Real-life use of remdesivir in hospitalised COVID-19 patients with severe pneumonia: an observational study from an Italian university hospital

ABSTRACT

Background and importanceSince June 2020, the European Medicines Agency granted conditional approval to the antiviral drug Veklury (remdesivir) as a treatment for COVID-19 pneumonia. Many studies have shown conflicting results regarding its efficacy. Data from observational studies should be encouraged in order to provide valuable information about its real-life effectiveness.Aim and objectivesThe aim of the study was to describe the effectiveness of remdesivir in terms of mortality rate and duration of hospitalisation in a cohort of patients admitted to an Italian University Hospital during the COVID-19 pandemic.Material and methodsWe carried out a retrospective observational study at a 1600-bed University hospital in Northern Italy. Our cohort included all patients who received remdesivir between September 2020 and April 2021, corresponding to the second and third pandemic waves in Italy. As a primary endpoint, we measured the mortality rate at any time after initiation of therapy. Secondary endpoints included 30-day mortality and duration of hospitalisation. As a post hoc analysis, we compared patients requiring high-flow oxygen supplementation (HFO) after starting remdesivir and patients who did not require HFO (eg, NHFO group). High-quality data were extracted from the medical records and from the Veklury AIFA (Agenzia Italiana del Farmaco) monitoring register. Statistical analyses were carried out with R (R Core Team 2021).ResultsThe study sample included 528 patients, mainly men (68.4%) with a median age of 66.7 years. The overall mortality rate was 5.1%, while the 30-day mortality rate was 4.2%. In the post hoc analysis, 291 patients (55.1%) fell in the NHFO group. HFO therapy confirmed a stronger association with mortality (11.0% HFO vs 0.3% NHFO, p<0.001). The NHFO group performed better in all the considered endpoints rate of discharge to home, mortality, intensive care unit admission/transfer, and length of hospital stay.Conclusion and relevanceIn our study, the mortality rate was similar to that reported in clinical studies. Since no reports of adverse drug reactions were notified, these data support remdesivir as a possible therapeutic option, given the positive benefit–risk profile. As expected, patients who required high-flow oxygen were at increased risk of negative outcomes. This seems to suggest that potential early use of remdesivir could optimise its clinical efficacy.References and/or acknowledgementsConflict of interestNo conflict of interest