Author information

¹Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria; Vienna Hepatic Hemodynamic Lab, Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.

²Liver Unit, Hospital General Universitario Gregorio Marañón, Madrid, Spain; Instituto De Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain; Universidad Complutense de Madrid, Madrid, Spain; Centro de Investigación Biomédica En Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.

³Liver Unit, Vall d'Hebron University Hospital, Vall d'Hebron Institut of Research (VHIR), Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain.

⁴Centro de Investigación Biomédica En Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain; Liver Unit, Hospital Clínic, IDIBAPS, Universitat de Barcelona, Barcelona, Spain.

⁵Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Italy; IRCCS Azienda Ospedaliero-Universitaria di Bologna, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Bologna, Italy.

⁶Hannover Medical School, Department of Gastroenterology, Hepatology, Infectious diseases and Endocrinology, Hannover, Germany.

⁷Gastroenterology and Multivisceral Transplant Unit, Department of Surgery, Oncology, and Gastroenterology, Padua University Hospital, Padua, Italy.

⁸Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria; Department of Internal Medicine IV, Klinik Ottakring, Vienna, Austria.

⁹Department of Internal Medicine IV, Ordensklinikum Linz Barmherzige Schwestern, Linz, Austria.

¹⁰Liver Unit, Hospital Universitario 12 De Octubre, Madrid, Spain.

¹¹Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria; Vienna Hepatic Hemodynamic Lab, Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria; Department of Internal Medicine IV, Klinik Ottakring, Vienna, Austria.

¹²Gastroenterology Unit, Hospital Universitario Fundación Alcorcón, Madrid, Spain.

¹³Gastroenterology Unit, Hospital Universitario Fundación Jimenez Díaz, Madrid, Spain.

¹⁴Liver Unit, Hospital Universitario Ramón y Cajal, Madrid, Spain.

¹⁵Gastroenterology Unit, Hospital Universitario Clínico San Carlos, Madrid, Spain.

¹⁶Gastroenterology Unit, Hospital Universitario La Princesa, Madrid, Spain.

¹⁷Liver Unit, Hospital General Universitario Gregorio Marañón, Madrid, Spain.

¹⁸Department of Internal Medicine IV, Klinik Ottakring, Vienna, Austria.

¹⁹Centro de Investigación Biomédica En Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain; Liver Unit, Vall d'Hebron University Hospital, Vall d'Hebron Institut of Research (VHIR), Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain.

²⁰Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria; Vienna Hepatic Hemodynamic Lab, Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria. Electronic address: mattias.mandorfer@meduniwien.ac.at.

²¹Liver Unit, Hospital Clínic, IDIBAPS, Universitat de Barcelona, Barcelona, Spain.

²²Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.

Abstract

Background & aims: Baveno VII has defined a clinically significant (i.e., prognostically meaningful) liver stiffness measurement (LSM)-decrease in cACLD by ≥20% associated with a final LSM<20 kPa, or any decrease to <10 kPa. However, these rules have not yet been validated against direct clinical endpoints.

Methods: We retrospectively analysed cACLD patients (LSM≥10 kPa) with paired liver stiffness measurement (LSM) before (BL) and after (FU) HCV-cure by interferon-free therapies from 15 European centers. The cumulative incidence of hepatic decompensation was compared according to these criteria, considering hepatocellular carcinoma and non-liver-related death as competing risks.

Results: 2335 patients followed for a median of 6 years were analysed. Median BL-LSM was 16.6 kPa with 37.1% having ≥20 kPa. After HCV-cure, FU-LSM decreased to a median of 10.9 kPa (<10 kPa: 1002 [42.9%], ≥20 kPa: 465 [19.9%]) translating into a median LSM-change of -5.3 (-8.8-[-2.4])kPa corresponding to -33.9 (-48.0-[-15.9])%. Patients achieving a clinically significant decrease (65.4%) had a significantly lower risk of hepatic decompensation (subdistribution hazard ratio [SHR]: 0.12 [95%CI: 0.04-0.35], p<0.001). However, these risk differences were primarily driven by a negligible risk in patients with FU-LSM <10 kPa (5y-cumulative incidence: 0.3%) compared to a high risk in patients with FU-LSM ≥20 kPa (16.6%). Patients with FU-LSM 10-19.9 kPa (37.4%) also had a low risk of hepatic decompensation (5y-cumulative incidence: 1.7%), and importantly, the risk of hepatic decompensation did not differ between those with/without an LSM-decrease ≥20% (p=0.550).

Conclusions: FU-LSM is key for risk stratification after HCV-cure and should guide clinical decision-making. LSM dynamics do not hold significant prognostic information in patients with FU-LSM 10-19.9 kPa, and thus, their consideration is not of sufficient incremental value in the specific context of HCV-cure.