Combining Hepatitis B Virus RNA and Hepatitis B Core–Related Antigen: Guidance for Safely Stopping Nucleos(t)ide Analogues in Hepatitis B e Antigen–Positive Patients With Chronic Hepatitis B

Abstract Background Safe nucleos(t)ide analogue discontinuation in chronic hepatitis B (CHB) is an unmet need. We aimed to investigate whether combining hepatitis B virus (HBV) RNA and hepatitis B core–related antigen (HBcrAg) could perform satisfactorily in predicting off-treatment outcomes. Methods The evaluation cohort included 127 hepatitis B e antigen (HBeAg)–positive patients from a multicenter prospective trial who stopped telbivudine-based therapy after achieving HBeAg seroconversion and HBV DNA 48 weeks. As validation, 59 patients treated with entecavir or tenofovir before discontinuation were analyzed. Results At the end of treatment (EOT), HBV RNA and HBcrAg were significant independent predictors of the clinical relapse risk. In the evaluation cohort, no clinical relapse occurred among patients with negative HBV RNA and HBcrAg