based on two large, open-label studies links the antiviral drug remdesivir (Veklury) to a 54% lower risk of all-cause death and shorter hospital stays compared with standard of care (SOC) alone in hospitalized COVID-19 patients requiring supplemental oxygen in 2020.
A Tulane University-led research team that included scientists from remdesivir maker Gilead Sciences compared data on the use of remdesivir from the extension phase of a landmark open-label study with that of real-world data on SOC COVID-19 treatment alone. The open-label study found no significant difference in benefit between remdesivir given for 5 or 10 days, while the real-world study found a 62% lower risk of death after 14 days of remdesivir.
Participants were adults hospitalized for COVID-19 with oxygen saturation of 94% or less while on oxygen support or ambient air and who had lung infiltrates up to May 2020. At baseline, 63% of patients received low-flow (LF) oxygen, 26% received high-flow oxygen/noninvasive positive-pressure ventilation (HF/NIPPV), and 12% received invasive mechanical ventilation/extracorporeal membrane oxygen (IMV/ECMO).
The research was published today in Clinical Infectious Diseases.
70% vs 53% left hospital by 28 days
By 28 days, 247 of 1,074 remdesivir recipients (13%) and 377 of 1,426 (26%) given only SOC had died. Among patients given remdesivir in addition to SOC and those given SOC alone, remdesivir lowered the risk of all-cause death by 28 days by 54% (hazard ratio [HR], 0.46; 95% confidence interval [CI], 0.39 to 0.54). This finding was seen at all levels of oxygen support, with the lowest risk for patients on low-flow oxygen.
Taken together, these findings suggest that the severity of COVID-19 upon initiation of remdesivir treatment affects clinical outcomes, and that there may be a window of opportunity to initiate remdesivir treatment to maximize treatment response.
By day 28, 70% of patients who received remdesivir plus SOC and 53% who received SOC alone had been released from the hospital, a 16% difference (HR, 1.16; 95% CI, 1.43 to 1.87).The benefit was observed in patients receiving LF or HF/NIPPV but not in those on IMV/ECMO.
"Taken together, these findings suggest that the severity of COVID-19 upon initiation of remdesivir treatment affects clinical outcomes, and that there may be a window of opportunity to initiate remdesivir treatment to maximize treatment response," the study authors wrote.
Hospital-stay results from the landmark study after 10 days of remdesivir showed comparable findings, with 56% of remdesivir recipients and 40% of SOC-alone patients released by 28 days (HR, 1.64), a 64% difference.
The researchers said that their findings may not be generalizable because the study took place in the first few months of the pandemic, preceding the emergence of SARS-CoV-2 variants, the vaccine rollout, and the use of combination therapies.
"Despite being limited by timing, this study provides further data to the evidence base supporting the potential benefits of remdesivir to reduce all-cause mortality and shorten hospital stays in patients hospitalized with COVID-19, compared with the SOC used in the early stages of the SARS-CoV-2 pandemic," they concluded.
In the United States, remdesivir is recommended for hospitalized COVID-19 patients and those with mild or moderate illness at high risk of severe disease within 7 days of symptom onset.
