HBcrAg Levels Are Associated With Virological Response to Treatment With Interferon in Patients With Hepatitis Delta.
HBcrAg Levels Are Associated With Virological Response to Treatment With Interferon in Patients With Hepatitis Delta.
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HBCrag水平与肝炎患者的干扰素治疗有关的病毒学反应有关。
DOI：
10.1002/hep4.1821
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发表时间：
2022-03
影响因子：
5.1
通讯作者：
HIDIT‐II Study Group
中科院分区：
文献类型：
--
作者：
Sandmann L;Yurdaydin C;Deterding K;Heidrich B;Hardtke S;Lehmann P;Bremer B;Manns MP;Cornberg M;Wedemeyer H;Maasoumy B;HIDIT‐II Study Group
丁型肝炎病毒（HDV）感染的标准治疗在大多数中心仍然是聚乙二醇干扰素α（peg-IFNα），这不仅与相当低的疗效相关，而且还与几种不良事件相关。B型肝炎核心相关抗原（HBcrAg）与肝内共价闭合环状DNA水平相关，先前已被建议作为基于IFN治疗B型肝炎病毒（HBV）单一感染的应答预测因子。本研究旨在研究HBcrAg在接受PEG-IFNα治疗的HBV/HDV合并感染患者的管理中的价值。Hep-Net-International-Delta-Hepatitis-Intervention Trial-2研究纳入了120例合并HBV/HDV感染的患者。患者接受PEG-IFNα和替诺福韦或安慰剂治疗96周。本分析纳入了治疗结束后24周（FU 24）有HDV-RNA结果的99例患者，其中32例患者（32.3%）在FU 24时检测不到HDV RNA。在基线、第12、24、48、96周和FU 24时测量HBcrAg。HBcrAg水平与HDV RNA无显著相关性，但与治疗结果显著相关。基线、第24周和第48周时HBcrAg水平< 4.5 log IU/mL对FU 24时达到检测不到HDV RNA具有高阴性预测值（NPV）（分别为81.8%、87.1%和95.0%）。同样，在FU 24之前病毒复发的患者中，第96周的HBcrAg水平显著较高（3.0 vs. 3.63 log IU/mL; P = 0.0089）。基线、第24周和第48周HBcrAg水平也与FU 24时达到HBsAg水平< 100 IU/mL的可能性相关（HBcrAg < 3.0 log IU/mL：NPV分别为91.7%、90.4%和92.3%）。当HBcrAg与其他病毒和临床参数相结合时，检测统计学得到改善。结论：HBcrAg与HBV/HDV合并感染患者对PEG-IFNα的治疗反应相关，可能是确定治疗无效的有希望的标志物。
Standard treatment of hepatitis delta virus (HDV) infection remains pegylated‐interferon alfa (peg‐IFNα) in most centers, which is not only associated with rather low efficacy but several adverse events. Hepatitis B core‐related antigen (HBcrAg) is linked to intrahepatic covalently closed circular DNA levels and has previously been suggested as response predictor in IFN‐based treatment of hepatitis B virus (HBV) mono‐infection. This study aimed to investigate the value of HBcrAg in the management of patients with HBV/HDV co‐infection undergoing peg‐IFNα treatment. The Hep‐Net‐International‐Delta‐Hepatitis‐Intervention Trial‐2 study included 120 patients co‐infected with HBV/HDV. Patients were treated for 96 weeks with peg‐IFNα and either tenofovir or placebo. Ninety‐nine patients with HDV‐RNA results 24 weeks after end of treatment (FU24) were included in this analysis, of whom 32 patients (32.3%) had undetectable HDV RNA at FU24. HBcrAg was measured at baseline, week 12, 24, 48, 96, and FU24. HBcrAg levels showed no significant correlation with HDV RNA but were significantly linked to treatment outcome. HBcrAg levels < 4.5 log IU/mL at baseline, week 24, and week 48 had high negative predictive value (NPV) for achieving undetectable HDV RNA at FU24 (81.8%, 87.1% and 95.0%, respectively). Similarly, HBcrAg levels at week 96 were significantly higher in patients with viral relapse until FU24 (3.0 vs. 3.63 log IU/mL; P = 0.0089). Baseline, week 24, and week 48 HBcrAg levels were also associated with the likelihood of achieving HBsAg level < 100 IU/mL at FU24 (HBcrAg < 3.0 log IU/mL: NPV 91.7%, 90.4% and 92.3%, respectively). Test statistics improved when combining HBcrAg with additional viral and clinical parameters. Conclusion: HBcrAg is linked to treatment response to peg‐IFNα in patients with HBV/HDV co‐infection and could be a promising marker to determine treatment futility.
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