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High Rates Of Liver Disease Progression And Mortality Observed In Patients With Non-alcoholic Fatty Liver Disease/non-alcoholic Steatohepatitis (NAFLD/NASH)

ILC 2019: New studies in Germany and France support the need for early detection and effective interventions among NAFLD/NASH patients

11 April 2019, Vienna, Austria

EASL (EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER)

Two independent national studies have reported high rates of liver disease progression and mortality among patients with non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH). The studies reported today at The International Liver Congress™ 2019 in Vienna, Austria, found that within 10 years of diagnosis, up to 11% of patients with NAFLD/NASH had progressed to advanced liver diseases (defined as NAFLD/NASH patients with compensated cirrhosis [CC], decompensated cirrhosis [DCC], liver transplant [LT] or hepatocellular carcinoma [HCC]), and up to 27% of patients with NAFLD/NASH and CC had developed liver decompensation.

Fatty liver is a complex condition that affects up to one-quarter of adults worldwide.1 The condition is considered to be the liver manifestation of metabolic syndrome2 and encompasses a histological spectrum from the relatively benign non-alcoholic fatty liver to NASH, which typically has an aggressive course.3 NAFLD/NASH can lead to cirrhosis or HCC,4 and is set to become the predominant cause of liver disease in many parts of the world;5 however, their natural history remains incompletely defined.3

In the first study, 215,655 NAFLD/NASH patients were identified retrospectively from a German insurance claims database (InGef; 2011–2016) with 100,644 new events of different liver severity stages identified during the follow-up: 79,245 events (78.7%) of non-progressive NAFLD/NASH, 411 events (0.4%) of CC, 20,614 events (20.5%) of DCC, 11 events (0.01%) of LT and 363 events (0.4%) of HCC. Amongst those with advanced liver diseases, mortality rate during 1 year of follow-up increased by up to 50% (range 8.8-51.2%), compared with non-progressive NAFLD/NASH patients (1.2%, p<0.0001). This trend continued over 5 years of follow-up, with only 2.8% of the non-progressive NAFLD/NASH patients dying, compared with 14.8% of CC patients, 25.6% of DCC patients, and 64.5% of HCC patients. After adjusting for patient demographics and comorbidities, the mortality risk increased significantly (p<.0001) with liver disease progression. As compared to non-progressors, the risk of mortality for NAFLD/NASH patients with CC, DCC, LT and HCC was 2.71, 4.21, 2.23 and 13.69 times higher respectively.

‘Perhaps most worryingly, during the 5-year study period, 11% of the NAFLD/NASH patients progressed to advanced liver diseases and 17% of CC patients progressed to DCC, after accounting for any dying patients,” said Professor Ali Canbay from the University of Magdeburg Medical School in Magdeburg, Germany, who presented the study findings. ‘This demonstrates very clearly the need for early detection and effective treatment to prevent progression and potentially reduce mortality.”

In the second study, French investigators identified 125,052 NAFLD/NASH patients from the French National Database on hospital care (PMSI; 2009–2015), of whom 1,491 (1.2%) were diagnosed with CC, 7,846 (6.3%) with DCC, and 1,144 (0.9%) with HCC. As was seen in Germany, a small cohort of patients progressed rapidly, with 5.6% of NAFLD/NASH patients progressing to more severe liver disease during 7 years of follow-up, and 27.5% of NAFLD/NASH patients with CC progressing to DCC. Mortality was high across all cohorts and increased with liver disease progression. After 1 year, 2.1% of NAFLD/NASH patients, 4.6% of CC patients, and 19.1% of DCC patients had died. The corresponding mortality rates after 7 years of follow-up were 7.9%, 16.3%, and 34.6% respectively.

‘Before this study, we had very limited data on the disease progression and mortality of NAFLD/NASH patients in our country,’ explained Professor Jerome Boursier from Angers University Hospital in Angers, France. ‘We were surprised by the high overall mortality rate among these patients (7.9%) – almost twice that of the general population of a similar age – as well as the apparent rate of under-diagnosis of cirrhotic patients, the majority only being identified following a decompensation event.’

‘This shows us we must direct greater effort into finding and treating NAFLD/NASH patients as early as possible, so we can stop or even reverse disease progression.’

Professor Philip Newsome (Vice-Secretary EASL) said, “These data demonstrate the significant morbidity and mortality found in patients with NAFLD and reinforces the need to identify those patients most at risk for appropriate treatment.”

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About The International Liver Congress™

This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ 2019 will take place from 10­–14 April 2019 at the Reed Messe Wien Congress and Exhibition Center, Vienna, Austria.

About The European Association for the Study of the Liver (EASL)

Since its foundation in 1966, this not-for-profit organization has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European association with international influence, and with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

Contact

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Onsite location references

Session title: ‘NAFLD – Clinical burden natural history’

Time, date and location of session: 16:45–17:00, 11 April 2019, Strauss 1–2

Presenter: Ali Canbay, Germany

Abstract: Increasing risk of disease progression and mortality in non-alcoholic fatty liver disease/non-alcoholic steatohepatitis patients with advanced liver disease: A German real-world analysis (PS-060)

Session title: ‘NAFLD: Clinical aspects except therapy’

Time, date and location of session: 09:00–19:00, 11 April 2019, Poster Area

Presenter: Jerome Boursier, France

Abstract: Increased risk of mortality with liver disease progression in non-alcoholic fatty liver disease/non-alcoholic steatohepatitis patients: An analysis of French national hospital care (THU-299)

Author disclosures

Ali Canbay is an advisor for Gilead Sciences, Inc. Nandita Kachru and A. Burak Ozbay are employees of Gilead Sciences, Inc. during the conduct of this study. Data analyses were performed by Xcenda GmbH, a consultant of Gilead Sciences, Inc., of which Dominic Meise and Jennifer Haas are employees. This study was funded by Gilead Sciences, Inc.

Jerome Boursier is a consultant for Abbvie, Allergan, Biorad, Diafir, Echosens, Genfit, Gilead Sciences, Inc., Intercept, Native, and Siemens. Jeremy Fraysse and Sanatan Shreay are employees of Gilead Sciences, Inc. Data analyses were performed by CEMKA-EVAL, a consultant for Gilead Sciences, Inc., of which Antoine Lafuma and Cecile Fabron are employees. This study was funded by Gilead Sciences, Inc.

References

  1. Younossi ZM, et al. Global epidemiology of non-alcoholic fatty liver disease – Meta-analytic assessment of prevalence, incidence, and outcomes. 2016;64(1):73–84.
  2. Wainwright P, Byrne Bidirectional relationships and disconnects between NAFLD and features of the metabolic syndrome. Int J Mol Sci. 2016;17(3):367.
  3. Bertot LC, Adams LA. The natural course of non-alcoholic fatty liver disease. Int J Mol Sci. 2016; 17(5): 774.
  4. Manne V, et al. Pathophysiology of non-alcoholic fatty liver disease/Non-alcoholic steatohepatitis. Clin Liver Dis. 2018;22(1):23–37.
  5. Loomba R, Sanyal AJ. The global NAFLD Nat Rev Gastroenterol Hepatol. 2013;10(11):686–90.