Comparison of Hepatitis B Virus Reactivation Between Patients With High HBV-DNA and Low HBV-DNA Loads Undergoing Immune Checkpoint Inhibitor and Concurrent Antiviral Prophylaxis: a Prospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 800
- Locations
- 4
- Primary Endpoint
- HBV Reactivation rate
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
high HBV-DNA group
patients with HBV-DNA >500 IU/ml
Intervention: ICI (Drug)
high HBV-DNA group
patients with HBV-DNA >500 IU/ml
Intervention: Antiviral Prophylaxis (Drug)
low HBV-DNA group
patients with HBV-DNA≤500 IU/ml
Intervention: ICI (Drug)
low HBV-DNA group
patients with HBV-DNA≤500 IU/ml
Intervention: Antiviral Prophylaxis (Drug)
Outcomes
Primary Outcomes
HBV Reactivation rate
Time Frame: 2 months
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)
Secondary Outcomes
- HBV-associated hepatitis(2 months)
- PD-1 inhibitor disruption due to hepatitis(2 months)
- overall survival(12 months)
- adverse event(30 Days after ICI)
Investigators
Shi Ming
Proffessor
Sun Yat-sen University