High rates of transition to immune active disease in a cohort of strictly defined immune tolerant patients with chronic hepatitis B: results from the RADICAL consortium.

Over 50% of strictly defined immune tolerant chronic hepatitis B patients transition to immune active disease within five years, especially those with high-normal ALT levels.

• Why it matters: Understanding the progression risk in immune tolerant patients is crucial because current guidelines question the need for treatment during this phase, yet many patients may develop active disease, fibrosis, or HCC.
• What they did: The study analyzed 951 mono-infected CHB patients from multiple centers over a median of 13 years, defining the immune tolerant phase with strict criteria and assessing transition risks to immune active disease, fibrosis, and HCC.
• The result: Most patients transitioned to immune active disease within five years, with high-normal ALT levels significantly increasing this risk, indicating a need for closer monitoring or early intervention.