O112 : HBsAg clearance after addition of 48 weeks of pegifn in HBeAg negative CHB patients on nucleos(T)ide therapy with undetectable hbvdna for at least one year: final results from ANRS-HB06 pegan study: multicenter randomized controlled phase III trial

Abstract

Background and Aims: Uncontrolled studies suggest that addition of PEGIFN in CHB patients receiving NUCs with undetectable serum HBVDNA may increase HBsAg clearance. We conducted a multicenter randomized controlled study to evaluate this strategy. Methods: The key inclusion criteria were: HBeAg negative CHB and documented negative HBVDNA while on stable NUC regimens for at least 1 year. Patients with PEGIFN contra-indications were excluded. From January 2011 to July 2012, 183 patients [86% male, mean age 47.6 years (range 28-74), HBVDNA undetectable for 198 weeks (range 13-1074)], were randomized to receive a 48 weeks course of 180 μg/w PEGIFN-alfa-2a (Pegasys) in addition to the backbone NUC regimens (Group 1: n = 90) or no additional therapy (Group 2: n = 93). Patients were stratified according to the HBsAg titers (