Cheng-Hao Tseng1, Yao-Chun Hsu2, Chi-Yang Chang3, Tai-Chung Tseng4, Ming-Shiang Wu4, Jaw-Town Lin3, Jia-Horng Kao5. 1. Division of Gastroenterology and Hepatology, E-DA Cancer Hospital/I-Shou University, Kaohsiung, Taiwan. 2. Division of Gastroenterology and Hepatology, Fu-Jen Catholic University Hospital, New Taipei, Taiwan; School of Medicine and Big Data Research Center, Fu-Jen Catholic University, New Taipei, Taiwan; Graduate Institute of Clinical Medicine, China Medical University, Taichung, Taiwan. 3. Division of Gastroenterology and Hepatology, Fu-Jen Catholic University Hospital, New Taipei, Taiwan; School of Medicine and Big Data Research Center, Fu-Jen Catholic University, New Taipei, Taiwan. 4. Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. 5. Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Clinical Medicine, National Taiwan University, Taipei, Taiwan. Electronic address: kaojh@ntu.edu.tw.
Abstract
BACKGROUND/ PURPOSE: The predictors of off-therapy response in patients treated with neucleos(t)ide analogue (NA) have not been elucidated. It remained unexplored whether serum level of hepatitis B core antibody (anti-HBc) at the end of NA therapy was associated with relapse risks. METHODS: This prospective study monitored 82 chronic hepatitis B (CHB) patients after discontinuing entecavir. All patients had been treated for 3 years or longer and serologically negative for viral DNA and HBeAg at treatment cessation. Patients were monitored for virological relapse (viral DNA > 2000 IU/mL), and clinical relapse (serum alanine aminotransferase > 80 U/L plus virological relapse). The association between anti-HBc levels and the risk of relapse was assessed by the Cox analysis. RESULTS: Clinical and virological relapses occurred in 29 and 60 participants, respectively, with the cumulative incidences of 23.7% (95% CI, 15.8-34.6%) and 62.0% (95% CI, 51.5-72.5%) at 1 year, and 36.2% (95% CI, 26.2-48.4%) and 78.8% (95% CI, 68.2-87.8%) at 2 years, respectively. There was a trend for an inverse association between anti-HBc and clinical relapse (crude hazard ratio [HR], 0.50; 95% CI, 0.24-1.05). All 3 patients with the level <100 IU/mL had a rapid clinical relapse (P = 0.002). This trend remained after adjustment for HBsAg and age (adjusted HR 0.50, 95% CI, 0.24-1.03). On the other hand, anti-HBc quantity was unrelated to virological relapse (crude HR, 0.97; 95% CI, 0.58-1.62; adjusted HR, 0.97; 95% CI, 0.58-1.60). CONCLUSION: This pilot study suggests a trend for an inverse association between anti-HBc levels and clinical relapse in CHB patients off entecavir.
BACKGROUND/ PURPOSE: The predictors of off-therapy response in patients treated with neucleos(t)ide analogue (NA) have not been elucidated. It remained unexplored whether serum level of hepatitis B core antibody (anti-HBc) at the end of NA therapy was associated with relapse risks. METHODS: This prospective study monitored 82 chronic hepatitis B (CHB) patients after discontinuing entecavir. All patients had been treated for 3 years or longer and serologically negative for viral DNA and HBeAg at treatment cessation. Patients were monitored for virological relapse (viral DNA > 2000 IU/mL), and clinical relapse (serum alanine aminotransferase > 80 U/L plus virological relapse). The association between anti-HBc levels and the risk of relapse was assessed by the Cox analysis. RESULTS: Clinical and virological relapses occurred in 29 and 60 participants, respectively, with the cumulative incidences of 23.7% (95% CI, 15.8-34.6%) and 62.0% (95% CI, 51.5-72.5%) at 1 year, and 36.2% (95% CI, 26.2-48.4%) and 78.8% (95% CI, 68.2-87.8%) at 2 years, respectively. There was a trend for an inverse association between anti-HBc and clinical relapse (crude hazard ratio [HR], 0.50; 95% CI, 0.24-1.05). All 3 patients with the level <100 IU/mL had a rapid clinical relapse (P = 0.002). This trend remained after adjustment for HBsAg and age (adjusted HR 0.50, 95% CI, 0.24-1.03). On the other hand, anti-HBc quantity was unrelated to virological relapse (crude HR, 0.97; 95% CI, 0.58-1.62; adjusted HR, 0.97; 95% CI, 0.58-1.60). CONCLUSION: This pilot study suggests a trend for an inverse association between anti-HBc levels and clinical relapse in CHB patients off entecavir.
Authors: Elia Moreno-Cubero; Robert T Sánchez Del Arco; Julia Peña-Asensio; Eduardo Sanz de Villalobos; Joaquín Míquel; Juan Ramón Larrubia Journal: World J Gastroenterol Date: 2018-05-07 Impact factor: 5.742