HBV : O-003 ; Maintenance of remission among lamivudine-resistant patients with complete virological response to adefovir add-on lamivudine after stopping lamivudine therapy : Interim analysis at 72 weeks = HBV : O-003 ; Maintenance of remission among lamivudine-resistant patients with complete virological response to adefovir add-on lamivudine after stopping lamivudine therapy : Interim analysis at 72 weeks

다국어 초록 (Multilingual Abstract)

Background/Aim: We aimed to determine the durability of the virological responses after lamivudine (LAM) discontinuation for chronic hepatitis B (CHB) patients with LAM-resistant hepatitis B virus (HBV), who responded to LAM plus adefovir (ADV) combination therapy, and the outcomes of ADV monotherapy compared to that of combination therapy. Methods: 73 patients with undetectable viral load (<20 IU/mL) and normal alanine aminotransferase (ALT) after combination therapy for at least 6 months were randomly assigned 1:1 to continue with combination therapy or switch to ADV monotherapy (37 patients combination arm, 36 patients ADV monotherapy arm). Viral rebound was defined as HBV DNA detection by quantitative PCR determined by two consecutive measurements after the study enrollment. Results: There were no significant differences between the combination arm and the ADV monotherapy arm according to the baseline characteristics. During 72 weeks of follow-up, 100% (37/37) patients in the combination arm had persistently undetectable HBV DNA, compared with 94.4% (34/36) patients in the ADV monotherapy arm (p. Two patients in the ADV monotherapy arm showed viral rebound, occurring at 24 and 48 weeks. These two patients had undetectable HBV DNA after switching back to combination therapy. Of these, no patient showed elevation of ALT during rebound. Conclusions: In our interim analysis, most patients (94.4%) showed maintaining virological response after LAM discontinuation. Our pilot randomized controlled study showed the efficacy of stopping LAM in LAM-resistant patients with complete virological response to ADV add-on LAM. LAM may be discontinued in patients who showed optimal viral suppression with ADV and LAM combination therapy for at least 6 months.