Liu Na, Yang Nan, Ma Wenqi, Yang Shujuan, Hu Chunhua, Li Juan, Zhao Yingren, Xu Guanghua, He Yingli
Department of Infectious Diseases, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Shaanxi Clinical Research Center for Infectious Diseases, Xi'an, China.
Front Med (Lausanne). 2021 Apr 8;8:655530. doi: 10.3389/fmed.2021.655530. eCollection 2021.
The optimal timing of initiating antiviral treatment for immune-tolerant (IT) patients remains unknown. We conducted this study in liver biopsy-proven IT patients to compare the long-term outcomes of untreated and treated patients suffering non-cirrhotic chronic hepatitis B (CHB). This retrospective cohort study recruited 171 consecutive treatment-naïve CHB patients who completed liver biopsy test. Patients were stratified into IT ( = 60), mildly-active (MA; = 31), immune-active (IA; = 80), according to alanine aminotransferase (ALT) and liver biopsy data. One hundred and nine patients receiving antiviral treatment constituted the treated set, and 62 patients under close follow-up comprised the untreated set. Primary outcomes were virological response, HBeAg seroconversion, HBsAg loss, ALT normalization, and liver stiffness measurement normalization (NCT03740789). The study population was predominantly male (62.6%) with a mean age of 31 years. The proportion of virological response in treated patients in the MA phase was 57.1%, and the proportion of HBeAg seroconversion was 28.6%, which showed no difference with the 43.8% virological response and 31.5% HBeAg seroconversion in IA patients. The proportions of virological response and seroconversion were 18.2 and 9.1%, respectively, in the IT phase, which were lower than the rates in the MA and IA phases. However, 95.5% of IT patients persisted normal ALT, and 100% of IT patients persisted normal liver stiffness measurement in the treated group. Therefore, antiviral treatment should be considered for CHB patients with high viral load regardless of phase to minimize further damage to hepatocytes.
免疫耐受（IT）患者开始抗病毒治疗的最佳时机仍不清楚。我们对经肝活检证实的IT患者进行了这项研究，以比较未经治疗和接受治疗的非肝硬化慢性乙型肝炎（CHB）患者的长期结局。这项回顾性队列研究招募了171例连续的未经治疗的CHB患者，这些患者均完成了肝活检检查。根据丙氨酸氨基转移酶（ALT）和肝活检数据，将患者分为IT组（n = 60）、轻度活动（MA；n = 31）、免疫活跃（IA；n = 80）组。109例接受抗病毒治疗的患者构成治疗组，62例接受密切随访的患者构成未治疗组。主要结局为病毒学应答、HBeAg血清学转换、HBsAg消失、ALT正常化和肝脏硬度测量正常化（NCT03740789）。研究人群以男性为主（62.6%），平均年龄为31岁。MA期治疗患者的病毒学应答率为57.1%，HBeAg血清学转换率为28.6%，与IA期患者43.8%的病毒学应答率和31.5%的HBeAg血清学转换率无差异。IT期的病毒学应答率和血清学转换率分别为18.2%和9.1%，低于MA期和IA期。然而，治疗组中95.5%的IT患者ALT持续正常，100%的IT患者肝脏硬度测量持续正常。因此，无论处于何阶段，对于病毒载量高的CHB患者均应考虑抗病毒治疗，以尽量减少对肝细胞的进一步损害。
