Meta-analysis of 50 studies shows indeterminate chronic hepatitis B affects 39% of patients with elevated HCC risk.

This systematic review and meta-analysis evaluated the prevalence, clinical presentation, and outcomes of patients with chronic hepatitis B (CHB) classified as being in an indeterminate phase according to AASLD 2018 or EASL 2017 guidelines. The analysis synthesized data from 50 included studies to characterize the burden and risks associated with this specific patient classification. The study design relied on observational data to report associations and incidence rates, rather than establishing causation.

Regarding prevalence, the pooled estimate for indeterminate patients under AASLD 2018 guidelines was 38.90% (95% CI: 33.51-44.57). Under EASL 2017 guidelines, the prevalence was 38.81% (95% CI: 31.22-46.99). These figures indicate that nearly 40% of CHB patients fall into this indeterminate category based on current guideline definitions.

The analysis further assessed the incidence of adverse outcomes. For patients meeting AASLD 2018 criteria, the incidence rate of hepatocellular carcinoma was 5.36 per 1000 person-years (95% CI: 1.38-9.35), and the incidence rate of liver-related events was 7.27 per 1000 person-years (95% CI: 0.00-22.21). Under EASL 2017 criteria, hepatocellular carcinoma incidence was 5.20 per 1000 person-years (95% CI: 1.41-8.99), while liver-related events occurred at a rate of 9.79 per 1000 person-years (95% CI: 0.00-25.35). Safety data, including adverse events and tolerability, were not reported in the source studies.

Key limitations include the reliance on observational data and the lack of specific intervention details or follow-up duration. The practice relevance is that indeterminate phase affects a substantial portion of CHB patients who are at risk for hepatocellular carcinoma and liver-related adverse outcomes. Further research is needed to inform treatment strategies specifically tailored for indeterminate CHB patients.