Comparison of HBV Reactivation Between Patients With High HBV-DNA and Low HBV-DNA Loads Undergoing ICI and Concurrent Antiviral Prophylaxis: a Prospective Observational Study

Sun Yat-sen University

Status

Enrolling

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Antiviral Prophylaxis

Drug: ICI

Study type

Observational

Funder types

Other

Identifiers

NCT04680598

SH003

Details and patient eligibility

About

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.

Enrollment

800 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 ICI 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.