High frequency of acute decompensation and cancer in patients with compensated cirrhosis due to nonalcoholic fatty liver disease: A retrospective cohort study.

The natural history of compensated cirrhosis due to nonalcoholic fatty liver disease (NAFLD) has not been completely characterized. The aim of the present study was to assess the incidence and risk factors of acute decompensation of cirrhosis, hepatocellular carcinoma, and extrahepatic cancers. This was a multicenter, retrospective, cohort study including 449 patients with compensated cirrhosis due to NAFLD. We calculated cumulative incidences and used competitive risk analysis to determine the risk factors associated with decompensation and cancer development. Over a median of 39 months of follow-up, 124 patients (28%) presented acute decompensation. The most frequent decompensation was ascites (21%) followed by hepatic encephalopathy (15%), variceal bleeding (9%), and spontaneous bacterial peritonitis (3%). Acute-on-chronic liver failure was diagnosed in 6% of patients during follow-up. Liver function parameters and specifically an albumin level below 40 g/L were independently associated with an increased risk of decompensation. The presence of ischemic heart disease was independently associated with acute decompensation. Seventy-eight patients (18%) developed hepatocellular carcinoma or extrahepatic cancers during follow-up (51 and 27, respectively). Conclusion: Patients with compensated cirrhosis due to NAFLD are at high risk of severe liver complications, such as the development of acute decompensation, in a relative short follow-up time. This population is at high risk of hepatic and extrahepatic cancers.

Survival and adverse events of elderly patients treated with sorafenib for hepatocellular carcinoma.

Introduction: The first-line treatment for advanced hepatocellular carcinoma (HCC) is atezolizumab plus bevacizumab, but its availability is not universal and elderly patients are underrepresented in clinical trials. There is little evidence of efficacy and tolerability in elderly patients under systemic treatment. The aims of this study were to characterize the profile of elderly patients treated with sorafenib, assess their survival and safety profile in order to extrapolate their eligibility for systemic treatment. Methods: Retrospective multicentre study of HCC patients aged ≥75 years old treated with sorafenib from January 2008 to December 2019. Demographic data, baseline characteristics, and variables related to HCC and sorafenib were recorded. Overall survival (OS) and safety were analyzed. Results: The study included 206 patients from 11 hospitals, median age 77.9 years; 71.4% men and 62.6% stage Barcelona Clinic Liver Cancer- C (BCLC-C). The main causes of cirrhosis were hepatitis C (60.7%) and alcohol (14.7%). Most patients (84.5%) started with sorafenib 800mg and 15.5% at lower dosage. Arterial hypertension (AHT) (74.2 vs 62.2%; standardized mean differences (STD): 26) and baseline ECOG-PS>0 (45.3 vs 34.7%; STD: 38.2) differed significantly between patients receiving low and full doses. Median OS was 15.4 months (18.2 in BCLC-B vs 13.6 in BCLC-C). OS was not modified by comorbidities, age or period with more expertise. Conclusions: Sorafenib appears to be safe in elderly patients with HCC. This is the first study to characterize the profile of elderly patients to be considered for systemic treatment. These findings could be used as the reference profile for elderly candidates for atezolizumab-bevacizumab.

Outcome of liver cancer patients with SARS-CoV-2 infection: An International, Multicentre, Cohort Study.

BACKGROUND & AIMS: Information about the impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients with liver cancer is lacking. This study characterizes the outcomes and mortality risk in this population. METHODS: Multicentre retrospective, cross-sectional, international study of liver cancer patients with SARS-CoV-2 infection registered between February and December 2020. Clinical data at SARS-CoV-2 diagnosis and outcomes were registered. RESULTS: Two hundred fifty patients from 38 centres were included, 218 with hepatocellular carcinoma (HCC) and 32 with intrahepatic cholangiocarcinoma (iCCA). The median age was 66.5 and 64.5 years, and 84.9% and 21.9% had cirrhosis in the HCC and iCCA cohorts respectively. Patients had advanced cancer stage at SARS-CoV-2 diagnosis in 39.0% of the HCC and 71.9% of the iCCA patients. After a median follow-up of 7.20 (IQR: 1.84-11.24) months, 100 (40%) patients have died, 48% of the deaths were SARS-CoV-2-related. Forty (18.4%) HCC patients died within 30-days. The death rate increase was significantly different according to the BCLC stage (6.10% [95% CI 2.24-12.74], 11.76% [95% CI 4.73-22.30], 20.69% [95% CI 11.35-31.96] and 34.52% [95% CI 17.03-52.78] for BCLC 0/A, B, C and D, respectively; p = .0017). The hazard ratio was 1.45 (95% CI 0.49-4.31; p = .5032) in BCLC-B versus 0/A, and 3.13 (95% CI 1.29-7.62; p = .0118) in BCLC-C versus 0/A in the competing risk Cox regression model. Nineteen out of 32 iCCA (59.4%) died, and 12 deaths were related to SARS-CoV-2 infection. CONCLUSIONS: This is the largest cohort of liver cancer patients infected with SARS-CoV-2. It characterizes the 30-day mortality risk of SARS-CoV-2 infected patients with HCC during this period.

Elastography is unable to exclude cirrhosis after sustained virological response in HCV-infected patients with advanced chronic liver disease.

BACKGROUND: Liver fibrosis and transient elastography (TE) correlation in hepatitis C virus (HCV)-infected patients with compensated advanced chronic liver disease (cACLD) after the sustained virological response (SVR) is unknown. AIMS: To evaluate TE accuracy at identifying cirrhosis 3 years after HCV-eradication. METHODS: Prospective, multi-centric study including HCV-cACLD patients before direct-acting antivirals (DAA). Diagnostic accuracy of TE (area under ROC, AUROC) to identify cirrhosis 3 years after SVR was evaluated. RESULTS: Among 746 HCV-infected patients (95.4% with TE ≥10 kPa), 76 (10.2%) underwent a liver biopsy 3 years after SVR. Before treatment, 46 (63%) showed a TE>15 kPa. The TE before DAA was the best variable for predicting cirrhosis (METAVIR, F4) after SVR (AUROC = 0.79). Liver function parameters, serological non-invasive tests (APRI and FIB-4), and TE values improved after SVR. However, liver biopsy 3 years after HCV elimination (median time = 38.4 months) showed cirrhosis in 41 (53.9%). Multivariate analysis (OR (95% CI), P) showed that HCV-genotype 3 (20.81 (2.12-201.47), .009), and TE before treatment (1.21 (1.09-1.34), <.001) were the only variables associated with cirrhosis after SVR. However, the accuracy of TE after SVR was poor (AUROC = 0.75) and 6 (27.3%) out of 22 patients with a TE <8 kPa had cirrhosis. Similar results were found with APRI and FIB-4 scores. CONCLUSIONS: Cirrhosis is present, 3 years after SVR, in more than half of HCV-cACLD patients even with the normalisation of liver function parameters, serological non-invasive tests and TE values. The low diagnostic accuracy of non-invasive methods after SVR reinforces the need for long-term surveillance.

Use of healthcare resources and drug expenditure before and after treatment of chronic hepatitis C with direct antiviral agents.

The aim of this study was to analyse the impact of treating chronic hepatitis C (CHC) with direct-acting agents (DAA) on the use of healthcare resources. We included all patients treated with DAA for CHC from January 2015 to December 2017 in Catalonia whose medical records from 12 months before to 24 months after treatment were available. Data were obtained from the Catalan Health Surveillance System. A total of 12,199 patients in Catalonia were treated with DAA for CHC. Of these, 11.3% had no-minimal fibrosis (F0-F1), 24.0% had moderate fibrosis (F2), 50.3% had significant fibrosis or cirrhosis (F3-F4), and 14.4% had decompensated cirrhosis. Use of healthcare resources decreased from the pre-treatment period to the post-treatment period for the following: hospital admissions due to complications of cirrhosis, from 0.19 to 0.12 per month per 100 patients (RR 0.57; 95% CI 0.47-0.68); length of hospital stay, from 12.9 to 12.2 days (RR 0.93; 95% CI 0.91-0.94); outpatient visits, from 65.0 to 49.2 (RR 0.75; 95% CI 0.74-0.75); and number of medication containers per patient per month, from 13.9 to 12.5 (RR 0.837; 95% CI 0.835-0.838). However, the number of invoices for antineoplastic treatment increased after DAA treatment, especially for patients with high morbidity or advanced fibrosis stage. In conclusion, a decrease in health resource use was seen in CHC patients treated with DAA, as measured by length of hospital stay, number of admissions due to cirrhosis complications, outpatient visits and overall drug invoicing. However, use of antineoplastic drugs increased significantly, especially in patients with cirrhosis and high morbidity.

Time Trends of Crohn's Disease in Catalonia from 2011 to 2017. Increasing Use of Biologics Correlates with a Reduced Need for Surgery.

BACKGROUND AND AIMS: Data from clinical trials suggest that biological drugs may improve the outcomes in Crohn's disease (CD) by reducing the need for surgery or hospitalization. The aim of this study is to evaluate the time-trends of the use of biological drugs and other treatments for CD, and its relationship with outcomes in Catalonia. MATERIALS AND METHODS: All patients with CD included in the Catalan Health Surveillance System (containing data on a population of more than 7.5 million) from 2011 to 2017 were identified. The exposures to different treatments for inflammatory bowel disease were retrieved from electronic invoicing records. RESULTS: Between 2011 and 2017, the use of salicylates, corticosteroids and immunosuppressive treatment fell from 28.8% to 17.1%, 15.8% to 13.7%, and 32.9% to 29.6%, respectively (p < 0.001). Biological treatment use rose from 15.0% to 18.7% (p < 0.001). Ostomy rates per 1000 patients/year fell from 13.2 in 2011 to 9.8 in 2017 (p = 0.003), and surgical resection rates from 24.1 to 18.0 (p < 0.001). The rate of CD-related hospitalizations per 1000 patients/year also fell, from 92.7 to 72.2 (p < 0.001). CONCLUSIONS: Biological drug use rose from 15.0% to 18.7% between 2011 and 2017. During this period, we observed an improvement in the outcomes of CD patients.

International and multicenter real-world study of sorafenib-treated patients with hepatocellular carcinoma under dialysis.

BACKGROUND & AIMS: Information on safety and efficacy of systemic treatment in patients with hepatocellular carcinoma (HCC) under dialysis are limited due to patient exclusion from clinical trials. Thus, we aimed to evaluate the rate, prevalence, tolerability, and outcome of sorafenib in this population. METHODS: We report a multicenter study comprising patients from Latin America and Europe. Patients treated with sorafenib were enrolled; demographics, dose modifications, adverse events (AEs), treatment duration, and outcome of patients undergoing dialysis were recorded. RESULTS: As of March 2018, 6156 HCC patients were treated in 44 centres and 22 patients were concomitantly under dialysis (0.36%). The median age was 65.5 years, 40.9% had hepatitis C, 75% had Child-Pugh A, and 85% were Barcelona Clinic Liver Cancer-C. The median time to first dose modification, treatment duration and overall survival rate were 2.4 months (interquartile ranges [IQR], 0.8-3.8), 10.8 months (IQR, 4.5-16.9), and 17.5 months (95% CI, 7.2-24.5), respectively. Seventeen patients required at least 1 dose modification. The main causes of first dose modification were asthenia/worsening of Eastern Cooperative Oncology Group-Performance Status and diarrhoea. At the time of death or last follow-up, four patients were still on treatment and 18 had discontinued sorafenib: 14 were due to tumour progression, 2 were sorafenib-related, and 2 were non-sorafenib-related AE. CONCLUSIONS: The outcomes observed in this cohort seem comparable to those in the non-dialysis population. Thus, to the best of our knowledge, this is the largest and most informative dataset regarding systemic treatment outcomes in HCC patients undergoing dialysis.

Impact of sustained virological response with DAAs on gastroesophageal varices and Baveno criteria in HCV-cirrhotic patients.

BACKGROUND: Direct-acting antivirals (DAAs) show high efficacy and safety in HCV-cirrhotic patients, but most maintain clinically significant portal hypertension after sustained virological response (SVR). Non-invasive Baveno and expanded-Baveno criteria can identify patients without high-risk gastroesophageal varices (GEV) who have no need for endoscopic surveillance. However, data after SVR are scarce. We performed a multicenter study to evaluate SVR effects over GEV and diagnostic accuracy of non-invasive criteria after SVR. METHODS: HCV-cirrhotic patients receiving DAAs and baseline endoscopic evaluation were included (November 2014-October 2015). GEV were classified as low risk (LR-GEV) (< 5 mm) or high risk (HR-GEV) (≥ 5 mm or with risk signs). Transient elastography (TE) and endoscopy were performed during follow-up. RESULTS: SVR was achieved in 230 (93.1%) of 247 included patients, 151 (65.7%) with endoscopic follow-up. Among 64/151 (42.4%) patients without baseline GEV, 8 (12.5%) developed GEV after SVR. Among 50/151 (33.1%) with baseline LR-GEV, 12 (24%) developed HR-GEV. Patients with GEV progression showed TE ≥ 25 kPa before treatment (64.7%) or ≥ 20 kPa after SVR (66.7%). Only 6% of patients without GEV and LSM < 25 kPa before treatment, and 10% of those with baseline LSM < 25 kPa and LSM < 20 kPa after SVR showed GEV progression after 36 months. The negative predictive value of Baveno and expanded-Baveno criteria to exclude HR-GEV was maintained after SVR (100% and 90.7%, respectively). CONCLUSIONS: HCV-cirrhotic patients can develop HR-GEV after SVR. Surveillance is especially recommended in those with GEV before antiviral treatment. Baveno and expanded-Baveno criteria can be safely applied after SVR. https://clinicaltrials.gov: NCT02758509.

Reseña historica de la Gerencia de Seguridad Industrial, ambiente e higiene ocupacional del Instituto Nacional de Higiene "Rafael Rangel" / Historical Overview Industrial Safety, environment and occupational of The National Institute of Hygiene "Rafael Rangel"

La Seguridad Industrial en el INHRR nace con la conformación del primer Comité de Higiene y Seguridad Industrial en el año 1997, cumpliendo con la Norma COVENIN 2270-95 "Conformación de Comités de Seguridad Industrial". En el año 1999, se asigna la creación de la Unidad de Seguridad Laboral y Ambiente a partir del Programa de Seguridad Laboral y Ambiente. Esta Unidad estaba adscrita a la Gerencia de Recursos Humanos del INHRR. El personal que conformó esta Unidad desde sus inicios hasta la actualidad, se ha caracterizado por ser un equipo multidisciplinario con experiencia en distintas áreas técnicas de la Institución y con conocimientos sólidos en trabajos como seguridad de laboratorio químico y biológico, entre otros. Profesionales altamente capacitados, comprometidos, con entrega, ética, mística de trabajo, calidad de servicio y sentido de pertenencia por la Institución. Posteriormente se integra al equipo de trabajo un Médico Ocupacional y una Enfermera Laboral con la finalidad de prestar la atención a los trabajadores y trabajadores de la Institución. En el año 1999, aproximadamente se crea la Brigada de Control de Emergencias de la Institución cumpliendo con la normativa nacional vigente. Dichos integrantes de esta brigada siempre han contado con capacitación o actualización continua en áreas de Combate y Supresión de Incendio Nivel I y II, Materiales Peligrosos Nivel Respondedor y Operaciones, Rescate Básico Nivel I, Primeros Auxilios Nivel I, Técnicas de Desalojo, Reanimación Cardio Pulmonar, entre otros. El 1ero de septiembre del 2013, mediante Punto de Cuenta al Consejo N° 01, Sesión N° 30 de fecha 10/10/2013, fue creada funcional y organizacionalmente la Gerencia de Seguridad Industrial, Ambiente e Higiene Ocupacional, adscrita a la Presidencia del Instituto, cuya función principal es velar por la seguridad laboral, industrial y ambiental tanto de las trabajadoras, trabajadores como instalaciones y el entorno de la Institución, enfatizando en las acciones preventivas, promoviendo la cultura de seguridad y prevención en la Institución, asesorando a las diferentes unidades en materia de seguridad laboral, salud y ambiente, realizando gestiones de manejo de desechos bioinfecciosos, planes de reciclaje de papel, capacitando al personal de la Institución en materia de seguridad, laboral y ambiente, apoyo e intercambio de saberes con Organismos del Estado, en otras actividades, todas estas enmarcadas en el fiel cumplimiento de las leyes, normativas y reglamentaciones vigentes en el País.

The Industrial Safety in the INHRR was born with the conformation of the first Committee of Hygiene and Industrial Safety in the year 1997, fulfilling with the Norm COVENIN 2270-95 "Conformation of Committees of Industrial Security". In 1999, the creation of the Occupational Safety and Environment Unit was assigned based on the Workplace Safety and Environment Program. This Unit was attached to the Human Resources Management of the INHRR. The staff that made up this Unit from its beginnings to the present, has been characterized as a multidisciplinary team with experience in different technical areas of the Institution and with solid knowledge in safe chemical and biological laboratory work, among others. Highly trained professionals, committed, with dedication, ethics, work mystique, quality of service and sense of belonging by the Institution. Later, an Occupational Physician and a Labor Nurse were integrated into the work team in order to provide care to the workers and workers of the Institution. In 1999 approximately the Emergency Control Brigade of the Institution was created, complying with the current national regulations. These members of this Brigade have always had training or continuous updating such areas of Combat and Suppression of Fire Level I and II, Hazardous Materials Level Responder and Operations, Basic Rescue Level I, First Aid Level I, Techniques of Eviction, Cardio Pulmonary Resuscitation among others. On September 1, 2013, through Point of Account to the Board N ° 01, Session N ° 30 dated 10/10/2013 the Management of Industrial Safety, Environment and Occupational Hygiene was created functionally and organizationally, attached to the Presidency of the Institute , whose main function is to ensure the occupational, industrial and environmental safety of both workers, workers and facilities and the environment of the institution, emphasizing preventive actions, promoting the culture of safety and prevention in the institution, advising the different units in matters of occupational safety, health and environment, carrying out management of bioinfectious waste management, paper recycling plans, training the staff of the institution on safety, labor and environment, support and exchange of knowledge with the State Agency, in other activities, all activities framed in faithful compliance with the laws, regulations and regulations in force in the country.

Utility of histology for the diagnosis of portal hypertensive gastroenteropathy. Concordance between the endoscopic image and gastrointestinal biopsies. Role of the CD34 marker. / Utilidad de la histología para el diagnóstico de la gastroenteropatía por hipertensión portal. Concordancia entre la imagen endoscópica y las biopsias gastrointestinales. Papel del marcador CD34.

INTRODUCTION: Upper gastroscopy in patients with cirrhosis often reveals non-specific lesions, which are usually oriented as portal hypertensive gastropathy (PHG). However, the diagnosis of PHG can be difficult, both from an endoscopic and histological point of view. The study of CD34 expression, which enhances the endothelial cells of the microvasculature, could help the differential diagnosis. The objectives of this study were to evaluate the correlation between endoscopy and histology in the diagnosis of PHG and to assess the utility of CD34 in the diagnosis of PHG. MATERIAL AND METHODS: The results of immunostaining with CD34 gastric fundus biopsies from 100 cirrhotic patients and 20 controls were compared with the endoscopic images. RESULTS: The correlation between the histology and the endoscopic diagnosis of PHG was very low (kappa=0.15). In addition, the measurement of the diameter of the gastric vessels enhanced by the use of immunohistochemical staining (CD34) did not show good correlation with the endoscopic diagnosis (p=.26) and did not provide relevant information for the histological diagnosis of PHG either. DISCUSSION: The correlation between histology and endoscopy is low for the diagnosis of PHG. The use of immunostaining for CD34 does not seem to improve the diagnostic yield of the histological study.

Apixaban-induced liver injury.

The use of new oral anticoagulants such as apixaban is increasing. We present the case of an 85-year-old patient who was diagnosed with mixed profile toxic hepatitis due to apixaban use. An etiological study was negative, except for anti-smooth muscle antibodies, and a liver biopsy ruled out autoimmune hepatitis. The patient was assigned a score of 7 on the CIOMS/RUCAM scale, indicating a probable causality. The liver injury improved after the withdrawal of apixaban. A previous meta-analysis reported that the risk of hepatotoxicity does not increase with the use of apixaban, nor were any cases reported in registry studies. Nonetheless, more than 120 possible cases currently appear in the European pharmacovigilance database (EudraVigilance). We suggest that apixaban should be considered as a possible cause of liver injury.

Validation of a self-reported work disability questionnaire for ulcerative colitis.

Ulcerative colitis (UC) may severely limit patients' capacity to work. Recently, we validated a work disability questionnaire (WDQ) for Crohn disease. As UC shares clinical characteristics with Crohn disease, we hypothesized that the questionnaire might also be useful for UC. The study was aimed to validate the WDQ for use in UC.Consecutive patients with UC (n = 142, 67 women; age 48 ±â€Š1) completed the UC-WDQ and the inflammatory bowel disease questionnaire-9 (IBDQ-9), and EuroQoL-5D quality-of-life questionnaires. Validation of the UC-WDQ included an assessment of its construct validity, including: discriminant validity, convergent validity, and reproducibility (test-retest). We also calculated the intraclass correlation and the Cronbach alpha.The UC-WDQ is a valid and reliable tool for measuring work disability in patients with UC.

Analysis of survival and prognostic factors in treatment of hepatocellular carcinoma in Spanish patients with drug-eluting bead transarterial chemoembolization.

BACKGROUND AND AIM: Drug-eluting bead transarterial chemoembolization (DEB-TACE) improves the survival of patients with hepatocellular carcinoma (HCC), intermediate stage [i.e. Barcelona Clinic Liver Cancer-B (BCLC-B)]. The aim of our study was to analyse the overall survival (OS) and prognostic factors of patients with HCC treated with DEB-TACE. PATIENTS AND METHODS: Patients' clinical course was recorded from January 2005 to July 2014. The median OS was obtained by the Kaplan-Meier method and compared using the log-rank test. The prognosis factors associated with OS were determined by a multivariate Cox regression analysis and the accuracy of the OS prediction was determined by calculation of the assessment for retreatment with TACE score (ART score). RESULTS: A cohort of 147 consecutive patients treated with DEB-TACE was included. Median age of the patients was 73.4 years. Overall, 68.7% were men, and all had cirrhosis, with 68.8% being hepatisis C virus positive. Moreover, 35.2% were staged as BCLC-A and 60.2% as BCLC-B. After a median follow-up of 19.2 months, 29.3% were alive, 4.3% needed treatment with sorafenib and 56.1% underwent DEB-TACE retreatment. Median OS was 22.8 [95% confidence interval (CI)=19.6-25.9]. After censoring for ascites and more than one nodule, OS was 23.87 (95% CI =20.72-27.01) and 26.89 (95% CI =21.00-32.78), respectively. The risk of death decreased by 22.3% with the number of DEB-TACE sessions (hazard ratio=0.777) and increased by 25.9% with higher Child-Pugh score (hazard ratio=1.259). Overall, 61.2% of the cohort had an ART score between 0 and 1.5. There were no statistical differences in OS between cohort groups with ART of 0-1.5 and at least 2.5. CONCLUSION: The results validate the efficacy and safety of DEB-TACE in patients with HCC and the importance of some prognostic factors for patient survival.

Idiopathic portal hypertension with regard to thiopurine treatment.

Idiopathic portal hypertension (IPH) is an infrequent adverse reaction to the use of thiopurines that tends to be overlooked. Herein, we present a patient with ileocolic Crohn's disease treated with azathioprine who presented ascites, esophageal varices and splenomegaly without any signs of liver cirrhosis. A portal hemodynamics study revealed a normal portosystemic gradient compatible with presinusoidal portal hypertension. Finally, IPH was diagnosed after a liver biopsy. IPH secondary to thiopurines is due to a 6-thioguanine nucleotide (6-TGN)-dependent reaction and occurs predominantly between three months and three years after the start of treatment. The onset is usually insidious and thrombocytopenia is the first manifestation. The definitive diagnosis is obtained by liver biopsy.

Inter and intra-observer concordance for the diagnosis of portal hypertension gastropathy.

INTRODUCTION: At present there is no fully accepted endoscopic classification for the assessment of the severity of portal hypertensive gastropathy (PHG). Few studies have evaluated inter and intra-observer concordance or the degree of concordance between different endoscopic classifications. OBJECTIVES: To evaluate inter and intra-observer agreement for the presence of portal hypertensive gastropathy and enteropathy using different endoscopic classifications. METHODS: Patients with liver cirrhosis were included into the study. Enteroscopy was performed under sedation. The location of lesions and their severity was recorded. Images were videotaped and subsequently evaluated independently by three different endoscopists, one of whom was the initial endoscopist. The agreement between observations was assessed using the kappa index. RESULTS: Seventy-four patients (mean age 63.2 years, 53 males and 21 females) were included. The agreement between the three endoscopists regarding the presence or absence of PHG using the Tanoue and McCormack classifications was very low (kappa scores = 0.16 and 0.27, respectively). CONCLUSIONS: The current classifications of portal hypertensive gastropathy have a very low degree of intra and inter-observer agreement for the diagnosis and assessment of gastropathy severity.

Resultados en la práctica clínica del tratamiento de la hepatitis crónica por virus B con tenofovir y entecavir / Results in clinical practice of treatment of chronic hepatitis b virus with tenofovirand entecavir

Actualmente hay pocos datos sobre los resultados obtenidos con tenofovir y entecavir en la práctica clínica. Objetivo: Valorar la respuesta viral y la seguridad de tenofovir y entecavir en un periodo de 5 años. Material y métodos: Estudio observacional en donde se incluyó a todos los pacientes con hepatitis crónica por virus B que iniciaron tratamiento con tenofovir o entecavir desde enero de 2008 hasta diciembre de 2012. Resultados: De un total de 70 pacientes: 42 (60%) en tratamiento con entecavir y 28 (40%) con tenofovir. Un 75,7% eran hombres, con una edad media de 53 (DE 14) años. Un 70% eran caucásicos. Se realizó biopsia hepática en 46 pacientes (F0 8,7%; F1 6,5%; F2 26,1%; F3 43,5% y F4 15,2%). El 51,4% eran naïve. Del grupo de pacientes previamente tratados, un 17,6% había recibido interferón; un 26,4% interferón inicialmente y luego análogos; y un 55,8% otros análogos de los nucleósidos o de los nucleótidos. El tiempo de seguimiento fue de 36 (DE 12) meses. El DNA del VHB inicial medio era de 31.570.006 UI/mL (rango 24-1.100.000.000 UI/mL).Todos ellos, excepto 3, presentaron un DNA indetectable al año del tratamiento. De los 10 con HBeAg+, 2 de ellos presentaron seroconversión. Los valores de creatinina y la estimación del filtrado glomerular (EFG) fueron de 0,9 (DE 0,3) mg/dL y de 93,92 ml/min/1,73 m² (DE 21,92) al inicio y creatinina 0,93 (DE 0,27) mg/dL y EFG 91,7392 ml/min/1,73 m² (DE 21,38) al año de seguimiento. Conclusiones: Entecavir y tenofovir son eficaces y seguros en la práctica clínica en pacientes con hepatitis crónica por virus B.

The current first line treatment for chronic hepatitis B virus is with entecavir andtenofovir. However, there are few data regarding the results obtained from these treatmentsin clinical practice. Objective: To assess viral response and safety of treatment with entecavir and tenofovir in a5-year follow-up. Material and methods: Observational study on patients with chronic hepatitis B virus who begantreatment with tenofovir or entecavir between January 2008 and December 2012. Results: Seventy patients were included; 42 (60%) were treated with entecavir and 28 (40%)with tenofovir. Of these, 75.7% were men, with an average age of 53 (SD ± 14) years, and mostwere white (70%). A liver biopsy was performed on 46 patients (F0 8.7%; F1 6.5%; F2 26.1%;F3 43.5% and F4 15.2%). Of all the patients, 51.4% were treatment naïve, and of the groupof previously treated patients, 17.6% had received interferon; 26.4% had received interferonfollowed by one or more analogues; and 55.8% had received other nucleoside or nucleotideanalogues.The time of follow-up was 36 (SD ± 12) months. The average initial DNA was 31,570,006UI/mL (range 24-1,100,000,000 UI/mL). All except 3 presented undetectable DNA after oneyear of treatment. Ten patients were HBeAg-positive at the beginning of the treatment and 2seroconverted. At the beginning of the treatment, creatinine was 0.9 (SD ± 0.3) mg/dL and theestimated glomerular filtration rate (eGFR) was 93.92 ml/min/1.73 m²(DE 21.92); both keepingstable after a year of treatment (creatinine levels 0.93 SD ± 0.27 mg/dL, eGFR 91.7392 SD± 21.38 ml/min/1.73 m²). Conclusions: Entecavir and tenofovir are safe and effective in clinical practice for the treatmentof chronic hepatitis B virus, both in treatment-naïve patients and in those previously treated.

Development and Validation of the Short Crohn's Disease Work Disability Questionnaire.

BACKGROUND: The aim was to develop and validate a self-reported short Crohn's disease work disability questionnaire (sCDWDQ). METHODS: (1) Development of a shortened questionnaire-Patients' responses to the validation process (n = 108) of a previously developed, 16-item Spanish Crohn's disease work disability questionnaire (CDWDQ) were analyzed using the Rasch model for multiple response items. After this process, a 9-item sCDWDQ was obtained. (2) Validation phase-The validation assessed the questionnaire's convergent validity, discriminant validity, test-retest reproducibility, and internal consistency. Spearman rank correlation, t test, intra-class correlation and Cronbach's alpha were used for the analysis. RESULTS: One hundred fifty-one patients were included in the validation phase. (1) Convergent validity was confirmed by correlations between the sCDWDQ and clinical activity (r = 0.66, P < 0.01), the short inflammatory bowel disease questionnaire IBDQ-9 (r = 0.74, P < 0.001), Euroqol-5D (r = 0.63, P < 0.01), the EuroQol-5D visual analog scale (r = 0.54, P < 0.01), and overall work impairment (r = 0.66, P < 0.01); (2) Discriminant validity-sCDWDQ scores were higher in patients with active disease (20.1 ± 6.3 versus 13.0 ± 3.8 inactive, P < 0.001), in those requiring previous sick leave (19.6 ± 6.9 versus no sick leave 14.2 ± 4.8, P < 0.01) and in those requiring hospitalization (20.0 ± 7.3 [n = 29] versus no hospitalization 14.1 ± 7.3 [n = 90], P < 0.01); (3) Internal consistency was also good (Cronbach's alpha = 0.92); and (4) Reproducibility-sCDWDQ measures obtained 2 weeks apart showed an excellent intraclass correlation coefficient of 0.92 (95% confidence interval, 0.90-0.94). CONCLUSIONS: The self-reported sCDWDQ appears to be a simple, valid, and reliable tool for measuring work disability in Crohn's disease.

Usefulness of indirect noninvasive methods in predicting progression to cirrhosis in chronic hepatitis C.

BACKGROUND AND AIMS: The ability of noninvasive methods to predict the development of cirrhosis has not been established. We evaluated the ability of three noninvasive methods [the Forns index, the aspartate aminotransferase-to-platelet ratio index (APRI), and the Non-Invasive Hepatitis-C-related Cirrhosis Early Detection (NIHCED) score] to determine the risk of developing cirrhosis in chronic hepatitis C. METHODS: Consecutive patients with chronic hepatitis C who had undergone liver biopsy between 1998 and 2004 were eligible. We used the three methods to evaluate patients at baseline and at follow-up (4-10 years later). When these methods yielded discordant or indeterminate results, a second liver biopsy was performed. Logistic regression models were fitted for each method to predict whether cirrhosis would appear and to predict long-term mortality from cirrhosis. RESULTS: We included 289 patients in our study. The mean scores at baseline and at follow-up, respectively, were as follows: Forns, 5.47 ± 1.95 and 6.56 ± 2.02; APRI, 1.1 ± 2.33 and 1.4 ± 1.53; and NIHCED, 7.79 ± 11.45 and 15.48 ± 15.28. The area under the receiver operating characteristic curve for predicting cirrhosis was 0.83 for Forns, 0.79 for APRI, and 0.76 for NIHCED. The sensitivity and specificity for predicting cirrhosis, respectively, were 75 and 71% for Forns (cutoff 4.7), 86 and 42% for APRI (cutoff 0.48), and 41 and 82% for NIHCED (cutoff 0). The area under the receiver operating characteristic curve for predicting mortality was 0.86 for Forns, 0.79 for APRI, and 0.84 for NIHCED. CONCLUSION: Indirect noninvasive markers could help identify patients with chronic hepatitis C at risk of progression to cirrhosis.