Hepatitis B Virus Reactivation Associated with New Classes of Immunosuppressants and Immunomodulators: A Systematic Review, Meta-analysis, and Expert Opinion
Abstract
BACKGROUND
Hepatitis B reactivation (HBVr) can be prevented by nucleos(t)ide analogues (NA). We conducted a systematic review and meta-analysis on the risk of HBVr associated with new classes of immunosuppressive and immunomodulatory therapies and developed a guidance for NA prophylaxis.
METHODS
A Medline and EMBASE database search was conducted on studies pertaining to 19 classes of immunosuppressive or immunomodulatory therapies published between 2010-2021. The outcomes of interest were incidence of HBVr with or without biochemical exacerbation. Pooled rates were calculated by generalized linear mixed models if there were ≥3 studies with available data. An expert panel reviewed the data and categorized the risk of HBVr associated with each class of drugs into low (10%).
RESULTS
1752 studies resulted from our search, of which 59 including 3424 HBsAg+ and 5799 HBsAg-/anti-HBc+ patients met eligibility criteria. Immune check point inhibitors, tyrosine kinase inhibitors, cytokine inhibitors, chimeric antigen receptor (CAR) T-cell immunotherapies, and corticosteroids were categorized as high HBVr risk in HBsAg+ patients; cytokine inhibitors, CAR T-cell immunotherapies, and corticosteroids as intermediate risk in HBsAg-/anti-HBc+ patients; and anti-TNF agents and immune check point inhibitors as low risk in HBsAg-/anti-HBc+ patients; based on medium-high quality evidence. Provisional recommendation was provided for drugs with low quality evidence. NA prophylaxis is recommended…
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Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid.
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