Lipid changes in HIV-patients switching to the coformulated single tablet FTC/RPV/TDF (Eviplera®). Efficacy and safety analysis. GeSida Study 8114.

INTRODUCTION Rilpivirine (RPV) has a better lipid profile than efavirenz (EFV) in naïve patients (1). Switching to RPV may be convenient for many patients, while maintaining a good immunovirological control (2). The aim of this study was to analyze lipid changes in HIV-patients at 24 weeks after switching to Eviplera® (emtricitabine/RPV/tenofovir disoproxil fumarate [FTC/RPV/TDF]). MATERIALS AND METHODS Retrospective, multicentre study of a cohort of asymptomatic HIV-patients who switched from a regimen based on 2 nucleoside reverse transcriptase inhibitors (NRTI)+protease inhibitor (PI)/non nucleoside reverse transcriptase inhibitor (NNRTI) or ritonavir boosted PI monotherapy to Eviplera® during February-December, 2013; all had undetectable HIV viral load for ≥3 months prior to switching. Patients with previous failures on antiretroviral therapy (ART) including TDF and/or FTC/3TC, with genotype tests showing resistance to components of Eviplera®, or who had changed the third drug of the ART during the study period were excluded. Changes in lipid profile and cardiovascular risk (CVR), and efficacy and safety at 24 weeks were analyzed. RESULTS Among 305 patients included in the study, 298 were analyzed (7 cases were excluded due to lack of data). Men 81.2%, mean age 44.5 years, 75.8% of HIV sexually transmitted. 233 (78.2%) patients switched from a regimen based on 2 NRTI+NNRTI (90.5% EFV/FTC/TDF). The most frequent reasons for switching were central nervous system (CNS) adverse events (31.0%), convenience (27.6%) and metabolic disorders (23.2%). At this time, 293 patients have reached 24 weeks: 281 (95.9%) have continued Eviplera®, 6 stopped it (3 adverse events, 2 virologic failures, 1 discontinuation) and 6 have been lost to follow up. Lipid profiles of 283 cases were available at 24 weeks and mean (mg/dL) baseline vs 24 weeks are: total cholesterol (193 vs 169; p=0.0001), HDL-c (49 vs 45; p=0.0001), LDL-c (114 vs 103; p=0.001), tryglycerides (158 vs 115; p=0.0001), total cholesterol to HDL-c ratio (4.2 vs 4.1; p=0.3). CVR decreased (8.7 vs 7.5%; p= 0.0001). CD4 counts were similar to baseline (653 vs 674 cells/µL; p=0.08), and 274 (96.8%) patients maintained viral suppression. CONCLUSIONS At 24 weeks after switching to Eviplera®, lipid profile and CVR improved while maintaining a good immunovirological control. Most subjects switched to Eviplera® from a regimen based on NNRTI, mainly EFV/FTC/TDF. CNS adverse events, convenience and metabolic disorders were the most frequent reasons for switching.

20 anys de Catalunya a la Unió Europea

Aquest llibre aprofita la efemèride del vintè aniversari de la integració de Catalunya a la UE per analitzar l´impacte de les principals polítiques europees i la seva influència en l´evolució de les polítiques a nivell català

Impacto del apoyo social y la morbilidad psíquica en la calidad de vida en pacientes tratados con antirretrovirales

The impact of the social support and the psychic morbidity on the quality of life of patients with antiretroviral therapy. The aim of this study is to analyse the existing relation between the psychic morbidity and social support and the quality of life. Besides this, the paper analyses the buffer rol that social support plays on the psychic morbidity in these patients. We studied 320 HIV+ patients in truatment with antiretrovirals, who attended the infectious disease services of four hospitals of the Autonomous Andalusian Community. Being associated a better quality of life to an absence of psychic morbidity and to the presence of social support, it is observed the relevant buffer role that the social support like shock absorber of the psychic morbidity in this one type of patients. These results show the importance that the psycho-social factors have during the course of chronic diseases.

Assessment of Epstein-Barr virus nucleic acids in gastric but not in breast cancer by next-generation sequencing of pooled Mexican samples

Gastric (GC) and breast (BrC) cancer are two of the most common and deadly tumours. Different lines of evidence suggest a possible causative role of viral infections for both GC and BrC. Wide genome sequencing (WGS) technologies allow searching for viral agents in tissues of patients with cancer. These technologies have already contributed to establish virus-cancer associations as well as to discovery new tumour viruses. The objective of this study was to document possible associations of viral infection with GC and BrC in Mexican patients. In order to gain idea about cost effective conditions of experimental sequencing, we first carried out an in silico simulation of WGS. The next-generation-platform IlluminaGallx was then used to sequence GC and BrC tumour samples. While we did not find viral sequences in tissues from BrC patients, multiple reads matching Epstein-Barr virus (EBV) sequences were found in GC tissues. An end-point polymerase chain reaction confirmed an enrichment of EBV sequences in one of the GC samples sequenced, validating the next-generation sequencing-bioinformatics pipeline.

Frequency and characteristics of familial melanoma in Spain: the FAM-GEM-1 Study.

INTRODUCTION Familial history of melanoma is a well-known risk factor for the disease, and 7% melanoma patients were reported to have a family history of melanoma. Data relating to the frequency and clinical and pathological characteristics of both familial and non-familial melanoma in Spain have been published, but these only include patients from specific areas of Spain and do not represent the data for the whole of Spain. PATIENTS AND METHODS An observational study conducted by the Spanish Group of Melanoma (GEM) analyzed the family history of patients diagnosed with melanoma between 2011 and 2013 in the dermatology and oncology departments. RESULTS In all, 1047 patients were analyzed, and 69 (6.6%) fulfilled criteria for classical familial melanoma (two or more first-degree relatives diagnosed with melanoma). Taking into account other risk factors for familial melanoma, such as multiple melanoma, pancreatic cancer in the family or second-degree relatives with melanoma, the number of patients fulfilling the criteria increased to 165 (15.8%). Using a univariate analysis, we determined that a Breslow index of less than 1 mm, negative mitosis, multiple melanoma, and a history of sunburns in childhood were more frequent in familial melanoma patients, but a multivariate analysis revealed no differences in any pathological or clinical factor between the two groups. CONCLUSIONS Similar to that observed in other countries, familial melanoma accounts for 6.6% of melanoma diagnoses in Spain. Although no differences in the multivariate analysis were found, some better prognosis factors, such as Breslow index, seem more frequent in familial melanoma, which reflect a better early detection marker and/or a different biological behavior.

Evaluation of the efficacy and safety of lanreotide in combination with targeted therapies in patients with neuroendocrine tumours in clinical practice: a retrospective cross-sectional analysis.

BACKGROUND Based on the mechanism of action, combining somatostatin analogues (SSAs) with mTOR inhibitors or antiangiogenic agents may provide synergistic effects for the treatment of patients with neuroendocrine tumours (NETs). Herein, we investigate the use of these treatment combinations in clinical practice. METHODS This retrospective cross-sectional analysis of patients with NETs treated with the SSA lanreotide and targeted therapies at 35 Spanish hospitals evaluated the efficacy and safety of lanreotide treatment combinations in clinical practice. The data of 159 treatment combinations with lanreotide in 133 patients was retrospectively collected. RESULTS Of the 133 patients, with a median age of 59.4 (16-83) years, 70 (52.6 %) patients were male, 64 (48.1 %) had pancreatic NET, 23 (17.3 %) had ECOG PS ≥2, 41 (30.8 %) had functioning tumours, 63 (47.7 %) underwent surgery of the primary tumour, 45 (33.8 %) had received prior chemotherapy, and 115 (86.5 %) had received prior SSAs. 115 patients received 1 lanreotide treatment combination and 18 patients received between 2 and 5 combinations. Lanreotide was mainly administered in combination with everolimus (73 combinations) or sunitinib (61 combinations). The probability of being progression-free was 78.5 % (6 months), 68.6 % (12 months) and 57.0 % (18 months) for patients who only received everolimus plus lanreotide (n = 57) and 89.3 % (6 months), 73.0 % (12 months), and 67.4 % (18 months) for patients who only received sunitinib and lanreotide (n = 50). In patients who only received everolimus plus lanreotide the median time-to-progression from the initiation of lanreotide combination treatment was 25.8 months (95 % CI, 11.3, 40.3) and it had not yet been reached among the subgroup of patients only receiving sunitinib plus lanreotide. The safety profile of the combination treatment was comparable to that of the targeted agent alone. CONCLUSIONS The combination of lanreotide and targeted therapies, mainly everolimus and sunitinib, is widely used in clinical practice without unexpected toxicities and suggests efficacy that should be explored in randomized prospective clinical trials.

Impact of inadequate empirical therapy on the mortality of patients with bloodstream infections: a propensity score-based analysis.

The impact of the adequacy of empirical therapy on outcome for patients with bloodstream infections (BSI) is key for determining whether adequate empirical coverage should be prioritized over other, more conservative approaches. Recent systematic reviews outlined the need for new studies in the field, using improved methodologies. We assessed the impact of inadequate empirical treatment on the mortality of patients with BSI in the present-day context, incorporating recent methodological recommendations. A prospective multicenter cohort including all BSI episodes in adult patients was performed in 15 hospitals in Andalucía, Spain, over a 2-month period in 2006 to 2007. The main outcome variables were 14- and 30-day mortality. Adjusted analyses were performed by multivariate analysis and propensity score-based matching. Eight hundred one episodes were included. Inadequate empirical therapy was administered in 199 (24.8%) episodes; mortality at days 14 and 30 was 18.55% and 22.6%, respectively. After controlling for age, Charlson index, Pitt score, neutropenia, source, etiology, and presentation with severe sepsis or shock, inadequate empirical treatment was associated with increased mortality at days 14 and 30 (odds ratios [ORs], 2.12 and 1.56; 95% confidence intervals [95% CI], 1.34 to 3.34 and 1.01 to 2.40, respectively). The adjusted ORs after a propensity score-based matched analysis were 3.03 and 1.70 (95% CI, 1.60 to 5.74 and 0.98 to 2.98, respectively). In conclusion, inadequate empirical therapy is independently associated with increased mortality in patients with BSI. Programs to improve the quality of empirical therapy in patients with suspicion of BSI and optimization of definitive therapy should be implemented.

Spain in Europe 2004-2008

In March of 2004, the Observatory of European Foreign Policy published a special monograph about Spain in Europe (1996-2004) in digital format. The objective of the monograph was to analyse Spain’s foreign policy agenda and strategy during the period of José María Aznar’s presidency. As the title suggests, one of the initial suppositions of the analysis is the Europeanization of Spanish foreign activities. Is that how it was? Did Aznar’s Spain see the world and relate to it through Brussels? The publication was well received, considering the number of visits received and above all the institutions which asked to link the publication to their web pages. Among these, the EUobserver published the introduction to the piece in English titled Aznar: thinking locally, acting in Europe (described by the EUobserver as a paper of utmost importance). The fact that the elections were held three days after the tragic events of the 11th of March dramatically increased interest in Spain and the implications for Europe. This publication is the second of its type, in this case analysing the period of the Zapatero government (2004-2008). Once again the starting premise (the Europeanization of the agenda and the methods employed) has been considered by the analysts. And once again the articles collected in this publication serve to “triangulate” the analysis. Spain and Europe are two vertices (more or less distant, in essence and in form) which the authors handle in their analysis of the case (third vertex).

España en Europa 2004-2008

En marzo de 2004 el Observatorio de Política Exterior Europea publicó, en versión digital, un monográfico especial sobre España en Europa (1996-2004). Su objetivo era analizar la agenda y la estrategia de España durante el período de José María Aznar en materia de relaciones internacionales. Como bien indicaba el título de aquella publicación, uno de los supuestos de partida del análisis era la europeización de la actividad internacional de España. ¿Era así?, ¿la España de Aznar veía el mundo y se aproximaba a él a través de Bruselas? Aquella publicación tuvo una buena acogida, a la vista de las visitas recibidas y sobre todo de las instituciones que nos pidieron vincular dicha publicación a sus páginas web y, entre ellas, hay que destacar que EUObserver publicó como comentario su artículo introductorio, en versión inglesa, Aznar: thinking locally, acting in Europe (calificado por EUObserver como lectura de máxima relevancia). El hecho de que las elecciones de 2004 se celebraran tres días después de los trágicos acontecimientos del 11-M hizo que el interés por España y por su proyección europea e internacional aumentara de manera destacada. La presente publicación constituye un segundo ejercicio de dicho tipo, en este caso para analizar el período del gobierno Zapatero (2004-2008). Una vez más, el supuesto de partida (la europeización de la agenda y del método) está en la mente de los analistas. Y una vez más los artículos recogidos en esta publicación hacen el ejercicio de “triangular” el análisis. España y Europa son dos vértices (más o menos alejados, en el fondo y en la forma) que los autores manejan en sus análisis de caso (tercer vértice)

España en Europa 1996-2004

Pensar globalmente, actuar localmente” es un slogan imprescindible en el discurso político de nuestros días. Pues bien, la práctica política, en materia de Unión Europea, de los dos gobiernos del Partido Popular, presididos por José María Aznar (1996-2004), nos permite acuñar un slogan de signo bien diferente: “pensar localmente, actuar en Europa”. En efecto, si algo caracteriza a estos ocho años de práctica política de José María Aznar es haber convertido sus preocupaciones domésticas en factor exclusivo de su estrategia europea, con independencia del contexto de cada momento y de la necesidad de encajar objetivos nacionales con objetivos europeos. De ahí que sea lógico que la campaña electoral que ha precedido a las elecciones generales del 14 de marzo no haya recogido ninguno de los temas que dominan en la agenda de la UE en el momento actual. Ni la ampliación, ni la Constitución, ni tampoco el proceso de conformación de un núcleo duro tienen cabida en el debate político españo

Spain in Europe 1996-2004

“Thinking globally, acting locally" is an essential slogan in the current political discourse. Yet, in view of the policies on the European Union carried out by the two governments of the People’s Party (PP) headed by José María Aznar between 1996 and 2004, we could coin a quite different slogan: "thinking locally, acting in Europe". Indeed, José María Aznar’s policy-making during the last eight years has been characterised by turning his domestic concerns into the ‘exclusive factor’ of his European strategy, regardless of the context and the need for fitting in national objectives with Europeans’. Hence, it was natural that the electoral campaign preceding the general elections held on Sunday, 14 March, did not deal with any of the topics prevailing in the EU’s current agenda. Neither enlargement nor the Constitution, nor the process of shaping a core group within the EU, seem to have room in Spain’s political debate...

Especial sobre los hechos del 11 de Septiembre

El 11 de septiembre marcó un antes y un después para el conjunto de la sociedad internacional. Los terribles atentados contra las Torres Gemelas pusieron sobre la mesa un nuevo conjunto de amenazas y riesgos difusos que diluyeron el tradicional escenario de seguridad. Asimismo, la subsecuente operación armada contra Afganistán abrió un nuevo debate sobre la intervención internacional y sobre la pervivencia de las organizaciones regionales e internacionales. Esta monografía se sitúa precisamente en este contexto e intenta ofrecer al lector unas primeras reflexiones sobre unos hechos que marcaron dramáticamente la historia contemporánea.

Estudio de la albúmina sérica y del índice de masa corporal como marcadores nutricionales en pacientes en hemodiálisis.

Background: Protein calorie malnutrition as well as systemic inflammation and metabolic disorders are common among patients with chronic renal failure undergoing renal replacement therapy (haemodialysis), which contributes to its morbidity and mortality. Aims: The aims of this work was to evaluate the nutritional status of patients in a hemodialysis treatment through the assessment of biochemical parameters nutritional as albumin, and anthropometric parameters of body mass index during ten years of follow up. Methods: In this work has been followed 90 patients of both sexes with chronic kidney disease who were treated with hemodialysis regularly on our unit for ten years. All patients were conducted quarterly measurements of plasma albumin (Alb), and other biochemical determinations, and anthropometric measurements of height, weight and body mass index calculated by the formula weight/height², grouped n BMI < 23 kg/m2 and albumin levels <3.8 g/dl according to the consensus of the panel of experts of the International Society for renal Nutrition and metabolism. Results: During the 10 years all patients showed a significant decline in the biochemical parameters and the albumin, change in BMI does not presented significant changes in relation to malnutrition. Conclusions: Malnutrition in patients on dialysis is a fact patent, BMI does not correspond with the biochemical parameters were observed, for what nutritional impairment in these patients is mainly expressed by serum albumin.

Pigment production by Streptococcus agalactiae in quasi-defined media.

A quasi-defined medium that supports the growth of Streptococcus agalactiae as pigmented colonies has been developed. The medium contains starch, a peptic digest of albumin, amino acids, nucleosides, vitamins, and salts. The presence of free cysteine, which could be replaced with other sulphur-containing compounds and to a lesser degree by reducing agents, was required for pigment formation.

Identification of serum and urine proteins responsible for enhanced pigment production by group B streptococci as amylases.

The serum and urine proteins responsible for enhanced pigment production in Streptococcus agalactiae in culture media were purified by chromatography and were identified as amylases by comparison of their amino acid composition with that calculated for proteins with known sequences. Similar pigment-enhancing activity was displayed by other amylases of nonanimal origin and by maltooligosaccharides.