Hospitalized patients with COVID-19 who were treated with Veklury® (remdesivir) had significantly lower risk for mortality compared with matched controls, according to 3 retrospective real-world studies presented at the 2021 World Microbe Forum.
The 3 studies included 98,654 hospitalized patients with COVID-19. The HealthVerity and Premier Healthcare databases were used to observe treatment trends and outcomes in the US for 2 retrospective comparative studies. A third analysis compared clinical outcomes in patients receiving a 10-day course of Veklury in the extension phase of the open-label SIMPLE-Severe study (ClinicalTrials.gov Identifier: NCT04292899) with patients receiving standard of care in a real-world retrospective longitudinal cohort study.
In the HealthVerity analysis, findings showed that patients treated with Veklury had a statistically significant 23% lower mortality risk compared with controls, regardless of baseline oxygen requirement (hazard ratio [HR] 0.77; 95% CI, 0.73-0.81). Patients who received a 5-day course of Veklury also had a significantly greater likelihood of discharge by day 28 compared with controls (HR 1.19; 95% CI, 1.14-1.25).
In the overall analysis of the Premier study, a significantly lower risk of mortality at day 14 (HR 0.76; 95% CI, 0.70-0.83; P <.0001) and at day 28 (HR 0.89; 95% CI, 0.82-0.96; P =.003) was observed in patients treated with Veklury within the first 2 days of hospitalization compared with those who did not receive Veklury. Among Veklury-treated patients who received no oxygen, low-flow oxygen, or invasive mechanical ventilation/ECMO at baseline, a significantly lower risk of mortality was noted at both day 14 and day 28. For patients on high-flow oxygen at baseline, the risk of mortality was significantly lower at 14 days, however the difference was not found to be statistically significant at 28 days.
In the SIMPLE-Severe analysis, treatment with Veklury resulted in a statistically significant 54% lower mortality risk at day 28 compared with those who did not receive Veklury, regardless of baseline oxygen requirements (HR 0.46; 95% CI, 0.39-0.54; P <.001). A significantly shorter time to discharge within 28 days was also observed in patients who completed a full 10-day course of Veklury compared with those who did not (HR 1.64; 95% CI, 1.43-1.87; P <.001). The time to discharge was not significant for patients receiving invasive mechanical ventilation or ECMO at baseline.
Veklury is currently approved for the treatment of COVID-19 in patients aged 12 years and older (weighing at least 40kg) requiring hospitalization.
Gilead’s Veklury® (remdesivir) associated with a reduction in mortality rate in hospitalized patients with COVID-19 across three analyses of large retrospective real-world data sets. [press release]. Foster City, CA: Gilead Sciences, Inc.; June 21, 2021.