Non-alcoholic fatty liver disease (NAFLD) is not due to heavy alcohol consumption, but is a health condition where the liver retains an excessive amount of fat. Although NAFLD normally does not result in more severe liver problems, some patients with NAFLD will develop non-alcoholic steatohepatitis (NASH). Because of unhealthy diet and other factors, NASH is becoming a serious and worsening problem in the Western world. It is projected to become the leading cause of liver transplants, with no approved treatment options available. Yet which and how many patients actually have this disease, and how many will progress to more serious liver disease is poorly understood. Many with NASH, perhaps one in five or greater, have fibrous deposits in the liver that are linked to inflammation and cell damage. Among these, NASH might also lead to more serious liver conditions, including early (compensated) or advanced (decompensated) cirrhosis, hepatocellular carcinoma (a type of liver cancer), a liver transplant operation, or death. This study will describe and measure the time that patients spend while having NAFLD or NASH, as well as the more severe liver conditions above (if any do occur), whether these patients have other common health problems like diabetes, and how much it costs to treat these liver diseases. This study will help to answer in greater detail than is currently known how many patients have NASH, how many are developing more serious liver disease and the estimated economic burden for helping patients to live with this disease and its consequences.
This study describes and quantifies patterns of liver disease progression and estimates the health and economic burden among patients diagnosed with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH) in the United Kingdom. Patients studied have a NAFLD or NASH index event during the observation period from 1 Jan 2007 to 1 July 2017 (earliest date in this range was the index date). Patients will be followed until censoring to determine whether NASH/NAFLD progressed to NASH Fibrosis Stage 3 (F3) or to compensated cirrhosis (CC), decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC), liver transplant (LT), or death. The number of days until censoring spent in each of these liver disease states will be calculated for by sex and age using survival analysis, with minimal duration cut-off criteria. Healthcare service and product utilisation events associated with each health state or selected comorbidities will be tracked for each patient. Utilisation events will be mapped to reference costs to determine absolute annualized or average monthly costs, and incremental costs for each disease state. Further analyses will describe findings by patient demographics and characteristics, physical assessment measures and comorbid endocrine and cardiovascular conditions. ANOVA (continuous-symmetric distributions), Kruskal-Wallis (continuous-asymmetric), and Chi-Square (categorical) will be used to test for significance of associations. Pairwise comparisons will be applied, adjusting for multiplicity.
NAFLD/NASH prevalence and progression
NAFLD/NASH-specific fibrosis Stage 3 prevalence and progression
NAFLD/NASH-specific compensated cirrhosis prevalence and progression
NAFLD/NASH-specific decompensated cirrhosis prevalence and progression
NAFLD/NASH-specific hepatocellular cancer prevalence and progression
NAFLD/NASH-specific liver transplant prevalence and progression
Utilisation of health services and products
Costs of health services and product costs (burden of illness)
Jie Ting - Chief Investigator - Gilead Sciences
Gregory Reardon - Corresponding Applicant - Keck Graduate Institute
Burak Ozbay - Collaborator - Gilead Sciences
Donald McPherson - Collaborator - Newcastle upon Tyne Hospitals NHS Foundation Trust
Gregory Reardon - Collaborator - Keck Graduate Institute
William Rosenberg - Collaborator - Royal Free London NHS Foundation Trust
HES Accident and Emergency;HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient;NCRAS Cancer Registration Data;ONS Death Registration Data;Patient Level Index of Multiple Deprivation