Meta-analysis finds immunotherapy efficacy in HCC varies by aetiology, strongest in HBV-related disease
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Key Takeaway
Consider HCC aetiology as a stratification factor for immunotherapy response, with strongest benefit observed in HBV-related disease.
This systematic review and meta-analysis examined 26 studies to compare the efficacy of immune checkpoint inhibitor (ICI)-based therapies versus non-ICI controls in hepatocellular carcinoma (HCC), stratified by aetiology (viral vs nonviral). The population included patients with HCC, with data sourced from multiple databases up to June 2025. The primary outcomes were overall survival (OS) and progression-free survival (PFS).
In indirect comparisons of ICI versus non-ICI controls, OS hazard ratios (HRs) were 0.67 for HBV-HCC, 0.84 for HCV-HCC, and 0.88 for nonviral HCC, indicating the survival benefit was most significant in HBV-related disease. For PFS, HRs were 0.58 for HBV-HCC, 0.75 for HCV-HCC, and 0.71 for nonviral HCC. In direct comparisons among patients receiving ICIs, viral HCC was associated with significantly superior PFS over nonviral HCC (HR 0.84), with a trend toward improved OS (HR 0.91).
Safety and tolerability data were not reported in the provided evidence. Key limitations include observed heterogeneity, partly attributable to geographic region and treatment-line variations. Funding and conflict of interest information was not reported.
The authors conclude that aetiology is a key determinant of treatment response and should be integrated as a stratification factor in clinical practice and trial design. These findings are based on aggregated observational and trial data; the trend toward improved OS in viral HCC requires cautious interpretation. Clinical application should consider this evidence alongside individual patient factors and treatment guidelines.
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View Original Abstract ↓
AIMS: The tumour immune microenvironment (TIME) of hepatocellular carcinoma (HCC) is distinctive across different aetiologies, potentially leading divergent responses to immune checkpoint inhibitors (ICIs). This study compared the efficacy of ICI-based therapies between viral and nonviral HCC.
MATERIALS AND METHODS: This review was implemented as per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, searching multiple databases for studies published up to June 2025. Studies reporting overall survival (OS) or progression-free survival (PFS) stratified by HCC aetiology (viral vs nonviral) were included. Pooled hazard ratios (HRs) were computed using random-effects models.
RESULTS: Analysis of 26 studies revealed a hierarchy in survival benefit. In the indirect comparison (ICI vs non-ICI controls), the survival benefit was most significant in hepatitis B virus-HCC (HBV-HCC) (OS HR: 0.67; PFS HR: 0.58), intermediate in hepatitis C virus-HCC (HCV-HCC) (OS HR: 0.84; PFS HR: 0.75), and most attenuated in nonviral HCC (OS HR: 0.88; PFS HR: 0.71). In the direct comparison among patients receiving ICIs, viral HCC was associated with significantly superior PFS (HR: 0.84) and a trend toward improved OS (HR: 0.91) over nonviral HCC. Heterogeneity was observed, partly due to geographic region and treatment-line variations.
CONCLUSION: Immunotherapy efficacy in HCC demonstrates a clear aetiology-based hierarchy, with the strongest benefit in HBV-HCC, intermediate in HCV-HCC, and most modest in nonviral HCC. Aetiology is a key determinant of treatment response and should be integrated as a stratification factor in clinical practice and trial design.
TRIAL NUMBER REGISTRATION: CRD42025638434.
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