Analysis of antiretroviral therapy interruption in people living with HIV during the 2010-2021 Period. / [Artículo traducido] Análisis de la interrupción de la terapia antirretroviral en personas que viven con VIH/sida durante el periodo 2010­2021.

OBJECTIVE: In the context of the advancement of antiretroviral therapy and, as the characteristics of people living with HIV progress toward an aging population, understanding the causes of treatment interruption becomes crucial. The aim of the study was to determine the change in reasons for antiretroviral treatment discontinuation for 12 years. Secondarily, compare annual antiretroviral regimen discontinuation rate and factors associated. METHODS: We conducted an analysis using data from people living with HIV who were receiving antiretroviral therapy and discontinued it for any reason. The study included people with HIV infection who visited an outpatient hospital pharmacy clinic from January 2010 to December 2021. Two periods were differentiated for the analysis: 2010-2015 and 2016-2021. The reasons for antiretroviral treatment discontinuation followed classification described by Swiss cohort. In the context of this study, it is pertinent to note that the term 'interruption' will be consistently used in this article to refer to the act of switching or stopping antiretroviral treatment. To examine factors associated with antiretroviral therapy discontinuation, we utilized Kaplan-Meier methods and Cox proportional models. RESULTS: We included 789 people living with HIV, predominantly male (81,5%). The main reason for discontinuation was clinical decision (50.2%) followed by adverse effects (37.9%). Focusing on clinical decision, we observed a trend change that went from antiretroviral treatment simplification regimen (56.1%) in the first part of the period analyzed to the therapeutic optimization (53.6%) in the second half. Furthermore, factors that were statistically significantly associated with antiretroviral treatment discontinuation were people with HIV ≥50 years (HR 1.60; 95%CI 1.25-2.04), post-discontinuation single-tablet regimen (HR 1.49; 95%CI 1.06-2.11) and antiretroviral drug classes. CONCLUSIONS: Over the 12 years there has been a change in the main cause of antiretroviral treatment discontinuation, currently therapeutic optimization being the main reason. Integrase inhibitors-based regimens and singletablet regimen strategies were less likely to be discontinued than others antiretroviral drug classes, allowing for better clinical management due to the efficacy profile, especially in people living with HIV ≥50 years with comorbidities.

Analysis of antiretroviral therapy interruption in people living with HIV during the 2010-2021 period.

INTRODUCTION: In the context of the advancement of antiretroviral therapy and as the characteristics of people living with HIV progress toward an ageing population, understanding the causes of treatment interruption becomes crucial. The aim of the study was to determine the change in reasons for antiretroviral treatment discontinuation for 12 years. Secondarily, compare annual antiretroviral regimen discontinuation rate and factors associated. METHODS: We conducted an analysis using data from people living with HIV who were receiving antiretroviral therapy and discontinued it for any reason. The study included people with HIV infection who visited an outpatient hospital pharmacy clinic from January 2010 to December 2021. Two periods were differentiated for the analysis: 2010-2015 and 2016-2021. The reasons for antiretroviral treatment discontinuation followed classification described by Swiss cohort. In the context of this study, it is pertinent to note that the term "discontinuation" is employed synonymously with "interruption". The term "discontinuation" will be consistently used in this article to refer to the act of switching or stopping antiretroviral treatment. To examine factors associated with antiretroviral therapy discontinuation, we utilised Kaplan-Meier methods and Cox proportional models. RESULTS: We included 789 people living with HIV, predominantly male (81.5%). The main reason for discontinuation was clinical decision (50.2%) followed by adverse effects (37.9%). Focusing on clinical decision, we observed a trend change that went from antiretroviral treatment simplification regimen (56.1%) in the first part of the period analysed to the therapeutic optimisation (53.6%) in the second half. Furthermore, factors that were statistically significantly associated with antiretroviral treatment discontinuation were people with HIV≥50 years (HR 1.60; 95%CI 1.25-2.04), post-discontinuation single-tablet regimen (HR 1.49; 95%CI 1.06-2.11) and antiretroviral drug classes. CONCLUSION: Over the 12 years, there has been a change in the main cause of antiretroviral treatment discontinuation, currently therapeutic optimisation being the main reason. Integrase inhibitors-based regimens and single-tablet regimen strategies were less likely to be discontinued than others antiretroviral drug classes, allowing for better clinical management due to the efficacy profile, especially in people living with HIV≥50 years with comorbidities.

Influencia de la polifarmacia en la presencia simultánea de alta complejidad farmacoterapéutica, interacciones medicamentosas y no adherencia a la medicación en pacientes con infección por VIH. Proyecto 3-HIT / Influence of polypharmacy in the simultaneous presence of high pharmacotherapeutic complexity, drug interactions and non-adherence to medication in patients with HIV infection. Project 3-HIT

Introducción: La alta complejidad farmacoterapéutica, las interacciones farmacológicas y la falta de adherencia a la medicación concomitante son circunstancias con consecuencias negativas en la evolución clínica de los pacientes con infección por VIH. El fenómeno 3-HIT se refiere a la ocurrencia simultánea de estas situaciones. El objetivo del estudio es determinar la prevalencia del fenómeno 3-HIT en la población VIH polimedicada así como determinar los factores relacionados con su ocurrencia. Métodos: Estudio observacional, retrospectivo y unicéntrico que incluyó a todos los pacientes ancianos en tratamiento antirretroviral activo en seguimiento farmacoterapéutico entre enero y marzo de 2020. Se realizó un modelo de regresión logística para evaluar los factores asociados a la ocurrencia del 3-HIT concepto con las variables significativamente asociadas a este fenómeno y aquellas consideradas clínicamente relevantes. Resultados: Se incluyeron 428 pacientes, registrándose una prevalencia de polifarmacia en el 25,9% de la muestra de estudio. El fenómeno 3-HIT se detectó en el 6,3% de los pacientes. Por cada fármaco concomitante prescrito, el riesgo de desarrollar el fenómeno 3-HIT aumenta 1,5 veces. Conclusión: La prevalencia del fenómeno 3-HIT es alta en pacientes VIH con polimedicación. Un cambio en el modelo de atención farmacéutica a un entorno multidimensional es esencial, junto con estrategias de optimización farmacoterapéutica para mejorar los resultados de salud de los pacientes.(AU)

Introduction: The high pharmacotherapeutic complexity, drug interactions and lack of adherence to concomitant medication are circumstances with negative consequences in the clinical evolution of patients with HIV infection. The 3-HIT phenomenon refers to the simultaneous occurrence of these situations. The objective of the study is to determine the prevalence of the phenomenon 3-HIT in the polymedicated HIV population as well as to determine factors related to its occurrence. Methods: Observational, retrospective and single-center study that included all elderly patients on active antiretroviral treatment in pharmacotherapeutic follow-up between January and March 2020. A logistic regression model was carried out to evaluate the factors associated with the occurrence of the 3-HIT concept with the variables significantly associated with this phenomenon and those considered clinically relevant. Results: 428 patients were included, registering a prevalence of polypharmacy in 25.9% of the study sample. The 3-HIT phenomenon was detected in 6.3% of the patients. For each concomitant drug prescribed the risk of developing the phenomenon 3-HIT increases 1.5 times. Conclusion: Prevalence of the phenomenon 3-HIT is high in HIV patients with polymedication. A change in the pharmaceutical care model to a multidimensional setting is essential, together with pharmacotherapeutic optimization strategies to improve patient health outcomes.(AU)

[Characterization of hospitalized patients with acute kidney injury associated with COVID-19 in Spain: Renal replacement therapy and mortality. FRA-COVID SEN Registry Data]. / Caracterización de la población con fracaso renal agudo durante la hospitalización por COVID-19 en España: tratamiento renal sustitutivo y mortalidad. Datos del Registro FRA-COVID SEN.

Background and objectives: Acute kidney injury (AKI) is common among hospitalized patients with COVID-19 and associated with worse prognosis. The Spanish Society of Nephrology created the AKI-COVID Registry to characterize the population admitted for COVID-19 that developed AKI in Spanish hospitals. The need of renal replacement therapy (RRT) therapeutic modalities, and mortality in these patients were assessed. Material and method: In a retrospective study, we analyzed data from the AKI-COVID Registry, which included patients hospitalized in 30 Spanish hospitals from May 2020 to November 2021. Clinical and demographic variables, factors related to the severity of COVID-19 and AKI, and survival data were recorded. A multivariate regression analysis was performed to study factors related to RRT and mortality. Results: Data from 730 patients were recorded. A total of 71.9% were men, with a mean age of 70 years (60-78), 70.1% were hypertensive, 32.9% diabetic, 33.3% with cardiovascular disease and 23.9% had some degree of chronic kidney disease (CKD). Pneumonia was diagnosed in 94.6%, requiring ventilatory support in 54.2% and admission to the ICU in 44.1% of cases.The median time from the onset of COVID-19 symptoms to the appearance of AKI (37.1% KDIGO I, 18.3% KDIGO II, 44.6% KDIGO III) was 6 days (4-10). A total of 235 (33.9%) patients required RRT: 155 patients with continuous renal replacement therapy, 89 alternate-day dialysis, 36 daily dialysis, 24 extended hemodialysis and 17 patients with hemodiafiltration. Smoking habit (OR 3.41), ventilatory support (OR 20.2), maximum creatinine value (OR 2.41) and time to AKI onset (OR 1.13) were predictors of the need for RRT; age was a protective factor (0.95). The group without RRT was characterized by older age, less severe AKI, shorter kidney injury onset and recovery time (p < 0.05). 38.6% of patients died during hospitalization; serious AKI and RRT were more frequent in the death group. In the multivariate analysis, age (OR 1.03), previous chronic kidney disease (OR 2.21), development of pneumonia (OR 2.89), ventilatory support (OR 3.34) and RRT (OR 2.28) were predictors of mortality while chronic treatment with ARBs was identified as a protective factor (OR 0.55). Conclusions: Patients with AKI during hospitalization for COVID-19 had a high mean age, comorbidities and severe infection. We defined two different clinical patterns: an AKI of early onset, in older patients that resolves in a few days without the need for RRT; and another more severe pattern, with greater need for RRT, and late onset, which was related to greater severity of the infectious disease. The severity of the infection, age and the presence of CKD prior to admission were identified as risk factors for mortality in these patients. In addition chronic treatment with ARBs was identified as a protective factor for mortality.

Hypogammaglobulinemia after front-line immunochemotherapy in patients with follicular lymphoma.

INTRODUCTION: Hypogammaglobulinemia after front-line immunochemotherapy for follicular lymphoma is a poorly studied adverse event that could be related to the appearance of severe and/or recurrent non-neutropenic infections which could affect the quality of life of the patients, even motivating a need of long-term replacement therapy with human immunoglobulins. METHODS: Observational, retrospective study aiming to estimate the incidence of hypogammaglobulinemia, as well as its severity and clinical consequences, and to explore possible predictive factors for its development. Specific immunoglobulin deficiencies were also studied. RESULTS: 76.5% of patients had hypogammaglobulinemia during or after front-line treatment, mostly grade 1-2; with 38.8% patients who developed clinically relevant infections and 20% patients requiring human immunoglobulins replacement therapy. A high-risk FLIPI score was identified as a risk factor for hypogammaglobulinemia (ods ratio: 4.51; 95% confidence interval: 1.29-15.68; p < 0.001) and basal gamma globulin level as a protective factor (odds ratio: 0.92; 95% confidence interval: 0.988-0.996; p = 0.018). Any type of immunochemotherapy regimen was associated with different risks of hypogammaglobulinemia in our study. CONCLUSIONS: Hypogammaglobulinemia appears in a high percentage of patients with follicular lymphoma in a real-world population, identifying a high-risk FLIPI score as a risk factor for its development and basal gamma globulins as a protective factor.

Upraising Stenotrophomonas maltophilia in Critically Ill Patients: A New Enemy?

Stenotrophomonas maltophilia (S. maltophilia), an important pathogen in immuno-compromised patients, has recently gained attention in patients admitted in intensive care units (ICU). We sought to investigate clinical features of infections caused by S. maltophilia in ICU patients and identify risk factors for mortality. We conducted a retrospective study in two multivalent non-COVID-19 ICUs of tertiary-teaching hospitals in Greece and Spain, including patients with isolated S. maltophilia from at least one clinical specimen along with clinical signs of infection. A total of 103 patients (66% male) were analyzed. Median age was 65.5 (54-73.3) years and mean APACHE II and SOFA scores upon ICU admission were 18.36 (±7.22) and 18.17 (±6.95), respectively. Pneumonia was the predominant clinical syndrome (72.8%), while 22% of cases were among hemato/oncology patients. Crude 28-day mortality rate was 54.8%, even though, 14-day clinical and microbiological response was 96%. Age, APACHE II on ICU admission, hemato-oncologic disease, and multi-organ failure were initially identified as potential predictors of mortality. In the multivariable analysis, only increasing age and hemato-oncologic disease were shown to be independent risk factors for 28-day mortality. High all-cause mortality was observed in critically ill patients with predominantly respiratory infections by S. maltophilia, despite initial clinical and laboratory response after targeted treatment. The study elucidates a potentially worrisome emerging pathogen in the ICU.

Potentially inappropriate medications according to Marc, STOPP and PRISCUS criteria in a cohort of elderly HIV+ patients. The COMMPI project / Prevalencia de medicamentos potencialmente inapropiados según criterios Marc, STOPP y PRISCUS en una cohorte de pacientes VIH+ de edad avanzada. Proyecto COMMPI

Introduction: The objective is to determine the prevalence of potentially inappropriate drugs according to the Marc, STOPP, and PRISCUS lists in elderly HIV patients. Patients and methods: It was an observational, retrospective, and multicenter study. People living with HIV 65 years or older who underwent chronic concomitant treatment were included. Descriptive and multivariate analyzes were performed to study the association between polypharmacy and potentially inappropriate medication compliance. Results: A total of 55 patients were included, 81.8% men and a median age of 69 years (IQR: 67-73). The median number of comorbidities was 3 (IQR: 2-5) and the most frequent pattern of multimorbidity was cardiometabolic (62.9%). The predominant antiretroviral treatment was triple therapy (65.5%). Polypharmacy was present in 70.9% of the patients and 25.5% had major polypharmacy. The most frequent polypharmacy pattern was cardiovascular (69.2%). The percentage of potentially inappropriate medications according to the Marc, STOPP and PRISCUS lists was 65.5%, 30.9% and 14.5%, respectively (p<0.001). Adjusted for age and sex, polypharmacy was not independently associated with potentially inappropriate medication compliance in any of the lists. Conclusion: Polypharmacy and potentially inappropriate medications have a high prevalence. There is great variability in the percentage according to the list applied. Age, sex, and presence of polypharmacy are not predisposing factors to the presence of potentially inappropriate medications. (AU)

Introducción: El objetivo de este estudio es determinar la prevalencia de medicamentos potencialmente inapropiados según los listados Marc, STOPP y Priscus en pacientes VIH+ de edad avanzada. Pacientes y métodos: Estudio observacional, transversal y multicéntrico. Se incluyeron aquellos pacientes VIH+ mayores de 65 años en tratamiento antirretroviral y tratamiento concomitante crónico. Para conocer la asociación entre polifarmacia y presencia de medicación potencialmente inapropiada se llevaron a cabo análisis descriptivos y multivariante.Resultados: Se incluyeron 55 pacientes (81.8% hombres); mediana de edad 69 años (RIQ 67-73). Todos presentaban alguna comorbilidad (mediana 3, RIQ 2-5). El patrón de multimorbilidad más frecuente fue cardio-metabólico (62.9%). La triple terapia fue el esquema de tratamiento antiretroviral predominante (65.5%) y el patrón de polifarmacia más frecuente fue el cardiovascular (69.2%). Se identificó presencia de polifarmacia en un 70,9% y un 25,5% polifarmacia mayor. El cumplimiento de algún criterio según el listado Marc, STOPP y PRISCUS observó en 65,5%, 30,9% y 14,5% de los pacientes (p<0.001). Según análisis multivariante se observa que la edad, sexo o presencia de polifarmacia no son factores determinantes de presencia de medicamentos inapropiados en los listados. Conclusión. La prevalencia de medicación potencialmente inapropiada según los listados utilizados fue alta, existiendo una gran variabilidad en la identificación entre las diferentes herramientas. Edad, sexo y polifarmacia no son factores predictivosde presencia de medicamentos potencialmente inapropiados. (AU)

Influence of polypharmacy in the simultaneous presence of high pharmacotherapeutic complexity, drug interactions and non-adherence to medication in patients with HIV infection. Project 3-HIT.

INTRODUCTION: The high pharmacotherapeutic complexity, drug interactions and lack of adherence to concomitant medication are circumstances with negative consequences in the clinical evolution of patients with HIV infection. The 3-HIT phenomenon refers to the simultaneous occurrence of these situations. The objective of the study is to determine the prevalence of the phenomenon 3-HIT in the polymedicated HIV population as well as to determine factors related to its occurrence. METHODS: Observational, retrospective and single-center study that included all elderly patients on active antiretroviral treatment in pharmacotherapeutic follow-up between January and March 2020. A logistic regression model was carried out to evaluate the factors associated with the occurrence of the 3-HIT concept with the variables significantly associated with this phenomenon and those considered clinically relevant. RESULTS: 428 patients were included, registering a prevalence of polypharmacy in 25.9% of the study sample. The 3-HIT phenomenon was detected in 6.3% of the patients. For each concomitant drug prescribed the risk of developing the phenomenon 3-HIT increases 1.5 times. CONCLUSION: Prevalence of the phenomenon 3-HIT is high in HIV patients with polymedication. A change in the pharmaceutical care model to a multidimensional setting is essential, together with pharmacotherapeutic optimization strategies to improve patient health outcomes.

Prevalence of compliance with PIMDINAC criteria among elderly people living with HIV and in non-infected outpatients with other chronic diseases.

BACKGROUND: There is a high prevalence of multimorbidity and polypharmacy among older people, especially in people living with HIV (PLWH) with an increased life expectancy due to effective antiretroviral therapy (ART). Consequently, there is a higher risk of potentially inappropriate medications (PIM), potential drug-drug interactions (DI), and problems of non-adherence to treatment (NAC) in older PLWH. PIMDINAC criteria (potentially inappropriate medications (PIM), drug-drug interactions (DI), and non-adherence to treatment (NAC)) purport to jointly analyse these problems. The purpose of the study was to compare the prevalence of PIMDINAC criteria among elderly PLWH and non-infected patients with chronic diseases, and to determine whether HIV infection constitutes a predictor of the presence of PIMDINAC criteria, totally or partially. METHODS: A cross sectional study was conducted between February and June 2020. HIV positive patients aged ≥65 years were compared with a group of patients with chronic conditions attending the outpatient hospital pharmacy service. RESULTS: The study involved 140 patients: 47 HIV positive and 93 HIV negative, and mean age was 69 versus 73 years, respectively (p=0.062). The prevalence of total PIMDINAC criteria was similar between the groups (12.5 vs 10.8%, p=0.505). In relation to inappropriate medication, no differences were observed between groups (48.9 vs 55.9%, p=0434). Drug-drug interactions were higher in patients with chronic conditions (52.7 vs 25.5%, p=0.002) compared with non-adherence, which was higher in people with HIV (22.6 vs 65.6%, p<0.001). No differences in polypharmacy (≥6 and 11 drugs) rates were observed. CONCLUSIONS: PIMDINAC criteria were highly prevalent in older PLWH, similar to non-infected patients. HIV infection in older people was associated with a lower risk of drug-drug interactions. However, non-adherence was a risk factor compared with age matched controls. Deprescribing strategies, including a capability-motivation-opportunity pharmaceutical care model based intervention should be implemented in clinical routines.

Prevalencia y factores asociados con la presencia de criterios PIMDINAC en pacientes VIH de edad avanzada / Prevalence of PIMDINAC criteria and associated factors in elderly HIV patients

IntroducciónEl envejecimiento de la población infectada por VIH podría relacionarse con prescripciones de medicación potencialmente inadecuadas, interacciones medicamentosas y falta de adherencia terapéutica. Los criterios PIMDINAC buscan analizar conjuntamente estos problemas. El objetivo del estudio es determinar la prevalencia de los criterios PIMDINAC en una población VIH de edad avanzada.MétodosEstudio observacional, transversal y multicéntrico que incluyó pacientes mayores de 65 años en seguimiento farmacoterapéutico entre febrero-abril de 2020. La variable principal fue el porcentaje de cumplimiento de los criterios PIMDINAC.ResultadosSe incluyeron 47 pacientes, registrándose un PIMDINAC total en un 12,5%. De forma aislada, se detectó no adherencia al tratamiento concomitante en un 65,6% de los pacientes, medicación potencialmente inadecuada en un 48,9% e interacciones medicamentosas en un 25,2%. El número de fármacos y la polifarmacia se relacionaron con una mayor aparición de criterios PIMDINAC.ConclusiónLa prevalencia de criterios PIMDINAC en pacientes VIH de edad avanzada es elevada.

IntroductionAging of people living with HIV could be related to potentially inappropriate medication prescriptions, drugs interactions and lack of drugs adherence. PIMDINAC criteria seek to jointly analyze these problems. The objective of this study is to determine the prevalence of PIMDINAC criteria in an elderly HIV population.MethodsObservational, cross-sectional, multicenter study that included patients older than 65 years in pharmacotherapeutic follow-up between February-April 2020. The main endpoint was the percentage of PIMDINAC criteria identified in the study population.ResultsForty-seven patientes were included, identifying total PIMDINAC in 12.5%. Non-adherence to concomitant treatment was detected in 65.6% of patients, potentially inappropriate medication in 48.9% and drugs interactions in 25.2%. The number of concomitant drugs and polypharmacy were associated with a higher appearance of PIMDINAC criteria.ConclusionThe prevalence of PIMDINAC criteria in elderly HIV patients is high.

Prevalence of PIMDINAC criteria and associated factors in elderly HIV patients.

INTRODUCTION: Aging of people living with HIV could be related to potentially inappropiate medication prescriptions, drugs interactions and lack of drugs adherence. PIMDINAC criteria seek to jointly analyze these problems. The objective of this study is to determine the prevalence of PIMDINAC criteria in an elderly HIV population. METHODS: Observational, cross-sectional, multicenter study that included patients older than 65 years in pharmacotherapeutic follow-up between February-April 2020. The main endpoint was the percentage of PIMDINAC criteria identified in the study population. RESULTS: Forty-seven patientes were included, identifying total PIMDINAC in 12.5%. Non-adherence to concomitant treatment was detected in 65.6% of patients, potentially inappropiate medication in 48.9% and drugs interactions in 25.2%. The number of concomitant drugs and polypharmacy were associated with a higher appearance of PIMDINAC criteria. CONCLUSION: The prevalence of PIMDINAC criteria in elderly HIV patients is high.

Clinical impact of procalcitonin-based algorithms for duration of antibiotic treatment in critically ill adult patients with sepsis: a meta-analysis of randomized clinical trials.

BACKGROUND: Our objective was to assess the impact on mortality, antibacterial therapy duration, and length of stay of using PCT to guide antibiotic cessation in critically ill patients with sepsis or septic shock. RESEARCH DESIGN AND METHODS: A systematic literature search was performed in PubMed, Embase, ISI Web of Knowledge, BioMed Central, ScienceDirect and the Cochrane Central Register of Controlled Trials, of clinical trials published in English before December 31, 2019. Eligible studies should be carried out in adults at ICU with sepsis, comparing the PCT-guided antimicrobial therapy with standard of care. A random effects model was used. RESULTS: Twelve studies were eligible with a total of 4292 patients included. The combined relative risk for 28-day mortality was 0.89 (95% CI: 0.79; 0.99), for the duration of antimicrobial therapy was -1.98 days (95% CI: -2.76, -1.21) and for ICU- length of stay was-1.21 days (95% CI: -4.16, 1.74). CONCLUSIONS: In critically ill adults with sepsis, a procalcitonin-guided strategy is associated with a significant shorter duration of antimicrobial therapy. This reduction was associated with a significant decrease in mortality although the length of ICU stay was not affected.

Effectiveness and safety of eribulin for human epidermal growth factor receptor 2 negative metastatic breast cancer in a real-world population.

BACKGROUND: Eribulin's clinical benefit remains unclear; so, studies analyzing its effectiveness in routine clinical practice are interesting. PATIENTS AND METHODS: This is a multicenter, retrospective study including patients with human epidermal growth factor receptor-2-negative metastatic breast cancer which assesses effectiveness and safety of eribulin. RESULTS: A total of 140 women were included, with a median age of 57 years. The median overall survival and progression-free survival were 8.8 (95% confidence interval: 6.1-11.4) and 2.8 months (95% confidence interval: 2.5-3.1), respectively. For patients with hormonal receptor expression, a significantly longer progression-free survival was observed: 3.4 (95%confidence interval: 2.3-4.5) versus triple negative: 2.0 (95%confidence interval: 1.7-2.3) months, p = 0.003. Also, those who had received capecitabine prior to eribulin had a higher median overall survival than those who had not received it (9.5 months, 95% confidence interval: 6.6-12.5 vs. 4.8 months, 95% confidence interval: 3.4-6.2; p = 0.001). When only triple-negative patients were included, median overall survival was 6.5 (95% confidence interval: 0.1-16.2) for those who had received previous capecitabine versus 4.3 (95% confidence interval: 2.8-5.8) months for patients who had not received it; p =0.006. The safety profile of eribulin was adequate. CONCLUSION: Effectiveness of eribulin in a real-life human epidermal growth factor receptor-2--negative population is lower than that observed in clinical trials. Its benefit seems to be higher in patients with hormonal receptor expression and patients who had received capecitabine prior to eribulin. The safety profile of eribulin is adequate.

Drug-drug interactions between treatment specific pharmacotherapy and concomitant medication in patients with COVID-19 in the first wave in Spain.

Primary aim was to assess prevalence and severity of potential and real drug-drug interactions (DDIs) among therapies for COVID-19 and concomitant medications in hospitalized patients with confirmed SARS-CoV-2 infection. The secondary aim was to analyze factors associated with rDDIs. An observational single center cohort study conducted at a tertiary hospital in Spain from March 1st to April 30th. rDDIs refer to interaction with concomitant drugs prescribed during hospital stay whereas potential DDIs (pDDIs) refer to those with domiciliary medication. DDIs checked with The University of Liverpool resource. Concomitant medications were categorized according to the Anatomical Therapeutic Chemical classification system. Binomial logistic regression was carried out to identify factors associated with rDDIs. A total of 174 patients were analyzed. DDIs were detected in 152 patients (87.4%) with a total of 417 rDDIs between COVID19-related drugs and involved hospital concomitant medication (60 different drugs) while pDDIs were detected in 105 patients (72.9%) with a total of 553 pDDIs. From all 417 rDDIs, 43.2% (n = 180) were associated with lopinavir/ritonavir and 52.9% (n = 221) with hydroxychloroquine, both of them the most prescribed (106 and 165 patients, respectively). The main mechanism of interaction observed was QTc prolongation. Clinically relevant rDDIs were identified among 81.1% (n = 338) ('potential interactions') and 14.6% (n = 61) (contraindicated) of the patients. Charlson index (OR 1.34, 95% IC 1.02-1.76) and number of drugs prescribed during admission (OR 1.42, 95% IC 1.12-1.81) were independently associated with rDDIs. Prevalence of patients with real and pDDIs was high, especially those clinically relevant. Both comorbidities and polypharmacy were found as risk factors independently associated with DDIs development.

Impact and acceptance of pharmacist-led interventions during HIV care in a third-level hospital in Spain using the Capacity-Motivation-Opportunity pharmaceutical care model: the IRAFE study.

INTRODUCTION: In recent decades, HIV has become a chronic disease with which the HIV specialist pharmacist plays a fundamental role. The traditional pharmaceutical care model followed to date relied excessively on the medication, obviating the uniqueness of each patient. The purpose of this study was to determine the influence and acceptance of a Capacity-Motivation-Opportunity (CMO)-based structured pharmaceutical care (PC) intervention in a multidisciplinary team for improving healthcare results. METHODS: Prospective single-centre study of a structured health intervention with patients living with HIV who attended hospital between January 2017 and June 2018 for any cause. Pharmacotherapeutic follow-up was applied according to the CMO PC model based on three key elements, namely stratification, motivational interview and new technologies. To assess differences in the variables collected before and after the intervention, Student's t-test or Wilcoxon test, and McNemar's test were used for quantitative and dichotomous variables, respectively. RESULTS: A total of 349 patients were included, 76.1% of which were men. The acceptance of pharmacist intervention by both doctors and patients was high [336 (97.7%) and 321 (93.3%)] and the adherence rate to antiretroviral therapy before intervention was lower than that observed afterwards (85.6%±33.7% vs 96.4%±17.7%; p<0.001). No differences were found between median viral load pre- versus post-intervention [1175 (62.75-26 050) copies/mL vs 274 (76.75-5542) copies/mL], although the undetectability rate was recorded as higher after intervention compared with the previous period [294 (85.5%) vs 274 (79.7%); p<0.001]. CONCLUSIONS: Our results could help HIV pharmacy clinic specialists to recognise high-risk patients and to develop personalised follow-up care, thereby ensuring good adherence and response to treatments.

Prevalence of PIMDINAC criteria and associated factors in elderly HIV patients. / Prevalencia y factores asociados con la presencia de criterios PIMDINAC en pacientes VIH de edad avanzada.

INTRODUCTION: Aging of people living with HIV could be related to potentially inappropriate medication prescriptions, drugs interactions and lack of drugs adherence. PIMDINAC criteria seek to jointly analyze these problems. The objective of this study is to determine the prevalence of PIMDINAC criteria in an elderly HIV population. METHODS: Observational, cross-sectional, multicenter study that included patients older than 65 years in pharmacotherapeutic follow-up between February-April 2020. The main endpoint was the percentage of PIMDINAC criteria identified in the study population. RESULTS: Forty-seven patientes were included, identifying total PIMDINAC in 12.5%. Non-adherence to concomitant treatment was detected in 65.6% of patients, potentially inappropriate medication in 48.9% and drugs interactions in 25.2%. The number of concomitant drugs and polypharmacy were associated with a higher appearance of PIMDINAC criteria. CONCLUSION: The prevalence of PIMDINAC criteria in elderly HIV patients is high.

High rate of major drug-drug interactions of lopinavir-ritonavir for COVID-19 treatment.

The impact of drug-drug interactions (DDI) between ritonavir-boosted lopinavir (LPV-r) to treat patients with coronavirus disease 2019 (COVID-19) and commonly used drugs in clinical practice is not well-known. Thus, we evaluated the rate and severity of DDI between LPV-r for COVID-19 treatment and concomitant medications. This was a cross-sectional study including all individuals diagnosed of SARS-CoV-2 infection treated with LPV-r and attended at a single center in Southern Spain (March 1st to April 30th, 2020). The frequency [95% confidence interval (95% CI)] of potential and major DDI were calculated. Overall, 469 patients were diagnosed of COVID-19, 125 (27%) of them were prescribed LPV-r. LPV-r had potential DDI with concomitant medications in 97 (78%, 95% CI 69-85%) patients, and in 33 (26%, 95% CI 19-35%) individuals showed major DDI. Twelve (36%) patients with major DDI and 14 (15%) individuals without major DDI died (p = 0.010). After adjustment, only the Charlson index was independently associated with death [adjusted OR (95% CI) for Charlson index ≥ 5: 85 (10-731), p < 0.001]. LPV-r was discontinued due to side effects in 31 (25%) patients. Management by the Infectious Diseases Unit was associated with a lower likelihood of major DDI [adjusted odds ratio (95% CI): 0.14 (0.04-0.53), p = 0.003). In conclusion, a high frequency of DDI between LPV-r for treating COVID-19 and concomitant medications was found, including major DDI. Patients with major DDI showed worse outcomes, but this association was explained by the older age and comorbidities. Patients managed by the Infectious Diseases Unit had lower risk of major DDI.

Mesenchymal stromal cells for the prophylaxis and treatment of graft-versus-host disease-a meta-analysis.

BACKGROUND: Graft-versus-host disease (GvHD) is the main life-threatening complication of allogeneic hematopoietic stem cell transplantation (HSCT). Thirty to 80% of GvHD patients do not respond to first-line treatment and a second-line treatment is not universally established. Based on their immunomodulatory properties, mesenchymal stromal cells (MSC) have been proposed for the prevention and the treatment of GvHD in patients undergoing HSCT. Unfortunately, previous studies reported conflicting results regarding the prophylactic and therapeutic effects of MSC for GvHD. Consequently, we carried out a meta-analysis to clarify whether MSC administration can improve the dismal outcome of these patients. METHODS: We carried out a systematic review and selected studies (2004-2019) reporting data about the administration of allogeneic MSC for the prevention (n = 654 patients) or treatment of acute (n = 943 patients) or chronic (n = 76 patients) GvHD after HSCT. Our primary outcome was overall survival at the last follow-up. The secondary outcomes were the response and development of GvHD. Subgroup analyses included age, MSC dose, first infusion day after HSCT, number of organs and organ-specific involvement, acute GvHD grade (I-IV), and chronic GvHD grade (limited or extensive). RESULTS: Patients infused with MSC for GvHD prophylaxis showed a 17% increased overall survival (95% CI, 1.02-1.33) and a reduced incidence of acute GvHD grade IV (RR = 0.22; 95% CI, 0.06-0.81) and chronic GvHD (RR = 0.64; 95% CI, 0.47-0.88) compared with controls. Overall survival of acute GvHD patients (0.50; 95% CI, 0.41-0.59) was positively correlated with MSC dose (P = 0.0214). The overall response was achieved in 67% (95% CI, 0.61-0.74) and was complete in 39% (95% CI, 0.31-0.48) of acute patients. Organ-specific response was higher for the skin. Twenty-two percent (95% CI, 0.16-0.29) of acute patients infused with MSC developed chronic GvHD. Sixty-four percent (95% CI, 0.47-0.80) of chronic patients infused with MSC survived; the overall response was 66% (95% CI, 0.55-0.76) and was complete in 23% (95% CI 0.12-0.34) of patients. CONCLUSIONS: Our meta-analysis indicates that allogeneic MSC could be instrumental for the prophylaxis and treatment of GvHD. Future trials should investigate the effect of the administration of MSC as an adjuvant therapy for the treatment of patients with GvHD from the onset of the disease.