Wu Fengping, Wang Yikai, Cui Dandan, Tian Yan, Lu Rui, Liu Chenrui, Li Mei, Li Yaping, Gao Ning, Jiang Zicheng, Li Xuemei, Zhai Song, Zhang Xin, Jia Xiaoli, Dang Shuangsuo
Department of Infectious Diseases, the Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710004, China.
Department of Infectious Diseases, Ankang Central Hospital, Ankang 725000, China.
J Clin Med. 2023 Jan 2;12(1):361. doi: 10.3390/jcm12010361.
Little is known about the treatment of patients with hepatitis B surface antigen (HBsAg) recurrence after being clinically cured by peginterferon alpha(peg-IFN-α)-based regimens. This study aimed to investigate the efficacy and safety of peg-IFNα-2b in re-treating patients with HBsAg recurrence after stopping peg-IFN α-based regimens. In this two-center, prospective observational study, 33 patients with HBsAg recurrence after stopping peg-IFN α-based regimens were enrolled and re-treated with an individualized course of peg-IFN α-2b. The hepatitis B virus (HBV) vaccine could be injected immediately after HBsAg clearance, according to patients’ willingness. All patients were monitored and followed-up for 48 weeks after peg-IFN α-2b re-treatment stop. The primary endpoint was HBsAg clearance at the end of follow-up. At baseline, all patients had HBsAg levels of <10 IU/mL and undetectable HBV DNA, with the median HBsAg level of 1.66 (0.56−2.87) IU/mL. After a median of 24 (24−30) weeks of peg-IFN α-2b re-treatment, 87.9% (29/33) of the patients achieved HBsAg clearance again and 66.7% (22/33) of the patients achieved HBsAg seroconversion. At the end of follow-up, the HBsAg clearance and HBsAg seroconversion rates decreased to 78.8% (26/33) and 51.5% (17/33), respectively. Furthermore, 88.9% (16/18) of the patients with HBsAg clearance benefited from receiving the HBV vaccine therapy. Generally, both peg-IFN α-2b and HBV vaccine therapy were well tolerated. A high functional cure rate can be achieved by a short-course of peg-IFN α-2b re-treatment in patients with HBsAg recurrence after stopping peg-IFN α-based regimens. Furthermore, injecting HBV vaccine is beneficial after HBsAg clearance.
对于经聚乙二醇干扰素α（peg-IFN-α）方案临床治愈后出现乙肝表面抗原（HBsAg）复发的患者的治疗，目前了解甚少。本研究旨在探讨聚乙二醇干扰素α-2b（peg-IFNα-2b）重新治疗停用基于peg-IFN-α方案后出现HBsAg复发患者的疗效和安全性。在这项双中心前瞻性观察研究中，纳入了33例停用基于peg-IFN-α方案后出现HBsAg复发的患者，并用个体化疗程的peg-IFNα-2b进行重新治疗。根据患者意愿，在HBsAg清除后可立即注射乙肝病毒（HBV）疫苗。所有患者在停用peg-IFNα-2b重新治疗后接受48周的监测和随访。主要终点是随访结束时的HBsAg清除情况。基线时，所有患者的HBsAg水平<10 IU/mL且HBV DNA检测不到，HBsAg水平中位数为1.66（0.56−2.87）IU/mL。在peg-IFNα-2b重新治疗中位24（24−30）周后，87.9%（29/33）的患者再次实现HBsAg清除，66.7%（22/33）的患者实现HBsAg血清学转换。随访结束时，HBsAg清除率和HBsAg血清学转换率分别降至78.8%（26/33）和51.5%（17/33）。此外，88.9%（16/18）的HBsAg清除患者从接受HBV疫苗治疗中获益。总体而言，peg-IFNα-2b和HBV疫苗治疗的耐受性均良好。对于停用基于peg-IFN-α方案后出现HBsAg复发的患者，短期疗程的peg-IFNα-2b重新治疗可实现较高的功能性治愈率。此外，在HBsAg清除后注射HBV疫苗是有益的。
