Severity and complications in infants with respiratory syncytial virus infection after the SARS-CoV-2 pandemic.

BACKGROUND: After the SARS-CoV-2 pandemic, there has been an increase in hospitalization for lower respiratory infection secondary to respiratory syncytial virus (RSV), with greater complications. Associated extrapulmonary alterations, biventricular dysfunction, acute kidney injury, among others, have been found. The objective of this study was to analize the evolution and complications in hospitalized children with lower respiratory infection secondary to RSV after COVID-19 pandemic. METHODS: All pediatric patients under 2 years of age admitted to the emergency department with RSV infection were included. Clinical characteristics, need for supplemental oxygen, use of amines, renal angina index, and requirement for renal replacement therapy were analyzed. Lung ultrasound was performed upon admission. Statistical analysis was carried out for the quantitative variables by means of mean and standard deviation, and qualitative variables by frequency and percentage. Differences in the distribution were evaluated with Fisher's exact distribution. RESULTS: 45 patients with RSV infection were identified, 26.7% required invasive mechanical ventilation and 11.1% requiered peritoneal dialysis. Fatality was observed in four cases, three of these younger than 12 months with a LUS score > 7; contrasts with 90.2% of survivors with a score < 7 (p = 0.0004). CONCLUSIONS: An increase in the incidence of bronchiolitis after pandemic was observed, with more than half having moderate to severe symptoms and requiring supplemental oxygen support in all patients upon admission. Acute kidney injury is the most common extrapulmonary manifestation.

INTRODUCCIÓN: Posterior a la pandemia por SARS-CoV-2 se ha observado un incremento en la hospitalización por virus respiratorio sincitial (VRS), con mayores complicaciones. Se han encontrado alteraciones extrapulmonares asociadas, disfunción biventricular y lesión renal aguda, entre otras. El objetivo de este estudio fue analizar la evolución y las complicaciones en niños hospitalizados con enfermedad respiratoria de vías bajas secundaria a infección por VRS tras la pandemia de COVID-19. MÉTODOS: Se incluyeron todos los menores de 2 años que ingresaron al servicio de urgencias con infección por VRS. Se analizaron las características clínicas, la necesidad de oxígeno suplementario, el uso de aminas, el índice de angina renal y el requerimiento de terapia de sustitución renal. Se realizó ecografía pulmonar al ingreso. En el análisis estadístico, para las variables cuantitativas se determinaron la media y la desviación estándar, y para las variables cualitativas la frecuencia y el porcentaje. Se evaluaron las diferencias de la distribución con la prueba exacta de Fisher. RESULTADOS: Hubo 45 pacientes con infección por VRS. El 26.7% requirieron ventilación mecánica invasiva y el 11.1% diálisis peritoneal. La letalidad fue de cuatro casos, tres de ellos menores de 12 meses con puntuación de LUS > 7; esto contrasta con el 90.2% de los sobrevivientes con puntaje < 7 (p = 0.0004). CONCLUSIONES: Se observó un aumento en la incidencia de bronquiolitis tras la pandemia, en más de la mitad de los casos con cuadros de moderados a graves, y todos requirieron oxígeno suplementario al ingreso. La lesión renal aguda fue la manifestación extrapulmonar más frecuente.

Respiratory syncytial virus: A new era / Virus respiratorio sincitial: un nuevo tiempo

Respiratory syncytial virus (RSV) is a major public health problem that has undergone significant changes in recent years. First of all, it has become easier to diagnose with highly reliable and rapidly available confirmatory tests. This has led to a better understanding of its epidemiology and RSV has gone from being a disease of the pediatric age group, severe only in infants and immunosuppressed children, to being a common disease in people of all ages, particularly important in patients of advanced age or with immunosuppressive diseases. Recent therapeutic and prophylactic advances, both with long-lasting monoclonal antibodies and vaccines, are another reason for satisfaction. For these reasons, the COVID and Emerging Pathogens Committee of the Illustrious Official College of Physicians of Madrid (ICOMEM) has considered it pertinent to review this subject in the light of new knowledge and new resources for dealing with this infection. We have formulated a series of questions that we believe will be of interest not only to members of the College but also to any non-expert in this subject, with a particular focus on the situation of RSV infection in Spain. (AU)

El Virus Respiratorio Sincitial (VRS), es un problema de salud pública de primera magnitud que en años recientes ha experimentado cambios muy importantes. En primer lugar, se ha producido una mayor facilidad diagnóstica con pruebas confirmatorias altamente fiables y rápidamente disponibles. Esto ha permitido conocer mejor su epidemiología y VRS ha pasado de ser una enfermedad de la edad pediátrica, grave sólo en lactantes y niños inmunodeprimidos, a ser una enfermedad común en personas de toda edad, particularmente importante en pacientes de edades avanzadas o con enfermedades que inmunodeprimen. Los avances terapéuticos y profilácticos, recientes, tanto con anticuerpos monoclonales de larga duración como con vacunas, constituyen otro motivo de satisfacción. Por estos motivos, el Comité de COVID y de patógenos emergentes del Ilustre Colegio Oficial de Médicos de Madrid (ICOMEM) ha considerado pertinente revisar este tema, a la luz de los nuevos conocimientos y de los nuevos recursos para afrontar esta infección. Hemos formulado una serie de preguntas que creemos de interés no sólo para los colegiados si no para cualquier persona no experta en este tema, con una vista particular en la situación de la infección por VRS en España. (AU)

Vacunar a la embarazada puede prevenir la bronquiolitis por virus respiratorio sincitial en el lactante / Vaccinating pregnant women can prevent respiratory syncytial virus bronchiolitis in infants

Conclusiones de los autores del estudio: la vacuna de proteína F prefusión contra el virus respiratorio sincitial, administrada a embarazadas en el último trimestre de embarazo, previene de infecciones respiratorias graves por dicho virus en sus lactantes, sin efectos adversos de importancia. Comentario de los revisores: la vacuna parece eficaz y segura, aunque las estimaciones de eficacia son imprecisas. Constituye una opción preventiva alternativa a la administración de nirsevimab en el recién nacido, con expectativas de impacto equiparables. (AU)

Authors´ conclusions: prefusion F protein vaccine against respiratory syncytial virus administered to pregnant women in the last trimester of pregnancy prevents this virus severe respiratory infections in their infants, without important adverse effects. Reviewers´ commentary: the vaccine appears effective and safe, although its efficacy estimates are imprecise. It constitutes an alternative preventive option to the administration of nirsevimab in the newborn, with comparable impact expectations. (AU)

Respiratory syncytial virus infection in adults: Differences with influenza.

INTRODUCTION: Respiratory syncytial virus (RSV) causes an acute respiratory illness similar to influenza, although there are few data comparing both of them in adults. The existence of clinical differences between these two infections could have implications for their management. MATERIALS AND METHODS: Retrospective observational cohort study including 63 adults with positive PCR for RSV and 221 for influenza during winter 2018-2019. Epidemiological, clinical characteristics and outcomes were contrasted between both groups. RESULTS: Compared to influenza, RSV-positive patients presented a higher association with active neoplasia (OR=2.9; 95% CI: 1.2-6.9), dependence for basic activities of daily living (OR=3.4; 95% CI: 1.4-8.2) and immunosuppression due to chronic glucocorticoid administration (OR=7.6; 95% CI: 1.6-36.1). At diagnosis, fever was less common (OR=0.3; 95% CI: 0.2-0.7), and C-reactive protein level ≥100mg/l was more frequent (OR=2.1; 95% CI: 1.0-4.5). They developed bacterial co-infection by Staphylococcus aureus in a higher proportion (OR=8.3; 95% CI: 1.5-46.9) and presented a greater need for admission to the intensive care unit (OR=5.4; 95% CI: 1.4-19.2). CONCLUSION: RSV is an important cause of respiratory illness in adults during the influenza season. It especially affects vulnerable patients with chronic underlying diseases, and has a higher morbidity than influenza. For all these reasons, specific detection, prevention and treatment of RSV is necessary in order to reduce the consumption of health care resources due to RSV disease in adults.

The MVA vector expressing the F protein of bovine respiratory syncytial virus is immunogenic in systemic and mucosal immunization routes.

Bovine respiratory syncytial virus (BRSV) affects both beef and dairy cattle, reaching morbidity and mortality rates of 60-80% and 20%, respectively. The aim of this study was to obtain a recombinant MVA expressing the BRSV F protein (MVA-F) as a vaccine against BRSV and to evaluate the immune response induced by MVA-F after systemic immunization in homologous and heterologous vaccination (MVA-F alone or combined with a subunit vaccine), and after intranasal immunization of mice. MVA-F administered by intraperitoneal route in a homologous scheme elicited levels of neutralizing antibodies similar to those obtained with inactivated BRSV as well as better levels of IFN-γ secretion. In addition, nasal administration of MVA-F elicited local and systemic immunity with a Th1 profile. This study suggests that MVA-F is a good candidate for further evaluations combining intranasal and intramuscular routes, in order to induce local and systemic immune responses, to improve the vaccine efficacy against BRSV infection.

Actualización en prevención de VRS: Nirsevimab vs vacunación en embarazadas (RSVpreF) / Update on RSV prevention: Nirsevimab vs vaccination in pregnant women (RSVpreF)

El anticuerpo monoclonal Nirsevimab fue el primero que se implantó para la prevención de infección por virus respiratorio sincitial (VRS) de todos los lactantes en sus primeros meses de vida. Recientemente se ha aprobado el uso de una vacuna en la embarazada (RSVpreF) con distinta forma de inmunización pero el mismo objetivo en el lactante. De este modo, surge la necesidad de valorar una nueva estrategia de inmunización. Desarrollo. Nirsevimab demostró en ensayos clínicos buenos datos de eficacia clínica y de seguridad. Tras su inclusión en la temporada epidémica 2023-2024, la cobertura en España ha sido muy alta y los resultados preliminares parecen mantener la tendencia de los ensayos. Queda pendiente una valoración adecuada de su eficiencia. RSVpreF tiene resultados similares pero, de momento, solo en ensayos y, aunque podría tener alguna ventaja inmunológica, se desconoce si se traduciría en eficacia real. Aún así, esta nueva vacuna respaldada por organismos sanitarios y científicos sería una alternativa segura y eficaz. Por otro lado, incluso con la implementación en el calendario vacunal de RSVpreF, Nirsevimab va a continuar siendo clave en la protección de ciertos lactantes. Conclusión. La aprobación de la vacuna en la embarazada RSVpreF añade una segunda herramienta inmunológica frente a la infección por VRS en lactantes. RSVpreF y Nirsevimab pueden desarrollar un papel complementario en la prevención de estas infecciones.(AU)

Introduction: Nirsevimab was the first monoclonal antibody to be implemented in order to prevent respiratory syncytial virus (RSV) infection in all infants in their first months of life. The use of a vaccine in pregnant women (RSVpreF) using a different way of immunization but still sharing the same objective in infants has recently been approved. Thus, there is a necessity to evaluate a new immunization strategy. Development. Nirsevimab showed good clinical efficacy and safety data in medical trials. After its inclusion in the 2023-2024 epidemic season, coverage in Spain has been very high and preliminary results seem to maintain the trend shown in the trials. An adequate assessment of its efficiency is still pending. RSVpreF has similar results but, for now, only in trials and although it could have some immunological advantages, it is unknown if it would result in actual efficacy. Even so, this new vaccine, supported by health and scientific organizations, would provide a safe and effective alternative. Nonetheless, even with the implementation in the RSVpreF vaccine schedule, Nirsevimab will continue to be a key factor in the protection of certain infants. Conclusion. The approval of the RSVpreF vaccine in pregnant women adds a second immunological tool against RSV infections in infants. RSVpreF and Nirsevimab may play a complementary role in the prevention of these infections.(AU)

Influencia de la pandemia dela COVID-19 en la distribución de la bronquiolitis aguda en España / Influence of the pandemic of COVID-19 in distribution of acute bronchiolitis in Spain

Fundamentos: La bronquiolitis es la primera causa de hospitalización en menores de un año, presentándose en forma de epidemias anuales. Desde el inicio de la pandemia por la enfermedad causada por el coronavirus SARS-CoV-2 (COVID-19) se ha producido un cambio en la transmisión de otros virus respiratorios. Nuestro objetivo en este trabajo fue describir cómo había afectado la pandemia de la COVID-19 a la distribución de la bronquiolitis aguda en nuestro país. Métodos: Realizamos un estudio descriptivo retrospectivo de los casos de bronquiolitis atendidos en una muestra de hospitales españoles que pertenecían a cuatro comunidades autónomas. Empleado el test chi-cuadrado y la pruebat de Student comparamos variables epidemiológicas y demográficas de los casos de bronquiolitis atendidos durante enero de 2021 y junio 2021, con los tres años anteriores (2018-2020). Resultados: Analizamos 6.124 casos de bronquiolitis (58,8% varones y 41,2% mujeres). La media de edad fue de 0,5 años (DE: 0,4). En 2020 observamos un descenso de casos de bronquiolitis con respecto a 2019 del 67%. Durante 2020 y 2021 la temporada epidémica empezó en enero-febrero y alcanzó su pico máximo en junio. Durante el primer semestre de 2021, el porcentaje más elevado de ingresos por bronquiolitis asociados a infección VRS fue observado en hospitales del centro de España correspondientes a la Comunidad Autónoma de Madrid (78,5% de los ingresos). Conclusiones: La pandemia por la COVID-19 modifica de manera significativa la estacionalidad de la bronquiolitis. En nuestro país, el flujo y distribución de la enfermedad no es uniforme, comenzado por el centro peninsular y, por último, la zona litoral.(AU)

Background: Bronchiolitis is the leading cause of hospitalization in children under one year of age, with annual epidemics. Sincethe onset of the SARS-CoV-2 coronavirus disease pandemic (COVID-19), there has been a change in the transmission of other respiratory viruses. Our aim in this paper was to describe how COVID-19 had affected the distribution of acute bronchiolitis in our country. Methods: We conducted a retrospective descriptive study of the cases of bronchiolitis treated in a sample of Spanish hospitals belonging to four autonomous communities. A chi-square test and Student’s t- test were used to compare epidemiological and demographicvariables between patients attending the hospital with bronchiolitis during January 2021-June 2021 with patients attending the hospital in the previous three years (2018-2020). Results: We analyzed 6,124 cases of bronchiolitis (58.8% males and 41.2% females). The mean age was 0.5 years (SD: 0.4). In 2020, weobserved a decrease of bronchiolitis cases compared to 2019 of 67%. During 2020 and 2021, the epidemic season started in January-February and peaked in June. During the first half of 2021, the highest percentage of admissions for bronchiolitis associated with RSVinfection was observed in hospitals in central Spain corresponding to the Autonomous Community of Madrid (78.5% of admissions).Conclusions: The COVID-19 pandemic significantly modifies the seasonality of bronchiolitis. In our country, the flow and distri-bution of the disease are not uniform. It starts in the center of Spain and ends on the coast.(AU)

Evidentia praxis: nirsevimab y prevención de bronquiolitis en lactantes nacidos a término / Evidentia praxis: Nirsevimab and bronchiolitis prevention in term-born infants

Analizamos la evidencia publicada sobre la eficacia y seguridad de nirsevimab, un anticuerpo monoclonal, empleado para prevenir las infecciones de vías respiratorias bajas (IVRB) por virus respiratorio sincitial (VRS) en el lactante a término. Encontramos un ensayo clínico aleatorizado controlado con placebo doble ciego que incluyó 3012 lactantes, nacidos a término o pretérmino tardío, menores de un año con un seguimiento de al menos 150 días. La calidad de la evidencia se clasificó como baja para IVRB muy grave y moderada para IVRB que precisara asistencia o ingreso. La evidencia se sustenta sobre un escaso número de eventos (para ingresos hospitalarios sólo 29 casos, para IVRB con atención médica 78), por lo que cualquier estimación debe considerarse imprecisa. La eficacia, estimada como reducción relativa del riesgo (RRR) fue del 76,4% (intervalo de confianza del 95% [IC 95]: 62,3 a 85,2) para IVRB por VRS y del 76,8% (IC 95: 49,4 a 89,4%) para ingreso. No se encontraron diferencias en cuanto a seguridad. Existen dudas sobre la importancia clínica, por los criterios de gravedad empleados, y sobre su impacto, con un número necesario a tratar para evitar una IVRB con ingreso de 63 y que requiera asistencia médica de 24. Por la información disponible parece una intervención segura, de la que no esperamos efectos adversos comunes, pero no podemos descartar efectos de baja frecuencia. Asimismo, esperamos contar pronto con estimaciones más precisas de eficacia y seguridad (AU)

We reviewed the published evidence on the efficacy and safety of nirsevimab, a monoclonal antibody, used to prevent respiratory syncytial virus (RSV) associated lower respiratory tract infections (LRTI) in term infants. We have found a randomized double-blind placebo-controlled clinical trial that included 3012 infants, born at term or late preterm, less than one year of age with a follow-up of at least 150 days. The quality of the evidence was classified as low for very severe LRTI and moderate for LRTI requiring medical care or admission. The evidence is based on a small number of events (only 29 cases for hospital admissions, 78 for IVRB with medical care), so any estimate must be considered imprecise. Efficacy, estimated as relative risk reduction (RRR) was 76.4% (95% confidence interval [95 CI]: 62.3 to 85.2) for RSV associated LRTI that required medical care and 76.8% (CI 95: 49.4 to 89.4%) for hospital admission. No differences were found in terms of safety. There are doubts about the clinical importance, due to the severity criteria used, and about its impact, with a number needed to treat of 63 to avoid a LRTI with hospital admission and of 24 to avoid LRTI requiring medical care. Based on the available information, it seems a safe intervention, from which we do not expect common adverse effects, but we cannot rule out low-frequency effects. We also expect to have more precise estimates of efficacy and safety soon. (AU)

Comentario del Comité Asesor de Vacunas de la Asociación Española de Pediatría a Evidencias en Pediatría sobre nirsevimab / Comment by the Advisory Committee on Vaccines of the Spanish Association of Paediatrics on Evidences in Paediatrics about nirsevimab

La bronquiolitis sigue siendo un problema de salud de primer orden en nuestro país, pues genera anualmente miles de consultas en Atención Primaria, colapso en las plantas de hospitalización y cuidados intensivos pediátricas y costes millonarios al Sistema Nacional de Salud. Su interés es máximo, además, porque la mayoría de los que requerirán ingreso hospitalario serán lactantes sanos, sin ningún tipo de factor de riesgo conocido. La altísima incidencia de la enfermedad y la ausencia de un tratamiento específico hace que los pediatras asistamos impasibles a esta epidemia anual, sin poder ofrecer una opción ni preventiva ni terapéutica a nuestros pacientes. En noviembre de 2022, la Agencia Europea de Medicamentos autorizó la comercialización de un anticuerpo monoclonal específico contra la proteína F del virus respiratorio sincitial (VRS), tras los resultados de los ensayos iniciales realizados en más de 3000 lactantes en los que se demostró una eficacia en la prevención de hospitalizaciones por VRS superior al 75%. En mayo de 2023 se comunicaron los resultados preliminares del estudio HARMONIE, llevado a cabo en más de 8000 individuos, representando la primera experiencia en vida real con el uso de nirsevimab y obteniéndose una eficacia superior al 80% en la prevención de hospitalización por bronquiolitis. En este texto se exponen los argumentos del Comité Asesor de Vacunas de la Asociación Española de Pediatría que sustentan la recomendación que hizo este organismo para su uso sistemático en recién nacidos y lactantes menores de 6 meses en España (AU)

Bronchiolitis continues to be a major health problem in Spain, as it generates thousands of consultations in primary care every year, a backlog in paediatric hospitalisation and intensive care wards, and millions in costs to the National Health System. Most of those who require hospital admission are healthy infants, without any known risk factor. The very high incidence of the disease and the absence of a specific treatment means that paediatricians are impassive in the face of this annual epidemic, unable to offer our patients either a preventive or therapeutic option. In November 2022, the European Medicines Agency granted marketing authorisation for a monoclonal antibody specific against respiratory syncytial virus (RSV) F protein, following results from initial trials in more than 3,000 infants that demonstrated greater than 75% efficacy in preventing RSV hospitalisations. Preliminary results from the HARMONIE study, conducted in over 8000 individuals, were reported in May 2023, representing the first real-life experience with the use of nirsevimab and showing greater than 80% efficacy in preventing hospitalisations for bronchiolitis. This text presents the arguments of the Vaccine Advisory Committee of the Spanish Association of Paediatrics to support the recommendation made by this group for its routine use in newborns and infants under 6 months of age in Spain(AU)

Nirsevimab para la prevención de la enfermedad por virus respiratorio sincitial en niños. Posicionamiento de la Sociedad Española de Infectología Pediátrica / Nirsevimab for the prevention of respiratory syncytial virus disease in children: Statement of the Spanish Society of Paediatric Infectious Disease (SEIP)

Introducción: Recientemente se ha aprobado en Europa y en España el uso de nirsevimab, un anticuerpo monoclonal (AcM) para la prevención de la enfermedad por virus respiratorio sincitial (VRS). Objetivos: Facilitar unas recomendaciones para la administración de nirsevimab para la prevención de la enfermedad por VRS. Métodos: Para la elaboración de estas recomendaciones, se decidió realizar una revisión crítica de la literatura, utilizando la metodología Delphi y la metodología GRADE. Se definió un grupo de expertos. Se realizaron tres rondas para definir las preguntas, manifestarse a favor o en contra, graduar la recomendación, y definir el acuerdo o el desacuerdo con las conclusiones. Resultados: En la población general de recién nacidos, se recomienda administrar rutinariamente nirsevimab para reducir la enfermedad y la hospitalización por bronquiolitis y enfermedad de vías bajas por VRS. Se recomienda administrar nirsevimab a todos los lactantes que nazcan en la estación de alta incidencia de VRS y aquellos que cuando esta comience, tengan menos de seis meses de edad. En los pacientes prematuros de 29 a 35 semanas de edad gestacional, en los lactantes con cardiopatía hemodinámicamente significativa y lactantes con enfermedad pulmonar crónica se recomienda rutinariamente administrar nirsevimab para reducir la enfermedad y la hospitalización por bronquiolitis y enfermedad de vías bajas por VRS. En los pacientes con indicación actual de palivizumab, se recomienda sustituir palivizumab por nirsevimab para reducir la carga de enfermedad de bronquiolitis. Conclusiones: Se recomienda administrar rutinariamente nirsevimab a todos los recién nacidos menores de seis meses nacidos en la estación de VRS o que tengan menos de seis meses cuando entran en la estación invernal, para reducir la carga de enfermedad y la hospitalización por bronquiolitis. (AU)

Introduction: Nirsevimab, a monoclonal antibody for the prevention of disease caused by respiratory syncytial virus (RSV), has recently been approved for use in Europe and Spain. Objectives: To provide recommendations for the administration of nirsevimab for prevention of RSV disease. Methods: The approach chosen to develop these recommendations involved a critical review of the literature and the use of the Delphi and GRADE methods. An expert group was formed. The group engaged in three rounds to define the questions, express support or opposition, grade recommendations and establish the agreement or disagreement with the conclusions. Results: In the general neonatal population, routine administration of nirsevimab is recommended to reduce the frequency of illness and hospitalisation for bronchiolitis and RSV lower respiratory tract infection. Nirsevimab is recommended for all infants born in high-incidence RSV season and infants aged less than 6 months at the season onset. In infants born preterm between 29 and 35 weeks of gestation, with haemodynamically significant heart disease or with chronic lung disease, routine administration of nirsevimab is recommended to reduce the incidence of disease and hospitalisation due to bronchiolitis and RSV lower respiratory tract infection. In patients in whom palivizumab is currently indicated, its substitution by nirsevimab is recommended to reduce the burden of bronchiolitis. Conclusions: Routine administration of nirsevimab to all infants aged less than 6 months born during the RSV season or aged less than 6 months at the start of the winter season is recommended to reduce the burden of disease and the frequency of hospitalization due to bronchiolitis. (AU)

Nirsevimab for the prevention of respiratory syncytial virus disease in children. Statement of the Spanish Society of Paediatric Infectious Disease (SEIP).

INTRODUCTION: Nirsevimab, a monoclonal antibody for the prevention of disease caused by respiratory syncytial virus (RSV), has recently been approved for use in Europe and Spain. OBJECTIVES: To provide recommendations for the administration of nirsevimab for prevention of RSV disease. METHODS: The approach chosen to develop these recommendations involved a critical review of the literature and the use of the Delphi and GRADE methods. An expert group was formed. The group engaged in three rounds to define the questions, express support or opposition, grade recommendations and establish the agreement or disagreement with the conclusions. RESULTS: In the general neonatal population, routine administration of nirsevimab is recommended to reduce the frequency of illness and hospitalisation for bronchiolitis and RSV lower respiratory tract infection. Nirsevimab is recommended for all infants born in high-incidence RSV season and infants aged less than 6 months at the season onset. In infants born preterm between 29 and 35 weeks of gestation, with haemodynamically significant heart disease or with chronic lung disease, routine administration of nirsevimab is recommended to reduce the incidence of disease and hospitalisation due to bronchiolitis and RSV lower respiratory tract infection. In patients in whom palivizumab is currently indicated, its substitution by nirsevimab is recommended to reduce the burden of bronchiolitis. CONCLUSIONS: Routine administration of nirsevimab to all infants aged less than 6 months born during the RSV season or aged less than 6 months at the start of the winter season is recommended to reduce the burden of disease and the frequency of hospitalization due to bronchiolitis.

Clinical relevance of viral codetection in infants with respiratory syncytial virus bronchiolitis.

INTRODUCTION: Respiratory syncytial virus (RSV) is the main cause of severe bronchiolitis, especially in infants. The aim of this study is to assess whether codetection of RSV and other respiratory viruses could affect the severity of this infection comparing with unique RSV detection. METHODS: A prospective study from 2016 to 2019 including children under 2 years who were admitted in the Emergency Service of the Hospital Universitari Arnau de Vilanova de Lleida (Spain) was performed. Nasopharyngeal samples from all patients were sent to the laboratory for RSV real-time PCR detection (GeneXpert®). A multiplex PCR that detects other respiratory viruses was done in all RSV-positive samples. Patients'medical records were checked to collect clinical data (hospital length of stay, BROSJOD score, ICU admission, need for ventilatory support or transfer to a reference hospital). Patients were divided in two groups: infants with unique RSV detection and infants with viral codetection. Bivariant analyses were performed to analyze the data obtained. RESULTS: During the period of study 437 RSV bronchiolitis were diagnosed. In 199 of them (177/437; 45,5%) another respiratory virus was detected concomitantly. Bivariant analyses do not show statistically significant differences between both groups. CONCLUSIONS: Viral codetection in infants with RSV bronchiolitis is frequent. However, it does not seems to affect the severity of this infection.

Influencia de la pandemia COVID-19 sobre la epidemiología de la bronquiolitis aguda / Influence of the COVID-19 pandemic on the epidemiology of acute bronchiolitis

Introducción: La pandemia COVID-19ha modificado la propagación de ciertos virus respiratorios causantes de bronquiolitis aguda. Analizamos la epidemiología de los ingresos por bronquiolitis durante la pandemia COVID-19 en comparación con ocho temporadas epidémicas anteriores. Métodos: Estudio observacional ambispectivo, que incluyó lactantes con bronquiolitis ingresados en un hospital terciario durante dos períodos: pandemia COVID-19 (15 de marzo de 2020 a 31 de agosto de 2021) y pre-pandemia (1 de septiembre de 2012 a 14 de marzo de 2020). Se recogieron características demográficas, clínicas y etiología. Resultados: Ingresaron 510 pacientes por bronquiolitis: 486 en el período pre-pandemia con una media de 61 ingresos por temporada vs. 24 durante la pandemia, observándose una reducción de ingresos del 60,7%. Durante la pandemia, el brote epidémico se inició con retraso abarcando la primavera-verano de 2021. El virus respiratorio sincitial fue el agente etiológico más frecuente en ambos períodos. Conclusiones: Observamos un cambio estacional de la bronquiolitis durante la pandemia COVID-19, probablemente influenciado por las medidas de control frente a SARS-CoV-2.(AU)

Introduction: The COVID-19 pandemic has changed the circulation of some viruses associated with acute bronchiolitis. We analyzed the epidemiology of bronchiolitis admissions during the COVID-19 pandemic compared with 8 previous epidemic seasons. Methods: An observational and ambispective study was performed, including infants admitted with bronchiolitis in a tertiary hospital during 2 periods: COVID-19 pandemic (15th March 2020 to 3rd August 2021) and pre-pandemic (1st September 2012 to 14th March 2020). Demographic, clinical data and etiologies were collected. Results: Five hundred ten patients were hospitalized with bronchiolitis: 486 in the pre-pandemic period with an average of 61 admissions per season vs. 24 during the pandemic, observing a 60.7% reduction in bronchiolitis admissions. During the pandemic, bronchiolitis outbreak was delayed until spring–summer 2021. Respiratory syncytial virus was the most frequent etiological agent in both periods. Conclusion: We observed a change in the seasonality of bronchiolitis during the pandemic COVID-19, possibly influenced by control measures against SARS-CoV-2..(AU)

Respiratory syncytial virus outbreak during the COVID-19 pandemic. How has it changed? / Epidemia de virus respiratorio sincitial durante la pandemia de COVID-19. ¿Cómo ha cambiado?

Introduction: The epidemiology of respiratory syncytial virus (RSV) infection has changed during the COVID-19 pandemic. Our objectives were to describe the RSV epidemic in 2021 and compare it with the previous years to the pandemic. Methods: Retrospective study performed in Madrid (Spain) in a large pediatric hospital comparing the epidemiology and clinical data of RSV admissions during 2021 and the two previous seasons. Results: 899 children were admitted for RSV infection during the study period. During 2021, the outbreak peaked in June and the last cases were identified in July. Previous seasons were detected in autumn-winter. The number of admissions in 2021 was significantly lower than in previous seasons. There were no differences between seasons regarding age, sex or disease severity. Conclusion: RSV hospitalizations during 2021 in Spain moved to summer with no cases in autumn and winter 2020–2021. Unlike other countries, clinical data were similar between epidemics.(AU)

Introducción: La epidemiología de la infección por virus respiratorio sincitial (VRS) ha cambiado durante la pandemia de COVID-19. Nuestros objetivos fueron describir la epidemia de VRS en 2021 y compararla con las de los años previos a la pandemia. Métodos: Estudio retrospectivo realizado en Madrid (España), en un hospital pediátrico terciario, que compara los datos epidemiológicos y clínicos de los ingresos por VRS durante 2021 y las 2 temporadas anteriores. Resultados: Ingresaron 899 niños por infección por VRS en el período de estudio. Durante 2021, el brote alcanzó su punto máximo en junio y los últimos casos se identificaron en julio. En las temporadas anteriores se detectaron en otoño-invierno. El número de hospitalizaciones en 2021 fue significativamente menor que en temporadas anteriores. No hubo diferencias entre temporadas en cuanto a edad, sexo o gravedad de la enfermedad. Conclusión: Las hospitalizaciones por VRS durante 2021 en España se trasladaron a verano, sin casos en otoño e invierno 2020-2021. A diferencia de otros países, los datos clínicos fueron similares entre epidemias.(AU)

Respiratory syncytial virus outbreak during the COVID-19 pandemic. How has it changed?

INTRODUCTION: The epidemiology of respiratory syncytial virus (RSV) infection has changed during the COVID-19 pandemic. Our objectives were to describe the RSV epidemic in 2021 and compare it with the previous years to the pandemic. METHODS: Retrospective study performed in Madrid (Spain) in a large pediatric hospital comparing the epidemiology and clinical data of RSV admissions during 2021 and the two previous seasons. RESULTS: 899 children were admitted for RSV infection during the study period. During 2021, the outbreak peaked in June and the last cases were identified in July. Previous seasons were detected in autumn-winter. The number of admissions in 2021 was significantly lower than in previous seasons. There were no differences between seasons regarding age, sex or disease severity. CONCLUSION: RSV hospitalizations during 2021 in Spain moved to summer with no cases in autumn and winter 2020-2021. Unlike other countries, clinical data were similar between epidemics.

Evaluación positiva de medicamentos: febrero, marzo y abril 2023 / Positive assessment of drugs: february, march and april 2023

Se reseñan los medicamentos evaluados y con dictamen positivo por comisión de expertos de la Agencia Española de Medicamentos y Productos Sanitarios o de la Agencia Europea del Medicamento hechos públicos en febrero, marzo y abril de 2023 considerados de mayor interés para los profesionales sanitarios. Se trata de opiniones técnicas positivas que son previas a la autorización y puesta en el mercado del medicamento. (AU)

The drugs assessed by the Spanish Agency for Medicines and Health Products or European Medicines Agency issued in February, March and April 2023, and considered of interest to healthcare professionals, are reviewed. These are positive technical reports prior to the authorization and placing on the market of the product. (AU)

Evaluación positiva de medicamentos: febrero, marzo y abril 2023 / Positive assessment of drugs: february, march and april 2023

Se reseñan los medicamentos evaluados y con dictamen positivo por comisión de expertos de la Agencia Española de Medicamentos y Productos Sanitarios o de la Agencia Europea del Medicamento hechos públicos en febrero, marzo y abril de 2023 considerados de mayor interés para los profesionales sanitarios. Se trata de opiniones técnicas positivas que son previas a la autorización y puesta en el mercado del medicamento. (AU)

The drugs assessed by the Spanish Agency for Medicines and Health Products or European Medicines Agency issued in February, March and April 2023, and considered of interest to healthcare professionals, are reviewed. These are positive technical reports prior to the authorization and placing on the market of the product. (AU)

EDP-938, un nuevo antiviral con actividad inhibidora frente a la nucleoproteína del virus respiratorio sincitial / EDP-938, a new antiviral with inhibitory activity against the nucleoprotein of the respiratory syncytial virus

La ausencia de una vacuna eficaz frente al virus respiratorio sincitial (VRS) ha determinado el desarrollo de diversos fármacos con capacidad para inhibir o bloquear su actividad replicadora. Los de primera generación, denominados inhibidores de la fusión, se fijan a la proteína F de la superficie viral y evitan la unión y entrada del virus en la célula. Sin embargo su baja eficacia ha determinado el inicio de los estudios con los compuestos de segunda generación capaces de unirse o bloquear la nucleoproteína (N); la mayoría de estos compuestos son análogos de las 1,4-benzodiacepinas. El EDP-938 ha mostrado una elevada eficacia frente al VRS. Los primeros ensayos realizados en humanos han mostrado que este antiviral se absorbe de forma rápida tras su administración oral y presenta una vida media de entre 11-18 horas La administración durante siete días de múltiples dosis orales de hasta 600 mg/día o 300 mg/2 veces al día, no presentaban apenas efectos adversos significativos y disminuía significativamente la carga viral a nivel del tracto respiratorio inferior. (AU)

The absence of an effective vaccine against respiratory syncytial virus (RSV) has led to the development of various drugs with the ability to inhibit or block its replicative activity. The first generation, called fusion inhibitors, bind to the protein on the viral surface and prevent the virus from binding and entering the cell. However, its low efficacy has determined the start of studies with second-generation compounds capable of binding or blocking the nucleoprotein (N); most of these compounds are analogs of 1,4-benzodiazepines. EDP-938 has shown high efficacy against RSV. The first trials in humans have shown that this antiviral is rapidly absorbed after oral administration and has a half-life of between 11-18 hours Administration for seven days of multiple oral doses of up to 600 mg/day or 300 mg/day/twice a day, there were hardly any significant adverse effects and the viral load in the lower respiratory tract decreased significantly. (AU)

Infección por virus respiratorio sincitial en adultos: diferencias con la gripe / Respiratory syncytial virus infection in adults: Differences with influenza

Introducción: El virus respiratorio sincitial (VRS) produce una enfermedad respiratoria aguda parecida a la gripe, aunque en adultos existen pocos datos que las comparen. La existencia de diferencias clínicas entre ambas infecciones podría conllevar implicaciones en su manejo. Materiales y métodos: Estudio observacional de cohortes retrospectivo incluyendo 63 adultos con PCR positiva para VRS y 221 para gripe durante el invierno 2018-2019. Se contrastaron las características epidemiológicas, clínicas y desenlaces entre ambos grupos. Resultados: En comparación con la gripe los pacientes VRS positivos asociaron mayor relación con neoplasia activa (OR=2,9; IC 95%: 1,2-6,9), dependencia para las actividades básicas de la vida diaria (OR=3,4; IC 95%: 1,4-8,2) e inmunosupresión por administración crónica de glucocorticoides (OR=7,6; IC 95%: 1,6-36,1). Al diagnóstico era menos común la presencia de fiebre (OR=0,3; IC 95%: 0,2-0,7) y más frecuente un nivel de proteína C reactiva≥100mg/l (OR=2,1; IC 95%: 1,0-4,5). Desarrollaron coinfección bacteriana por Staphylococcus aureus en mayor proporción (OR=8,3; IC 95%: 1,5-46,9) y presentaron una mayor necesidad de ingreso en la unidad de cuidados intensivos (OR=5,4; IC 95%: 1,4-19,2). Conclusión: El VRS es una causa importante de enfermedad respiratoria en adultos durante la época de gripe. Afecta especialmente a pacientes vulnerables con enfermedades crónicas de base, y presenta una morbilidad clínica superior a la gripe. Por todo ello es necesaria la detección, prevención y tratamiento específicos del VRS con el objetivo de reducir el consumo de recursos sanitarios que supone la enfermedad por VRS en adultos.(AU)

Introduction: Respiratory syncytial virus (RSV) causes an acute respiratory illness similar to influenza, although there are few data comparing both of them in adults. The existence of clinical differences between these two infections could have implications for their management. Materials and methods: Retrospective observational cohort study including 63 adults with positive PCR for RSV and 221 for influenza during winter 2018–2019. Epidemiological, clinical characteristics and outcomes were contrasted between both groups. Results: Compared to influenza, RSV-positive patients presented a higher association with active neoplasia (OR=2.9; 95% CI: 1.2–6.9), dependence for basic activities of daily living (OR=3.4; 95% CI: 1.4–8.2) and immunosuppression due to chronic glucocorticoid administration (OR=7.6; 95% CI: 1.6–36.1). At diagnosis, fever was less common (OR=.3; 95% CI: .2–.7), and C-reactive protein level ≥100mg/L was more frequent (OR=2.1; 95% CI: 1.0–4.5). They developed bacterial co-infection by Staphylococcus aureus in a higher proportion (OR=8.3; 95% CI: 1.5–46.9) and presented a greater need for admission to the intensive care unit (OR=5.4; 95% CI: 1.4–19.2). Conclusion: RSV is an important cause of respiratory illness in adults during the influenza season. It especially affects vulnerable patients with chronic underlying diseases, and has a higher clinical morbidity than influenza. For all these reasons, specific detection, prevention and treatment of RSV is necessary in order to reduce the consumption of health care resources due to RSV disease in adults.(AU)

Influence of the COVID-19 pandemic on the epidemiology of acute bronchiolitis.

INTRODUCTION: The COVID-19 pandemic has changed the circulation of some viruses associated with acute bronchiolitis. We analyzed the epidemiology of bronchiolitis admissions during the COVID-19 pandemic compared with 8 previous epidemic seasons. METHODS: An observational and ambispective study was performed, including infants admitted with bronchiolitis in a tertiary hospital during 2 periods: COVID-19 pandemic (15th March 2020 to 3rd August 2021) and pre-pandemic (1st September 2012 to 14th March 2020). Demographic, clinical data and etiologies were collected. RESULTS: Five hundred ten patients were hospitalized with bronchiolitis: 486 in the pre pandemic period with an average of 61 admissions per season vs 24 during the pandemic, observing a 60.7% reduction in bronchiolitis admissions. During the pandemic, bronchiolitis outbreak was delayed until spring-summer 2021. Respiratory syncytial virus was the most frequent etiological agent in both periods. CONCLUSION: We observed a change in the seasonality of bronchiolitis during the pandemic COVID-19, possibly influenced by control measures against SARS-CoV-2.