HBV DNA AND HBSAG LEVELS AT 24 WEEKS OFF-TREATMENT PREDICT CLINICAL RELAPSE AND HBSAG LOSS IN HBEAG NEGATIVE PATIENTS WHO DISCONTINUED ANTIVIRAL THERAPY

Abstract

<p>Background & aims. Patients who discontinue nucleo(s)tide analogue (NUC) therapy are at risk of viral rebound and severe hepatitis flares, necessitating intensive off-treatment followup. Methods. We studied the association between HBsAg and HBV DNA levels at off-treatment FU W24 with subsequent clinical relapse and HBsAg loss was in a multicentre cohort of HBeAg negative chronic hepatitis B patients who discontinued NUC therapy. Results. We studied 475 patients, 82% Asian and 55% treated with entecavir. Patients with higher HBV DNA levels at FU W24 had a higher risk of clinical relapse (hazard ratio [HR] 1.576, p100 IU/mL and HBV DNA >100 IU/mL (p<0.001). Conclusions. Among HBeAg negative CHB patients who discontinued antiviral therapy and who did not experience clinical relapse before FU W24, serum levels of HBV DNA and HBsAg at FU W24 can be used to predict subsequent clinical relapse and HBsAg clearance. A combination of HBsAg <100 IU/mL with HBV DNA <100 IU/mL identifies patients with a low risk of relapse and excellent chances of HBsAg loss, and could potentially be used as an early surrogate endpoint for studies aiming at finite therapy in HBV. <br></p>