Clinical Research Directory

Residual Histological Disease Across Treatment Pathways in Chronic Hepatitis B

Sponsor: Istanbul Medeniyet University

Summary

This retrospective, two-center observational study evaluates contemporary non-biopsy treatment pathways in treatment-naïve adults with chronic hepatitis B who underwent liver biopsy in routine clinical practice. The study retrospectively reconstructs the evaluable components of the WHO 2024, EASL 2025, APASL 2026, and Turkish Social Security Institution Health Implementation Communiqué (SUT) treatment pathways. The main objectives are to determine the proportion of patients classified as pathway-positive and to assess the frequency of clinically relevant histological disease among patients classified as pathway-negative. Histological disease is primarily defined as a histological activity index of at least 6 and/or Ishak fibrosis stage of at least 2. Analyses are performed overall and by study center, with additional sensitivity analyses using alternative histological definitions, a common biopsy period, and alternative alanine aminotransferase thresholds.

Official title: Residual Histological Disease After Classification by Contemporary Non-Biopsy Treatment Pathways in Treatment-Naïve Chronic Hepatitis B: A Two-Center Retrospective Cohort Study

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