对于接受化疗的乙型肝炎患者，建议预防性抗病毒治疗，但化疗停止后理想的治疗持续时间需要更多证据来阐明。本研究旨在比较6个月和12个月的短有限间隔-nucleos(t)的复发率按低乙型肝炎病毒 (HBV)-DNA < 2000 IU/ml 或高 HBV DNA ≥ 2000 IU/ml 分层的患者接受 ide 类似物 (NA) 治疗。患者在化疗前 1 周开始替诺福韦或恩替卡韦治疗，并被分配到按 HBV DNA 预处理分层后随机分为不同治疗持续时间组： (1) 6 个月或 12 个月疗程时 HBV DNA < 2000 IU/ml； (2) 6 个月或 12 个月期间 HBV DNA ≥ 2000 IU/ml。病毒学复发 (VR) 定义为 HBV DNA > 2000 IU/ml，临床复发 (CR) 定义为随访期间 HBV DNA > 2000 IU/ml 且丙氨酸转氨酶 > 80 IU/L。主要终点是比较停止抗病毒治疗一年后各组之间的耐久性。次要终点是抗病毒治疗停止后长期随访时的VR和CR率。本研究入组了61名患者，其中5名患者失访或肿瘤复发。 1 年 VR 和 CR 率分别为 46.4% 和 14.3%，长期随访时分别为 55.3% 和 16.1%。 VR 和 CR 率显示各组之间没有差异。治疗前 HBV DNA ≥ 2000 IU/ml 和治疗结束时乙型肝炎表面抗原 (HBsAg) ≥ 500 IU/ml 是 VR 的预测因子（风险比 [HR]：2.98；p = 0.010 和 HR：2.38； p = 0.037）。停止化疗后 NA 巩固从 6 个月延长至 12 个月并不影响 HBV 的 VR 或 CR。治疗前高 HBV DNA 和治疗结束时 HBsAg 水平可以预测化疗停止抗病毒治疗后的 VR。版权所有 © 2023。由 Elsevier Ltd 出版。

Prophylaxis antiviral therapy is recommended for patients with hepatitis B receiving chemotherapy but the ideal treatment duration after chemotherapy cessation needs more evidence for clarification.This study aimed to compare the relapse rate of short finite intervals of 6 months and 12 months of -nucleos(t)ide analogue (NA) therapy in patients stratified by low hepatitis B virus (HBV)-DNA of < 2000 IU/ml or high HBV DNA of ≥ 2000 IU/ml.Patients started tenofovir or entecavir treatment 1 week before chemotherapy and were assigned to different treatment duration groups randomly after stratified by HBV DNA pretreatment: (1) HBV DNA of < 2000 IU/ml at 6-month or 12-month duration; (2)HBV DNA of ≥ 2000 IU/ml at 6-month or 12-month duration. Virological relapse (VR) was defined as HBV DNA of > 2000 IU/ml, and clinical relapse (CR) was defined as HBV DNA of > 2000 IU/ml and alanine aminotransferase of > 80 IU/L during the follow-up period. The primary endpoint was to compare the durability between groups 1 year after antiviral therapy cessation. The secondary endpoint was VR and CR rate at long-term follow-up after antiviral therapy cessation.This study enrolled 61 patients, and 5 patients were lost to follow-up or tumor recurrence. VR and CR rates were 46.4% and 14.3% at 1-year and 55.3% and 16.1%, at long-term follow-up, respectively. VR and CR rates demonstrated no difference between the groups. Pretreatment HBV DNA at ≥ 2000 IU/ml and end-of-treatment hepatitis B surface antigen (HBsAg) at ≥ 500 IU/ml were the predictor of VR (hazard ratio [HR]: 2.98; p = 0.010 and HR: 2.38; p = 0.037).Prolongation from 6 months to 12 months of NA consolidation after chemotherapy cessation did not affect the VR or CR of HBV. High pretreatment HBV DNA and end-of-treatment HBsAg levels could predict VR after antiviral therapy cessation for chemotherapy.Copyright © 2023. Published by Elsevier Ltd.