Tseng C.-H.Hsu Y.-C.Chang C.-Y.TAI-CHUNG TSENGMING-SHIANG WULin J.-T.JIA-HORNG KAO2021-09-042021-09-0420180929-6646https://www.scopus.com/inward/record.uri?eid=2-s2.0-85039444865&doi=10.1016%2fj.jfma.2017.11.012&partnerID=40&md5=185853993116b77687fc9e0af6dd3431https://scholars.lib.ntu.edu.tw/handle/123456789/581833Background/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. ? 2017[SDGs]SDG3alanine aminotransferase; entecavir; hepatitis B core antibody; hepatitis B surface antigen; hepatitis B(e) antigen; virus DNA; alanine aminotransferase; antivirus agent; entecavir; guanine; hepatitis B antibody; hepatitis B core antigen; virus DNA; adult; age; alanine aminotransferase blood level; Article; chronic hepatitis B; cohort analysis; drug withdrawal; female; follow up; human; incidence; major clinical study; male; off therapy response; pilot study; prospective study; relapse; treatment response; analogs and derivatives; blood; chronic hepatitis B; genetics; Hepatitis B virus; immunology; middle aged; proportional hazards model; recurrent disease; Taiwan; treatment outcome; treatment withdrawal; Adult; Alanine Transaminase; Antiviral Agents; DNA, Viral; Female; Guanine; Hepatitis B Antibodies; Hepatitis B Core Antigens; Hepatitis B virus; Hepatitis B, Chronic; Humans; Male; Middle Aged; Pilot Projects; Proportional Hazards Models; Prospective Studies; Recurrence; Taiwan; Treatment Outcome; Withholding Treatmentjournal article10.1016/j.jfma.2017.11.012292494172-s2.0-85039444865