Eun Ju Cho,1 Su Jong Yu,1 So Young Kwon,2 Ji-Hoon Kim,3 Do Young Kim,4 Won Kim,5 June Sung Lee,6 Jin Woo Lee,7 Youn Jae Lee,8 Hee Bok Chae,9 Jung-Hwan Yoon1 1Department of Internal Medicine, Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea; 2Department of Internal Medicine, Konkuk University School of Medicine, KonKuk University Hospital, Seoul, South Korea; 3Department of Internal Medicine, Korea University Guro Hospital, Korea University College of

more »

... dicine, Seoul, South Korea; 4Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea; 5Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, South Korea; 6Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, South Korea; 7Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea; 8Department of Gastroenterology, Inje University Busan Paik Hospital, Busan, South Korea; 9Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea Background: Little clinical data are available about the effect of food on the antiviral efficacy of entecavir for chronic hepatitis B virus (HBV) infection. The present study evaluated whether entecavir administration in the fed state had comparable efficacy to the fasted condition for maintenance of viral suppression in HBV-infected patients with virological response on entecavir therapy.Methods: In this multicenter, randomized, open-label, noninferiority study, patients who were currently receiving entecavir and showed a serum HBV DNA level of <20 IU/mL were randomized to take entecavir either under the fasted or fed condition for 48 weeks.Results: We randomly assigned 50 patients to the fasted group and 46 patients to the fed group. The full analysis set consisted of 49 patients in the fasted group and 44 patients in the fed group. At week 4 [...]