Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, 123 Ta-Pei Rd, Niao-Sung 833, Kaohsiung City, Taiwan.
Hepatol Int. 2021 Apr;15(2):301-309. doi: 10.1007/s12072-021-10159-w. Epub 2021 Mar 4.
BACKGROUND/PURPOSE: The study investigated the role of hepatitis B core-related antigen (HBcrAg) in hepatitis B virus (HBV) relapse after stopping tenofovir disoproxil fumarate (TDF) in HBeAg-negative patients.
A total of 185 HBeAg-negative patients without cirrhosis who had stopped TDF treatment for at least 6 months were recruited. All patients fulfilled the stopping criteria proposed by the Asian Pacific Association for the Study of the Liver 2012.
The 3-year cumulative incidences of virological relapse, clinical relapse, and hepatitis B surface antigen (HBsAg) loss were 72, 60.1 and 14.5%, respectively. End-of-treatment (EOT) HBsAg level was an independent predictor of virological relapse (hazard ratio (HR): 2.263; 95% confidence interval (CI): 1.779-2.887), clinical relapse (HR 1.773; 95% CI 1.367-2.298), and HBsAg loss (HR 0.179; 95% CI 0.096-0.335). Among patients who had HBsAg < 100 and ≥ 100 IU/mL, the 3-year virological relapse rates were 37.4% and 85.3% (p < 0.001), clinical relapse rates were 30.3 and 71.7% (p < 0.001), and HBsAg loss rates were 40.6 and 2.6% (p < 0.001), respectively. Among the 53 patients with EOT HBsAg level < 100 IU/mL, the 3-year virological relapse rates in patients with baseline HBcrAg levels < 4.7 and ≥ 4.7 log U/mL were 20.3 and 60.4% (p = 0.003), and the clinical relapse rates were 10.3 and 59.5% (p < 0.001) respectively. Additionally, the 3-year HBsAg loss rates in patients with baseline HBcrAg ≤ 3 and > 3 log U/mL were 42.9 and 7.9% (p < 0.001).
The combination of EOT HBsAg and baseline HBcrAg levels could further reduce the risk of HBV relapse after stopping TDF therapy in HBeAg-negative patients.
背景/目的：本研究旨在探讨乙型肝炎病毒（HBV）核心相关抗原（HBcrAg）在 HBeAg 阴性患者停止使用富马酸替诺福韦二吡呋酯（TDF）后病毒复发中的作用。
共纳入 185 例 HBeAg 阴性、已停止 TDF 治疗至少 6 个月且无肝硬化的患者。所有患者均符合亚太肝病学会 2012 年提出的停药标准。
随访 3 年，病毒学复发、临床复发和乙型肝炎表面抗原（HBsAg）丢失的累积发生率分别为 72%、60.1%和 14.5%。治疗结束时（EOT）HBsAg 水平是病毒学复发（风险比（HR）：2.263；95%置信区间（CI）：1.779-2.887）、临床复发（HR 1.773；95% CI 1.367-2.298）和 HBsAg 丢失（HR 0.179；95% CI 0.096-0.335）的独立预测因素。在 HBsAg<100 和≥100 IU/mL 的患者中，随访 3 年的病毒学复发率分别为 37.4%和 85.3%（p<0.001），临床复发率分别为 30.3%和 71.7%（p<0.001），HBsAg 丢失率分别为 40.6%和 2.6%（p<0.001）。在 EOT HBsAg<100 IU/mL 的 53 例患者中，基线 HBcrAg<4.7 和≥4.7 log U/mL 的患者 3 年病毒学复发率分别为 20.3%和 60.4%（p=0.003），临床复发率分别为 10.3%和 59.5%（p<0.001）。此外，基线 HBcrAg≤3 和>3 log U/mL 的患者 3 年 HBsAg 丢失率分别为 42.9%和 7.9%（p<0.001）。
在 HBeAg 阴性患者中，EOT HBsAg 和基线 HBcrAg 水平相结合可进一步降低 TDF 停药后 HBV 复发的风险。
