Cited by 390Liver Disease Diagnosis and TreatmentLiver physiology and pathologyLiver Diseases and Immunity

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

Sanyal, Arun J., Harrison, Stephen A., Ratziu, Vlad, Abdelmalek, Manal F., Diehl, Anna Mae, Caldwell, Stephen, Shiffman, Mitchell L., Aguilar Schall, Raul, Jia, Catherine, McColgan, Bryan, Djedjos, C. Stephen, McHutchison, John G., Subramanian, G. Mani, Myers, Robert P., Younossi, Zobair, Muir, Andrew J., Afdhal, Nezam H., Bosch, Jaime, Goodman, Zachary·2019·Hepatology

DOI 10.1002/hep.30664

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Abstract

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. Liver biopsies and HVPG measurements (only for patients with F4 fibrosis) were collected at screening and at weeks 48 and 96. Patients were assessed for Ishak fibrosis stage, hepatic collagen content and alpha-smooth muscle actin (by morphometry), NAFLD Activity Score (NAS), and serum markers of fibrosis. Associations with progression to cirrhosis (in patients with F3 fibrosis) and liver-related clinical events (in patients with F4 fibrosis) were determined. Progression to cirrhosis occurred in 22% (48/217) of F3 patients, and liver-related clinical events occurred in 19% (50/258) of patients with cirrhosis. Factors significantly associated with progression to cirrhosis included higher baseline values of and greater increases in hepatic collagen content, level of alpha-smooth muscle actin, and Enhanced Liver Fibrosis score. Similar factors, plus lack of fibrosis stage improvement (hazard ratio, 9.30; 95% confidence interval, 1.28-67.37), higher HVPG at baseline, and greater increase in HVPG over time, were associated with an increased risk of liver-related clinical events in patients with cirrhosis. Disease progression was not associated with the NAS at baseline or changes in NAS during treatment after adjustment for fibrosis stage. Conclusion: In patients with advanced fibrosis due to NASH, the primary determinant of clinical disease progression is fibrosis and its change over time.

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Authors: Sanyal, A. J., Harrison, S. A., Ratziu, V., Abdelmalek, M. F., Diehl, A. M., Caldwell, S., Shiffman, M. L., Aguilar Schall, R., Jia, C., McColgan, B., Djedjos, C. S., McHutchison, J. G., Subramanian, G. M., Myers, R. P., Younossi, Z., Muir, A. J., Afdhal, N. H., Bosch, J., & Goodman, Z.
Affiliations: Virginia Commonwealth University (US)
Pinnacle Clinical Research (US)
Pitié-Salpêtrière Hospital (FR)
Duke Clinical Research Institute (US)
University of Virginia (US)
Liver Institute of Virginia,Richmond,VA
Gilead Sciences, Inc,Foster City,CA
Gilead Sciences (United States) (US)
Inova Fairfax Hospital (US)
Beth Israel Deaconess Medical Center (US)
University of Bern (CH)
Corresponding author: Sanyal, Arun J.
ORCID: Sanyal, Arun J.
Harrison, Stephen A.
Ratziu, Vlad
Abdelmalek, Manal F.
Diehl, Anna Mae
Caldwell, Stephen
Shiffman, Mitchell L.
Subramanian, G. Mani
Younossi, Zobair
Muir, Andrew J.
Afdhal, Nezam H.
Bosch, Jaime
Goodman, Zachary
Venue: Hepatology
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2019-05-28
Volume: 70
Issue: 6
Pages: 1913-1927
ISSN: 0270-9139 (ISSN-L)
1527-3350
DOI: 10.1002/hep.30664
OpenAlex: W2938096756
Cited by: 390
References: 27
Citations by year: 2026: 32 · 2025: 53 · 2024: 57 · 2023: 83 · 2022: 55 · 2021: 54 · 2020: 49 · 2019: 6
FWCI: 31.24
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
doi.wiley.com/10.1002/tdm_license_1.1 (tdm)
Locations: Hepatology (publishedVersion)
PubMed (publishedVersion)
BORIS (University Library Bern) (submittedVersion)
Topics: Health Sciences › Medicine › Hepatology › Liver Disease Diagnosis and Treatment
Health Sciences › Medicine › Hepatology › Liver physiology and pathology
Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
Keywords: nonalcoholic steatohepatitis, liver fibrosis, disease progression, liver cirrhosis, hepatic venous pressure gradient, alpha-smooth muscle actin, enhanced liver fibrosis test, NAFLD activity score, compensated cirrhosis, bridging fibrosis
MeSH terms: Actins, Female, Hepatic Veins, Humans, Liver Cirrhosis, Male, Middle Aged, Prognosis, Venous Pressure, Randomized Controlled Trials as Topic, Disease Progression, Antibodies, Monoclonal, Humanized, Non-alcoholic Fatty Liver Disease

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

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