Concomitant food intake does not affect the efficacy of entecavir in chronic hepatitis B patients with virological response: a randomized, multicenter, noninferiority trial

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 Medicine, 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