The odds of liver decompensation and mortality are higher in patients with non-alcoholic fatty liver disease (NAFLD) in whom fibrosis is in an advanced stage, according to results of the multicenter phase II NAFLD Database Study reported in the New England Journal of Medicine.

The study prospectively examined 1773 adults with biopsy-confirmed NAFLD from December 2009 to April 2019. The patients were followed up for an average of 4 years. The median BMI was 33. Mean daily alcohol consumption was less than 30 g for men and less than 20 g for women. More than 65% participants were female. Steatohepatitis was present in 55% of the participants and 20% had borderline steatohepatitis; 30% showed stages F3 or F4 fibrosis on biopsy.

Results showed that the incidence of liver complications increased with progression of fibrosis (F0-F2 [no, mild, or moderate fibrosis], F3 [bridging fibrosis] and F4 [cirrhosis]). The incidence of liver cancer was 0.04, 0.34, and 0.14, respectively, per 100 person-years, variceal hemorrhage 0.00, 0.06, 0.70 respectively, per 100 person-years, encephalopathy 0.02, 0.75, 2.39 respectively, per 100 person-years and ascites 0.04, 0.52, 1.20 respectively, per 100 person-years.

Mortality rate per 100 person-years in patients with stage 4 fibrosis was 1.76; mortality rate in patients with stage F3 was 0.89, while in patients with early fibrosis (stages  F0-F2), the mortality rate per 100 person-years was 0.32.

Patients with stage 4 fibrosis had higher incidence of type 2 diabetes compared to patients with F0-F2 fibrosis; 7.5 vs 4.5 events per 100 person-years, respectively. Patients with stage 4 fibrosis also were found to have higher incidence of decrease in glomerular filtration rate (≥40%).

NAFLD patients with advanced fibrosis at baseline were more likely to die from any cause compared to those with early fibrosis stages. They also had a higher probability of liver decompensation events. Some patients with NAFLD may develop nonalcoholic steatohepatitis (NASH), which progresses further to cirrhosis and end-stage liver disease resulting in liver failure and the subsequent need for a liver transplant. Hence, patients with advanced liver fibrosis must be regularly and carefully monitored for any signs of liver decompensation.

Reference

1. Sanyal AJ, et al. Prospective study of outcomes in adults with nonalcoholic fatty liver disease. N Engl J Med. 2021 Oct 21;385(17):1559-1569. doi: 10.1056/NEJMoa2029349.