A new year and a new roadmap for the journal in challenging times.

Sixteen months have passed since I had the honor of being appointed editor-in-chief of Revista Española de Enfermedades Digestivas (The Spanish Journal of Gastroenterology) (REED) and thank the Spanish Society of Digestive Diseases (SEPD) for trusting me in this new phase of the REED history. Four months later, in November 2021, Dr Juan-Ramon Larrubia joined the journal as Executive Editor. We thank the former Editor-in-Chief and deputy-editor Enrique Peéez-Cuadrado and Javier A. Cienfuegos, respectively, their devoted work putting the journal on an upward trajectory since 2016, one year before the REED centenary, they set the bar very high.

A new year and a new roadmap for the journal in challenging times

Sixteen months have passed since I had the honor of being appointed editor-in-chief of Revista Española de Enfermedades Digestivas (The Spanish Journal of Gastroenterology) (REED) and thank the Spanish Society of Digestive Diseases (SEPD) for trusting me in this new phase of the REED history. Four months later, in November 2021, Dr Juan-Ramon Larrubia joined the journal as Executive Editor. We thank the former Editor-in-Chief and deputy-editor Enrique Peéez-Cuadrado and Javier A. Cienfuegos, respectively, their devoted work putting the journal on an upward trajectory since 2016, one year before the REED centenary, they set the bar very high (AU)

Hepatocellular carcinoma risk in hepatitis C stage-3 fibrosis after sustained virological response with direct-acting antivirals.

BACKGROUND & AIMS: Patients with chronic hepatitis C and stage 3 fibrosis are thought to remain at risk of hepatocellular carcinoma after sustained virological response. We investigated this risk in a large cohort of patients with well-defined stage 3 fibrosis. METHODS: We performed a multicentre, ambispective, observational study of chronic hepatitis C patients with sustained virological response after treatment with direct-acting antivirals started between January and December 2015. Baseline stage 3 was defined in a two-step procedure: we selected patients with transient elastography values of 9.5-14.5 kPa and subsequently excluded those with nodular liver surface, splenomegaly, ascites or collaterals on imaging, thrombopenia or esophago-gastric varices. Patients were screened twice-yearly using ultrasound. RESULTS: The final sample comprised 506 patients (median age, 57.4 years; males, 59.9%; diabetes, 17.2%; overweight, 44.1%; genotype 3, 8.9%; HIV coinfection, 18.4%; altered liver values, 15.2%). Median follow-up was 33.7 (22.1-39.1) months. Five hepatocellular carcinomas and 1 cholangiocarcinoma were detected after a median of 29.4 months (95% CI: 26.8-39.3), with an incidence of 0.47/100 patients/year (95% CI: 0.17-1.01). In the multivariate analysis, only males older than 55 years had a significant higher risk (hazard ratio 7.2 [95% CI: 1.2-41.7; P = .029]) with an incidence of 1.1/100 patients/year (95% CI: 0.3-2.8). CONCLUSIONS: In a large, well-defined cohort of patients with baseline hepatitis C stage-3 fibrosis, the incidence of primary liver tumours was low after sustained virological response and far from the threshold for cost-effectiveness of screening, except in males older than 55 years.

Obeticholic Acid and Fibrates in Primary Biliary Cholangitis: Comparative Effects in a Multicentric Observational Study.

INTRODUCTION: Obeticholic acid (OCA) and fibrates therapy results in biochemical improvement in placebo-controlled trials in patients with primary biliary cholangitis and insufficient response to ursodeoxycholic acid. There is scarce information outside of clinical trials. Therefore, we have assessed the effectiveness and adverse events of these treatments. METHODS: Data from patients included in the ColHai registry treated with OCA, fibrates, or both were recorded during a year, as well as adverse events and treatment discontinuation. RESULTS: Eighty-six patients were treated with OCA, 250 with fibrates (81% bezafibrate; 19% fenofibrate), and 15 with OCA plus fibrates. OCA group had baseline significantly higher alkaline phosphatase (ALP) (P = 0.01) and lower platelets (P = 0.03) than fibrates. Both treatments significantly decreased ALP, gamma-glutamyl transferase (GGT), and transaminases and improved Globe score. Albumin and immunoglobulin type M improved in the fibrates group. ALP decrease was higher under fibrates, whereas alanine aminotransferase decline was higher under OCA. Although baseline transaminases and GGT were higher in patients with OCA plus fibrates, significant ALP, GGT, alanine aminotransferase, and Globe score improvement were observed during triple therapy. Adverse events were reported in 14.7% of patients (21.3% OCA; 17.6% fenofibrate; 10.7% bezafibrate), mainly pruritus (10.1% with OCA). Discontinuation was more frequent in fenofibrate treatment mainly because of intolerance or adverse events. DISCUSSION: Second-line therapy with OCA or fibrates improves hepatic biochemistry and the GLOBE score in primary biliary cholangitis patients with suboptimal response to ursodeoxycholic acid. Simultaneous treatment with OCA and fibrates improved ALP as well.

Plan asistencial coordinado para la eliminación del virus de la hepatitis C en el centro de ayuda integral al drogodependiente (CAID) / Coordinated assistance plan for the elimination of hepatitis C virus at the centro de ayuda integral al drogodependiente (CAID (Comprehensive Care Centre for Drug Addicts))

Introducción: La población que se inyecta droga presenta una alta prevalencia de VHC y elevado riesgo de transmisión. Es prioritario establecer un plan ágil de diagnóstico y tratamiento. Objetivos1) Valorar la efectividad de un nuevo plan asistencial coordinado de derivación desde el Centro de Atención Integral al Drogodependiente (CAID) a atención especializada y 2) conocer la prevalencia del VHC, características clínicas, efectividad y seguridad del tratamiento en esta población. MétodosSe analizaron retrospectivamente 1.300 serologías solicitadas por el CAID entre 1998-2018, se calculó la seroprevalencia de VHC y se valoró la eficiencia del circuito clásico de derivación CAID-atención especializada. Se diseñó un plan asistencial coordinado entre especialistas implicados en el diagnóstico y tratamiento. Desde octubre de 2018 se incluyeron 11 pacientes en el nuevo plan y se comparó el rendimiento de ambos circuitos de derivación. Resultados: Con el circuito clásico, se perdió un 48,2% (83/172) de los pacientes. Un 14,5% (172/1.300) presentaron serología VHC positiva, en comparación con población general OR = 19; IC 95% 14,3-25. La prevalencia de infección activa fue del 80,3% (90/112). Con el nuevo circuito acudieron el 100% (11/11) (p = 0,0003). De los 11 pacientes derivados mediante el nuevo plan, 76,9% (8/11) tenían infección activa y el 100% (8/8) fueron tratados con agentes antivirales directos con éxito. Conclusiones: El nuevo plan asistencial coordinado CAID-atención especializada presenta alta efectividad, en comparación con el circuito clásico de derivación. La seroprevalencia y prevalencia de infección activa en la población del CAID es muy elevada. Los tratamientos con agentes antivirales directos son efectivos y seguros.(AU)

Introduction: The drug-injecting population has a high prevalence of hepatitis C virus (HCV) and high risk of transmission. It is a priority to establish an agile diagnostic and treatment plan. Objectives1) Assess the effectiveness of a new coordinated care plan of referral from the Comprehensive Care Centre for Drug Addicts (CAID) to specialised care and 2) Determine the prevalence of HCV, clinical characteristics, effectiveness and safety of treatment in this population. Methods: 1,300 serologies requested by the CAID between 1998 and 2018 were retrospectively analysed, the seroprevalence of HCV was calculated and the efficiency of the traditional CAID-specialised care referral system was evaluated. A care plan was designed and coordinated among specialists involved in diagnosis and treatment. Since October 2018, 11 patients have been included in the new plan and the performance of both referral systems was compared. Results: With the traditional system, 48.2% (83/172) of the patients were lost. 14.5% (172/1,300) presented positive HCV serology, compared to the general population OR = 19; 95% CI 14.3-25. The prevalence of active infection was 80.3% (90/112). The prevalence of active infection was 80.3% (90/112). Of the 11 patients referred by the new plan, 76.9% (8/11) had active infection and 100% (8/8) were treated with Direct Antiviral Agents successfully. Conclusions: The new coordinated CAID-specialised care plan presents high effectiveness in comparison with the traditional referral system. The seroprevalence and prevalence of active infection in the CAID population is very high. Treatments with Direct Antiviral Agents are effective and safe.(AU)

Effectiveness and safety of obeticholic acid in a Southern European multicentre cohort of patients with primary biliary cholangitis and suboptimal response to ursodeoxycholic acid.

BACKGROUND: Obeticholic acid (OCA) was recently approved as the only on-label alternative for patients with primary biliary cholangitis (PBC) with intolerance or suboptimal response to ursodeoxycholic acid (UDCA). However, few data are available outside clinical trials. AIM: To assess the effectiveness and safety of OCA in a real-world cohort of patients with non-effective UDCA therapy. METHODS: Open-label, prospective, real-world, multicentre study, enrolling consecutive patients who did not meet Paris II criteria, from 18 institutions in Spain and Portugal. Effectiveness was assessed by the changes in GLOBE and UK-PBC scores from baseline. POISE and Paris II criteria were evaluated after 12 months of OCA . Liver fibrosis was evaluated by FIB-4 and AST to platelet ratio index (APRI). RESULTS: One hundred and twenty patients were eligible, median time since PBC diagnosis 9.3 (4.0-13.8) years, 21.7% had cirrhosis, and 26.7% received had previous or concomitant treatment with fibrates. Seventy-eight patients completed at least 1 year of OCA. The Globe-PBC score decreased to 0.17 (95% CI 0.05 to 0.28; P = 0.005) and the UK-PBC score decreased to 0.81 (95% CI -0.19 to 1.80; P = 0.11). There was a significant decrease in alkaline phosphatase of 81.3 U/L (95% CI 42.5 to 120; P < 0.001), ALT 22.1 U/L (95% CI 10.4 to 33.8; P < 0.001) and bilirubin 0.12 mg/dL (95% CI 0 to 0.24; P = 0.044). FIB-4 and APRI remained stable. According to the POISE criteria, 29.5% (23 out of 78) achieved response. The adverse events rate was 35%; 11.67% discontinued (8.3% due to pruritus). CONCLUSIONS: This study supports data from phase III trials with significant improvement of PBC-Globe continuous prognostic marker score among OCA-treated patients with good tolerability.

Coordinated assistance plan for the elimination of hepatitis C virus at the centro de ayuda integral al drogodependiente (CAID (Comprehensive Care Centre for Drug Addicts)). / Plan asistencial coordinado para la eliminación del virus de la hepatitis C en el centro de ayuda integral al drogodependiente (CAID).

INTRODUCTION: The drug-injecting population has a high prevalence of hepatitis C virus (HCV) and high risk of transmission. It is a priority to establish an agile diagnostic and treatment plan. OBJECTIVES: 1) Assess the effectiveness of a new coordinated care plan of referral from the Comprehensive Care Centre for Drug Addicts (CAID) to specialised care and 2) Determine the prevalence of HCV, clinical characteristics, effectiveness and safety of treatment in this population. METHODS: 1,300 serologies requested by the CAID between 1998 and 2018 were retrospectively analysed, the seroprevalence of HCV was calculated and the efficiency of the traditional CAID-specialised care referral system was evaluated. A care plan was designed and coordinated among specialists involved in diagnosis and treatment. Since October 2018, 11 patients have been included in the new plan and the performance of both referral systems was compared. RESULTS: With the traditional system, 48.2% (83/172) of the patients were lost. 14.5% (172/1,300) presented positive HCV serology, compared to the general population OR = 19; 95% CI 14.3-25. The prevalence of active infection was 80.3% (90/112). The prevalence of active infection was 80.3% (90/112). Of the 11 patients referred by the new plan, 76.9% (8/11) had active infection and 100% (8/8) were treated with Direct Antiviral Agents successfully. CONCLUSIONS: The new coordinated CAID-specialised care plan presents high effectiveness in comparison with the traditional referral system. The seroprevalence and prevalence of active infection in the CAID population is very high. Treatments with Direct Antiviral Agents are effective and safe.

A Model Based on Noninvasive Markers Predicts Very Low Hepatocellular Carcinoma Risk After Viral Response in Hepatitis C Virus-Advanced Fibrosis.

BACKGROUND AND AIMS: Patients with hepatitis C virus (HCV) and advanced fibrosis remain at risk of hepatocellular carcinoma (HCC) after sustained viral response (SVR) and need lifelong surveillance. Because HCC risk is not homogenous and may decrease with fibrosis regression, we aimed to identify patients with low HCC risk based on the prediction of noninvasive markers and its changes after SVR. APPROACH AND RESULTS: This is a multicenter cohort study, including patients with HCV and compensated advanced fibrosis that achieved SVR after direct antivirals. Clinical and transient elastography (TE) data were registered at baseline, 1 year, and 3 years after the end of treatment (EOT). All patients underwent liver ultrasound scan every 6 months. Patients with clinical evaluation 1 year after EOT were eligible. Univariate and multivariate Cox regression analysis were performed, and predictive models were constructed. HCC occurrence rates were evaluated by Kaplan-Meier. Nine hundred and ninety-three patients were eligible (56% male; 44% female; median age 62 years), 35 developed HCC (3.9%), and the median follow-up was 45 months (range 13-53). Baseline liver stiffness measurement (LSM) (HR 1.040; 95% CI 1.017-1.064), serum albumin (HR 0.400; 95% CI 0.174-0.923), 1-year DeltaLSM (HR 0.993; 95% CI 0.987-0.998), and 1-year FIB-4 score (HR 1.095; 95% CI 1.046-1.146) were independent factors associated with HCC. The TE-based HCC risk model predicted 0% of HCC occurrence at 3 years in patients with score 0 (baseline LSM ≤ 17.3 kPa, albumin >4.2 g/dL, and 1-year DeltaLSM > 25.5%) versus 5.2% in patients with score 1-3 (Harrell's C 0.779; log-rank 0.002). An alternative model with FIB-4 similarly predicted HCC risk. CONCLUSIONS: A combination of baseline and dynamic changes in noninvasive markers may help to identify patients with a very low risk of HCC development after SVR.

Reflex testing. A key tool for the elimination of hepatitis C.

Hepatitis C is a major cause of liver cirrhosis and hepatocellular carcinoma, as well as the primary indication for liver transplant in Europe. The highly effective direct-acting antivirals currently available make it possible to achieve the hepatitis C elimination targets set by the World Health Organization. For this, population screening and reflect testing are fundamental strategies.

Reflex testing. A key tool for the elimination of hepatitis C

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Los servicios de digestivo en el Sistema Nacional de Salud del siglo XXI. Estándares de organización y funcionamiento para un servicio centrado en el paciente / No disponible

La Sociedad Española de Patología Digestiva ha elaborado un documento de consenso sobre los estándares y recomendaciones que considera fundamentales en la organización de las unidades de digestivo para desarrollar sus actividades con eficiencia y calidad. Se han definido cuatro grupos de procesos clave: la atención al paciente adulto agudamente enfermo, la endoscopia digestiva ambulatoria, la consulta e interconsulta en patología digestiva y la asistencia integral del paciente con patología digestiva crónica compleja. Como procesos de soporte se han identificado la estructura y el funcionamiento de las unidades de digestivo y, como procesos estratégicos, la formación e investigación. Se han elaborado, asimismo, los estándares para algunas unidades funcionales y monográficas de digestivo: Unidad de Endoscopia Digestiva, Unidad de Hepatología y Unidad Multidisciplinar de Enfermedad Inflamatoria Intestinal, así como para determinados procedimientos: colangiopancreatografía retrógrada endoscópica, colonoscopia y gastroscopia. Los estándares serán ampliados a otras unidades y procedimientos en la medida en que se vayan desarrollando. Los estándares elaborados deben ser revisados en el plazo máximo de cinco años

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Digestive units in the National Health System of the 21st century. Organizational and management standards for a patient-centered service.

The Spanish Society of Digestive Pathology has set a consensus document on the standards and recommendations for gastroenterology units (GU). These standards are considered as relevant in the organization and management of the unit to develop their activities with efficiency and quality. Four key groups of processes have been identified: a) care for the acutely ill adult patient; b) outpatient digestive endoscopy; c) in-hospital support to other services and outpatient clinics; and d) management of patients with chronic complex digestive pathology. Standards for organization and management of the unit were classified within the group of support processes, and training and research as strategic processes. Standards have also been developed for some functional and monographic units such as endoscopy, hepatology and inflammatory bowel disease; as well as for certain procedures including endoscopic retrograde cholangiopancreatography, colonoscopy and gastroscopy. The standards will be set for other units and procedures as they are developed. The standards developed must be reviewed within a maximum period of five years.

Clinical Outcome Event Adjudication in a 10-Year Prospective Study of Nucleos(t)ide Analogue Therapy for Chronic Hepatitis B.

Background and Aims: In the REALM (Randomized, Observational Study of Entecavir to Assess Long-Term Outcomes Associated with Nucleoside/Nucleotide Monotherapy for Patients with Chronic HBV Infection) study, 12,378 patients with chronic hepatitis B virus (HBV) infection received up to 10 years of randomized therapy with entecavir or another HBV nucleos(t)ide analogue. Monitored clinical outcome events (COEs) included malignant neoplasms, HBV disease progression events, and deaths. An external event adjudication committee (EAC) was convened to provide real-time review of reported COEs to optimize data quality, and minimize potential adverse effects of the large cohort, interdisciplinary outcome assessments, geographic scope, and long duration. Methods: The EAC comprised an international group of hepatologists and oncologists with expertise in diagnosis of targeted COEs. The EAC reviewed and adjudicated COEs according to prospectively defined diagnostic criteria captured in the EAC charter. Operational processes, including data collection and query procedures, were implemented to optimize efficiency of data recovery to maximize capture of adjudicated COEs, the primary study outcome measure. Results: A total of 1724 COEs were reported and 1465 of these events were adjudicated by the EAC as reported by the investigators (85.0% overall concordance). Concordance by COE type varied: deaths, 99.6%; hepatocellular carcinoma (HCC), 83.3%; non-HCC malignancies, 88.0%; non-HCC HBV disease progression, 68.2%. Reasons for lack of concordance were most commonly lack of adequate supporting data to support an adjudicated diagnosis or evidence that the event pre-dated the study. Conclusions: The REALM EAC performed a critical role in ensuring data quality and consistency; EAC performance was facilitated by well-defined diagnostic criteria, effective data capture, and efficient operational processes. Trial registration: ClinicalTrials.gov NCT00388674.

The contribution of telemedicine to hepatitis C elimination in a correctional facility

Background: micro-elimination has been recently proposed as an efficient strategy to achieve global hepatitis C virus (HCV) elimination. The Spanish Health Ministry Strategic Plan for hepatitis C infection highlighted intervention in prisons as a priority action. However, there are important barriers associated with the specialized care provision to the penitentiary population. Aims: to assess the contribution of telemedicine for HCV elimination in a correctional facility in Spain. Methods: an open label program of HCV elimination via telemedicine was started on February 3rd, 2015 in a large penitentiary of 1,200 inmates, as an alternative to referring patients to specialists. An anonymous satisfaction survey was performed among a random sample of inmates and all participating doctors. Results: the prevalence of HCV viremia prior to program initiation was 12.4%. One hundred and thirty-one patients received DAA HCV treatment during the period 2015-2018; 42.74% had a HCV-HIV co-infection. Overall, 97% achieved a sustained virological response (SVR). A second regime of DAA successfully rescued non-responder patients and the HCV prevalence was zero at the end of the program. Satisfaction was high or very high according to 67% of inmates and all participating doctors. Conclusion: telemedicine is an effective tool for HCV elimination in penitentiary correctional facilities where referral to specialists is difficult. The extensive use of this technology should be recommended in this setting in order to facilitate equitable access to specialized care

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The contribution of telemedicine to hepatitis C elimination in a correctional facility.

BACKGROUND: micro-elimination has been recently proposed as an efficient strategy to achieve global hepatitis C virus (HCV) elimination. The Spanish Health Ministry Strategic Plan for hepatitis C infection highlighted intervention in prisons as a priority action. However, there are important barriers associated with the specialized care provision to the penitentiary population. AIMS: to assess the contribution of telemedicine for HCV elimination in a correctional facility in Spain. METHODS: an open label program of HCV elimination via telemedicine was started on February 3rd, 2015 in a large penitentiary of 1,200 inmates, as an alternative to referring patients to specialists. An anonymous satisfaction survey was performed among a random sample of inmates and all participating doctors. RESULTS: the prevalence of HCV viremia prior to program initiation was 12.4%. One hundred and thirty-one patients received DAA HCV treatment during the period 2015-2018; 42.74% had a HCV-HIV co-infection. Overall, 97% achieved a sustained virological response (SVR). A second regime of DAA successfully rescued non-responder patients and the HCV prevalence was zero at the end of the program. Satisfaction was high or very high according to 67% of inmates and all participating doctors. CONCLUSION: telemedicine is an effective tool for HCV elimination in penitentiary correctional facilities where referral to specialists is difficult. The extensive use of this technology should be recommended in this setting in order to facilitate equitable access to specialized care.

Higher levels of serum uric acid influences hepatic damage in patients with non-alcoholic fatty liver disease (NAFLD)

Background: recent evidence suggests a causal link between serum uric acid and the metabolic syndrome, diabetes mellitus, arterial hypertension, and renal and cardiac disease. Uric acid is an endogenous danger signal and activator of the inflammasome, and has been independently associated with an increased risk of cirrhosis. Aim and methods: six hundred and thirty-four patients from the nation-wide HEPAMET registry with biopsy-proven NAFLD (53% NASH) were analyzed to determine whether hyperuricemia is related with advanced liver damage in patients with non-alcoholic fatty liver disease (NAFLD). Patients were divided into three groups according to the tertile levels of serum uric acid and gender. Results: the cohort was composed of 50% females, with a mean age of 49 years (range 19-80). Patients in the top third of serum uric acid levels were older (p = 0.017); they had a higher body mass index (p < 0.01), arterial blood pressure (p = 0.05), triglyceridemia (p = 0.012), serum creatinine (p < 0.001) and total cholesterol (p = 0.016) and lower HDL-cholesterol (p = 0.004). According to the univariate analysis, the variables associated with patients in the top third were more advanced steatosis (p = 0.02), liver fibrosis (F2-F4 vs F0-1; p = 0.011), NASH (p = 0.002) and NAS score (p = 0.05). According to the multivariate logistic regression analysis, the top third of uric acid level was independently associated with steatosis (adjusted hazard ratio 1.7; CI 95%: 1.05-2.8) and NASH (adjusted hazard ratio 1.8; CI 95%: 1.08-3.0) but not with advanced fibrosis (F2-F4) (adjusted hazard ratio 1.09; CI 95%: 0.63-1.87). Conclusion: higher levels of serum uric acid were independently associated with hepatocellular steatosis and NASH in a cohort of patients with NAFLD. Serum uric acid levels warrants further evaluation as a component of the current non-invasive NAFLD scores of histopathological damage

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Higher levels of serum uric acid influences hepatic damage in patients with non-alcoholic fatty liver disease (NAFLD).

BACKGROUND: recent evidence suggests a causal link between serum uric acid and the metabolic syndrome, diabetes mellitus, arterial hypertension, and renal and cardiac disease. Uric acid is an endogenous danger signal and activator of the inflammasome, and has been independently associated with an increased risk of cirrhosis. AIM AND METHODS: six hundred and thirty-four patients from the nation-wide HEPAMET registry with biopsy-proven NAFLD (53% NASH) were analyzed to determine whether hyperuricemia is related with advanced liver damage in patients with non-alcoholic fatty liver disease (NAFLD). Patients were divided into three groups according to the tertile levels of serum uric acid and gender. RESULTS: the cohort was composed of 50% females, with a mean age of 49 years (range 19-80). Patients in the top third of serum uric acid levels were older (p = 0.017); they had a higher body mass index (p < 0.01), arterial blood pressure (p = 0.05), triglyceridemia (p = 0.012), serum creatinine (p < 0.001) and total cholesterol (p = 0.016) and lower HDL-cholesterol (p = 0.004). According to the univariate analysis, the variables associated with patients in the top third were more advanced steatosis (p = 0.02), liver fibrosis (F2-F4 vs F0-1; p = 0.011), NASH (p = 0.002) and NAS score (p = 0.05). According to the multivariate logistic regression analysis, the top third of uric acid level was independently associated with steatosis (adjusted hazard ratio 1.7; CI 95%: 1.05-2.8) and NASH (adjusted hazard ratio 1.8; CI 95%: 1.08-3.0) but not with advanced fibrosis (F2-F4) (adjusted hazard ratio 1.09; CI 95%: 0.63-1.87). CONCLUSION: higher levels of serum uric acid were independently associated with hepatocellular steatosis and NASH in a cohort of patients with NAFLD. Serum uric acid levels warrants further evaluation as a component of the current non-invasive NAFLD scores of histopathological damage.

Hepatitis B en pacientes con hepatitis C tratados con agentes antivirales directos / Hepatitis B virus in patients with chronic hepatitis C treated with direct antiviral agents

Introducción: se han comunicado casos de reactivación de virus de la hepatitis B (VHB) en pacientes con virus de la hepatitis C (VHC) tratados con agentes antivirales directos (AAD). Objetivos y métodos: los objetivos del presente estudio son: a) conocer la prevalencia de la coinfección VHB/VHC en pacientes VHC tratados con AAD en la Comunidad de Madrid (CM) y determinar la incidencia y relevancia clínica de la reactivación del VHB; y b) conocer las tasas de cribado del VHB en pacientes VHC en nuestra comunidad. Se evaluaron 1.337 pacientes VHC consecutivos tratados con AAD en dos hospitales del sur de la CM desde enero de 2015 hasta junio de 2017. Resultados: nueve de los 1.337 (0,67%) presentaban HBsAg positivo y 356 (26,6%) presentaban algún marcador de infección VHB pasada. Dos de los cuatro (50%) pacientes HBsAg positivo sin tratamiento desarrollaron reactivación virológica VHB pero no bioquímica. De los 356 con patrón de infección VHB pasada, el 100% presentó transaminasas normales al finalizar el tratamiento y durante el seguimiento. La tasa de cribado VHB ascendió al 92,9% de la cohorte. Conclusiones: la prevalencia de infección VHB (HBsAg positivos) en pacientes con hepatitis crónica por VHC en la zona sur de la CM es baja. La reactivación del VHB en pacientes HBsAg positivo que reciben AAD es frecuente, pero sin relevancia clínica. En nuestro medio existe una alta tasa de cribado del VHB en pacientes con VHC candidatos a recibir AAD

Introduction: cases of hepatitis B virus (HBV) reactivation have been reported in patients with hepatitis C virus (HCV) treated with direct antiviral agents (DAA). Objectives and methods: the main objectives of the present study are: a) to determine the prevalence of HBV/HCV coinfection in HCV patients treated with DAAs in the Autonomous Community of Madrid (CM) and also to determine the incidence and clinical relevance of HBV reactivation; and b) to determine the HBV screening rates in HCV patients in our region. For that purpose, 1,337 HCV patients were consecutively treated with DAAs in two hospitals located in South CM between January 2015 and June 2017. Results: nine of the 1,337 (0.67%) participants were HBsAg positive and 356 (26.6%) had previous HBV infection markers. Two of the four (50%) HBsAg positive patients with untreated HBV developed a virological reactivation, but not a biochemical reaction. Of the 356 patients with previous HBV infection markers, all had normal transaminases at the end of treatment and during follow-up. The HBV screening rate amounted to 92.9% of the cohort. Conclusions: the prevalence of HBV (HBsAg positive) infection in patients with chronic hepatitis C in the southern area of the CM is low. HBV reactivation in HBsAg positive patients treated with DAAs is common, although without clinical relevance. In our region, there is a high rate of HBV screening in patients with HCV that are likely treated with DAAs

Hepatitis B virus in patients with chronic hepatitis C treated with direct antiviral agents.

INTRODUCTION: cases of hepatitis B virus (HBV) reactivation have been reported in patients with hepatitis C virus (HCV) treated with direct antiviral agents (DAA). OBJECTIVES AND METHODS: the main objectives of the present study are: a) to determine the prevalence of HBV/HCV coinfection in HCV patients treated with DAAs in the Autonomous Community of Madrid (CM) and also to determine the incidence and clinical relevance of HBV reactivation; and b) to determine the HBV screening rates in HCV patients in our region. For that purpose, 1,337 HCV patients were consecutively treated with DAAs in two hospitals located in South CM between January 2015 and June 2017. RESULTS: nine of the 1,337 (0.67%) participants were HBsAg positive and 356 (26.6%) had previous HBV infection markers. Two of the four (50%) HBsAg positive patients with untreated HBV developed a virological reactivation, but not a biochemical reaction. Of the 356 patients with previous HBV infection markers, all had normal transaminases at the end of treatment and during follow-up. The HBV screening rate amounted to 92.9% of the cohort. CONCLUSIONS: the prevalence of HBV (HBsAg positive) infection in patients with chronic hepatitis C in the southern area of the CM is low. HBV reactivation in HBsAg positive patients treated with DAAs is common, although without clinical relevance. In our region, there is a high rate of HBV screening in patients with HCV that are likely treated with DAAs.

RECALAD. La asistencia al paciente en las unidades de Aparato Digestivo en el Sistema Nacional de salud. Estudio piloto, 2015 / RECALAD. Patient care at National Health System Digestive Care Units - A pilot study, 2015

Objetivo: elaborar un diagnóstico de situación sobre la asistencia en las unidades de aparato digestivo (UAD) en España. Material y métodos: estudio descriptivo transversal entre las UAD en hospitales generales de agudos del Sistema Nacional de Salud (datos referidos a 2015). Las variables de estudio fueron recogidas mediante un cuestionario sobre su estructura, cartera de servicios, actividad, formación, investigación y buenas prácticas. Asimismo, se analizaron las altas hospitalarias por enfermedades del área de digestivo mediante el Conjunto Mínimo Básico de Datos (2005-2014). Resultados: fueron invitados 209 hospitales, con 55 respuestas (26,3%). El promedio de altas de hospitalización es de 1.139 ± 653 por UAD/año y de 100 ± 66/año por digestólogo dedicado. La tasa de ingresos por mil habitantes y año en UAD en 2014 fue de 280, con una estancia media de 7,4 días. El análisis del CMBD 2005-2014 muestra un progresivo aumento en el número de altas dadas (37% más en 2014 frente a 2005), con una disminución del 28% en la tasa bruta de mortalidad intrahospitalaria (3,7% en 2014) y un ligero descenso (14%) de la estancia media (7,6 días en 2014). Se aprecia notable variabilidad en indicadores de estructura, actividad y resultados. Las tasas de mortalidad y reingresos, así como la estancia media, varían más del 100% entre UAD y existen asimismo notables dispersiones en frecuentación y resultados entre comunidades autónomas. Conclusiones: la encuesta RECALAD 2015 desvela aspectos relevantes sobre la organización, estructura y gestión de las UAD. La notable variabilidad hallada probablemente indica notables diferencias en eficiencia y productividad y, por tanto, un amplio margen de mejora (AU)

Objectives: To reach a situation diagnosis on the status of patient management at digestive care units (DCUs) in Spain. Material and methods: A cross-sectional descriptive study across DCUs in general acute care hospitals within the Spanish National Health System (data referred to 2015). The study variables were collected with a questionnaire including items on structure, services portfolio, activity, education, research, and good practice. Hospital discharge rates for digestive diseases were also assessed using the minimum basic data set (2005-2014). Results: Two hundred and nine hospitals invited, 55 responders (26.3%). Average discharges from hospital were 1,139 ± 653 per DCU/year, and 100 ± 66 per year per dedicated gastroenterologist. In 2014, admission rate to DCUs per 1,000 population and year was 280, with a mean stay of 7.4 days. The analysis of the MBDS for 2005-2014 reveals a progressive increase in the number of discharges (37% more in 2014 versus 2005), with a 28% decrease in hospital gross mortality rate (3.7% in 2014) and a slightly reduced (14%) mean stay (7.6 days in 2014). Considerable variability may be seen in structure, activity, and results indicators. Mortality and readmission rates, as well as mean stay, vary more than 100% amongst DCUs, and major dispersions also exist in frequentation and results amongst autonomous communities. Conclusions: The RECALAD 2015 survey unveiled relevant aspects related to DCUs organization, structure, and management. The notable variability encountered likely reflects relevant differences in efficiency and productivity, and thus points out there is ample room for improvement (AU)