Background and Importance Sotrovimab is indicated in treatment of COVID19 in adults and adolescents who do not require supplemental oxygen and who are at increased risk of progressing to COVID-severe. The drug is administered according to prioritisation criteria published by the Spanish Agency of Medicines and Health Products (AEMPS)1.
Aim and Objectives To analyse the effectiveness of sotrovimab and to know the profile of patients.
Material and Methods Observational, retrospective and descriptive study in a tertiary level hospital. Patients who had received sotrovimab from January/2022-May/2022 were included. Variables: sex, age, mild-moderate/severe disease, vaccination-COVID, risk factors, hospitalisation/death at 29 day. Effectiveness was measured as rate of patients without progression to COVID-severe (defined as hospitalisation/death at 29 days). Variables were collected from digital medical records and in-hospital electronic prescribing.
Results Thirty-seven patients were included, mean age=61 years (21-82), 20 women (54.05%). Twenty-nine patients (78.38%) had mild-moderate COVID. 29 patients (78.38%) had received a complete vaccination regimen (3 doses), 6 patients (16.22%) two doses and 2 patients (5.41%) not vaccinated. Risk factors: 23 hypertension (62.16%), 13 diabetes (35.14%), 5 obesity (13.51%) and 4 asthma (10.81%). All patients were immunosuppressed. 17 patients (45.94%) with 2 risk factors, 9 with 3 risk factors (24.32%), 7 with 1 risk factor (18.91%) and 2 patients (5.40%) with 4 risk factors. According to the AEMPS prioritisation criteria, all belonged to the group of ‘Immunocompromised persons and high-risk conditions, regardless of vaccination status’. The high-risk conditions were: 23 patients (62.16%) had received solid organ transplantation with immunosuppressive treatment, 13 patients (35.14%) had received immunosuppressive treatment with antiCD20 in the previous 6 months (100% rituximab) and 1 patient (2.7%) was receiving active treatment with myelotoxic chemotherapy (inotuzumab) for acute lymphocytic leukaemia. 7 patients (18.9%) were hospitalised/dead at 29 days (3 exitus). All these patients had received rituximab. 30 patients (81.1%) did not progress to severe COVID. During the study period, 6 patients attended the emergency department, without admission.
Conclusion and Relevance Most patients presented good response and tolerance to treatment. This result was independent of previous treatments or risk factors. Previous treatment with anti-CD20 seems to show a tendency to progression to severe COVID. Long-term studies are needed to confirm results
References and/or Acknowledgements 1. https://www.aemps.gob.es/medicamentos-de-uso-humano/acceso-a-medicamentos-en-situaciones-especiales/criterios-para-valorar-la-administracion-de-las-nuevas-alternativas-terapeuticas-antivirales-frente-a-la-infeccion-por-sars-cov-2/
Conflict of Interest No conflict of interest
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