Switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir-based therapy: 96-week pooled analysis.

OBJECTIVE: To evaluate the efficacy and safety of 96 weeks of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) treatment in participants switching from dolutegravir (DTG)-based therapy. DESIGN: Studies 1489 (NCT02607930) and 1490 (NCT02607956) were phase 3 randomized, double-blind, active-controlled, first-line therapy trials in people with HIV-1. After 144 weeks of DTG-based or B/F/TAF treatment, participants could enter a 96-week open-label extension (OLE) of B/F/TAF. METHODS: A pooled analysis evaluated viral suppression (HIV-1 RNA <50 copies/mL) and changes in CD4+ cell count at OLE Weeks 48 and 96, treatment-emergent resistance, safety and tolerability after switch from a DTG-based regimen to B/F/TAF. Outcomes by prior treatment were summarized using descriptive statistics and compared by two-sided Wilcoxon rank sum test. RESULTS: At OLE Week 96, participants who switched to B/F/TAF (N=519) maintained high levels of virologic suppression (99.5% and 99.1% in those switching from DTG/abacavir/lamivudine and DTG+F/TAF, respectively) and CD4+ cell count, with no treatment-emergent resistance to B/F/TAF. Twenty-one participants experienced drug-related adverse events (AEs) after switching, with diarrhea, weight gain and headache occurring most commonly. There were no cases of proximal renal tubulopathy, drug-related Grade 4 AEs or serious AEs. Two participants discontinued B/F/TAF due to treatment-related AEs. Participants who switched from DTG/abacavir/lamivudine experienced statistically significant greater weight gain than those who switched from DTG+F/TAF; however, median weight change from the blinded phase baseline to OLE Week 96 was numerically similar across treatment groups. CONCLUSIONS: This medium-term analysis demonstrates the safety and efficacy of switching to B/F/TAF from a DTG-containing regimen in people with HIV-1.

Tuberculosis in Spain: An opinion paper / Tuberculosis en España: Un documento de opinión

This document is the result of the deliberations of the Committee on Emerging Pathogens and COVID-19 of the Il lustrious Official College of Physicians of Madrid (ICOMEM) regarding the current situation of tuberculosis, particularly in Spain. We have reviewed aspects such as the evolution of its incidence, the populations currently most exposed and the health care circuits for the care of these patients in Spain. We have also discussed latent tuberculosis, the reality of extrapul monary disease in the XXI century and the means available in daily practice for the diagnosis of both latent and active forms. The contribution of molecular biology, which has changed the perspective of this disease, was another topic of discussion. The paper tries to put into perspective both the classical drugs and their resistance figures and the availability and indications of the new ones. In addition, the reality of direct observa tion in the administration of antituberculosis drugs has been discussed. All this revolution is making it possible to shorten the treatment time for tuberculosis, a subject that has also been reviewed. If everything is done well, the risk of relapse of tuberculosis is small but it exists. On the other hand, many special situations have been discussed in this paper, such as tuberculosis in pediatric age and tuberculosis as a cause for concern in surgery and intensive care. The status of the BCG vaccine and its present indications as well as the future of new vaccines to achieve the old dream of eradicating this disease have been discussed. Finally, the ethical and medicolegal impli cations of this disease are not a minor issue and our situation in this regard has been reviewed (AU)

El presente documento es el resultado de las deliberacio nes del Comité sobre Patógenos Emergentes y COVID-19 del Ilustre Colegio Oficial de Médicos de Madrid (ICOMEM) en re lación a la situación actual de la tuberculosis, particularmente en España. Hemos revisado aspectos tales como la evolución de su incidencia, las poblaciones actualmente más expuestas y los circuitos sanitarios para la atención a estos pacientes en España. Se ha discutido también la tuberculosis latente, la rea lidad de la enfermedad extrapulmonar en el siglo XXI y los me dios de que en la práctica diaria se dispone para el diagnóstico tanto de las formas latentes como de las activas. La aportación de la biología molecular que ha cambiado la perspectiva de es ta enfermedad ha constituido otro de los temas de debate. El documento trata de poner en perspectiva tanto los fármacos clásicos y sus cifras de resistencia como la disponibilidad e in dicaciones de los nuevos. Junto a esto, se ha discutido la rea lidad de la observación directa en la administración de fárma cos antituberculosos. Toda esta revolución está posibilitando el acortamiento del tiempo de tratamiento de la tuberculosis tema que ha sido igualmente revisado. Si todo se hace bien, el riesgo de recaída de la tuberculosis es pequeño pero existen te. Por otra parte, muchas situaciones especiales han merecido discusión en este documento como por ejemplo la tuberculosis en edad pediátrica y la tuberculosis como causa de preocupa ción en cirugía y cuidados intensivos. Se ha discutido tanto la situación de la vacuna BCG y sus indicaciones presentes, co mo el futuro de nuevas vacunas que permitan alcanzar el viejo sueño de erradicar esta enfermedad. Finalmente, las implica ciones éticas y medicolegales que esta enfermedad plantea no son un tema menor y se ha revisado nuestra situación en este particular (AU)

Sexually transmitted infections in Spain: Current status / Infecciones de transmisión sexual en España: Situación actual

Sexually Transmitted Infections (STI) are a major public health problem. The problems inherent to their diagnosis, treatment and prevention have to do not only with their nature, but also with organizational issues and overlapping competencies of the different health authorities in Spain. The real situation of STI in Spain, at present, is poorly known. For this reason, the Scientific Committee on COVID and Emerging Pathogens of the Illustrious Official College of Physicians of Madrid (ICOMEM) has formulated a series of questions on this subject which were distributed, not only among the members of the Committee, but also among experts outside it. The central health authorities provide very high and increasing figures for gonococcal infection, syphilis, Chlamydia trachomatis infection and lymphogranuloma venereum (LGV). Both HIV infection and Monkeypox are two important STI caused by viruses in our environment, to which it should be added, mainly, Herpes simplex virus (HSV) and Human papillomavirus (HPV) infections. Emerging microorganisms such as Mycoplasma genitalium pose not only pathogenic challenges but also therapeutic problems, as in the case of N. gonohrroeae. The pathways that patients with suspected STI follow until they are adequately diagnosed and treated are not well known in Spain. Experts understand that this problem is fundamentally managed in public health institutions, and that Primary Care and Hospital Emergency Services, together with some institutions that deal monographically with this problem, are the recipients of most of these patients (AU)

Las Infecciones de Transmisión Sexual (ITS) constituyen un problema de Salud Pública de primera magnitud. Los prob lemas inherentes a su diagnóstico, tratamiento y prevención tienen que ver no solo con la naturaleza de las mismas, sino también con problemas de organización y de solapamiento de competencias de las distintas autoridades sanitarias. La situación real de las ITS en España no se conoce bien en el momento actual. Por este motivo, el Comité Científico sobre COVID y Patógenos emergentes del Ilustre Colegio Ofi cial de Médicos de Madrid (ICOMEM) se ha formulado una se rie de preguntas sobre este tema que ha distribuido, no sólo entre los miembros del Comité, sino también entre expertos ajenos al mismo. Las autoridades ministeriales aportan cifras muy elevadas y crecientes de infección gonocócica, sífilis, in fección por Chlamydia trachomatis y Linfogranuloma venéreo. Tanto la infección por VIH como Monkeypox son en nuestro medio dos importantes ITS causadas por virus a las que deben añadirse, principalmente, las infecciones por el Virus herpes simplex (VHS) y el Virus del Papiloma Humano (HPV). Emer gen patógenos como Mycoplasma genitalium que plantean no sólo retos patogénicos si no también problemas terapéuticos, como ocurre en el caso de N. gonohrroeae. Los caminos que siguen los pacientes con sospecha de ITS hasta su adecuado diagnóstico y tratamiento no se conocen bien en España. Los expertos entienden que este problema es fundamentalmente manejado en instituciones sanitarias de titularidad pública, y que los servicios de Atención Primaria y de Urgencias Hospitalarias, junto con algunas instituciones monográficamente destinadas a este problema, son los re ceptores de la mayor parte de estas enfermedades. Una de las dificultades más serias de las ITS estriba en la disponibilidad de las pruebas microbiológicas necesarias para su diagnóstico, particularmente en esta época de externalización de servicios de Microbiología (AU)

Advantages and disadvantages of maintaining the mandatory use of masks in health centers and nursing homes in Spain. How and when is it justified to maintain it? / Ventajas e inconvenientes de mantener la obligatoriedad del uso de las mascarillas en centros sanitarios y sociosanitarios en España. ¿Cómo y cuándo está justificado mantenerla?

We address the advantages and disadvantages of main taining the mandatory use of masks in health centers and nursing homes in the current epidemiological situation in Spain and after the declaration of the World Health Organiza tion on May 5, 2023 of the end of COVID-19 as public health emergency. We advocate for prudence and flexibility, respect ing the individual decision to wear a mask and emphasizing the need for its use when symptoms suggestive of a respira tory infection appear, in situations of special vulnerability (such as immunosuppression), or when caring for patients with those infections. At present, given the observed low risk of se vere COVID-19 and the low transmission of other respiratory infections, we believe that it is disproportionate to maintain the mandatory use of masks in a general way in health centers and nursing homes. However, this could change depending on the results of epidemiological surveillance and it would be necessary to reconsider returning to the obligation in periods with a high incidence of respiratory infections (AU)

Abordamos las ventajas e inconvenientes de mantener la obligatoriedad del uso de las mascarillas en centros sani tarios y sociosanitarios en la situación epidemiológica actual de España y tras la declaración de la Organización Mundial de la Salud el 5 de mayo de 2023 del fin de la COVID-19 como emergencia de salud pública. Propugnamos prudencia y flexi bilidad, respetando la decisión individual de usar mascarilla y enfatizando la necesidad de su uso ante la aparición de sín tomas sugestivos de infección respiratoria, en situaciones de especial vulnerabilidad (como inmunodepresión) o al attender pacientes con dichas infecciones. En la actualidad, dado el ba jo riesgo observado de COVID-19 grave y la baja transmisión de otras infecciones respiratorias, creemos que es despropor cionado mantener el uso obligatorio de mascarillas de forma generalizada en centros sanitarios y sociosanitarios. No obs tante, esto podría cambiar en función de los resultados de la vigilancia epidemiológica y habría que reconsiderar volver a la obligatoriedad en periodos con alta incidencia de infecciones respiratorias (AU)

A Risk Assessment Tool for Predicting Fragility Fractures in People with HIV: Derivation and Internal Validation of the FRESIA Model.

People with HIV have a higher risk of fracture than the general population. Because of the low performance of the existing prediction tools, there is controversy surrounding fracture risk estimation in this population. The aim of the study was to develop a model for predicting the long-term risk of fragility fractures in people with HIV. We included 11,899 individuals aged ≥30 years from the Spanish HIV/AIDS research network cohort. We identified incident fragility fractures from medical records, defined as nontraumatic or those occurring after a casual fall, at major osteoporotic sites (hip, clinical spine, forearm, proximal humerus). Our model accounted for the competing risk of death and included 12 candidate predictors to estimate the time to first fragility fracture. We assessed the discrimination and calibration of the model and compared it with the FRAX tool. The incidence rate of fragility fractures was 4.34 (95% CI 3.61 to 5.22) per 1000 person-years. The final prediction model included age, chronic kidney disease, and chronic obstructive pulmonary disease as significant predictors. The model accurately predicted the 5- and 10-year risk of fragility fractures, with an area under the receiving operator characteristic curve of 0.768 (95% CI 0.722 to 0.814) and agreement between the observed and expected probabilities. Furthermore, it demonstrated better discrimination and calibration than the FRAX tool, improving the classification of over 35% of individuals with fragility fractures compared to FRAX. Our prediction model demonstrated accuracy in predicting the long-term risk of fragility fractures. It can assist in making personalized intervention decisions for individuals with HIV and could potentially replace the current tools recommended for fracture risk assessment in this population. © 2023 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Status of Herpes Zoster and Herpes Zoster Vaccines in 2023: A position paper / Situación del herpes zóster y de las vacunas contra el mismo en 2023: Un documento de opinión

Herpes zoster infection (HZ) is an important public health problem due to its high incidence and frequent complications, especially post-herpetic neuropathy . The incidence of HZ increases with age and is more frequent in immunocompromised patients. It is estimated that at least 60,000 people develop HZ each year in Spain.The usual forms of HZ are so clinically characteristic that they do not usually require microbiological confirmation, which is reserved for cases without cutaneous manifestations or with atypical presentation.There are currently two vaccines approved by the regulatory agencies and marketed in Spain to prevent the onset of HZ and its complications. The first (Zostavax®) was marketed by the company MSD and licensed in Europe in 2006 and is a live attenuated virus vaccine that is administered in a single dose, while the second (Shingrix®) is a recombinant vaccine, marketed in 2017 and requires two doses. While the former cannot be administered to immunocompromised persons, the latter can be prescribed to any group of adults.The criteria for the indication and financing of these vaccines have not been uniform in the various autonomous communities of Spain.These and other aspects of HZ have been discussed by a group of experts from the Illustrious Official College of Physicians of Madrid (ICOMEM) whose criteria and opinions are included in this paper. (AU)

La infección por herpes zoster (HZ) es un importante problema de salud pública, por su elevada incidencia y frecuentes complicaciones; en especial la neuropatía post herpética. La incidencia de HZ aumenta con la edad y es más frecuente en inmunodeprimidos. Se calcula que, al menos, 60.000 personas desarrollan HZ cada año en España. Las formas habituales de HZ son tan características clínicamente que no suelen requerir confirmación microbiológica que se reserva para casos sin manifestaciones cutáneas o con manifestaciones atípicas En la actualidad, existen en España dos vacunas aprobadas por las agencias reguladoras y comercializadas para prevenir la aparición de HZ y sus complicaciones. La primera (Zostavax®) fue comercializada por la compañía MSD y autorizada en Europa en 2006 y es una vacuna de virus vivos atenuados que se administra en dosis única, mientras que la segunda (Shingrix®) es una vacuna recombinante, comercializada en 2017 y requiere dos dosis. Mientras la primera no puede ser administrada a inmunodeprimidos, la segunda puede administrarse a cualquier grupo de personas. Los criterios de indicación y de financiación de estas vacunas no han sido uniformes en las diversas comunidades autónomas de España. Estos y otros aspectos sobre HZ han sido discutidos por un grupo de expertos del Ilustre Colegio Oficial de Médicos de Madrid (ICOMEM) cuyo criterio y opinión recogemos en este trabajo. (AU)

Insights for COVID-19 in 2023 / Perspectivas de COVID-19 para 2023

Predictions for a near end of the pandemic by the World Health Organization should be interpreted with caution. Current evidence indicates that the efficacy of a fourth dose of classical mRNA vaccines (BT162b2 or mRNA-1273) is low and short-lived in preventing SARS-CoV-2 infection in its predominant variant (Omicron). However, its efficacy is high against severe symptomatic infection, hospitalization and death. The new vaccines being introduced are bivalent and active against the Omicron variants. Potential new vaccines to be introduced in the coming year include a vaccine based on a recombinant protein that emulates the receptor binding domain of the Spike protein under development by the Spanish company Hipra, as well as vaccines for nasal or oral administration. Available information suggests that vaccines against COVID-19 can be administered in association with influenza vaccination without particular complications. New drugs against COVID-19, both antiviral and anti-inflammatory, are under investigation, but this does not seem to be the case with monoclonal antibodies. The indication to use masks in some circumstances will be maintained next year in view of the accumulation of scientific data on their efficacy. Finally, the long COVID or Post-COVID syndrome may continue to affect a very high proportion of patients who have had the disease, requiring combined diagnostic and therapeutic resources. (AU)

Las predicciones para un próximo fin de la pandemia de la Organización Mundial de la Salud deben interpretarse con precaución. La evidencia actual indica que la eficacia de una cuarta dosis de las vacunas clásicas ARNm (BNT162b2 o mRNA-1273) es baja y de corta duración para prevenir la infección de SARS-CoV-2 en su variante predominante (Omicron). No obstante, su eficacia es alta frente a la infección sintomática grave, hospitalización y muerte. Las nuevas vacunas que están siendo introducidas son bivalentes y activas frente a las variantes Omicron. Entre las potenciales nuevas vacunas que se introducirán en el próximo año, se encuentra una vacuna basada en una proteína recombinante que emula el dominio de unión al receptor de la proteína Spike en desarrollo por la compañía española Hipra, así como vacunas de administración nasal u oral. La información disponible apunta a que las vacunas frente al COVID-19 podrán administrarse asociadas a la vacunación antigripal sin particulares complicaciones. Se encuentran en investigación nuevos fármacos frente a COVID-19 tanto antivirales como anti-inflamatorios pero no parece ocurrir lo mismo con los anticuerpos monoclonales. La indicación de utilizar mascarillas en algunas circunstancias se mantendrá el próximo año en vista a la acumulación de datos científicos sobre su eficacia. Finalmente, el síndrome del COVID largo o Post-COVID puede que siga afectando a una proporción muy elevada de los pacientes que sufrieron la enfermedad, requiriendo recursos diagnósticos y terapéuticos combinados. (AU)

Conventional versus extended-pulsed fidaxomicin dosing in patients at high risk of recurrence of Clostridioides difficile infection: a propensity score analysis.

INTRODUCTION: The main challenge in the treatment of Clostridioides difficile infection (CDI) is to reduce recurrence rates. Fidaxomicin improves the recurrence rate of CDI compared with vancomycin. Extended-pulsed dosing of fidaxomicin was associated with lower recurrence rates in one clinical trial but has never been directly compared with conventional fidaxomicin dosing. METHODS: To compare the recurrence rate of fidaxomicin conventional dosing (FCD) and fidaxomicin in extended-pulsed dosing (FEPD) in conditions of clinical practice at a single institution. We performed propensity score matching taking the variables age, severity and previous episode as confounders to evaluate patients with a similar recurrence risk. RESULTS: In total, 254 episodes of CDI treated with fidaxomicin were evaluated: 170 (66.9%) received FCD, and 84 (33.1%) received FEPD. More patients who received FCD were hospitalized for CDI, had severe CDI and had a diagnosis based on toxin detection. In contrast, the proportion of patients receiving proton pump inhibitors was higher in those receiving FEPD. The crude recurrence rates in FCD- and FEPD-treated patients were 20.0% and 10.7%, respectively (OR:0.48; 95% CI 0.22-1.05; P = 0.068). We did not find any differences in CDI recurrence rate in patients receiving FEPD versus FCD (OR = 0.74; 95% CI 0.27-2.04) by propensity score analysis. CONCLUSIONS: Although the recurrence rate with FEPD was numerically lower than that observed with FCD, we have not been able to show that the recurrence rate of CDI is different depending on the dosage regimen of fidaxomicin. Clinical trials or large observational studies comparing the two dosing regimens of fidaxomicin are needed.

Understanding Sexualized Drug Use: Substances, Reasons, Consequences, and Self-Perceptions among Men Who Have Sex with Other Men in Spain.

Sexualized drug use (SDU) has been identified as a health risk factor among gay, bisexual, and other men who have sex with men (GBMSM). This study aimed to analyze the associations between SDU frequency and a broad set of substances, motives, consequences, and self-perceptions. Sampling was conducted through an online survey. The final sample consisted of 185 GBMSM aged between 18 and 78 years old (mean age = 38.38, SD = 11.52) who engaged in SDU. We analyzed the frequency of SDU in terms of practicing it "once," "moderately" ("once a month or less" or "a few times a month"), or "frequently" (from "once a week" to "daily") during the previous 18 months. A questionnaire was administered through which sociodemographic variables, substances, reasons, consequences, and self-perceptions of SDU practice were analyzed. Participants who did so frequently were significantly more likely to use mephedrone, methamphetamine, and GHB/GBL than those who performed SDU less often (large effect sizes). In addition, habitual SDU was associated with motivations to achieve pleasurable emotions and sensations and manage negative feelings. Health implications, such as blackout moments, were also significantly related to frequent SDUs. Finally, those who practiced frequent SDU perceived it as a severe problem and wanted to control it. These data indicate the importance of raising awareness of chemsex as a public health problem among GBMSM. Specific identification, education, and prevention programs need to be strengthened to reduce the incidence of the most undesirable implications of SDU among GBMSM.

Monkeypox in humans: a new outbreak / Monkeypox (Viruela del mono) en humanos: un nuevo brote

Infection caused by Monkeypox Virus (MPVX) has small rodents as its natural reservoir and both monkeys and humans are occasional hosts. The causative agent is an Orthopoxvirus (MPVX) that was isolated in monkeys in 1958 and proved capable of passing to humans in 1970. It remained contained in Africa, causing isolated episodes of infection, until 2003 when an outbreak occurred in the United States following importation of animals from that continent. Since then, anecdotal cases have continued to be reported outside Africa, usually very clearly linked to travelers to those countries, but in May 2022, a broad outbreak of this disease has begun, now affecting several continents, with the emergence of human cases of MPVX (H-MPVX) infection mainly among Men that have Sex with Men (MSM). The disease has an incubation time ranging from 5 to 15 days and is characterized by the presence of pustules, fever, malaise and headache. The presence of significant regional lymphadenopathy is a differential feature with episodes of classical smallpox. Proctitis and pharyngitis, with minimal skin lesions, may be another form of presentation. Diagnosis can be confirmed by PCR testing of lesions or by demonstration of MPVX in other body fluids or tissues, although in the appropriate epidemiologic setting the clinical picture is highly suggestive of the disease. Effective drug treatment has been developed as part of programs to protect against potential bioterrorist agents and smallpox vaccinees are known to have high protection against monkeypox. New vaccines are available, but neither the drugs nor the vaccines are yet freely available on the market. (AU)

La infección causada por el Virus de la Viruela del Mono o Monkeypox (MPVX) tiene como reservorio natural los pequeños roedores y tanto el mono como el hombre son huéspedes ocasionales. El agente causal es un Orthopoxvirus (MPVX) que fue aislado en monos en 1958 y se demostró capaz de pasar a humanos en 1970. Se mantuvo contenido en África, causando episodios aislados de infección, hasta el año 2003 en que se produjo un brote en los Estados Unidos tras la importación de animales desde dicho continente. Desde entonces, han seguido comunicándose casos fuera de África, por lo general muy claramente vinculados a viajeros a dichos países, pero en mayo de 2022 se ha iniciado un brote amplio de esta enfermedad que afecta ya a varios continentes, con la aparición de casos humanos de infección por MPVX (H-MPVX) principalmente vinculados a fiestas en las que hay relaciones sexuales de hombres con hombres (HSH). La enfermedad tiene un tiempo de incubación que puede oscilar entre 5 y 15 días y se caracteriza por la presencia de pústulas, fiebre, malestar general y cefalea. La presencia de importantes adenopatías regionales es una característica diferencial con los episodios de viruela clásica. La proctitis y la faringitis, con mínimas lesiones cutáneas, pueden ser otras formas de presentación. El diagnóstico puede confirmarse con una prueba de PCR en las lesiones o con la demostración de MPVX en otros fluidos o tejidos corporales, aunque en el contexto epidemiológico oportuno el cuadro clínico es altamente sugerente de la enfermedad. Hay tratamiento medicamentoso eficaz que ha sido desarrollado como parte de los programas de protección frente a potenciales agentes bioterroristas y se sabe que los vacunados de viruela tienen una protección elevada frente a H-MPVX. Se dispone de nuevas vacunas, pero ni los medicamentos ni las vacunas están todavía libremente disponibles en el mercado. (AU)

COVID-19: Some unresolved issues / COVID-19: Algunos asuntos no resueltos

Two years after the COVID-19 pandemic, many uncertainties persist about the causal agent, the disease and its future. This document contains the reflection of the COVID-19 working group of the Official College of Physicians of Madrid (ICOMEM) in relation to some questions that remain unresolved. The document includes considerations on the origin of the virus, the current indication for diagnostic tests, the value of severity scores in the onset of the disease and the added risk posed by hypertension or dementia. We also discuss the possibility of deducing viral behavior from the examination of the structure of the complete viral genome, the future of some drug associations and the current role of therapeutic resources such as corticosteroids or extracorporeal oxygenation (ECMO). We review the scarce existing information on the reality of COVID 19 in Africa, the uncertainties about the future of the pandemic and the status of vaccines, and the data and uncertainties about the long-term pulmonary sequelae of those who suffered severe pneumonia. (AU)

Cuando han transcurrido ya dos años de la pandemia de COVID-19 persisten muchas incertidumbres sobre el agente causal, la enfermedad y su futuro. El presente documento contiene la reflexión del grupo de trabajo sobre COVID-19 del Ilustre Colegio Oficial de Médicos de Madrid (ICOMEM) en relación a algunas preguntas que nos parecen sin resolver. El documento incluye reflexiones sobre el origen del virus, la indicación actual de pruebas diagnósticas, el valor de los “scores” de gravedad en el comienzo de la enfermedad y el riesgo añadido que supone la hipertensión o la demencia. Se discute también, la posibilidad de deducir del examen de la estructura del genoma viral completo el comportamiento viral, el futuro de algunas asociaciones de fármacos y el papel actual de recursos terapéuticos como los corticoides o la oxigenación extracorpórea (ECMO). Revisamos la escasa información existente sobre la realidad de la COVID-19 en África, las incertidumbres sobre el futuro de la pandemia y la situación de las vacunas y los datos e incertidumbres sobre las secuelas pulmonares a largo plazo de los que padecieron neumonía grave. (AU)

Lessons from COVID-19 for future disasters: an opinion paper / Lecciones de la COVID-19 para futuras catástrofes: un documento de opinión

A “Pandemic/Disaster Law” is needed to condense and organize the current dispersed and multiple legislation. The State must exercise a single power and command appropriate to each situation, with national validity. The production of plans for the use of land and real estate as potential centers for health care, shelter or refuge is recommended. There should be specific disaster plans at least for Primary Health Care, Hospitals and Socio-sanitary Centers. The guarantee of the maintenance of communication and supply routes is essential, as well as the guarantee of the autochthonous production of basic goods. The pandemic has highlighted the need to redefine the training plans for physicians who, in their different specialties, have to undertake reforms that allow a more versatile and transversal training. National research must have plans to be able to respond quickly to questions posed by the various crises, using all the nation’s resources and in particular, all the data and capabilities of the health sector. Contingency plans must consider ethical aspects, and meet the needs of patients and families with a humanized approach. In circumstances of catastrophe, conflicts increase and require a bioethical response that allows the best decisions to be made, with the utmost respect for people’s values. Rapid, efficient and truthful communication systems must be contained in a special project for this sector in critic circumstances. Finally, we believe that the creation of National Coordination Centers for major disasters and Public Health can contribute to better face the crises of the future. (AU)

Es necesaria una “Ley de Pandemias/catástrofes” que condense y ordene la dispersa y múltiple legislación actual. El Estado tiene que ejercer un poder y mando único adecuado a cada situación, con vigencia nacional. Se recomienda la confección de planes de utilización de suelo e inmuebles como centros potenciales de asistencia sanitaria, refugio o albergue. Deberán existir planes de catástrofes específicos al menos para la Atención Primaria, Atención Hospitalaria y Centros Sociosanitarios. La garantía del mantenimiento de las vías de comunicación y abastecimiento es esencial, así como la garantía de producción autóctona de materias de primera necesidad. La pandemia ha puesto de manifiesto la necesidad de redefinir los planes de formación de los médicos que en sus distintas especialidades tienen que asumir reformas que permitan un entrenamiento más versátil y transversal. La investigación nacional debe tener planes para poder responder con rapidez a preguntas que planteen las distintas crisis, utilizando para ello, todos los recursos de la nación y en particular todos los datos y capacidades del sector sanitario. Los planes de contingencia deben considerar los aspectos éticos, y cubrir las necesidades de pacientes y familias con un enfoque humanizado. En circunstancias de catástrofe aumentan los conflictos que requieren una respuesta bioética que permita tomar las mejores decisiones, con el máximo respeto a los valores de las personas. La comunicación, rápida, eficiente y veraz debe estar contenida en un proyecto especial para este sector en circunstancias de crisis. Pensamos finalmente que la creación de un Centro coordinador nacional de grandes catástrofes y Salud Pública puede contribuir a enfrentarnos mejor a las crisis del futuro. (AU)

COVID in Pediatric Age: an opinion paper / COVID en la edad pediátrica: un documento de opinión

The incidence of COVID in pediatrics was underestimated during the first months of the pandemic due to the oligosymptomatic nature of the infection in many children and thescarcity of diagnostic tests applied to this population. It is nowaccepted that children are infected and transmit the diseasein the same way as adults. On the contrary, children have lesssevere and less lethal COVID, probably due to a lower maturityof the child’s immune system, a lower number of ACE2 receptors and the lower presence of comorbidities in this populationgroup.The development of a multisystemic inflammatory syndrome after SARS-CoV-2 infection in children, despite its rarity, is a very serious condition that frequently requires intensivecare. Other less severe post-COVID manifestations have beendescribed in children but are not yet well defined.COVID has had and continues to have a significant psychological impact on the children themselves, on their caregiversand on the exacerbation of pre-existing psychiatric conditions.We apply adult therapeutic principles to children but withvery low levels of evidence. Information on the tolerability of the available medications in this population group is stillscarce. The mortality of COVID in children is very low and generally affects children with significant comorbidities.There are, at present, three vaccines licensed for pediatricuse which are compatible with all other vaccines applicable tochildren.In these circumstances, there has been much speculationabout the indication for vaccination in the pediatric age group,but given its good tolerance, there are clinical and ethical reasons that, in our opinion, justify it. (AU)

La incidencia de COVID en pediatría ha estado infraestimada durante los primeros meses de la pandemia por el carácter oligosintomático de la infección en muchos niños y porla escasez de pruebas diagnósticas aplicadas a esta población.Hoy se admite que los niños se infectan y transmiten la enfermedad igual que los adultos. Por el contrario, los niños tienencuadros clínicos menos graves y letales lo cuál parece relacionado con una menor madurez del sistema inmune del niño,una menor cantidad de receptores ACE2 y la menor presenciade comorbilidades en este grupo de población.El desarrollo de un síndrome inflamatorio multisistémicotras la infección por SARS-CoV-2 en niños, pese a su rareza, esun cuadro muy grave que frecuentemente requiere cuidadosintensivos. Se han descrito otros cuadros post-COVID en niños,menos graves, pero todavía no muy bien definidos.La COVID-19 ha tenido y tiene un importante impacto psicológico en los propios niños, en sus cuidadores y en la exacerbación de cuadros psiquiátricos pre-existentes.Aplicamos a los niños los principios terapéuticos de losadultos pero con niveles muy bajos de evidencia y la toleranciade los medicamentos disponibles en este grupo de poblaciónes todavía mal conocida. La mortalidad de la COVID en niñoses muy baja e incide generalmente en niños con importantescomorbilidades.Hay, en el momento presente, tres vacunas autorizadaspara el uso pediátrico y las vacunas frente a SARS-CoV-2 soncompatibles con el resto de las vacunas aplicables a niños.En estas circunstancias se ha especulado mucho sobre laindicación de vacunación en la edad pediátrica pero dada subuena tolerancia, existen, en nuestra opinión, razones clínicasy éticas que la justifican. (AU)

Booster or additional vaccination doses in patients vaccinated against COVID-19 / Dosis vacunales de recuerdo o adicionales en pacientes vacunados frente a COVID-19

Several health organizations, mainly in Western countries, have recently authorized the use of a booster dose of the COVID-19 vaccine for patients previously vaccinated with mRNA vaccines, with criteria that do not always coincide. The COVID Scientific Committee of the Illustrious College of Physicians of Madrid (ICOMEM) has received and asked several questions about this situation, to which the group has tried to give answers, after deliberation and consensus. The efficacy of the vaccines administered so far is beyond doubt and they have managed to reduce, fundamentally, the severe forms of the disease. The duration of this protection is not well known, is different in different individuals and for different variants of the virus and is not easily predictable with laboratory tests. Data on the real impact of a supplementary or “booster” dose in the scientific literature are scarce for the moment and its application in large populations such as those in the state of Israel may be associated with a decrease in the risk of new and severe episodes in the short observation period available. We also lack sufficient data on the safety and potential adverse effects of these supplementary doses and we do not know the ideal time to administer them in different situations.In this state of affairs, it seems prudent to administer supplemental doses to those exposed to a higher risk, such as immunocompromised individuals and the elderly. On the other hand, we consider that this is not the time to accelerate, on the spur of the moment, a massive administration of a third dose to other population groups that are less exposed and at lower risk, without waiting for adequate scientific information, which will undoubtedly arrive gradually. We do not believe that this position is incompatible with the practical and ethical warnings made by the World Health Organization in this respect. (AU)

Varias organizaciones sanitarias, fundamentalmente de países occidentales, han autorizado recientemente el uso de una dosis de refuerzo de la vacuna frente al COVID-19 para pacientes previamente vacunados con vacunas mRNA, con criterios no siempre coincidentes. El Comité Científico de COVID, del Ilustre Colegio de Médicos de Madrid (ICOMEM) ha recibido y se ha formulado diversas preguntas sobre esta situación, a la que el grupo ha tratado de dar respuestas, tras deliberación y consenso. La eficacia de las vacunas administradas hasta el momento está fuera de toda duda y han logrado disminuir, fundamentalmente, las formas graves de enfermedad. La duración de esa protección no se conoce bien, es diferente en distintos individuos y para distintas variantes del virus y no es fácilmente predecible con pruebas de laboratorio. Los datos sobre el impacto real de una dosis complementaria o “booster” en la literatura científica son escasos por el momento y su aplicación en grandes poblaciones como las del estado de Israel pueden asociarse a una disminución del riesgo de nuevos episodios y episodios graves en el corto periodo de observación disponible. Carecemos también de datos suficientes sobre la seguridad y potenciales efectos adversos de estas dosis complementarias e ignoramos el momento idóneo de administrarlas en distintas situaciones. En este estado de cosas, parece prudente administrar dosis complementarias a aquellos expuestos a un mayor riesgo, como pueden ser los individuos inmunodeprimidos y las personas mayores. Por el contrario, consideramos que no es este el momento de acelerar improvisadamente una administración masiva de una tercera dosis a otros grupos de población menos expuesta y de menor riesgo, sin esperar la adecuada información científica, que sin duda irá llegando paulatinamente. No creemos que esta posición, sea incompatible con las advertencias prácticas y éticas que realiza la Organización Mundial de la Salud a este respecto. (AU)

Pharmacological treatment of COVID-19: an opinion paper / Tratamiento farmacológico del COVID-19: un documento de opinión

The precocity and efficacy of the vaccines developed so far against COVID-19 has been the most significant and saving advance against the pandemic. The development of vaccines has not prevented, during the whole period of the pandemic, the constant search for therapeutic medicines, both among existing drugs with different indications and in the development of new drugs. The Scientific Committee of the COVID-19 of the Illustrious College of Physicians of Madrid wanted to offer an early, simplified and critical approach to these new drugs, to new developments in immunotherapy and to what has been learned from the immune response modulators already known and which have proven effective against the virus, in order to help understand the current situation. (AU)

La precocidad y la eficacia de las vacunas desarrolladas hasta ahora frente al COVID-19, ha sido el avance más significativo y salvador frente a la pandemia. El desarrollo vacunal no ha impedido, durante todo el periodo de la pandemia, la búsqueda constante de remedios terapéuticos, tanto entre los medicamentos ya existentes y con indicaciones diversas, como en el desarrollo de nuevos fármacos. Sobre estos nuevos fármacos, sobre las novedades en la inmunoterapia y sobre lo aprendido de los moduladores de la respuesta inmune ya conocidos y que se han mostrado eficaces frente al virus, el Comité Científico del COVID-19 del Ilustre Colegio de Médicos de Madrid ha querido ofrecer una aproximación precoz, simplificada y critica que pueda ayudar a comprender la situación actual. (AU)

Mental Health Symptoms Associated with Sexualized Drug Use (Chemsex) among Men Who Have Sex with Men: A Systematic Review.

BACKGROUND: Sexualized drug use (SDU), also known as chemsex, refers to the use of psychoactive substances for sexual purposes among men who have sex with men (MSM), which has been associated with mental health symptoms. The objective of this review is to systematically review the available evidence on mental health outcomes in MSM who use sexualized drugs. METHODS: To prepare this systematic review, search strategies were developed and applied to the Web of Science, Science Direct, PubMed, and Scopus databases. A total of 117 articles were found, of which 12 were selected for the final review. RESULTS: Those MSM who practiced SDU were more likely to experience from depression, anxiety, or a substance dependence, although these results were not found in all the studies analyzed. Among those who practiced the administration of intravenous drugs (referred to as slamsex), the mental health symptoms were more severe. CONCLUSIONS: This systematic review contributes to a fuller understanding of the mental health symptoms present in MSM who consume drugs for sexual purposes. Greater uniformity in data collection instruments is required, as well as the need to conduct a more in-depth assessment of the psychosocial adjustment of people who practice chemsex.

Personality and adherence to antiretroviral therapy in HIV-infected adult patients.

OBJECTIVE: Antiretroviral therapy (ART) has been able to transform HIV infection into a chronic disease. However, ART adherence remains an important barrier and personality traits have been postulated as a factor to be considered. This study aims to identify personality traits that can affect ART adherence, taking into account other potentially influencing factors. METHODS: Case-control study. Controls and cases were classified using the percentage ART dispensation as recorded in the Hospital Pharmacy database. Controls were defined as people living with HIV/AIDS (PLWHA) with percentage ART dispensation during the last year >95% and cases were defined as PLWHA with percentage ART dispensation during the last year <90%. Sociodemographic, clinical parameters of HIV infection, psychopathological and neuropsychological factors were collected. Personality was assessed using the NEO PI-R Personality Inventory, questionnaire based on the Five Factor Model of Personality. Statistical analysis was performed using logistic regression (SPSS v.22). RESULTS: 125 PLWHA were included: 79 controls and 46 cases. After adjusting for confounding variables, logistic regression analysis showed that poor adherence was associated with Neuroticism (OR 1.2, 95%CI: 1.021-1.385) and Impulsivity (N5) (OR 1.5, 95%CI: 1.066-2.163). In contrast, each additional point in Order (C2) (OR 0.8, 95%CI: 0.679-0.992) or Values (O6) (OR 0.8, 95%CI: 0.710-0.974) were associated with good ART adherence. CONCLUSIONS: Personality is a variable to be considered in ART adherence. Implementation of the personality in the assessment of PLWHA helps identify those individuals potentially more likely to exhibit poorer ART adherence.

COVID-19 and geographical area of origin.

OBJECTIVES: To describe and compare the main clinical characteristics and outcome measures in hospitalized patients with confirmed coronavirus disease 2019 (COVID-19) according to geographical area of origin. METHODS: A retrospective analysis of patients hospitalized with confirmed COVID-19 at a referral centre in Madrid, Spain, during March-May 2020 was performed. Recorded variables (age, gender, intensive care unit (ICU) admission, outcome), and geographical area of origin were compared for Europeans and non-Europeans (Latin Americans, Asians and Africans). RESULTS: In total, 2345 patients with confirmed COVID-19 hospitalized during the study period were included in the study. Of these, 1956 (83.4%) were European and 389 (16.6%) were non-European (of whom over 90%, 354/389, were Latin American). Non-Europeans were significantly younger than Europeans (mean 54 (SD 13.5) versus 70.4 (SD 15.1) years, p < 0.001); the majority were male (1420/2345, 60.6%), with no significant differences in gender between Europeans and non-Europeans (1197/1956 (61.2%) male in the European group versus 223/389 (57.3%) male in the non-European group, p 0.15). In-hospital mortality overall was higher in Europeans (443/1956, 22.7%) than in non-Europeans (40/389, 10.3%) (p < 0.001), but there were no significant differences when adjusted for age/gender (OR 1.27, 95% CI 0.86-1.88). Non-Europeans were more frequently admitted to ICU (71/389, 18.3%) compared with Europeans (187/1956, 9.6%) (p < 0.001) and a difference in ICU admission rate was also found when adjusted for age/gender (OR 1.43, 95% CI 1.03-1.98). CONCLUSIONS: No significant differences in mortality were observed between Europeans and non-Europeans (mainly Latin Americans), but an increase in ICU admission rate was found in non-Europeans.

What Should Be Known by a Urologist About the Medical Management of COVID-19's Patients?

PURPOSE OF REVIEW: The alarming number of confirmed COVID-19 cases put a strain on the healthcare systems, which had to reallocate human and technical resources to respond to the emergency. Many urologists became integrated into multidisciplinary teams, dealing with this respiratory illness and its unknown management. It aims to summarize the epidemiological, clinical, diagnostical, and therapeutical characteristics of COVID-19, from a practical perspective, to ease COVID-19 management to non-physician staff. RECENT FINDINGS: We performed a narrative review of the literature regarding COVID-19, updated to May 8th, 2020, at PubMed and COVID resource platforms of the main scientific editorials. COVID-19, characterized by fever, myalgias, dyspnea, and dry cough, varies widely from asymptomatic infection to death. Arrhythmias and thrombotic events are prevalent. Lymphopenia and inflammatory reactant elevation on laboratory, as well as bilateral and peripheral ground-glass opacities or consolidations on X-Ray, are usually found in its assessment. Little is known about SARS-CoV-2 immunology. To date, no therapy has demonstrated efficacy in COVID-19. Of-level or compassionate-use therapies are prescribed in the context of clinical trials. We should become familiar with specific adverse events and pharmacological interactions. The COVID-19 pandemic has paralyzed the urological activity, and its long-term consequences are unpredictable. Despite not being used to deal with respiratory diseases, the urologists become easily qualified to manage COVID-19 by following protocols and being integrated into multidisciplinary teams, helping to overcome the pandemic.

Organisational and financial consequences of the early discharge of patients treated for acute bacterial skin and skin structure infection and osteomyelitis in infectious disease departments in Greece, Italy and Spain: a scenario analysis.

OBJECTIVE: The aim of the analysis is to assess the organisational and economic consequences of adopting an early discharge strategy for the treatment of acute bacterial skin and skin structure infection (ABSSSI) and osteomyelitis within infectious disease departments. SETTING: Infectious disease departments in Greece, Italy and Spain. PARTICIPANTS: No patients were involved in the analysis performed. INTERVENTIONS: An analytic framework was developed to consider two alternative scenarios: standard hospitalisation care or an early discharge strategy for patients hospitalised due to ABSSSI and osteomyelitis, from the perspective of the National Health Services of Greece, Italy and Spain. The variables considered were: the number of annual hospitalisations eligible for early discharge, the antibiotic treatments considered (ie, oral antibiotics and intravenous long-acting antibiotics), diagnosis-related group (DRG) reimbursements, number of days of hospitalisation, incidence and costs of hospital-acquired infections, additional follow-up visits and intravenous administrations. Data were based on published literature and expert opinions. PRIMARY AND SECONDARY OUTCOME MEASURES: Number of days of hospitalisation avoided and direct medical costs avoided. RESULTS: The total number of days of hospitalisation avoided on a yearly basis would be between 2216 and 5595 in Greece (-8/-21 hospital beds), between 15 848 and 38 444 in Italy (-57/-135 hospital beds) and between 7529 and 23 520 in Spain (-27/-85 hospital beds). From an economic perspective, the impact of the early discharge scenario is a reduction between €45 036 and €149 552 in Greece, a reduction between €182 132 and €437 990 in Italy and a reduction between €292 284 and €884 035 in Spain. CONCLUSIONS: The early discharge strategy presented would have a positive organisational impact on National Health Services, leading to potential savings in beds, and to a reduction of hospital-acquired infections and costs.