Risk of hepatitis B reactivation with use of TKIs, warns Health Canada

A recent review of data from clinical trials and post-marketing experience has shown that hepatitis B virus (HBV) reactivation can occur in chronic HBV carriers, after they received BCR-ABL tyrosine kinase inhibitors (TKIs), according medicines regulator Health Canada. Some of these cases included acute hepatic failure or fulminant hepatitis leading to liver transplantation or death.

These case reports indicate that HBV reactivation may occur at any time during BCR-ABL TKI treatment. Some of these patients had a documented history of hepatitis B. An increase in viral load or positive serology after initiating treatment with a BCR-ABL TKI occurred with HBV reactivation. For other cases, the serologic status at baseline was not known. HBV reactivation is considered to be a class-effect of BCR-ABL TKIs, although the mechanism and the frequency of HBV reactivation during exposure is not known at this time.

Cases of reactivation of HBV have occurred in patients who are chronic carriers of HBV after they received BCR-ABL TKIs. Some cases of HBV reactivation resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome.