Epidemiology of chronic liver diseases in the USA in the past three decades.

Objective: Given significant advances in treatment of viral hepatitis and the growing epidemic of obesity, the burden of the different types of liver diseases in the USA may be changing. Our aim was to assess the shift in the prevalence of different liver disease aetiologies in the USA over the past three decades.

Design: National Health and Nutrition Examination Surveys (NHANES; cross-sectional 1988-1994 and 1999-2016) were used.

Changing demographics among populations prescribed HCV treatment, 2013-2017.

Objectives: We analyzed the demographics and disease characteristics of patients prescribed treatment for chronic hepatitis C virus (HCV) infection from 2013 through 2017, a time frame that encompasses the expansion of available direct-acting antiviral inhibitors.

Study Design: Retrospective analysis.

Methods: Using a proprietary disease-management program, data for 19,944 patients receiving HCV treatment were collected from providers and specialty pharmacies.

Prevalence, mortality and healthcare utilization among Medicare beneficiaries with Hepatitis C in Haemodialysis units.

Hepatitis C (HCV) is more common among patients with end-stage renal disease requiring haemodialysis compared to the general population. Thus, we aimed to assess trends in prevalence, health resource utilization and mortality among Medicare beneficiaries with HCV on haemodialysis. This is a retrospective study of outpatient and inpatient claims for Medicare beneficiaries receiving haemodialysis (2005-2016).

The global epidemiology of NAFLD and NASH in patients with type 2 diabetes: A systematic review and meta-analysis.

Background & Aims: Although non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH) and NASH with advanced fibrosis are closely associated with type 2 diabetes mellitus (T2DM), their global prevalence rates have not been well described. Our aim was to estimate the prevalence of NAFLD, NASH, and advanced fibrosis among patients with T2DM, by regions of the world.

Methods: We searched for terms including NAFLD, NASH and T2DM in studies published from January 1989 to September 2018, using PubMed, Ovid MEDLINE®, EMBASE and Web of Science.

Noninvasive Tests Accurately Identify Advanced Fibrosis due to NASH: Baseline Data From the STELLAR Trials.

Accurate noninvasive tests (NITs) are needed to replace liver biopsy for identifying advanced fibrosis caused by nonalcoholic steatohepatitis (NASH). We analyzed screening data from two phase 3 trials of selonsertib to assess the ability of NITs to discriminate advanced fibrosis. Centrally read biopsies from the STELLAR studies, which enrolled patients with bridging fibrosis and compensated cirrhosis, were staged according to the NASH Clinical Research Network classification.

REGENERATE: Design of a pivotal, randomised, phase 3 study evaluating the safety and efficacy of obeticholic acid in patients with fibrosis due to nonalcoholic steatohepatitis.

Background: Nonalcoholic steatohepatitis (NASH) is a chronic, progressive, and severe form of nonalcoholic fatty liver disease. In FLINT, obeticholic acid (OCA) treatment improved multiple histological NASH features. The design and endpoints of REGENERATE, an ongoing phase 3 study, further evaluate OCA treatment in patients with fibrosis due to NASH.

Patient-reported outcomes in patients chronic viral hepatitis without cirrhosis: The impact of hepatitis B and C viral replication.

Background & Aim: Chronic infections with hepatitis B or C (HBV and HCV) are associated with adverse clinical outcomes and patient-reported outcomes (PROs). The aim is to compare PRO scores in patients with chronic HBV and HCV without advanced liver disease before and after suppression/clearance of their infection.

Methods: Patients with HCV and HBV infection prior to initiation of antiviral treatment and after viral suppression/eradication completed PRO questionnaires.

Trends in hospitalizations for chronic liver disease-related liver failure in the United States, 2005-2014.

Background & Aims: Current estimates of the population-based disease burden of liver failure or end-stage liver disease (ESLD) are lacking. We investigated recent trends in hospitalizations and in-hospital mortality among patients with ESLD in the United States (US).

Methods: A retrospective analysis was performed utilizing the National Inpatient Sample from 2005 to 2014.

The Natural History of Advanced Fibrosis Due to Nonalcoholic Steatohepatitis: Data From the Simtuzumab Trials.

Progression of nonalcoholic steatohepatitis (NASH) is incompletely characterized. We analyzed data on longitudinal changes in liver histology, hepatic venous pressure gradient (HVPG), and serum markers of fibrosis in 475 patients with NASH with bridging fibrosis (F3) or compensated cirrhosis (F4) enrolled in two phase 2b, placebo-controlled trials of simtuzumab. The trials were terminated after 96 weeks because of lack of efficacy, so data from treatment groups were combined.

Prevalence and long-term outcomes of non-alcoholic fatty liver disease among elderly individuals from the United States.

Background: The prevalence and outcomes of non-alcoholic fatty liver disease (NAFLD) among elderly have not been well described. Our aim was to assess the prevalence, risk factors and mortality of NAFLD in individuals older than 60 years.

Methods: The data from the Third National Health and Nutrition Examination Survey with linked mortality files were utilized.

Cytokine balance is restored as patient-reported outcomes improve in patients recovering from chronic hepatitis C.

Background & Aims: Chronic hepatitis C (CHC) has a negative impact on patient-reported outcomes (PROs). Although most CHC patients who achieve sustained virologic response (SVR) show an improvement in PRO scores, some continue to experience impairment in PROs. The aim was to investigate if serum biomarkers (selected neurotransmitters and cytokines) are associated with changes in PROs in CHC patients who achieve SVR.

Not Achieving Sustained Viral Eradication of Hepatitis C Virus After Treatment Leads to Worsening Patient-reported Outcomes.

Background: The causative relationship between the clearance of infections and long-term, health-related quality-of-life (HRQL) improvements in patients with hepatitis C virus (HCV) has been generally accepted. The aim of this study was to assess long-term HRQL trends in HCV patients who did not achieve sustained virologic responses (SVRs) after treatment with direct-acting antivirals.

Methods: HCV patients who completed treatment in clinical trials and did not achieve SVRs were enrolled in a long-term registry (#NCT01457768).

Burden of Primary Biliary Cholangitis Among Inpatient Population in the United States.

Primary biliary cholangitis (PBC) is an autoimmune liver disease that can lead to cirrhosis and liver failure. Our aim was to assess the recent trends in the mortality rates and health care utilization of patients with PBC seen in the inpatient setting in the United States. We used the National (Nationwide) Inpatient Sample data (2005-2014).

Disease Burden of Hepatocellular Carcinoma: A Global Perspective.

Liver cancer is one of the leading causes of cancer-related mortality around the world. Hepatocellular carcinoma (HCC) is the primary cancer of the liver, accounting for the majority of liver cancers. The risk factors associated with HCC include chronic infections with HBV and HCV, alcoholic liver disease, and nonalcoholic fatty liver disease.

Reduced Patient-Reported Outcome Scores Associate With Level of Fibrosis in Patients With Nonalcoholic Steatohepatitis.

Background: Patient-reported outcomes (PROs) are used to measure patients' experience with their disease. However, there are few PRO data from patients with NASH. We collected data from the STELLAR clinical trials to assess PROs for NASH and advanced fibrosis.

Impact of hepatitis C virus and insurance coverage on mortality.

Objectives: To assess the association of payer status and mortality in hepatitis C virus (HCV)-infected patients.

Study Design: For this retrospective observational study, we used the National Health and Nutrition Examination Survey from 2000 to 2010. Adults with complete data on medical questionnaires, HCV RNA, insurance types, and mortality follow-ups were included.

Systematic review with meta-analysis: extrahepatic manifestations in chronic hepatitis C virus-infected patients in East Asia.

Background: Although the prevalence of extrahepatic manifestations of chronic hepatitis C virus (HCV) infection has been reported from Western countries, their prevalence in East Asian countries is not well known.

Aim: To perform a systematic review to quantify the prevalence of selected extrahepatic manifestations of HCV among patients from East Asia.

Methods: Medline, CINAHL, EMBASE, Cochrane and country-specific databases were reviewed according to standard guidelines for meta-analyses.

Aerobic capacity and exercise performance in nonalcoholic fatty liver disease.

Background: Nonalcoholic fatty liver disease (NAFLD) is one of the leading causes of chronic liver disease worldwide. Exercise has proven effective in treating NAFLD, and many clinical initiatives seek to increase uptake of exercise in this population. This study aimed to elucidate the physiological responses of individuals with NAFLD to graded exercise testing.

Hepatic sonic hedgehog protein expression measured by computer assisted morphometry significantly correlates with features of non-alcoholic steatohepatitis.

Background: Hepatic expression of Sonic Hedgehog (SHH) is associated with Non-alcoholic fatty liver disease (NAFLD) and development of Non-alcoholic steatohepatitis (NASH). Hepatic SHH detection increases with the diagnosis of NASH. This pilot study was designed to confirm that staining for SHH is useful in NASH diagnosis and determine whether quantification of staining by computer assisted morphometry (CAM) can be used to assess severity of ballooning degeneration.

Patients With Lean Nonalcoholic Fatty Liver Disease Are Metabolically Abnormal and Have a Higher Risk for Mortality.

Nonalcoholic fatty liver disease (NAFLD) is an increasingly recognized and common cause of chronic liver disease worldwide. Although most patients with NAFLD are obese, a smaller group of NAFLD patients are lean. This study explored the long-term outcomes of lean patients with NAFLD in the United States.

A Comprehensive Review of Patient-reported Outcomes in Patients With Chronic Liver Diseases.

Chronic liver disease (CLD) is a global health problem with chronic viral hepatitis, alcohol-related liver disease, and nonalcoholic fatty liver disease being important causes of mortality. Besides its clinical burden, patients with CLD also suffer from impairment of their health-related quality of life and other patient-reported outcomes (PRO). In this context, a combination of both clinical and PROs will allow assessment of the comprehensive burden of liver disease on patients.

Race/ethnicity-based temporal changes in prevalence of NAFLD-related advanced fibrosis in the United States, 2005-2016.

Background And Aim: Advanced fibrosis associated with nonalcoholic fatty liver disease (NAFLD) has been reported to have a higher risk of hepatic and non-hepatic mortality. We aim to study the recent trends in the prevalence of NAFLD-related advanced fibrosis in a large population sample.

Methods: Cross-sectional data from 28,739 participants in the National Health and Nutrition Examination Survey (NHANES) from 2005 to 2016 were utilized.

Implementation of Value-based Medicine (VBM) to Patients With Chronic Hepatitis C (HCV) Infection.

Introduction: With the significant clinical and economic burden of chronic HCV, effective treatment must be provided efficiently and appropriately. VBM is predicated upon improving health outcomes (clinical and quality) while optimizing the cost of delivering these outcomes. This review explores the concepts of VBM and how it can be used as a strategy for HCV eradication, using the United States as a case example.