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Introduction It is well known that patients with chronic hepatitis B (CHB) receiving cytotoxic chemotherapy may reactivate hepatitis B virus (HBV)
.
However, the risk of immune checkpoint inhibitors (ICI) causing HBV reactivation is not yet fully understood
.
Recently, Clin Gastroenterol Hepatol (impact factor 8.
549) released a historical cohort study to assess the risk of HBV reactivation and liver adverse events in cancer patients receiving ICI treatment
.
The results showed that during ICI treatment, patients receiving preventive antiviral therapy rarely experienced HBV reactivation
.
However, hepatitis B surface antigen (HBsAg)-positive patients who have not received preventive antiviral treatment or have poor compliance with treatment may experience HBV reactivation
.
Research method This study uses a large database containing various cancer types [hepatocellular carcinoma (HCC) and non-HCC] and virological serology (HBsAg-positive and HBsAg-negative patients), included in the period from January 2015 to September 2020 Cancer patients receiving ICI treatment, if the patient is diagnosed with viral hepatitis other than HBV (such as hepatitis C virus infection), it will be excluded
.
In the end, a total of 3465 eligible patients were included
.
The primary endpoint is the occurrence of HBV reactivation, which is defined as: (1) HBsAg-positive patients, ①HBV DNA increased by 2 log (100 times) from the baseline level; ② HBV DNA previously undetectable ≥ 3 log (1000) IU/mL or ③If baseline data is not available, HBV DNA≥4 log(10000)IU/mL; (2) HBsAg negative and hepatitis B core antibody (anti-HBc) positive patients, ① HBV DNA can be detected or ② HBsAg serum reversal
.
The secondary endpoint is the occurrence of liver adverse events during ICI treatment.
According to the definition of adverse event evaluation standard version 5.
0: (1) Grade 3 hepatitis is defined as if the baseline value is normal and the alanine aminotransferase (ALT) rises >5× Upper limit of normal (ULN) -20×ULN; if the baseline value is abnormal, ALT>5-20×baseline value
.
(2) Grade 4 hepatitis is defined as elevated ALT>20×ULN (if the baseline value is normal); ALT>20×baseline value (if the baseline value is abnormal)
.
The results of the study showed that the average age of the patients was 62.
2 years, of which 68.
8% were men
.
Among 3465 eligible patients, 511 (14.
7%) were HBsAg positive
.
1.
The incidence of HBV reactivation The incidence of HBV reactivation in all patients, HBsAg-positive patients and HBsAg-negative patients were 0.
14% (5/3465), 1.
0% (5/511) and 0.
0% (0/2954), respectively
.
Among HBsAg-positive patients, the HBV reactivation rates of HCC and non-HCC patients were 0.
5% (2/409) and 2.
9% (3/102), respectively
.
The reactivation rates of HBV in patients who received and did not receive preventive antiviral therapy were 0.
4% (2/464) and 6.
4% (3/47), respectively
.
2.
The occurrence of adverse liver events 23 cases of HBsAg-positive patients (4.
5%) and 218 cases of HBsAg-negative patients (7.
4%) developed grade 3-4 hepatitis
.
Among them, the causes of grade 3-4 hepatitis in HBsAg-positive patients include intrahepatic disease progression, immune-related hepatitis, HBV reactivation, cholangitis caused by HCC rupture, and hypovolemic shock
.
There were no deaths related to HBV
.
The incidence of liver adverse events in HCC patients is higher than that in non-HCC patients
.
In addition, after HBsAg-positive patients received ICI treatment, only 2 cases (0.
4%) had HBsAg serum clearance
.
Conclusion In HBsAg-positive patients, preventive antiviral therapy can effectively prevent HBV reactivation during ICI treatment
.
However, HBsAg-positive patients who have not received preventive antiviral treatment or have poor compliance with treatment may experience HBV reactivation
.
Therefore, as long as appropriate HBV serological screening and preventive antiviral treatment are performed before ICI treatment, ICI can be safely used for cancer patients
.
Literature index: Yoo S, Lee D, Shim JH, et al.
Risk of Hepatitis B Virus Reactivation in Patients Treated With Immunotherapy for Anti-cancer Treatment[J].
Clin Gastroenterol Hepatol.
2021 Jun 26:S1542-3565(21)00683 -2.
.
However, the risk of immune checkpoint inhibitors (ICI) causing HBV reactivation is not yet fully understood
.
Recently, Clin Gastroenterol Hepatol (impact factor 8.
549) released a historical cohort study to assess the risk of HBV reactivation and liver adverse events in cancer patients receiving ICI treatment
.
The results showed that during ICI treatment, patients receiving preventive antiviral therapy rarely experienced HBV reactivation
.
However, hepatitis B surface antigen (HBsAg)-positive patients who have not received preventive antiviral treatment or have poor compliance with treatment may experience HBV reactivation
.
Research method This study uses a large database containing various cancer types [hepatocellular carcinoma (HCC) and non-HCC] and virological serology (HBsAg-positive and HBsAg-negative patients), included in the period from January 2015 to September 2020 Cancer patients receiving ICI treatment, if the patient is diagnosed with viral hepatitis other than HBV (such as hepatitis C virus infection), it will be excluded
.
In the end, a total of 3465 eligible patients were included
.
The primary endpoint is the occurrence of HBV reactivation, which is defined as: (1) HBsAg-positive patients, ①HBV DNA increased by 2 log (100 times) from the baseline level; ② HBV DNA previously undetectable ≥ 3 log (1000) IU/mL or ③If baseline data is not available, HBV DNA≥4 log(10000)IU/mL; (2) HBsAg negative and hepatitis B core antibody (anti-HBc) positive patients, ① HBV DNA can be detected or ② HBsAg serum reversal
.
The secondary endpoint is the occurrence of liver adverse events during ICI treatment.
According to the definition of adverse event evaluation standard version 5.
0: (1) Grade 3 hepatitis is defined as if the baseline value is normal and the alanine aminotransferase (ALT) rises >5× Upper limit of normal (ULN) -20×ULN; if the baseline value is abnormal, ALT>5-20×baseline value
.
(2) Grade 4 hepatitis is defined as elevated ALT>20×ULN (if the baseline value is normal); ALT>20×baseline value (if the baseline value is abnormal)
.
The results of the study showed that the average age of the patients was 62.
2 years, of which 68.
8% were men
.
Among 3465 eligible patients, 511 (14.
7%) were HBsAg positive
.
1.
The incidence of HBV reactivation The incidence of HBV reactivation in all patients, HBsAg-positive patients and HBsAg-negative patients were 0.
14% (5/3465), 1.
0% (5/511) and 0.
0% (0/2954), respectively
.
Among HBsAg-positive patients, the HBV reactivation rates of HCC and non-HCC patients were 0.
5% (2/409) and 2.
9% (3/102), respectively
.
The reactivation rates of HBV in patients who received and did not receive preventive antiviral therapy were 0.
4% (2/464) and 6.
4% (3/47), respectively
.
2.
The occurrence of adverse liver events 23 cases of HBsAg-positive patients (4.
5%) and 218 cases of HBsAg-negative patients (7.
4%) developed grade 3-4 hepatitis
.
Among them, the causes of grade 3-4 hepatitis in HBsAg-positive patients include intrahepatic disease progression, immune-related hepatitis, HBV reactivation, cholangitis caused by HCC rupture, and hypovolemic shock
.
There were no deaths related to HBV
.
The incidence of liver adverse events in HCC patients is higher than that in non-HCC patients
.
In addition, after HBsAg-positive patients received ICI treatment, only 2 cases (0.
4%) had HBsAg serum clearance
.
Conclusion In HBsAg-positive patients, preventive antiviral therapy can effectively prevent HBV reactivation during ICI treatment
.
However, HBsAg-positive patients who have not received preventive antiviral treatment or have poor compliance with treatment may experience HBV reactivation
.
Therefore, as long as appropriate HBV serological screening and preventive antiviral treatment are performed before ICI treatment, ICI can be safely used for cancer patients
.
Literature index: Yoo S, Lee D, Shim JH, et al.
Risk of Hepatitis B Virus Reactivation in Patients Treated With Immunotherapy for Anti-cancer Treatment[J].
Clin Gastroenterol Hepatol.
2021 Jun 26:S1542-3565(21)00683 -2.