ABSTRACT
Background and ImportanceRemdesivir was the first antiviral authorised by the European Medicines Agency for the treatment of CoVID-19 disease.Aim and ObjectivesThe aim is to describe the effectiveness and safety of remdesivir in patients with SARS-CoV-2 infection in real clinical practice.Material and MethodsObservational, descriptive, retrospective study in a level-II hospital.Hospitalised patients with SARS-CoV-2 infection and prescription of remdesivir from April21-March22 were included. Data were obtained from the Unidosis Farmatools® module and MambrinoXXI®.Variables: sex, age, recommendations of remdesivir datasheet (time from symptom onset to administration ≤7-days, dosing regimen, duration of treatment and glomerular filtration rate (GFR) (contraindicated if <30mL/min).Effectiveness assessment: hospital stay, Intensive Care Unit (ICU) admission, clinical recovery inpatients with 5-day treatment.Safety assessment: elevated transaminases (pre-and-post-remdesivir levels;contraindicated if ≥5 times upper limit of normal-LSN)Results59 patients were included, 64% male, median age 67(30-101) years.100% started within 7-days of symptomatology onset (median: 3-days) and complied with the recommended dosing regimen. In 93.2% the duration was 5-days, one patient remained on treatment for 7-days and 3 discontinued earlier due to clinical worsening. Mean GFR: 79ml/min and96.6% complied with the recommendation (GFR>30ml/min).The median hospital stay was 8-days (3-133). Twelve patients required admission to the ICU, two of whom died. Clinical recovery was achieved in 91.1% of patients who completed the 5-day regimen. During the hospital stay, 7 patients died with a median age of 85 years (59-95).Prior to administration, 22.2% patients showed transaminase levels above the LSN, including one patient with 5LSN. After administration, transaminases increased in 31.1%, including 5 patients with 5LSN, 2 of whom had initially normal values.Conclusion and RelevanceAll patients received remdesivir as early as recommended and according to the conclusions of the pivotal clinical trial, where this subgroup was postulated to have the greatest clinical benefit. Although one third of patients had elevated transaminasemia, none required treatment discontinuation. However, other parameters would need to be collected to assess safety more comprehensively. Despite the limitations of the study, in our experience, remdesivir appears to have a good effectiveness and safety profile and may be a therapeutic alternative in the treatment of COVID-19disease.References and/or AcknowledgementsConflict of InterestNo conflict of interest