Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
J Viral Hepat. 2021 Aug;28(8):1141-1149. doi: 10.1111/jvh.13528. Epub 2021 May 18.
This study investigated the ability of hepatitis B core-related antigen (HBcrAg) to predict hepatitis B virus (HBV) relapse in HBeAg-negative patients after cessation of entecavir therapy. A total of 301 HBeAg-negative patients without cirrhosis who had stopped entecavir therapy for at least 12 months were recruited. All patients fulfilled the stopping criteria proposed by the APASL 2012 guidelines. The five-year cumulative rates of virological relapse, clinical relapse and HBsAg loss were 71.6%, 57.3% and 18.7%, respectively. Serum HBsAg at end of treatment (EOT) was an independent predictor of virological relapse, clinical relapse and HBsAg loss; an EOT HBsAg of 150 IU/ml was the optimal cut-off value. The 5-year virological relapse rates for patients with <150 and ≥150 IU/ml HBsAg at EOT were 43.3% and 82.2% (p < 0.001), clinical relapse rates were 32.3% and 66.3% (p < 0.001), and HBsAg loss rates were 46.1% and 5.2% (p < 0.001), respectively. A baseline HBcrAg of 4 IU/ml was the optimal cut-off value for predicting HBV relapse. Among patients with an EOT HBsAg <150 IU/ml, the five-year virological relapse rates for patients with baseline HBcrAg levels ≤4 and >4 log U/ml were 27.9% and 59.1% (p = 0.006) and the clinical relapse rates were 18% and 48.1% (p = 0.014), respectively. EOT HBcrAg was not a significant predictor of virological or clinical relapse after cessation of entecavir. In conclusion, the combination of an EOT HBsAg of 150 IU/ml and baseline HBcrAg of 4 log U/ml can effectively predict the risk of HBV relapse after stopping entecavir therapy.
本研究旨在探讨乙型肝炎核心相关抗原（HBcrAg）能否预测 HBeAg 阴性患者停止恩替卡韦治疗后乙型肝炎病毒（HBV）的复发。共纳入 301 例无肝硬化且已停止恩替卡韦治疗至少 12 个月的 HBeAg 阴性患者。所有患者均符合 2012 年亚太肝脏研究学会（APASL）停药标准。病毒学复发、临床复发和 HBsAg 丢失的 5 年累积发生率分别为 71.6%、57.3%和 18.7%。治疗结束时（EOT）血清 HBsAg 是病毒学复发、临床复发和 HBsAg 丢失的独立预测因素；EOT HBsAg 为 150IU/ml 时为最佳截断值。EOT HBsAg<150 和≥150IU/ml 的患者 5 年病毒学复发率分别为 43.3%和 82.2%（p<0.001），临床复发率分别为 32.3%和 66.3%（p<0.001），HBsAg 丢失率分别为 46.1%和 5.2%（p<0.001）。基线 HBcrAg 为 4IU/ml 时是预测 HBV 复发的最佳截断值。在 EOT HBsAg<150IU/ml 的患者中，基线 HBcrAg 水平≤4 和>4log U/ml 的患者 5 年病毒学复发率分别为 27.9%和 59.1%（p=0.006），临床复发率分别为 18%和 48.1%（p=0.014）。EOT HBcrAg 不是停止恩替卡韦后病毒学或临床复发的显著预测因素。综上所述，EOT HBsAg 为 150IU/ml 和基线 HBcrAg 为 4log U/ml 的联合可有效预测停止恩替卡韦治疗后 HBV 复发的风险。
