Comparison of HBV reactivation between patients with high HBV-DNA and low HBV-DNA loads undergoing PD-1 inhibitor and concurrent antiviral prophylaxis.

Abstract

BACKGROUND:

Programmed cell death protein-1 (PD-1) inhibitor is recommended to treat advanced hepatocellular carcinoma (HCC). However, the safety of PD-1 inhibitor in patients with high HBV-DNA load is unknown because of the potential risk of hepatitis B virus (HBV) reactivation. This study was to compare the HBV reactivation between patients with low HBV-DNA loads and high HBV-DNA loads undergoing antiviral prophylaxis and PD-1 inhibitor.

METHODS:

This was a retrospective study including consecutive hepatitis B surface antigen-positive HCC patients who received PD-1 inhibitor and concurrent antiviral prophylaxis for prevention of clinical hepatitis. Patients were divided into low HBV-DNA group (low group, ≤ 500 IU/ml) and high HBV-DNA group (high group, > 500 IU/ml) according to the baseline HBV-DNA level. The incidences of HBV reactivation, HBV-associated hepatitis, and PD-1 inhibitor disruption were compared between the two groups.

RESULTS:

Two hundred two eligible patients were included: 94 in the low group and 108 in the high group. Seven patients (5 in the low group and 2 in the high group) developed HBV reactivation, and all recovered from HBV reactivation and HBV-associated hepatitis. The incidence of HBV reactivation in the two groups was low (5.3% vs 1.9%, P = 0.34). There was also no difference in the incidence of HBV-associated hepatitis (P = 0.56), or PD-1 inhibitor disruption (P = 0.82). The multivariable analysis showed PD-1 inhibitor with hepatic arterial infusion chemotherapy was the only significant risk factor for HBV reactivation (P = 0.04) and hepatitis (P = 0.002).

CONCLUSION:

With concurrent antiviral prophylaxis, HBV-DNA load higher than 500 IU/ml should not be a contraindication for PD-1 inhibitor.

• Authors: Min-Ke He, Chuan Peng, Yang Zhao, Run-Bin Liang, Zhi-Cheng Lai, Anna Kan, Qi-Jiong Li, Wei Wei, Yao-Jun Zhang, Min-Shan Chen, Rong-Ping Guo, Ming Shi
• Journal: Cancer immunology, immunotherapy : CII (Cancer Immunol Immunother) Vol. 70 Issue 11 Pg. 3207-3216 (Nov 2021) ISSN: 1432-0851 [Electronic] Germany
• PMID: 33813646 (Publication Type: Comparative Study, Journal Article)
• Copyright: © 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Chemical References

• Antiviral Agents
• DNA, Viral
• Immune Checkpoint Inhibitors

Topics

• Adult
• Aged
• Antiviral Agents (therapeutic use)
• Carcinoma, Hepatocellular (drug therapy, virology)
• DNA, Viral (blood)
• Female
• Hepatitis B (epidemiology, prevention & control)
• Hepatitis B virus (drug effects, physiology)
• Humans
• Immune Checkpoint Inhibitors (adverse effects)
• Incidence
• Liver Neoplasms (drug therapy, virology)
• Male
• Middle Aged
• Retrospective Studies
• Viral Load
• Virus Activation (drug effects)