The summaries are free for public
use. The Chronic Liver Disease
Foundation will continue to add and
archive summaries of articles deemed
relevant to CLDF by the Board of
Trustees and its Advisors.
Abstract Details
Relationship of ELF and PIIINP With Liver Histology and Response to Vitamin E or Pioglitazone in the PIVENS Trial
Hepatol Commun. 2021 Feb 5;5(5):786-797. doi: 10.1002/hep4.1680. eCollection 2021 May.
Samer Gawrieh1, Laura A Wilson2, Katherine P Yates2, Oscar W Cummings3, Eduardo Vilar-Gomez1, Veeral Ajmera4, Kris V Kowdley5, William M Rosenberg6, James Tonascia2, Naga Chalasani1
Author information
1Division of Gastroenterology and Hepatology Department of Medicine Indiana University Indianapolis IN USA.
2Department of Epidemiology Bloomberg School of Public Health Johns Hopkins University Baltimore MD USA.
3Department of Pathology Indiana University Indianapolis IN USA.
4Division of Gastroenterology and Hepatology Department of Medicine University of California San Diego San Diego CA USA.
5Liver Institute Northwest Seattle WA USA.
6Division of Medicine University College London London United Kingdom.
Abstract
Enhanced liver fibrosis score (ELF) and one of its components, amino-terminal propeptide of type III procollagen (PIIINP) are promising noninvasive biomarkers of liver histology in patients with nonalcoholic steatohepatitis (NASH). We evaluated the association of ELF and PIIINP with fibrosis stages at baseline and end of treatment (EOT) with vitamin E or pioglitazone in the PIVENS trial (Pioglitazone vs. Vitamin E vs. Placebo for the Treatment of Nondiabetic Patients With NASH) and characterized ELF and PIIINP changes and their associations with changes in the histological endpoints. ELF and PIIINP were measured at baseline and weeks 16, 48, and 96 on sera from 243 PIVENS participants. Baseline and EOT ELF were significantly associated with fibrosis stage (P < 0.001). The area under the curve for ELF's detection of clinically significant and advanced fibrosis in baseline biopsies was 0.74 and 0.79, respectively (P < 0.001). There was a significant drop in ELF score at weeks 48 and 96 in patients who achieved the NAFLD activity score (NAS)-based primary end point (P = 0.007) but not in those who experienced NASH resolution (P = 0.24) or fibrosis improvement (P = 0.50). Change in PIIINP was significantly associated with NASH resolution and improvement in NAS-based histological endpoint and fibrosis (P < 0.05 for all). Over the study period, both ELF and PIIINP significantly decreased with vitamin E (P < 0.05), but only PIIINP decreased with pioglitazone (P < 0.001). Conclusion: ELF is significantly associated with clinically significant and advanced fibrosis in patients with NASH, but its longitudinal changes were not associated with improvement in fibrosis or NASH resolution. PIIINP, one of its components, appears promising for identifying longitudinal histologic changes in patients with NASH and is worthy of further investigation.