Benefit-risk considerations of immunotherapy in chronic hepatitis B
摘要
Efforts are underway to develop treatments for chronic hepatitis B virus (HBV) infection that achieve a functional cure after a finite course of therapy. Immune checkpoint inhibitor (ICI) treatments targeting PD-1/PD-L1 have entered clinical development given their potential to restore HBV-specific T & B cell magnitude and function in chronic hepatitis B (CHB) patients. However, their risk–benefit profile in CHB is not fully understood. The HBV Forum of the Forum for Collaborative Research at the University of California, Berkeley established an ICI Working Group comprising experts in academia, clinical practice, pharmaceutical companies, patient representatives, and regulatory authorities, to analyze the occurrence of immune-related adverse events (irAEs) in cancer patients treated with ICIs as first-line therapy based on published literature as a proxy to help inform potential risks of ICIs in non-cancer CHB patients. Understanding that the patient populations affect the risk–benefit profile in clinical decisions, the working group also assessed potential benefits by reviewing publicly available data on clinical trials evaluating ICIs targeting PD-1/PD-L1 in CHB patients to understand overall utility and clinical value of ICIs. This Perspective outlines lessons learned from reviewing these risk–benefit data and provides considerations for the use of other immunotherapy drug classes in CHB treatment paradigms.