Comparison of HBV Reactivation Between Patients With High HBV-DNA and Low HBV-DNA Loads Undergoing PD-1 Inhibitor and Concurrent Antiviral Prophylaxis: a Prospective Observational Study
Comparison of HBV Reactivation Between Patients With High HBV-DNA and Low HBV-DNA Loads Undergoing PD-1 Inhibitor and Concurrent Antiviral Prophylaxis: a Prospective Observational Study
rogrammed 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 a 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.
Inclusion Criteria:

 -  The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European
 Association for the Study of the Liver (EASL)

 -  Seropositive for hepatitis B surface antigen (HBsAg)

 -  Received concurrent antiviral prophylaxis and at least one cycle of PD-1 inhibitor
 treatment. Prior use of antiviral therapy was allowed

 -  Adherence to antiviral therapy

 -  A life expectancy of 3 months or more

 -  An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2

 Exclusion Criteria:

 -  other positive viral markers, including IgM antibodies to hepatitis A virus, the
 hepatitis C virus viral load, IgG antibodies to hepatitis D virus, IgM antibodies to
 hepatitis E virus

 -  Antibodies to human immunodeficiency virus,

 -  A lack of HBV DNA and liver function testing before the first immunotherapy and during
 the follow-up period.