4CPS-055 Evaluation of use, effectiveness and safety of isavuconazol

Background and importanceIsavuconazole (ISA) is an authorised antifungal for the treatment of invasive fungal infection (IFI) by Aspergillus in adult patients in which amphotericin B is not appropriate.Aim and objectivesTo assess the conditions of use and effectiveness of ISA versus voriconazole (VORI) compared with the SECURE pivotal study in a third level hospital, and describe adverse events in the ISA group.Material and methodsAn observational, retrospective study was conducted between September 2018 and September 2019. Variables collected were sex, age, type of infection, causative fungus, duration of treatment and immunosuppressive treatment. Clinical response (CR), considered as resolution of symptoms and no need for subsequent antifungals, was used to evaluate the effectiveness of ISA and VORI. For safety, adverse events (AEs) were recorded. Data compilation was carried out through assisted electronic prescription and electronic medical history. Comparison of proportions was made using the χ2 test (R-commander).ResultsDuring the study period, 32 patients were analysed (10 ISA vs 22 VORI). Median age was 54.5 versus 66.5 years (IR 46.25–60; 58–77.5) and the percentage of men was 90% versus 68%.IFI tested by cultures occurred in 60% versus 54% of patients. Fungal species detected were (number): Aspergillus fumigatus (2 vs 8), A flavus (2 vs 0), A niger (1 vs 0), A terreus (0 vs 2), A sydowii (0 vs 1), Candida lusitaniae (1 vs 0) and Lichtheimia (1 vs 0). The rest were diagnosed as probable IFI (positive galactomannan ag test or CT image).Median duration of treatment was 49 versus 15 days (IR: 14.25–73.5;11–44.5). CR was achieved in 3 patients (30%) with ISA versus 10 (45%) with VORI (p=0.4093). The AEs registered for ISA were liver disorders (n=3), phlebitis (n=1), diarrhoea (n=1) and grade 2 cytopenias (n=1). Dose adjustment was required in three patients due to interaction with immunosuppressants.Conclusion and relevanceAmong our population, ISA was a relatively effective and safe alternative, without relevant differences compared with VORI in terms of effectiveness, according to the SECURE pivotal study. A larger sample size would be necessary to verify these data.References and/or acknowledgements1. Informe de Posicionamiento Terapéutico de isavuconazol (Cresemba) en el tratamiento de la aspergilosis invasora y la mucormicosis (Internet). Disponible en: https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT-isavuconazol-Cresemba