Cure of chronic hepatitis C (CHC) can lead to improvement of health‐related quality of life and other patient‐reported outcomes (PROs). While extensive PRO data for CHC patients who were enrolled in ...clinical trials are available, similar data for patients seen in real‐world practices are scarce. Our aim was to assess PROs of CHC patients enrolled from real‐world practices from different regions and to compare them with those enrolled in clinical trials. CHC patients seen in clinical practices and not receiving treatment were enrolled in the Global Liver Registry (GLR). Clinical and PRO (FACIT‐F, CLDQ‐HCV, WPAI) data were collected and compared with the baseline data from CHC patients enrolled in clinical trials. N = 12,171 CHC patients were included (GLR n = 3146, clinical trial subjects n = 9025). Patients were from 30 countries from 6 out of 7 Global Burden of Disease (GBD) super‐regions. Compared with clinical trial enrollees, patients from GLR were less commonly enrolled from High‐Income GBD super‐region, older, more commonly female, less employed, had more type 2 diabetes, anxiety and clinically overt fatigue but less cirrhosis (all p < 0.001). Out of 15 PRO domain and summary scores, 12 were lower in GLR patients than in subjects enrolled in clinical trials (p < 0.001). In multiple regression models, anxiety, depression, and fatigue were associated with significant PRO impairment in CHC patients (p < 0.05). After adjustment for the clinico‐demographic confounders, the association of PRO scores of CHC patients with enrolment settings was no longer significant (all p > 0.05). In conclusion, hepatitis C patients seen in the real‐world practices have PRO impairment driven by fatigue and psychiatric comorbidities.
To investigate the efficacy and safety of Abexol and atorvastatin in patients with non-alcoholic fatty liver disease (NAFLD).Material and methods: The present study had a monocentric, randomized, ...double-blinded, comparative design with 4 parallel groups - group 1 (Abexol), group 2 (atorvastatin), group 3 (combined therapy) and group 4 (placebo) - to which dietary recommendations and physical activity practice were provided twice a day, for 24 weeks. Significant changes in the ultrasound analysis of the liver were considered a primary efficacy variable. Insulin resistance improvement (HOMA2-IR) was considered as a co-primary efficacy criterion. Significant changes in the serum levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST), lipid profile variables and the anthropometric variables were evaluated as secondary variables of effectiveness. Statistical analysis of all data was according to the intention to treat method.
The groups were statistically homogeneous at baseline conditions. At the end of the 6 months of treatment about 50% of the patients in all groups showed a decrease of at least one degree in echogenicity, while the rest remained the same. There were no significant changes in the values of liver enzymes or anthropometric variables evaluated. Treatment with atorvastatin and combined therapy significantly reduced levels of low-density lipoprotein-cholesterol (LDL-C) and total cholesterol. The treatments were safe and well tolerated, although in the atorvastatin group the number of adverse events reported was greater than in the rest of the groups.
Abexol and atorvastatin showed comparable efficacy and safety in patients with NAFLD, with advantages for treatment with atorvastatin with respect to its effects on the lipid profile of these patients.
Non-Alcoholic Fatty Liver Disease in Cuba Castellanos-Fernández, Marlen Ivón; Crespo-Ramírez, Eduardo; Del Valle-Díaz, Sergio ...
MEDICC review,
01/2021, Letnik:
23, Številka:
1
Journal Article
Odprti dostop
With a global adult prevalence of 24%, non-alcoholic fatty liver disease is a global health problem that parallels the worldwide increase of obesity. Its frequency, clinical characteristics and ...related diseases in Cuba remain unknown.
Describe the clinical characteristics, comorbidities and personal habits of patients with non-alcoholic fatty liver disease who are being treated in secondary and tertiary health facilities in seven Cuban provinces.
A cross-sectional, multicenter study was carried out in 6601 adults seen at gastroenterology outpatient clinics of nine hospitals in seven Cuban provinces from September 2018 through May 2019. Non-alcoholic fatty liver disease was diagnosed by abdominal ultrasound. The study included 1070 patients who met the diagnostic and study criteria and agreed to participate. Their personal habits and anthropometric and clinical characteristics, comorbidities and other aspects of their medical histories were recorded.
Of the 1070 participants, 60.7% (649) were women. Participants' average age was 54.5 years and average body mass index was 30.5 kg/m2. A total of 397 (37.1%) were overweight and 574 (53.6%) were obese, 945 (88.3%) led a sedentary lifestyle, 564 (52.7%) had high blood pressure, 406 (37.9%) had lipid disorders and 301 (28.1%) were diabetic. While 484 (45.2%) of patients were asymptomatic, the most frequent clinical signs and symptoms were fatigue (262; 24.5%), dyspepsia (209; 19.5%), abdominal pain (306; 28.5%) and hepatomegaly (189; 17.7%). Liver cirrhosis was present in 37 (3.5%) patients at the time of diagnosis. Family history of type 2 diabetes mellitus and obesity were identified in 391 (36.5%) and 279 (26.1%) of participants, respectively.
Prevalence of non-alcoholic fatty liver disease in these Cuban patients coincides with that reported in the Caribbean region, which has high levels of obesity, overweight and sedentary lifestyles. Most were asymptomatic, female or had metabolism-related comorbidities such as high blood pressure, type 2 diabetes mellitus and dyslipidemia.
The Latin American Association for the Study of the Liver (Asociación Latinoamericana para el Estudio del Hígado; ALEH) represents liver professionals in Latin America with the mission of promoting ...liver health and quality patient care by advancing the science and practice of hepatology and contributing to the development of a regional health policy framework. Fatty liver disease associated with metabolic dysfunction is of specific concern in the ALEH region, where its prevalence is one of the highest globally, second only to the Middle East. A recent consensus from an international panel recommended a new definition of fatty liver disease associated with metabolic dysfunction, including a shift in name from non-alcoholic fatty liver disease (NAFLD) to metabolic-associated fatty liver disease (MAFLD), and adoption of a set of positive criteria to diagnose the disease, independent of alcohol intake or other liver diseases. Given, the importance of this proposal, ALEH invited leading members of regional nations to come to a consensus on it from a local perspective. We reached a consensus to endorse the proposal that the disease should be renamed as MAFLD and that the disease should be diagnosed by the proposed simple and easily applicable criteria. We expect that this change in nosology will result in improvements in disease awareness and in advances in scientific, economic, public health, political, and regulatory aspects of the disease.
•Patient reported outcomes (PROs) are important to understanding the impact a disease from the patients’ point of view.•Chronic liver disease (CLD) can carry a high clinical and PRO burden.•PRO data ...are few among patients with CLD who reside in the Latin America and the Caribbean areas.•Using valid and reliable PRO instruments, we quantified PROs for patients with CLD living in Cuba.•We determined that patients from Cuba with hepatitis C virus and autoimmune liver disease had the worst PRO scores most likely related to more severe underlying liver disease (fibrosis) and/or to extrahepatic manifestations (fatigue, abdominal pain, anxiety, and depression).
Patient-reported outcomes (PROs) are important for comprehensive assessment of chronic liver disease (CLD). Latin America and the Caribbean have a high burden of CLD, but PROs are lacking. We assessed health-related quality of life (HRQL) in Cuban patients with compensated CLD.
A cross sectional study performed of adult patients with a diagnosis of chronic viral infection B and C (HBV, HCV), non-alcoholic fatty liver diseases (NAFLD) and autoimmune liver diseases (AILD) including autoimmune hepatitis (AIH), primary biliary cholangitis (PBC) and overlap syndrome (AIH+PBC). PROs were collected using: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Work Productivity and Activity-Specific Health Problem (WPAI: SHP), and the Chronic Liver Disease Questionnaire (CLDQ)-disease-specific.
543 patients enrolled, n=91 (HBV), n=188 (HCV), n=221 (NAFLD), n=43 (AILD). Of those with AILD, 22 had AIH, 14 PBC, and 7 overlap AIH/PBC. Mean age was 53.5 years, 64.1% female, 69.2% white, and 58.0% employed. Patients with HCV and AILD had more severe liver disease. A significant impairment in PROs was observed in HCV group whereas the AILD patients had more activity impairment. CLDQ-HRQL scores were significantly lower for patients with NAFLD and AILD compared to HBV. Male gender and exercising ≥90min/week predicted better HRQL. The strongest independent predictors of HRQL impairment were fatigue, abdominal pain, anxiety, and depression (p<0.05).
HRQL for Cuban patients with compensated CLD differs according to the CLD etiology. Patients with HCV and AILD had the worst PRO scores most likely related to severe underlying liver disease and/or extrahepatic manifestations.
Patients with fatty liver disease may experience stigma from the disease or comorbidities. In this cross-sectional study, we aimed to understand stigma among patients with nonalcoholic fatty liver ...disease (NAFLD)/nonalcoholic steatohepatitis (NASH) and healthcare providers.
Members of the Global NASH Council created two surveys about experiences/attitudes toward NAFLD and related diagnostic terms: a 68-item patient and a 41-item provider survey.
Surveys were completed by 1,976 patients with NAFLD across 23 countries (51% Middle East/North Africa MENA, 19% Europe, 17% USA, 8% Southeast Asia, 5% South Asia) and 825 healthcare providers (67% gastroenterologists/hepatologists) across 25 countries (39% MENA, 28% Southeast Asia, 22% USA, 6% South Asia, 3% Europe). Of all patients, 48% ever disclosed having NAFLD/NASH to family/friends; the most commonly used term was “fatty liver” (88% at least sometimes); “metabolic disease” or “MAFLD” were rarely used (never by >84%). Regarding various perceptions of diagnostic terms by patients, there were no substantial differences between “NAFLD”, “fatty liver disease (FLD)”, “NASH”, or “MAFLD”. The most popular response was being neither comfortable nor uncomfortable with either term (56%-71%), with slightly greater discomfort with “FLD” among the US and South Asian patients (47-52% uncomfortable). Although 26% of patients reported stigma related to overweight/obesity, only 8% reported a history of stigmatization or discrimination due to NAFLD. Among providers, 38% believed that the term “fatty” was stigmatizing, while 34% believed that “nonalcoholic” was stigmatizing, more commonly in MENA (43%); 42% providers (gastroenterologists/hepatologists 45% vs. 37% other specialties, p = 0.03) believed that the name change to metabolic dysfunction-associated steatotic liver disease (or MASLD) might reduce stigma. Regarding the new nomenclature, the percentage of providers reporting “steatotic liver disease” as stigmatizing was low (14%).
The perception of NAFLD stigma varies among patients, providers, geographic locations and sub-specialties.
Over the past decades, efforts have been made to change the nomenclature of nonalcoholic fatty liver disease (NAFLD) to better align with its underlying pathogenetic pathways and remove any potential stigma associated with the name. Given the paucity of data related to stigma in NAFLD, we undertook this global comprehensive survey to assess stigma in NAFLD among patients and providers from around the world. We found there is a disconnect between physicians and patients related to stigma and related nomenclature. With this knowledge, educational programs can be developed to better target stigma in NAFLD among all stakeholders and to provide a better opportunity for the new nomenclature to address the issues of stigma.
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•In this global cross-sectional survey study, we found a discordance between the terms patients and providers felt created stigma.•The term “obesity” was more often reported as stigmatizing by patients than the term “fatty”.•The percentage of providers reporting “steatotic liver disease” as stigmatizing was low (13.8%).•Providers reported they lacked the communication skills needed to talk about this disease.•Patients’ and providers’ responses varied by region.
Introduction: The effectiveness of the national immunization program has impacted on the reduction of the incidence of hepatitis B virus (HBV) infection in Cuba; however, the number of chronically ...infected patients is not negligible. These patients are diagnosed in the clinical practice, although the epidemiological studies that indicate the presence of the disease are insufficient. Objective: To describe the main clinical, biomolecular and immunological characteristics of patients with chronic hepatitis B virus infection treated at the National Institute of Gastroenterology, Havana, Cuba.Materials and methods: A total of 97 patients who had at least a 6-month history of chronic HBV infection were recruited at the above mentioned institution from January 2016 to January 2018. Descriptive statistical analyzes were performed to identify the clinical characteristics. Biochemical and virological studies, analysis of both liver stiffness values measured by transient elastography and use of antiviral therapy were also carried out.Results: All patients completed the follow-up. It was observed that 61,9 % of them were male and the median (range) age was 46 (18-84) years. The mean time since the diagnosis of the infection was 11.7 ± 8,9 years. Inactive disease without liver fibrosis or light fibrosis was present in 61,9 %. Only 2 % were negative for hepatitis B surface antigen with quantitative analysis of HBV DNA; also, 81,4 % of patients had detectable viral load and 85,5 % received one or more antiviral treatments, mainly nucleotide analogues. Conclusions: The patients with chronic HBV infection studied are mostly in the inactive phase of their disease, without significant evidence of liver damage and detectable levels of viremia. All of them have received some antiviral treatment.
Introducción: La efectividad del programa nacional de inmunización ha impactado en la reducción de la incidencia del virus de la hepatitis B en Cuba; sin embargo, no es despreciable la cantidad de pacientes infectados crónicos, que por esta causa, se detectan en la práctica asistencial, aunque insuficientes los estudios epidemiológicos que los caracterizan.Objetivo: Describir las principales características clínicas, biomoleculares e inmunológicas de los pacientes con VHB crónica atendidos en el Instituto de Gastroenterología de Cuba.Materiales y métodos: 97 pacientes que tenían al menos un historial de 6 meses de infección crónica con VHB fueron reclutados en la propia institución desde enero 2016 hasta enero 2018. Se realizaron análisis estadísticos descriptivos para las características clínicas, estudios bioquímicos, virológicos, grado de dureza hepática (medido por elastografía transitoria) y terapia antiviral. Resultados: Todos los pacientes completaron el seguimiento; 61,9% eran varones y la mediana (rango) de edad fue de 46 (18-84) años. La media de tiempo desde el diagnóstico de la infección fue de 11,7 ± 8,9 años. El 61,9% tenían enfermedad inactiva sin fibrosis hepática o fibrosis ligera. Solamente el 2% eran negativos para el antígeno de superficie de la hepatitis B con el DNA cuantificable del VHB, el 81,4% tenían carga viral detectable y el 85,5% recibieron uno o más tratamientos antivirales, principalmente los análogos del nucleótido/sido. Conclusiones: Los pacientes con la infección crónica del VHB estudiados, en su mayoría se encuentran en fase inactiva de su enfermedad, sin evidencia significativa de daño hepático, con niveles detectables de viremia y han recibido algún tratamiento antiviral.
The reduction of the incidence of hepatitis B virus (HBV) infection in Cuba can be attributed to the effectiveness of the national immunization program. However, the number of patients with chronic ...HBV observed in clinical practice is not negligible.
A cross-sectional study was conducted to describe the main clinical characteristics of patients with chronic hepatitis B virus infection.
A total of 146 patients who had at least a 6-month history of hepatitis B surface antigen positivity were recruited between 2013 and 2015. Descriptive statistical analysis of the epidemiologic, clinical, biochemical, and virologic variables was performed.
Men accounted for 67.8% of patients, and the median age was 43 years. The median time since diagnosis of infection was 9 years. Among the patients, 59% had chronic hepatitis, 34% had liver cirrhosis, and 7% were inactive carriers. Concomitant diagnoses demonstrated that 16.4% of patients had malignancies, predominantly lymphoma. Only 64.4% of patients had received antiviral treatment, and lamivudine was the most commonly used (61.6%) drug. Moreover, 70% of patients were identified during an inactive phase.
Patients with chronic HBV infection are still a health problem in the adult Cuban population, especially in patients with concomitant malignancies.
RESUMEN Introducción: La calidad de vida relacionada con la salud medida a través de los “resultados reportados por pacientes”, del inglés: patient reported outcomes (PROs) permite la detección ...efectiva de problemas físicos y psicológicos en pacientes con hepatitis crónica. Objetivo: Describir las dimensiones de calidad de vida más afectadas reportados por pacientes con infección crónica por virus de la Hepatitis C y B. Material y Métodos: Se realizó un estudio descriptivo, transversal desde junio 2018 hasta diciembre 2020 en el Instituto de Gastroenterología (IGE). Entre 1 706 pacientes con diagnóstico VHB y VHC atendidos, la muestra quedó constituida por 366 adultos con infección crónica por los virus de hepatitis B (VHB) y C (VHC). Se registraron los resultados de las encuestas: Evaluación Funcional para el Tratamiento de Enfermedades Crónicas -Fatiga (FACIT-F) y Cuestionario de Impedimento de la Productividad y Actividad Laboral- Problema de salud específico (WPAI-SPH) y parámetros clínico-demográficos. Resultados: Se identificaron 271 (74,0 %) pacientes con diagnóstico de VHC y 95 (26,0 %) de VHB, con edad media 54,0 ± 12,7 años, 209 (57,1 %) mujeres. La puntuación total de la FACIT-F estuvo más afectada en VHC (FACIT-F: HVB: 129,0 ± 15,9 vs. VHC: 111,2 ± 23,5; p<0,0001), quienes a su vez tuvieron mayor deterioro de la actividad laboral (WPAI-SPH: VHB: 0,309 ± 0,312 vs. VHC: 0,386 ± 0,333; p<0,05). Conclusiones: Los pacientes con VHC vivencian una peor calidad de vida que compromete su bienestar, rendimiento laboral y cotidiano.
Population-based studies on the clinical course and prognosis of autoimmune hepatitis (AIH) from Caribbean countries are limited.
The aim of this study was to provide information regarding the ...clinical and laboratory findings, histological profile, treatments, and outcomes of patients with AIH with long-term follow-up in a tertiary referral center.
A retrospective study was performed at the National Institute of Gastroenterology in Havana, Cuba, by enrolling 82 patients with a well-documented, long-term clinical course of AIH. Clinical and laboratory findings, histological profiles, treatments, and outcomes were analyzed.
At diagnosis, 73 (89%) patients had AIH type 1, 84.1% were women, and their median age was 46.5 years (range, 17–79 years). The median follow-up period was 84 months (interquartile range, 12–276 months). Clinical onset was mild or subclinical in 72% of patients and asymptomatic in 12.2%. At diagnosis, the Hennes's median score was 6 (range, 3–8). Complications were seen in 44 (53.6%) patients, 42 (51.2%) with liver-related complications and 9 (10.9%) without liver-related complications. Cirrhosis was present at diagnosis in 32 (39%) patients. Cirrhosis was subsequently diagnosed in the other 28 patients who were not cirrhotic at diagnosis, over a median follow-up of 12 (IQR, 2-84) months. During follow-up, 6 patients died (7.3%). Cumulative survival at 5 and 10 years was 98.4% and 89%, respectively. A complete biochemical response was achieved in 79% of patients in a mean (SD) of 11.7 (11.6) months. Side effects due to treatment were reported in 76 (92.7%) patients, and no pretreatment factors were found to predict treatment response.
These Cuban patients with AIH had acceptable disease remission rate and a prompt treatment response. Although most patients had advanced-stage liver disease at diagnosis or developed during follow-up, the cumulative survival rate was high when patients were receiving and complying with treatment.
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