The burden of hospitalisations for COVID-19 in France: a study of all cases in the national insurance claims database in 2020

Background: The economic consequences of the recent COVID-19 pandemic were substantial. However, direct medical costs in France have not been determined. Objective: To describe patient characteristics, intensity of care, mortality, and direct medical costs in patients hospitalised for COVID-19 infections in France. Study design: A retrospective study of the French national hospital claims database for 2020. Setting: Hospital care. Patients or other participants: All patients hospitalised for COVID-19 in 2020 were included and classified by hospitalisation duration into acute phase and prolonged COVID-19. Intervention: Stratification by intensity of care (Level 1: no or low-flow oxygen support;Level 2: non-invasive ventilation;Level 3: mechanical ventilation). Main outcome measure: Cost of hospital care in 2020 Euros from a payer perspective. Results: 199,455 patients were hospitalised for COVID-19 in France in 2020. 17,824 patients (8.9%) received mechanical ventilation and 32,602 patients (16.3%) died. Mean per patient cost was €5,510 ± 7,142. This cost was highest in patients receiving Level 3 care, patients aged >80 years and in those with prolonged COVID. Conclusion: The economic burden of hospitalisations for COVID-19 infections in France during 2020 was substantial. The study provides robust baseline data to benchmark advances in the standard of care and to nurture epidemiological models. © 2023 Creativ-Ceutical. Published by Informa UK Limited, trading as Taylor & Francis Group.

RESPIR'Nantes Study: What About the Safety ?

Introduction: Remdesivir, has been evaluated in the treatment of SARS-CoV-2 pneumonia in several clinical trials, then it has been used in routine care since the European approval in this indication. Objective(s): The main objective of the RESPIR'Nantes study was to describe the clinical outcome and safety of patients treated with remdesivir in real life. We chose here to focus on safety outcomes. Method(s): To describe the safety, we considered adverse events (AEs), based on those reported to date in the Summary of Product Characteristics and potential post-marketing signals from the international pharmacovigilance database Vigilyze-. AEs were classified according to the System Organ Class (SOC) of the Medical Dictionary of Adverse Events terminology. The AEs of SOC ''hepatobiliary disorders'' and ''renal and urinary disorders'' being the most reported to date, a detailed analysis was performed Results: A total of 76 patients were included in the study from March 13 to December 31, 2020. The most common AEs were metabolism and nutrition disorders, hepatobiliary disorders, gastrointestinal disorders and renal and urinary disorders. Patients with hepatobiliary disorders had mainly include transaminases increases and 60% had pre-existing hepatobiliary disease that worsened during treatment. The median time to onset or worsening of hepatobiliary disease was one day [1-2]. It led to discontinuation of treatment in one case. Among patients with renal and urinary disorders, 50% had increased blood creatinine levels prior therapy initiation. The median time to onset or worsening of renal and urinary disorders was one day [0-16]. It led to discontinuation of treatment in two cases. Conclusion(s): A potential signal of pharmacovigilance has been identified for liver and renal disorders in Vigilyze and we have reported the expected remdesivir Aes. However, it is difficult to suspect remdesivir only without considering the pathology itself, but remdesevir appears to have favorable safety profile in patients who require minimal supplemental oxygen.

RESPIR'Nantes Study: What About the Safety ?: An International Journal of Medical Toxicology and Drug Experience

Introduction: Remdesivir, has been evaluated in the treatment of SARS-CoV-2 pneumonia in several clinical trials, then it has been used in routine care since the European approval in this indication. Objective: The main objective of the RESPIR'Nantes study was to describe the clinical outcome and safety of patients treated with remdesivir in real life. We chose here to focus on safety outcomes. Methods: To describe the safety, we considered adverse events (AEs), based on those reported to date in the Summary of Product Characteristics and potential post-marketing signals from the inter- national pharmacovigilance database Vigilyze®. AEs were classified according to the System Organ Class (SOC) of the Medical Dic- tionary of Adverse Events terminology. The AEs of SOC "hepatobiliary disorders" and "renal and urinary disorders" being the most reported to date, a detailed analysis was performed Results: A total of 76 patients were included in the study from March 13 to December 31, 2020. The most common AEs were metabolism and nutrition disorders, hepatobiliary disorders, gastrointestinal dis- orders and renal and urinary disorders. Patients with hepatobiliary disorders had mainly include transami- nases increases and 60% had pre-existing hepatobiliary disease that worsened during treatment. The median time to onset or worsening of hepatobiliary disease was one day [1-2]. It led to discontinuation of treatment in one case. Among patients with renal and urinary disor- ders, 50% had increased blood creatinine levels prior therapy initiation. The median time to onset or worsening of renal and urinary disorders was one day [0-16]. It led to discontinuation of treatment in two cases. Conclusion: A potential signal of pharmacovigilance has been identified for liver and renal disorders in Vigilyze® and we have reported the expected remdesivir Aes. However, it is difficult to suspect remdesivir only without considering the pathology itself, but remdesevir appears to have favorable safety profile in patients who require minimal supplemental oxygen.

RESPIR'Nantes study: What about the safety?

Introduction: Remdesivir has been evaluated in the treatment of SARS-CoV-2 pneumonia in several clinical trials, then it has been used in routine care since the European approval in this indication. The main objective of the RESPIR'Nantes study was to describe the clinical outcome and safety of patients treated with remdesivir in real life. We chose here to focus on safety outcomes. Material and methods: To describe the safety, we considered adverse events (AEs), based on those reported to date in the Summary of Product Characteristics and potential post-marketing signals from the international pharmacovigilance database Vigilyze®. AEs were classified according to the System Organ Class (SOC) of the Medical Dictionary of Adverse Events terminology. The AEs of SOC "hepatobiliary disorders and "renal and urinary disorders" being the most reported to date, a detailed analysis was performed. Results: A total of 76 patients were included in the study from March 13 to December 31, 2020. The most common AEs were metabolism and nutrition disorders, hepatobiliary disorders, gastrointestinal disorders and renal and urinary disorders. Patients with hepatobiliary disorders had mainly include transaminases increases and 60% had pre-existing hepatobiliary disease that worsened during treatment. The median time to onset or worsening of hepatobiliary disease was one day [1-2]. It led to discontinuation of treatment in one case. Among patients with renal and urinary disorders, 50% had increased blood creatinine levels prior therapy initiation. The median time to onset or worsening of renal and urinary disorders was one day [0-16]. It led to discontinuation of treatment in two cases. Discussion/Conclusion: A potential signal of pharmacovigilance has been identified for liver and renal disorders in Vigilyze® and we have reported the expected remdesivir AEs. However, it is difficult to suspect remdesivir only without considering the pathology itself. Remdesevir appears to have favorable safety profile in patients who require minimal supplemental oxygen.

Impact de santé publique de la COVID-19 chez les patients français traités en ambulatoire, présentant au moins un facteur de risque de forme sévère

Introduction La situation sanitaire causée par la COVID-19 est très dynamique, tant au niveau mondial qu'en France, avec à la fois l'arrivée de nouveaux variants et donc des changements de positionnement des traitements, mais une protection accrue contre les formes sévères par les vaccins. Dans ce contexte, il apparaît utile, voire nécessaire d'estimer le poids du fardeau sanitaire et économique de la COVID-19, pour soutenir les choix futurs des allocations de ressources et pour permettre la comparaison avec d'autres maladies. L'objectif de cette étude est d'apporter des premiers éléments de réponse, en présentant les résultats d'un modèle de simulation, simple mais flexible, permettant d'évaluer l'impact de santé publique de la COVID-19 chez les patients français traités en ambulatoire, présentant au moins un facteur de risque de forme sévère. Matériels et méthodes La population d'intérêt est représentée par la population de la cohorte d'autorisation temporaire d'utilisation (ATU) de Ronapreve (moyenne de 63 ans). La première partie de ce modèle de simulation permet de refléter la phase aigüe de la COVID-19 (un mois), avec un arbre de décision. Les patients sont pris en charge soit en ambulatoire soit à l'hôpital, selon des probabilités dérivées de la même cohorte d'ATU. A l'issue de cette phase, les patients peuvent être « en vie sans forme longue », « en vie avec une forme longue traitée en ambulatoire », « en vie avec une forme longue ou prolongée traitée à l'hôpital », ou « décédé ». La seconde partie permet de simuler le devenir des patients sur 2 ans, à l'aide d'une chaîne de Markov. Dans chaque partie du modèle, les caractéristiques des séjours hospitaliers, que ce soit leur durée, la mortalité ou le coût associé, ont été documentées par une analyse de la base de données du PMSI. Plusieurs analyses de scénarios ont été réalisées. Résultats Sur 1 000 patients sont observées 382 hospitalisations, dont 258 au cours du premier mois, 407 formes longues ou prolongées de la COVID-19 et 37 décès. De façon générale, le modèle permet d'estimer le fardeau de la COVID-19 à 0,7 jours de vie perdu le premier mois, avec un coût associé de 1 578 €, et à 27 jours de vie perdus sur l'ensemble de l'horizon temporel, avec un coût associé de 4 280 €. La charge sanitaire et financière la plus élevée est observée pour les patients âgés de plus de 80 ans et pour les patients non vaccinés. Les scénarios menés avec un variant moins sévère, ou avec l'arrivée de nouveaux traitements efficaces permettent de documenter la réduction non négligeable du poids de ce fardeau. Conclusion Cette étude permet de quantifier le fardeau considérable lié à la COVID-19 en France chez les patients infectés et traités en ambulatoire, présentant au moins un facteur de risque de forme sévère. Il semble indispensable de mettre en place des stratégies capables de réduire ce fardeau, en particulier chez les patients les plus vulnérables. Liens d'intérêts déclarés Roche SA France

Clinical Outcomes of Hospitalized COVID-19 Patients Treated with Remdesivir-NEAT ID 909REM Study

Background. There are few real-world data on the use of remdesivir (RDV) looking at timing of initiation in relation to symptom onset and severity of presenting disease. Methods. We conducted multi-country retrospective study of clinical practice and use of RDV in COVID-19 patients. De-identified medical records data were entered into an e-CRF. Primary endpoints were all-cause mortality at day 28 and hospitalization duration. We assessed time from symptom onset to RDV start and re-admission. We included adults with PCR-confirmed symptomatic COVID-19 who were hospitalized after Aug 31, 2020 and received at least 1 dose of RDV. Descriptive analyses were conducted. Kaplan-Meier methods were used to calculate the mortality rate, LogRank test to compare groups defined by severity of disease. Competing risk regression with discharge and death as competing events was used to estimate duration of hospitalization, and Gray's test to compare the groups. Results. 448 patients in 5 countries (12 sites) were included. Demographics are summarized (table) by 3 disease severity groups at baseline: no supplemental oxygen (NSO), low flow oxygen ≤6 L/min (LFO), and high-flow oxygen > 6L/min (HFO). No demographic differences were found between groups except for the higher percentage of cancer/chemotherapy patients in NSO group. Corticosteroids use was HFO 73.6%, LFO 62.7%, NSO 58.0%. Mortality rate was significantly lower in NSO, and LFO groups compared with HFO (6.2%, 10.2%, 23.6%, respectively;Fig1). Median duration of hospitalization was 9 (95%CI 8-10), 9 (8-9), 13 (10-15) days, respectively (Fig2). Median time from first symptom to RDV start was 7 days in all 3 groups. Patients started RDV on day 1 of hospitalization in HFO and LFO and day 2 on NSO groups. And received a 5 day course (median). Readmission within 28-days of discharge was < 5% and similar across all 3 groups. Conclusion. In this real-world cohort of COVID-19 positive hospitalized patients, RDV use was consistent across countries. RDV was started within a median of 7 days from symptom within 2 days of admission and given for a median of 5 days. Higher mortality rate and duration of hospitalization was seen in the HFO group and similar rates seen in the LFO and NSO groups. Readmission was consistently low across all 3 groups.

L'obesite est un facteur de risque d'intubation dans formes graves de pneumopathie COVID-19 : une etude cas-controles.

Declaration de liens d'interets: Les auteurs declarent ne pas avoir de liens d'interets. Copyright © 2020