Gilead Announces New Clinical Data on Remdesivir (Veklury) Demonstrating Reduced Hospitalization Risk and Improved Outcomes in COVID-19 Patients

On April 24, Gilead Sciences announced the latest data from two studies on remdesivir (remdesivir, trade name: Veklury) for the treatment of hospitalized and non-hospitalized patients with COVID-19.

The first study was a retrospective observational analysis of real-world treatment data (from the Premier Healthcare database), which included 853,219 patients hospitalized for COVID-19 across the United States. The analysis found that more than 50% of hospitalized COVID-19 patients received remdesivir, primarily in combination with other therapies.

As the pandemic progressed, the proportion of patients taking Remdesivir within two days of hospitalization increased from 41% to 91% between May 2020 and December 2021. During this period, with the emergence of new variants and fluctuations in disease severity, the median length of stay (LOS) decreased from 7 days to 6 days, and patients on invasive ventilation/extracorporeal membrane oxygenation (ECMO) benefited the most (reduced from 15 to 11 days).

The utilization rate of the Intensive Care Unit (ICU) decreased from 34% to 27%, with the greatest benefit observed in patients receiving high-flow oxygen/non-invasive ventilation (66% to 52%), while the overall ICU length of stay (LOS) remained unchanged. The total mortality rate stabilized at 16%, with the most significant reduction seen in patients requiring low-flow supplemental oxygen (15% to 12%). These results underscore the role of remdesivir as a foundational treatment for hospitalized COVID-19 patients, emphasizing the need for early intervention before patients progress to more severe stages.

Analysis of another double-blind, placebo-controlled Phase III trial (PINETREE) showed that a three-day course of remdesivir significantly reduced the risk of hospitalization for patients. Starting remdesivir at any time within 7 days of symptom onset reduced hospitalizations among patients with severe COVID-19. The earlier remdesivir was administered, the greater the patient benefit. The risk of hospitalization was reduced by 90% in patients who received remdesivir within 5 days of symptom onset and by 81% in patients who received Veklury after 5 days of symptom onset.

This new analysis builds on the previously presented primary endpoint analysis, in which the risk of COVID-19-related hospitalization or all-cause death by Day 28 was reduced by 87% in the remdesivir group compared to placebo, with statistical significance (0.7% [2/279], p=0.008).