HBV : PO-06 ; Relapse rate and the predicting factors for sustained virologic response after withdrawal of oral nucleos(t)ide analogue therapy in chronic hepatitis B = HBV : PO-06 ; Relapse rate and the predicting factors for sustained virologic response after withdrawal of oral nucleos(t)ide analogue therapy in chronic hepatitis B

다국어 초록 (Multilingual Abstract)

Background: Current goals of antiviral therapy in chronic hepatitis B patients are ALT normalization, undetectable HBV DNA level and HBsAg loss. However, HBsAg loss rarely occurs during oral nucleos(t)ide analogue (NA) therapy, and it is not certain how long NA should be maintained in patients who obtain virologic response but still have HBsAg in the serum. Thus, the aim of this study was to determine the relapse rate and the predicting factors of sustained virologic response after withdrawal of oral NA therapy in chronic hepatitis B patients. Methods: CHB patients who were withdrawn from NA (entecavir, lamivudine, clevudine) after at least 6 months of undetectable HBV DNA were enrolled in this retrospective study. The clinical, biochemical and virologic data was obtained and compared in patients with or without viral relapse. The cummulative relapse rate was assessed by Kaplan-Meier method, and multivariate analysis with predictors of sustained viral response by logistic regression analysis. Results: Total 105 CHB patients discontinued NA therapy between April 2003 and March 2012. Among CHB patients, 75, 16, 14 were treated with entecavir, lamivudine and clevudine, respectively. Overall 3, 6, 12 month relapse rates after NA withdrawal were 25.9%, 61.7% and 75.3%, respectively. The 6 month relapse rate was 58.8% in entecavir group, 68.7% in lamivudine group, 69% in clevudine group (p=0.571). In multivariate analysis, duration of oral NA treatment after achievement of virologic response was the only significant predicting factor associated with sustained virologic response. (p=0.042,HR ; 0.001) Conclusions: Early withdrawal of oral NA therapy is associated with high relapse rate regardless of clinical characteristic, biochemical and virologic factors. Prolonged NA therapy may increase the chance for sustained virologic response after withdrawal of NA in CHB