Validation and refinement of the Baveno VII criteria for risk stratification in compensated advanced chronic liver disease after HCV-cure

Background  Baveno-VII has established criteria for excluding clinically significant portal hypertension (CSPH) after HCV-cure in compensated advanced chronic liver disease (cACLD, post-treatment liver stiffness measurement (LSM) <12kPa & platelet count (PLT) >150G/L). In contrast, post-treatment LSM values ≥25kPa indicate CSPH and a substantial risk of hepatic decompensation, despite HCV-cure. However, the long-term prognostic value of these criteria has yet to be independently validated and determinants of decompensation in the gray zone have yet to be identified.

Methods  We analyzed cACLD patients with paired LSM & PLT before and after HCV-cure by interferon-free therapies from 7 European regions. Fine & Gray competing risk regression models adjusted for clustered data were used to study risk of hepatic decompensation across risk strata. Factors associated with hepatic decompensation in the gray zone were studied using backward elimination.

Results  2347 cACLD patients (mean age 60±12years, 60% male, 21% diabetes) were followed for a median of 6.0years during which 65 patients (2.8%) developed hepatic decompensation. In the subgroup of patients who have not been analyzed previously(n=1527), Baveno-VII-criteria for excluding CSPH identified patients at a negligible risk of decompensation (at 6 years: 0.5%), while those for ruling-in CSPH identified a high-risk population (at 6 years: 11.4%). In the overall study population, decompensation in gray zone patients was uncommon (2.0%, incidence rate 0.4/100 patient years) and was associated with diabetes (adjusted subdistribution hazard ratio (SHR): 2.61 (95%CI:1.70-4.00),p<0.001) and post-treatment γ-GT (SHR: 1.38 (95%CI:1.11-1.73),p=0.003) independently of LSM, PLT, and albumin. Diabetes or elevated γ-GT identified a subset of gray zone patients (39%) at higher risk (at 6 years: 3.6%).

Conclusions  Baveno-VII-criteria for excluding/ruling-in CSPH in HCV-cured patients accurately stratify decompensation risk. The increased risk of hepatic decompensation in gray zone patients with diabetes and/or elevated γ-GT highlights the importance of managing cofactors.

Publikationsverlauf

Artikel online veröffentlicht:
24. Mai 2023