Comparison of the first and sixth waves of the SARS-COV-2 coronavirus pandemic in patients with immune-mediated disease Comparación entre la primera y la sexta ola de la pandemia por el coronavirus SARS-COV-2 en pacientes con enfermedad inmunomediada

Introduction Recent evidence shows that COVID-19 infection does not have a worse prognosis in patients with immune-mediated inflammatory diseases (IMID), although they develop a worse response to vaccination. Objective To compare the incidence of COVID-19 and clinical features in patients with IMID between the first and sixth waves. Method Prospective observational study of two cohorts of IMID patients diagnosed with COVID-19. First cohort March to May 2020, and second cohort December/2021 to February/2022. Sociodemographic and clinical variables were collected and, in the second cohort, COVID-19 vaccination status. Statistical analysis established differences in characteristics and clinical course between the two cohorts. Results In total, 1627 patients were followed up, of whom 77 (4.60%) contracted COVID-19 during the first wave and 184 in the sixth wave (11.3%). In the sixth wave, there were fewer hospitalisations, intensive care unit admissions, and deaths than in the first wave (p = .000) and 180 patients (97.8%) had at least one dose of vaccine. Conclusion Early detection and vaccination have prevented the occurrence of serious complications.

Comparison of the first and sixth waves of the SARS-COV-2 coronavirus pandemic in patients with immune-mediated disease.

INTRODUCTION: Recent evidence shows that COVID-19 infection does not have a worse prognosis in patients with immune-mediated inflammatory diseases (IMID), although they develop a worse response to vaccination. OBJECTIVE: To compare the incidence of COVID-19 and clinical features in patients with IMID between the first and sixth waves. METHOD: Prospective observational study of two cohorts of IMID patients diagnosed with COVID-19. First cohort March to May 2020, and second cohort December/2021 to February/2022. Sociodemographic and clinical variables were collected and, in the second cohort, COVID-19 vaccination status. Statistical analysis established differences in characteristics and clinical course between the two cohorts. RESULTS: In total, 1627 patients were followed up, of whom 77 (4.60%) contracted COVID-19 during the first wave and 184 in the sixth wave (11.3%). In the sixth wave, there were fewer hospitalisations, intensive care unit admissions, and deaths than in the first wave (p=.000) and 180 patients (97.8%) had at least one dose of vaccine. CONCLUSION: Early detection and vaccination have prevented the occurrence of serious complications.

Effectiveness of a flash glucose monitoring systems implementation program through a group and telematic educational intervention in adults with type 1 diabetes.

OBJECTIVES: Verifying the clinical effectiveness and the impact on quality-of-life parameters, fear of hypoglycaemia and satisfaction with the treatment obtained with a flash glucose monitoring (MFG) devices implantation program that includes a telematic and group educational intervention in adults with type 1 diabetes. PATIENTS AND METHODS: Prospective quasi-experimental study, carried out during the COVID-19 pandemic period with a 9-month follow-up at the Virgen Macarena University Hospital, Sevilla. RESULTS: Eighty-eight participants were included (men: 46.6%; mean age (years) 38.08, SD: 9.38); years of DM1 evolution: 18.4 (SD: 10.49); treatment with multiple doses insulin (MDI) 70.5% vs 29.5% subcutaneous insulin infusion therapy (CSII)). Baseline HbA1c was 7.74% (1.08). After the intervention, the global decrease in HbA1c was -0.45% (95% CI [-0.6, -0.25], P < 0.01), increasing to -1.08% in the group that started with HbA1c ≥ 8% (P < 0.01). A mean decrease in the Fear of Hypoglycemia 15 (FH15) test score of -6.5 points was observed (P < 0.01). In the global score of the Spanish version of Diabetes Quality Of Life (DQOL-s) test, the decrease was -8.44 points (P < 0.01). In Diabetes Treatment Satisfaction Questionnaire test (DTQ-s), global score increased in + 4 points (P < 0.01). CONCLUSIONS: The incorporation of an educational program in group and telematic format within the development of MFG devices implantation strategies is an effective option, with associated benefits in quality of life and fear of hypoglycemia in adult patients with DM1. This option can be implemented in usual clinical practice.

Consortium Framework Using Blockchain for Asthma Healthcare in Pandemics.

Asthma is a deadly disease that affects the lungs and air supply of the human body. Coronavirus and its variants also affect the airways of the lungs. Asthma patients approach hospitals mostly in a critical condition and require emergency treatment, which creates a burden on health institutions during pandemics. The similar symptoms of asthma and coronavirus create confusion for health workers during patient handling and treatment of disease. The unavailability of patient history to physicians causes complications in proper diagnostics and treatments. Many asthma patient deaths have been reported especially during pandemics, which necessitates an efficient framework for asthma patients. In this article, we have proposed a blockchain consortium healthcare framework for asthma patients. The proposed framework helps in managing asthma healthcare units, coronavirus patient records and vaccination centers, insurance companies, and government agencies, which are connected through the secure blockchain network. The proposed framework increases data security and scalability as it stores encrypted patient data on the Interplanetary File System (IPFS) and keeps data hash values on the blockchain. The patient data are traceable and accessible to physicians and stakeholders, which helps in accurate diagnostics, timely treatment, and the management of patients. The smart contract ensures the execution of all business rules. The patient profile generation mechanism is also discussed. The experiment results revealed that the proposed framework has better transaction throughput, query delay, and security than existing solutions.

Dynamics of B-Cell Responses after SARS-CoV-2 Vaccination in Spain.

The high mortality rate due to COVID-19 has necessitated the mass vaccination against SARS-CoV-2 to induce protective humoral and cellular immunity. (1) Objective: To study the dynamics of SARS-CoV-2-specific B cells after two doses of the Pfizer-BioNTech SARS-CoV-2 vaccine. (2) Methods: Immunophenotyping and cellular cultures were used to determine the kinetics of B-cell subpopulations and vaccine responses in volunteers before and seven days, three months and seven months after the second dose in Spain (n = 19). (3) Results: Seven days after immunisation, memory B cells and plasmablasts expressing receptors for factors implicated in the maturation of plasma cells were augmented in blood. Three months after vaccination, SARS-CoV-2 spike-specific plasmablasts disappeared from circulation while spike-specific memory-B cells circulated, with heterogeneous dynamics among individuals. (4) Conclusion: After vaccination, specific plasmablasts equipped with receptors for maturation factors were quickly generated and disappeared rapidly from the blood, while specific memory B cells circulated for at least seven months.

Efectividad de un programa de implantación de sistemas de monitorización flash de glucosa a través de una intervención educativa grupal y telemática en adultos con diabetes tipo 1

Resumen Objetivo Comprobar la efectividad clínica y la repercusión sobre los parámetros de calidad de vida, miedo a hipoglucemias y satisfacción con el tratamiento obtenidas con un programa de implantación de sistemas de monitorización intermitente o tipo flash de glucosa (MFG) que incluye una intervención educativa telemática y grupal en adultos con diabetes mellitus tipo 1 (DM1). Material y métodos Estudio cuasiexperimental prospectivo, realizado durante el período de pandemia COVID-19 con un seguimiento de 9 meses en el Hospital Universitario Virgen Macarena, Sevilla. Resultados Se analizaron 88 participantes (varones: 46,6%;edad media: 38,08 años (desviación estándar [DE]: 9,38);tiempo de evolución DM1: 18,4 años (DE: 10,49);tratamiento con múltiples dosis de insulina (MDI) 70,5 vs. 29,5% bombas de infusión subcutánea continua de insulina (ISCI)). HbA1c basal del 7,74% (DE: 1,08). Tras la intervención el descenso global de HbA1c fue del −0,45% (p<0,01), aumentando a −1,08% en el grupo que partía con HbA1c≥8% (p<0,01). El descenso medio en la puntuación del test Fear of Hypoglycaemia (FH15) fue de −6,5 puntos (p<0,01), en el test Diabetes Quality of Life en español (EsDQOL): −8,44 puntos (p<0,01), y en el test Diabetes Treatment Satisfaction Questionnaire (DTQ-s): +4 puntos (p<0,01). No se registraron eventos adversos locales ni complicaciones agudas o crónicas de la diabetes durante el seguimiento. Conclusión La incorporación de un programa educativo en formato grupal y telemático sobre el uso de dispositivos de MFG dentro del desarrollo de estrategias de implantación de estos sistemas es una opción efectiva y con beneficios asociados en calidad de vida y miedo a hipoglucemias, implementable en la práctica clínica habitual en pacientes adultos con DM1. Objectives Verifying the clinical effectiveness and the impact on quality-of-life parameters, fear of hypoglycaemia and satisfaction with the treatment obtained with a flash glucose monitoring (MFG) devices implantation program that includes a telematic and group educational intervention in adults with type 1 diabetes. Patients and methods Prospective quasi-experimental study, carried out during the COVID-19 pandemic period with a 9-month follow-up at the Virgen Macarena University Hospital, Sevilla. Results Eighty-eight participants were included (men: 46.6%;mean age (years) 38.08, SD: 9.38);years of DM1 evolution: 18.4 (SD: 10.49);treatment with multiple doses insulin (MDI) 70.5% vs 29.5% subcutaneous insulin infusion therapy (CSII)). Baseline HbA1c was 7.74% (1.08). After the intervention, the global decrease in HbA1c was −0.45% (95% CI [−0.6, −0.25], P<.01), increasing to −1.08% in the group that started with HbA1c≥8% (P<.01). A mean decrease in the Fear of Hypoglycemia 15 (FH15) test score of −6.5 points was observed (P<.01). In the global score of the spanish version of Diabetes Quality Of Life (DQOL-s) test, the decrease was −8.44 points (P<.01). In Diabetes Treatment Satisfaction Questionnaire test (DTQ-s), global score increased in +4 points (P<.01). Conclusions The incorporation of an educational program in group and telematic format within the development of MFG devices implantation strategies is an effective option, with associated benefits in quality of life and fear of hypoglycemia in adult patients with DM1. This option can be implemented in usual clinical practice.

Genomic Characterization of Host Factors Related to SARS-CoV-2 Infection in People with Dementia and Control Populations: The GR@ACE/DEGESCO Study.

Emerging studies have suggested several chromosomal regions as potential host genetic factors involved in the susceptibility to SARS-CoV-2 infection and disease outcome. We nested a COVID-19 genome-wide association study using the GR@ACE/DEGESCO study, searching for susceptibility factors associated with COVID-19 disease. To this end, we compared 221 COVID-19 confirmed cases with 17,035 individuals in whom the COVID-19 disease status was unknown. Then, we performed a meta-analysis with the publicly available data from the COVID-19 Host Genetics Initiative. Because the APOE locus has been suggested as a potential modifier of COVID-19 disease, we added sensitivity analyses stratifying by dementia status or by disease severity. We confirmed the existence of the 3p21.31 region (LZTFL1, SLC6A20) implicated in the susceptibility to SARS-CoV-2 infection and TYK2 gene might be involved in COVID-19 severity. Nevertheless, no statistically significant association was observed in the COVID-19 fatal outcome or in the stratified analyses (dementia-only and non-dementia strata) for the APOE locus not supporting its involvement in SARS-CoV-2 pathobiology or COVID-19 prognosis.

Food Insecurity and the Hispanic Population during the COVID-19 Pandemic.

Historically, food insecurity has been a problem for the Hispanic/Latino population in the United States. Variations in food insecurity exist among this population by origin, immigration status, household composition, and region. The coronavirus pandemic has exacerbated existing vulnerabilities this population faces with food insecurity including limited economic resources, reliance on programs unprepared for atypical circumstances, closure of avenues providing access to meals, and unemployment. This paper reviews key factors related to the current rate of food insecurity among the Hispanic/Latino population in the mainland United States and is an exemplar of similar variability found in Puerto Rico. Recommendations for reducing food insecurity in this population are provided. (word count:109).

Personal and vaccination history as factors associated with SARS-CoV-2 infection.

BACKGROUND AND OBJECTIVE: SARS-CoV-2 has been and is a major global Public Health challenge. Since the beginning of the pandemic, different comorbidities have been postulated and associated with spectra of increased severity and mortality. The objectives of this research are: 1) to analyse the factors associated with SARS-CoV-2 infection (COVID-19) in a health area in northern Spain; 2) to understand the possible role of influenza vaccination and pneumococcal vaccination in the development of COVID-19. MATERIALS AND METHOD: A test-negative case-control study was conducted. Variables related to personal and vaccination history were considered. Although the epidemiological definition of the case varied over time, the reference definition was that corresponding to 31/01/2020 in Spain. A bivariate and multivariate analysis was performed. RESULTS: The sample included 188 patients, of which 63 were cases and 125 controls. The results show that obesity increases the risk 2.4-fold of suffering this infection (IC 95% 1,301-4,521) and ARA-2 increases it 2.2-fold (95% CI 1,256-6,982). On the other hand, anti-pneumococcal vaccination of 13 serotypes showed results close to statistical significance (OR = 0.4; 95% CI 0.170-1,006). CONCLUSION: Obesity and the use of ARA-2 increases the risk of COVID-19. Scientific knowledge about factors associated with COVID-19 should be expanded. The authors consider that the present research raises the need further investigate the role of vaccines in this infection and their possible heterologous properties.

ANTECEDENTES Y OBJETIVO: El SARS-CoV-2 ha supuesto un importante reto de salud pública. Desde el inicio de la pandemia, se han postulado diferentes comorbilidades que se han asociado con espectros de mayor gravedad y mortalidad. Los objetivos de la presente investigación son: 1) analizar los factores asociados a la infección por SARS-CoV-2 (COVID-19) en un área sanitaria del norte de España; 2) conocer el posible papel de la vacunación antigripal y antineumocócica en el desarrollo de la COVID-19. MATERIALES Y MÉTODOS: Se ha realizado un estudio de casos y controles de test negativo. Se tuvieron en cuenta variables relacionadas con los antecedentes personales y vacunales. A pesar de que la definición epidemiológica de caso fue variando a lo largo del tiempo, se tuvo como referencia la correspondiente al 31 de enero del 2020 en España. Se efectuó un análisis bivariante y multivariante. RESULTADOS: La muestra incluyó a 188 pacientes, de los cuales 63 fueron casos y 125 controles. Los resultados muestran que la obesidad aumenta 2,4 veces el riesgo de padecer esta infección (IC 95% 1.301 a 4.521) y los antagonistas de los receptores de la angiotensina II (ARA-2) lo aumentan 2,2 veces (IC 95% 1.256 a 6.982). Por otro lado, la vacunación antineumocócica conjugada de 13 serotipos mostró resultados cercanos a la significación estadística (OR = 0,4; IC 95% 0,170 a 1.006). CONCLUSIONES: La obesidad y el uso de fármacos ARA-2 aumentan el riesgo de la COVID-19. El conocimiento científico sobre los factores asociados a la COVID-19 debe seguir ampliándose. La presente investigación plantea la necesidad de profundizar en el papel de las vacunas sobre esta infección y sus posibles propiedades heterólogas.

Early use of tocilizumab in patients with severe pneumonia secondary to severe acute respiratory syndrome coronavirus 2 infection and poor prognostic criteria: Impact on mortality rate and intensive care unit admission.

ABSTRACT: The coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2, keeps spreading globally. Evidence suggests that a subgroup of patients with severe symptomatology might have cytokine storms, which increases mortality. The use of interleukin-6 (IL-6) inhibitors may help in controlling the pathological immune response to the virus. Tocilizumab, a monoclonal antibody against IL-6, stands as an optional treatment for COVID-19 patients presenting this inflammatory hyper-response.We conducted a retrospective, observational, cohort study including 50 patients affected by COVID-19 with severe pneumonia and poor prognosis criteria, who have also undergone standard treatment; 36 of these patients additionally received tocilizumab in an early stage. The need for intensive care unit (ICU) admission, mortality, recovery of respiratory function, and improvement of biochemical and hematological parameters were compared between cohorts.Most patients were men, non-smokers and the most frequently reported comorbidities were hypertension and diabetes. Recurrent symptoms were fever, cough, and dyspnoea. 54.8% of patients from the tocilizumab group needed intubation, while in the control group 85.7% needed it. Treatment with tocilizumab significatively increased IL-6 levels, (554.45; CI 95% 186.69, 1032.93; P < .05) while C-reactive protein mean levels were reduced (-108.19; CI 95% -140.15, -75.33; P < .05), but no significant difference was found between cohorts. In comparison with the controls, tocilizumab reduced mortality (25.0% vs 42.9%, P = .021) and the number of ICU admissions (63.9% vs 100.0%, P = .021). 44.1% of patients treated with tocilizumab showed favorable radiological evolution, when compared with 15.4% of patients from the control group.Tocilizumab may improve clinical symptoms and mitigate deterioration observed in severe COVID-19 patients, and could be considered as an effective therapeutic option in subjects experiencing a significant inflammatory response to the disease.

A host transcriptomic signature for identification of respiratory viral infections in the community.

BACKGROUND: Fever-7 is a test evaluating host mRNA expression levels of IFI27, JUP, LAX, HK3, TNIP1, GPAA1 and CTSB in blood able to detect viral infections. This test has been validated mostly in hospital settings. Here we have evaluated Fever-7 to identify the presence of respiratory viral infections in a Community Health Center. METHODS: A prospective study was conducted in the "Servicio de Urgencias de Atención Primaria" in Salamanca, Spain. Patients with clinical signs of respiratory infection and at least one point in the National Early Warning Score were recruited. Fever-7 mRNAs were profiled on a Nanostring nCounter® SPRINT instrument from blood collected upon patient enrolment. Viral diagnosis was performed on nasopharyngeal aspirates (NPAs) using the Biofire-RP2 panel. RESULTS: A respiratory virus was detected in the NPAs of 66 of the 100 patients enrolled. Median National Early Warning Score was 7 in the group with no virus detected and 6.5 in the group with a respiratory viral infection (P > .05). The Fever-7 score yielded an overall AUC of 0.81 to predict a positive viral syndromic test. The optimal operating point for the Fever-7 score yielded a sensitivity of 82% with a specificity of 71%. Multivariate analysis showed that Fever-7 was a robust marker of viral infection independently of age, sex, major comorbidities and disease severity at presentation (OR [CI95%], 3.73 [2.14-6.51], P < .001). CONCLUSIONS: Fever-7 is a promising host immune mRNA signature for the early identification of a respiratory viral infection in the community.

[Personal and vaccination history as factors associated with SARS-CoV-2 infection]. / Antecedentes personales y vacunales como factores asociados a la infección por SARS-CoV-2.

BACKGROUND AND OBJECTIVE: SARS-CoV-2 has been and is a major global Public Health challenge. Since the beginning of the pandemic, different comorbidities have been postulated and associated with spectra of increased severity and mortality. The objectives of this research are: 1) to analyse the factors associated with SARS-CoV-2 infection (COVID-19) in a health area in northern Spain; 2) to understand the possible role of influenza vaccination and pneumococcal vaccination in the development of COVID-19. MATERIALS AND METHOD: A test-negative case-control study was conducted. Variables related to personal and vaccination history were considered. Although the epidemiological definition of the case varied over time, the reference definition was that corresponding to 31/01/2020 in Spain. A bivariate and multivariate analysis was performed. RESULTS: The sample included 188 patients, of which 63 were cases and 125 controls. The results show that obesity increases the risk 2.4-fold of suffering this infection (IC 95% 1,301-4,521) and ARA-2 increases it 2.2-fold (95% CI 1,256-6,982). On the other hand, anti-pneumococcal vaccination of 13 serotypes showed results close to statistical significance (OR = 0.4; 95% CI 0.170-1,006). CONCLUSION: Obesity and the use of ARA-2 increases the risk of COVID-19. Scientific knowledge about factors associated with COVID-19 should be expanded. The authors consider that the present research raises the need further investigate the role of vaccines in this infection and their possible heterologous properties.

Estimating and Characterizing COVID-19 Deaths, Puerto Rico, March-July 2020.

OBJECTIVES: Using the Council of State and Territorial Epidemiologists (CSTE) classification guidelines, we characterized coronavirus disease 2019 (COVID-19)-associated confirmed and probable deaths in Puerto Rico during March-July 2020. We also estimated the total number of possible deaths due to COVID-19 in Puerto Rico during the same period. METHODS: We described data on COVID-19-associated mortality, in which the lower bound was the sum of confirmed and probable COVID-19 deaths and the upper bound was excess mortality, estimated as the difference between observed deaths and average expected deaths. We obtained data from the Puerto Rico Department of Health COVID-19 Mortality Surveillance System, the Centers for Disease Control and Prevention's National Electronic Disease Surveillance System Base System, and the National Center for Health Statistics. RESULTS: During March-July 2020, 225 COVID-19-associated deaths were identified in Puerto Rico (119 confirmed deaths and 106 probable deaths). The median age of decedents was 73 (interquartile range, 59-83); 60 (26.7%) deaths occurred in the Metropolitana region, and 140 (62.2%) deaths occurred among men. Of the 225 decedents, 180 (83.6%) had been hospitalized and 93 (41.3%) had required mechanical ventilation. Influenza and pneumonia (48.0%), sepsis (28.9%), and respiratory failure (27.1%) were the most common conditions contributing to COVID-19 deaths based on death certificates. Based on excess mortality calculations, as many as 638 COVID-19-associated deaths could have occurred during the study period, up to 413 more COVID-19-associated deaths than originally reported. CONCLUSIONS: Including probable deaths per the CSTE guidelines and monitoring all-cause excess mortality can lead to a better estimation of COVID-19-associated deaths and serve as a model to enhance mortality surveillance in other US jurisdictions.

Release of the Fourth Season of Money Heist: Analysis of Its Social Audience on Twitter during Lockdown in Spain

Nowadays we are witnessing a significant change in content consumption. This, together with the global health situation, has caused some behaviors to accelerate. This research focuses on the specific case of the lockdown in Spain and the coincidence with the launch of the fourth season of Money Heist compared to the launch of season three. Starting with a review of the theoretical framework, in which the related concepts of coronavirus, television, and Video on Demand (VOD) platforms are presented, the importance of transmedia communication is also introduced. The methodological aspect is developed through content analysis and in-depth interviews. The tool used on the first methodology has been Twlets. With regard to the sources, the specific bibliography of the audiovisual sector, the official profile of the series on Twitter and personal interviews with professionals from the communication department of the production company, Vancouver Media, and from the series directing were taken into account. The methodology used to carry out this work has been the analysis of quantitative–qualitative content of the various sources consulted. The results of the study are presented in graphs, crossing the data from the different sources to detect the strategies of marketing and communication used for the release of the fourth season of the series. These results reflect the change in the communication strategy, the behavior of the social audience of the Twitter account of Money Heist (La Casa de Papel) and its relationship with the period of lockdown in Spain.

Incidence of VTE and Bleeding Among Hospitalized Patients With Coronavirus Disease 2019: A Systematic Review and Meta-analysis.

BACKGROUND: Individual studies have reported widely variable rates for VTE and bleeding among hospitalized patients with coronavirus disease 2019 (COVID-19). RESEARCH QUESTION: What is the incidence of VTE and bleeding among hospitalized patients with COVID-19? METHODS: In this systematic review and meta-analysis, 15 standard sources and COVID-19-specific sources were searched between January 1, 2020, and July 31, 2020, with no restriction according to language. Incidence estimates were pooled by using random effects meta-analyses. Heterogeneity was evaluated by using the I2 statistic, and publication bias was assessed by using the Begg and Egger tests. RESULTS: The pooled incidence was 17.0% (95% CI, 13.4-20.9) for VTE, 12.1% (95% CI, 8.4-16.4) for DVT, 7.1% (95% CI, 5.3-9.1) for pulmonary embolism (PE), 7.8% (95% CI, 2.6-15.3) for bleeding, and 3.9% (95% CI, 1.2-7.9) for major bleeding. In subgroup meta-analyses, the incidence of VTE was higher when assessed according to screening (33.1% vs 9.8% by clinical diagnosis), among patients in the ICU (27.9% vs 7.1% in the ward), in prospective studies (25.5% vs 12.4% in retrospective studies), and with the inclusion of catheter-associated thrombosis/isolated distal DVTs and isolated subsegmental PEs. The highest pooled incidence estimate of bleeding was reported for patients receiving intermediate- or full-dose anticoagulation (21.4%) and the lowest in the only prospective study that assessed bleeding events (2.7%). INTERPRETATION: Among hospitalized patients with COVID-19, the overall estimated pooled incidence of VTE was 17.0%, with higher rates with routine screening, inclusion of distal DVT, and subsegmental PE, in critically ill patients and in prospective studies. Bleeding events were observed in 7.8% of patients and were sensitive to use of escalated doses of anticoagulants and nature of data collection. Additional studies are required to ascertain the significance of various thrombotic events and to identify strategies to improve patient outcomes. TRIAL REGISTRY: PROSPERO; No.: CRD42020198864; URL: https://www.crd.york.ac.uk/prospero/.

Preventive Efficacy of Tenofovir/Emtricitabine Against Severe Acute Respiratory Syndrome Coronavirus 2 Among Pre-Exposure Prophylaxis Users.

BACKGROUND: The preventive effect that tenofovir/emtricitabine (FTC) could have against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human immunodeficiency virus-negative people is unknown. The objective of this study was to analyze the seroprevalence and clinical manifestations of COVID-19 among users of pre-exposure prophylaxis (PrEP), disoproxil fumarate/FTC (TDF/FTC), or tenofovir alafenamide (TAF)/FTC and to compare it to that of a control group. METHODS: An observational descriptive study of the seroprevalence of antibodies for SARS-CoV-2 among men who have sex with men and transgender women without use of PrEP (Group 1; n = 250) and PrEP users with TDF/FTC (n = 409) or TAF/FTC (n = 91) (Group 2; n = 500) was conducted from May11, 2020 to June 27, 2020. All participants were provided with a structured questionnaire that collected information on the variables to be analyzed, and testing for immunoglobulin G antibodies to SARS-CoV-2 (chemiluminescent microparticle immunoassay) was then carried out. RESULTS: The seroprevalence of SARS-CoV-2 was 9.2% (95% confidence interval [CI], 5.9-13.5) in the group without PrEP and 15.0% (95% CI, 12.0-18.4) in the group with PrEP (P = .026). Among users of TDF/FTC it was 14.7% (95% CI, 11.4-18.5), and in users of TAF/FTC it was 16.5% (95% CI, 9.5-25.7) (P = .661). In those who tested positive for SARS-CoV-2 and receiving PrEP, 57.4% manifested symptoms, compared with 78.3% in the control group (P = .070). In users of TDF/FTC the figure was 53.3% and in users of TAF/FTC the figure was 73.3% (P = .100). The duration of symptoms was 11.5 days in the control group, 9.0 days in PrEP users (P = .116), 7.0 days in users of TDF/FTC, and 13.0 days in users of TAF/FTC (P = .100). CONCLUSIONS: Users of PrEP, TDF/FTC, or TAF/FTC presented a higher seroprevalence to SARS-CoV-2 than the control group. No statistically significant differences were found in relation to clinical manifestations. The PrEP users should use the same prevention measures as those indicated for the general population.