Immune checkpoint inhibitor (ICI), including programmed cell death protein-1 (PD-1) inhibitor or programmed cell death-Ligand 1 (PD-L1) inhibitor , is recommended to treat advanced hepatocellular carcinoma (HCC). However, the safety of ICI 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 ICI.
Study Type
OBSERVATIONAL
Enrollment
800
Patients received ICI, including PD-1 inhibitor (pembrolizumab, toripalimab, nivolumab, sintilimab, camrelizumab) or PD-L1 inhibitor (atezolizumab)
Patient received concurrent antiviral prophylaxis, such as tenofovir, entecavir
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGGuangzhou Twelfth People 's Hospital
Guangzhou, Guangdong, China
RECRUITINGKaiping Central Hospital
Kaiping, Guangdong, China
RECRUITINGZhongShan People 's Hospital
Zhongshan, China
RECRUITINGHBV Reactivation rate
HBV Reactivation rate was defined as one of the following according to the American Association for the Study of Liver Diseases (AASLD) 2018 hepatitis B guidelines: (i) a ≥2 log (100-fold) increase in HBV DNA compared to the baseline level, (ii) HBV DNA ≥3 log (1,000) IU/mL in a patient with previously undetectable level (since HBV DNA levels fluctuate)
Time frame: 2 months
HBV-associated hepatitis
HBV-associated hepatitis was defined as HBV Reactivation plus an ALT increase to ≥3 times the baseline level and \>100 U/L according to the AASLD 2018 Hepatitis B Guidance
Time frame: 2 months
PD-1 inhibitor disruption due to hepatitis
PD-1 inhibitor disruption due to hepatitis was defined as either premature termination or a delay of at least 7 days between PD-1 inhibitor cycles because of hepatitis.
Time frame: 2 months
overall survival
Time frame: 12 months
adverse event
Time frame: 30 Days after ICI
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