Magic™ Anti-HBV Surface Antigen Monoclonal antibody, Clone N2303097

Background/Aims: Hepatitis B reactivation (HBVR) is an important risk of treatment with tumor necrosis factor inhibitors (anti-TNF). While antiviral prophylaxis is recommended before treatment in hepatitis B surface antigen (HBsAg) positive patients, there is no clear approach for the follow-up or prophylactic treatment of patients with past hepatitis B virus (HBV) infection. This study aimed to evaluate patients with past HBV infection treated with anti-TNF for HBVR and/or HBVR-associated biochemical breakthrough. Materials and Methods: Patients who received anti-TNF therapy and had past HBV infection (HBsAg negative, anti-HBc IgG positive, anti-HBs negative or positive) were screened and evaluated at 3-month intervals for viral and biochemical breakthrough according to a liver function test (ALT) and HBV DNA level. Results: A total of 653 patients who received anti-TNF therapy were screened. Ninety of these patients had past HBV infection and had not received antiviral prophylaxis. Anti-HBs positivity and isolated anti-HBc IgG positivity were seen in 87.7% (n: 79) and 12.2% (n: 11) of these patients, respectively. No HBVR was seen in 20% (n: 18) of patients who were followed up regularly, and no HBVR-associated biochemical breakthrough was found in patients who were not followed up regularly in terms of HBV DNA level (80%, n: 72) during the follow-up period (26 +/- 16 months). Conclusion: The use of anti-TNF in patients with past HBV infection has a low risk for HBVR. A follow-up for the ALT and HBV DNA levels at 3-month intervals may be more reasonable than administering antiviral prophylaxis to all patients.

BACKGROUND The presence of significant liver fibrosis in hepatitis B virus (HBV)-infected individuals with persistently normal serum alanine aminotransferase (PNALT) levels is a strong indicator for initiating antiviral therapy. Serum ceruloplasmin (CP) is negatively correlated with liver fibrosis in HBV-infected individuals. AIM To examine the potential value of serum CP and develop a noninvasive index including CP to assess significant fibrosis among HBV-infected individuals with PNALT. METHODS Two hundred and seventy-five HBV-infected individuals with PNALT were retrospectively evaluated. The association between CP and fibrotic stages was statistically analyzed. A predictive index including CP [Ceruloplasmin hepatitis B virus (CPHBV)] was constructed to predict significant fibrosis and compared to previously reported models. RESULTS Serum CP had an inverse correlation with liver fibrosis (r= -0.600). Using CP, the areas under the curves (AUCs) to predict significant fibrosis, advanced fibrosis, and cirrhosis were 0.774, 0.812, and 0.853, respectively. The CPHBV model was developed using CP, platelets (PLT), and HBsAg levels to predict significant fibrosis. The AUCs of this model to predict significant fibrosis, advanced fibrosis, and cirrhosis were 0.842, 0.920, and 0.904, respectively. CPHBV was superior to previous models like the aspartate aminotransferase (AST)-to-PLT ratio index, Fibrosis-4 score, gamma-glutamyl transpeptidase-to-PLT ratio, Forn's score, and S-index in predicting significant fibrosis in HBV-infected individuals with PNALT. CONCLUSION CPHBV could accurately predict liver fibrosis in HBV-infected individuals with PNALT. Therefore, CPHBV can be a valuable tool for antiviral treatment decisions.