Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China; Department of Hepatology Division 2, Peking University Ditan Teaching Hospital, Beijing, 100015, China.
Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.
Virol Sin. 2022 Jun;37(3):390-397. doi: 10.1016/j.virs.2022.03.001. Epub 2022 Mar 4.
Hepatitis B surface antigen (HBsAg) clearance is considered as functional cure in patients with chronic hepatitis B (CHB). This study aimed to assess the durability of HBsAg clearance achieved by interferon-based therapies in patients with CHB who were originally positive for hepatitis B envelope antigen (HBeAg). In this prospective study, HBeAg-positive CHB patients with confirmed HBsAg loss under interferon-based therapies were enrolled within 12 weeks from end of treatment and followed up for 48 weeks. Virological markers, biochemical indicators, and liver imaging examinations were observed every 3-6 months. Sustained functional cure was analysed as primary outcome. Factor associated with sustained HBsAg loss or reversion was also investigated. The rate of HBsAg loss sustainability was 91.8% (212/231). Patients receiving consolidation treatment for 12-24 weeks or ≥ 24 weeks had higher rates of sustained HBsAg negativity than those receiving consolidation treatment for < 12 weeks (98.3% and 91.2% vs. 86.7%, P = 0.068), and the former groups had significantly higher anti-HBs levels than the later (P < 0.05). The cumulative incidence of HBsAg reversion and HBV DNA reversion was 8.2% and 3.9%, respectively. Consolidation treatment of ≥ 12 weeks [odd ratio (OR) 3.318, 95% confidence interval (CI) 1.077-10.224, P = 0.037) was a predictor of sustained functional cure, and HBeAg-positivity at cessation of treatment (OR 12.271, 95% CI 1.076-139.919, P = 0.043) was a predictor of HBsAg reversion. Interferon-alpha induced functional cure was durable and a consolidation treatment of ≥ 12-24 weeks was needed after HBsAg loss in HBeAg-positive CHB patients.
乙肝表面抗原 (HBsAg) 清除被认为是慢性乙型肝炎 (CHB) 患者的功能性治愈。本研究旨在评估最初 HBeAg 阳性的 CHB 患者在接受基于干扰素的治疗后获得的 HBsAg 清除的持久性。在这项前瞻性研究中,在治疗结束后 12 周内从接受基于干扰素的治疗并确认 HBsAg 丢失的 HBeAg 阳性 CHB 患者中招募患者,并随访 48 周。每 3-6 个月观察病毒学标志物、生化指标和肝脏成像检查。持续性功能性治愈被分析为主要结局。还研究了与持续 HBsAg 丢失或逆转相关的因素。HBsAg 丢失可持续性的比率为 91.8%(212/231)。接受 12-24 周或≥24 周巩固治疗的患者比接受<12 周巩固治疗的患者具有更高的持续 HBsAg 阴性率(98.3%和 91.2%比 86.7%,P=0.068),且前两组的抗-HBs 水平显著高于后两组(P<0.05)。HBsAg 逆转和 HBV DNA 逆转的累积发生率分别为 8.2%和 3.9%。巩固治疗≥12 周[优势比 (OR) 3.318,95%置信区间 (CI) 1.077-10.224,P=0.037]是持续功能性治愈的预测因素,而治疗结束时 HBeAg 阳性[OR 12.271,95%CI 1.076-139.919,P=0.043]是 HBsAg 逆转的预测因素。干扰素-α诱导的功能性治愈是持久的,在 HBeAg 阳性 CHB 患者 HBsAg 丢失后需要进行≥12-24 周的巩固治疗。