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Hepatitis B Virus Reactivation in Cancer Patients Treated With Immune Checkpoint Inhibitors

Ethan A Burns1, Ibrahim N Muhsen2, Kartik Anand3

  • 1Houston Methodist Cancer Center, Outpatient Center.

Journal of Immunotherapy (Hagerstown, Md. : 1997)
|January 22, 2021
PubMed

Insights

Immune checkpoint inhibitors like Pembrolizumab may increase the risk of hepatitis B reactivation (HBVr). This study found a significant association between Pembrolizumab and HBVr, highlighting the need for further research.

Area of Science:

  • Oncology
  • Immunology
  • Pharmacovigilance

Background:

  • Immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, and CTLA-4 are used in cancer therapy.
  • Adverse events, including immune-mediated toxicities, are associated with ICIs.
  • Hepatitis B reactivation (HBVr) has been reported with PD-1/PD-L1 inhibitors, potentially disrupting cancer treatment.

Purpose of the Study:

  • To investigate the association between specific immune checkpoint inhibitors and hepatitis B reactivation.
  • To analyze reported cases of HBVr in patients receiving PD-1/PD-L1 inhibitors using the FDA Adverse Events Reporting System (FAERS).

Main Methods:

  • Retrospective literature review and analysis of FAERS data from drug approval to June 30, 2020.
  • Inclusion of PD-1/PD-L1 inhibitors: Pembrolizumab, Atezolizumab, Nivolumab, Durvalumab, Avelumab.
  • Disproportionality signal analysis using Reporting Odds Ratio (ROR) with 95% Confidence Intervals (CI) and Fisher exact test.

Main Results:

  • Pembrolizumab showed a statistically significant signal for HBVr (ROR: 2.32, 95% CI: 1.11-4.28, P=0.013).
  • No significant HBVr signals were detected for Ipilimumab or Avelumab.
  • Other analyzed PD-1/PD-L1 inhibitors did not yield statistically significant findings for HBVr.

Conclusions:

  • Pembrolizumab is associated with a higher risk of hepatitis B reactivation compared to other analyzed ICIs.
  • The findings underscore the importance of monitoring for HBVr in patients receiving ICIs, particularly Pembrolizumab.
  • Further prospective studies are recommended to validate these pharmacovigilance findings and establish definitive risk assessments.

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