Gilead has revealed data from three retrospective studies detailing the real-world treatment of hospitalised COVID-19 patients who received its antiviral treatment Veklury.
Veklury (remdesivir) has been approved for emergency use in adult and paediatric patients, aged 12 years and older and weighing at least 40kg, who have been hospitalised with COVID-19 in the US.
Gilead said that the real-world data shows Veklury significantly lowers the risk of mortality compared with matched controls, adding that the reduction in mortality was observed across a ‘spectrum’ of baseline oxygen requirements.
The first analysis of US-based claims data from HealthVerity, performed in collaboration with Aetion, assessed the mortality and likelihood of discharge in hospitalised COVID-19 patients treated with Veklury versus matched controls between 1 May 2020 and 3 May 2021.
In the overall population, Veklury-treated patients had a 23% lower mortality risk compared with controls, with a greater likelihood of discharge by day 28 in patients completing a full five-day course of Veklury compared with controls.
Another comparative analysis of data from the Premier Healthcare Database assessed the mortality of hospitalised patients treated with Veklury versus matched patients who didn’t receive the drug between August and November 2020.
In this analysis, patients treated with Gilead’s drug had a ‘significantly’ lower risk of mortality overall at both day 14 and day 28 compared with patients who did not receive Veklury.
The final analysis – from the SIMPLE-Severe study – in hospitalised adult patients with severe COVID-19 found that in the overall population, treatment with Veklury was associated with a 54% lower mortality risk at day 28 versus the control group, regardless of patients’ baseline oxygen requirements.
Previously, Gilead presented data from the double-blind, placebo-controlled ACTT-1 clinical trial of Veklury in hospitalised patients with COVID-19.
In this trial, there was a trend toward reduced mortality at day 29 in Veklury-treated patients compared with placebo in the overall study population, although this result was not statistically significant.
In a statement, Gilead said that there was a range of disease severity in the overall study population. As a result, the pharma company conducted a post-hoc analysis with no adjustment for multiple testing to determine whether there were differences in mortality based on a patient’s baseline clinical status.
This analysis showed that patients requiring low-flow oxygen at baseline who received Veklury achieved a statistically significant 70% reduction in mortality at day 29.
However, the difference in mortality in other subgroups based on baseline clinical status remained statistically insignificant.