Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy.

Novel HBV Biomarkers to Assess the Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy: an Observational Prospective Multicenter Study.

The goal of this observational study is to evalue the cumulative proportion of patients with OBI who do not develop HBsAg seroreversion and/or an increase of serum HBV DNA by at least 1 log above the lower limit of detection of the assay in a patient who had previously undetectable HBsAg and HBV DNA in serum during the study.

Inclusion Criteria:

• Life-expectancy (as estimated by treating physician) ≥ 6 months;
• Patients HBsAg negative
• Patients HBcAb positive with or without HBV-DNA detectable
• Patients with cancer undergoing immunotherapy with or without chemotherapy

Exclusion Criteria:

• Patients who did not give informed consent
• Patients under prophylaxis for HBV
• Patients vaccinated for hepatitis B
• Patients with HBsAg positivity
• Patients with HIV positivity
• Patients with current history of alcohol (more than 5 alcohol unit daily) and drug use
• Patients with other cause of liver disease with known etiology (autoimmune liver disorder and storage liver disease)
• Patients with current active Hepatitis C virus (HCV-positive)
• Patients with hepatocellular carcinoma (HCC)