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TNF-α Inhibitors and HBV Reactivation Risk in HBsAg-/Anti-HBc+ Patients: A Systematic Review and Meta-Analysis.

Meng Hsuan Kuo1, Ping-Hung Ko2,3, Chen-Chou Lee1

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PubMed
Summary

Tumour necrosis factor-α (TNF-α) inhibitor potency does not significantly change hepatitis B virus reactivation (HBVr) risk in HBsAg-/anti-HBc+ patients. Surveillance is crucial, especially for those negative for anti-HBs antibodies.

Keywords:
HBV reactivationHBsAg−/anti‐HBc+TNF‐α inhibitorpotency of TNF inhibitor

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Area of Science:

  • Immunology and Infectious Diseases
  • Hepatology
  • Rheumatology

Background:

  • Tumour necrosis factor-α (TNF-α) inhibitors are vital for immune-mediated inflammatory diseases.
  • These therapies may trigger hepatitis B virus reactivation (HBVr) in HBsAg-/anti-HBc+ individuals.
  • Current guidelines suggest higher risk with potent agents, but evidence is limited.

Purpose of the Study:

  • To systematically review and meta-analyze HBVr risk associated with TNF-α inhibitor potency.
  • To identify predictors of HBVr in HBsAg-/anti-HBc+ patients.
  • To evaluate the impact of TNF-α inhibitor potency on HBVr risk.

Main Methods:

  • Systematic review and meta-analysis of cohort studies and randomized trials.
  • Searched PubMed, Embase, and Cochrane Central Register up to May 29, 2025.
  • Assessed risk of bias using Newcastle-Ottawa Scale and RoB 2.0; pooled data using random-effects meta-analysis.

Main Results:

  • Pooled HBVr incidence was 2.3% (95% CI 1.1%-4.8%) across 13 cohorts (1492 patients).
  • High-potency (3.9%) and low-potency (3.6%) TNF-α inhibitors showed comparable HBVr risk (RR 0.92; 95% CI 0.47-1.79).
  • Anti-HBs seronegativity significantly increased HBVr risk (8.2% vs. 3.1%; RR 2.77; 95% CI 1.42-5.39).

Conclusions:

  • TNF-α inhibitor potency does not significantly alter the low HBVr risk in HBsAg-/anti-HBc+ patients.
  • Continued patient surveillance is recommended.
  • Particular attention should be given to anti-HBs-negative individuals due to elevated risk.