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乙型肝炎病毒前基因组RNA在慢性乙型肝炎患者抗病毒治疗停药决策中的临床意义

[Clinical significance of hepatitis B virus pgRNA for deciding antiviral therapy discontinuation in patients with chronic hepatitis B].

作者信息

He J Z, Xu Y F, Lei X Z

机构信息

West China School of Medicine, Sichuan University, Chengdu 610041, China.

Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu 610041, China.

出版信息

Zhonghua Gan Zang Bing Za Zhi. 2022 Sep 20;30(9):970-975. doi: 10.3760/cma.j.cn501113-20210305-00110.

Abstract

To explore the clinical significance of hepatitis B pregenomic RNA (pgRNA) for deciding antiviral therapy discontinuation in patients with chronic hepatitis B (CHB). Data of patients with CHB who were treated with long-term antiviral therapy in the Center for Infectious Diseases, West China Hospital of Sichuan University from January 2019 to December 2019 were collected. Drug discontinuity after evaluation of high-sensitivity HBV DNA and HBV pgRNA (HBV DNA ≤20 IU/ml and HBV pgRNA<150 copies/ml) was observed. The prospective observational study on 91 patients with HBeAg-negative CHB was conducted. The clinical conditions were followed up 3, 6 and 12 months after the drug discontinuation. The relationship between HBV pgRNA and relapse after drug discontinuation was analyzed. From observation to 12 months after drug discontinuation, a total of 34 patients (37.4%) had developed recurrence and resumed antiviral therapy, and the cumulative recurrence rate within 12 months of drug discontinuation was 46.8%. Among the relapsed patients, 14 (41.2%) had biochemical breakthroughs, and all achieved good biochemical and virological responses after the resumption of antiviral therapy. The Cox multivariate proportional hazards regression analysis showed that the level of HBV pgRNA before drug discontinuation and the type of antiviral drugs taken were associated with recurrence after drug discontinuation. The risk of recurrence after drug withdrawal in the HBV pgRNA ≤50 copies/ml group was 2.316 times higher than that in the HBV pgRNA negative group (=2.316, 95%: 1.047-5.126, =0.038). The risk of recurrence after drug withdrawal in the HBV pgRNA >50 copies/ml group was 3.45 times higher than that in the HBV pgRNA negative group (=3.450, 95%: 1.338-8.892, =0.010). HBV pgRNA can be used to predict the risk of recurrence after antiviral therapy discontinuation in patients with CHB. Patients with negative serum HBV pgRNA before drug discontinuation have a relatively low risk of relapse after drug discontinuation, and drug discontinuation is not recommended for patients with HBV pgRNA >50 copies/ml.

摘要

探讨乙肝病毒前基因组RNA(pgRNA)在慢性乙型肝炎(CHB)患者抗病毒治疗停药决策中的临床意义。收集2019年1月至2019年12月在四川大学华西医院传染病中心接受长期抗病毒治疗的CHB患者的数据。观察在高灵敏度乙肝病毒DNA(HBV DNA)和乙肝病毒pgRNA评估后停药情况(HBV DNA≤20 IU/ml且HBV pgRNA<150拷贝/ml)。对91例HBeAg阴性CHB患者进行前瞻性观察研究。在停药后3、6和12个月对临床情况进行随访。分析HBV pgRNA与停药后复发的关系。从观察到停药后12个月,共有34例患者(37.4%)复发并恢复抗病毒治疗,停药后12个月内的累积复发率为46.8%。在复发患者中,14例(41.2%)出现生化突破,所有患者在恢复抗病毒治疗后均获得良好的生化和病毒学应答。Cox多因素比例风险回归分析显示,停药前HBV pgRNA水平和所服用的抗病毒药物类型与停药后复发有关。HBV pgRNA≤50拷贝/ml组停药后复发风险比HBV pgRNA阴性组高2.316倍(=2.316,95%:1.047 - 5.126,=0.038)。HBV pgRNA>50拷贝/ml组停药后复发风险比HBV pgRNA阴性组高3.45倍(=3.450,95%:1.338 - 8.892,=0.010)。HBV pgRNA可用于预测CHB患者抗病毒治疗停药后复发风险。停药前血清HBV pgRNA阴性的患者停药后复发风险相对较低,不建议HBV pgRNA>50拷贝/ml的患者停药。

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