Hepatitis B Surface Antigen Loss in Antiviral-treated Patients with HBeAg(+) Chronic Hepatits B (CHB) Infection: Observations from Antiviral-naive Patients Treated with Entecavir (ETV) or lamivudine (LVD)

Abstract

Background: Hepatitis B surface antigen (HBsAg) loss and HBsAg seroconversion are considered an important goal of HBV therapy but are seldom achieved with current treatments. We describe baseline characteristics and Wk 24 treatment responses of patients who demonstrated confirmed HBsAg loss by Wk 120 (on-treatment or during the 24-week follow-up period). Methods: A total of 709 nucleosidenaı ¨ve, HBeAg( ) patients received ETV 0.5 mg (n 354) or LVD 100 mg (n 355) once daily for a minimum of 52 Wks and maximum of 96 Wks in the randomized, double-blind ETV-022 trial. Entry criteria included: biopsy-confirmed liver disease, serum HBV DNA by bDNA levels 3 MEq/mL, ALT levels 1.3-10 x ULN and no prior nucleoside therapy 12 Wks. Serum HBV DNA, HBV serology (HBeAg/anti-HBe) and ALT were measured on treatment and through 24 weeks off-treatment . Results: HBsAg loss was confirmed in 28/709 (4%) patients (18 for ETV and 10 for LVD) by Wk 120. Baseline characteristics and Wk 24 treatment responses for patients with confirmed HBsAg loss by Wk 120 are presented below. Conclusions: Patients with confirmed HBsAg loss by Wk 120 were characterized by genotype A or D, male sex and Caucasian race at baseline and by HBeAg loss and HBeAg seroconversion at Wk 24.