Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
Department of Gynecology and Obstetrics, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
J Viral Hepat. 2019 Jul;26 Suppl 1:32-41. doi: 10.1111/jvh.13151.
Hepatitis B surface antigen (HBsAg) loss is considered a functional cure in chronic hepatitis B (CHB). However, the durability of HBsAg loss after stopping treatment remains unknown. This study aimed to assess the sustained functional cure achieved by interferon therapy in hepatitis B envelope antigen (HBeAg)-negative CHB patients. In this prospective study, 176 HBeAg-negative CHB patients with functional cure were enrolled for 12 weeks of cessation treatment, and treatment information and baseline data were collected. Hepatitis B virus (HBV) biomarkers and clinical biochemical indicators were evaluated every 3 months; liver imaging examinations were performed every 3-6 months during the 48-week follow-up. The sustained functional cure was evaluated. After the 48-week follow-up, the sustained functional cure rate was 86.63%. The cumulative rates of HBsAg reversion and HBV DNA reversion were 12.79% and 2.33%, respectively. Consolidation treatment ≥ 12 weeks after HBsAg loss achieved a significantly higher rate of sustained functional cure and significantly lower rate of HBsAg reversion than consolidation treatment < 12 weeks (76.19% vs 90.00%, P = 0.022 and 23.81% vs 9.23%, P = 0.014, respectively). Patients with hepatitis B surface antibody (HBsAb) had higher rate of sustained functional cure than patients achieving HBsAg loss but without HBsAb (89.86% vs 73.53%, P = 0.012). Consolidation treatment ≥ 12 weeks (odds ratio [OR] 16.478; 95% confidence interval [CI], 2.135-127.151; P = 0.007) and high HBsAb levels (OR 8.312; 95% CI, 1.824-37.881; P = 0.006) were independent predictors of sustained functional cure. Results suggested that 12 weeks of consolidation therapy after HBsAg clearance and elevated HBsAb levels help to improve functional cure.
乙肝表面抗原（HBsAg）丢失被认为是慢性乙型肝炎（CHB）的功能性治愈。然而，停止治疗后 HBsAg 丢失的持久性仍不清楚。本研究旨在评估干扰素治疗在 HBeAg 阴性 CHB 患者中实现的持续功能性治愈。在这项前瞻性研究中，纳入了 176 例 HBeAg 阴性 CHB 患者，这些患者在 12 周的停药治疗中达到了功能性治愈，并收集了治疗信息和基线数据。每 3 个月评估乙型肝炎病毒（HBV）标志物和临床生化指标；在 48 周随访期间，每 3-6 个月进行一次肝脏影像学检查。评估持续的功能性治愈。在 48 周随访后，持续功能性治愈率为 86.63%。HBsAg 逆转和 HBV DNA 逆转的累积率分别为 12.79%和 2.33%。HBsAg 丢失后巩固治疗≥12 周的持续功能性治愈率显著高于巩固治疗<12 周（76.19% vs. 90.00%，P=0.022；23.81% vs. 9.23%，P=0.014）。与仅 HBsAg 丢失而无 HBsAb 的患者相比，HBsAb 阳性的患者持续功能性治愈率更高（89.86% vs. 73.53%，P=0.012）。巩固治疗≥12 周（比值比[OR] 16.478；95%置信区间[CI]，2.135-127.151；P=0.007）和高 HBsAb 水平（OR 8.312；95% CI，1.824-37.881；P=0.006）是持续功能性治愈的独立预测因素。结果表明，HBsAg 清除后 12 周的巩固治疗和升高的 HBsAb 水平有助于提高功能性治愈。
