慢性乙型肝炎患者在生物标志物定义的免疫耐受期中肝细胞

StephenW

Negligible risks of hepatocellular carcinoma during biomarker-defined immune-tolerant phase for patients with chronic hepatitis B
Mi Young Jeon  1   2 , Beom Kyung Kim  1   3   2 , Jae Seung Lee  1   3   2 , Hye Won Lee  1   3   2 , Jun Yong Park  1   3   2 , Do Young Kim  1   3   2 , Sang Hoon Ahn  1   3   2 , Kwang-Hyub Han  1   3   2 , Seung Up Kim  1   3   2
Affiliations
Affiliations

    1
    Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.
    2
    Yonsei Liver Center, Severance Hospital, Seoul, Korea.
    3
    Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, South Korea.

    PMID: 33317247 DOI: 10.3350/cmh.2020.0216

Abstract

Background: The immune-tolerant (IT) phase of chronic hepatitis B (CHB) patients is not generally indicative of antiviral therapy (AVT). We assessed and compared the risk of hepatocellular carcinoma (HCC) during the IT-phase stringently defined by a low fibrosis-4 (FIB-4) index, compared to that in patients undergoing AVT.

Methods: Among 125 untreated patients that were hepatitis B e-antigen positive, HBV-DNA >20,000 IU/ml, with normal alanine aminotransferase level from 2012 to 2018, those with a FIB-4 index of <1.45 were classified into the IT-group. The cumulative probability of HCC was estimated using Kaplan-Meier analysis. All patients were assessed until HCC development (intention-to-treat [ITT] analysis), whereas those suspected of experiencing CHB phase switch were assessed using the per-protocol (PP) and censored at the time of phase switch.

Results: The cumulative probability of HCC at 1-, 3-, and 5-years among the IT-group was zero, compared to AVT-treated patients with FIB-4 indices <1.45 during the same period: 0.2%, 0.6%, and 1.4%, respectively (P=0.264 for ITT and P=0.533 for PP). Among the initially screened 125 untreated patients, those with a FIB-4 index of ≥1.45 had a higher risk of HCC compared to the IT-group (P=0.005). Furthermore, among AVT-treated patients, those with a FIB-4 index of ≥1.45 had a higher risk of HCC compared to their counterpart (P<0.001).

Conclusion: The risk of HCC was negligible in the IT-group stringently defined by a low FIB-4 index. However, given that a higher HCC risk exists among untreated patients with higher FIB-4, appropriate criteria for AVT should be established.

Keywords: Antiviral therapy; FIB-4 index; Hepatitis B; Hepatocellular carcinoma; Immune-tolerance.

StephenW

慢性乙型肝炎患者在生物标志物定义的免疫耐受期中肝细胞癌的风险可忽略不计
Mi Young Jeon 1 2，Beom Kyung Kim 1 3 2，Jae Seung Lee 1 3 2，Hye Won Lee 1 3 2，Jun Yong Park 1 3 2，Do Young Kim 1 3 2，Sang Hoon Ahn 1 3 2，Kwang- Hyub Han 1 3 2，Seung Up Kim 1 3 2
隶属关系
隶属关系

    1个
    延世大学医学院内科，韩国首尔。
    2
    韩国首尔遣散医院延世肝脏中心。
    3
    延世大学医学院胃肠病研究所，韩国首尔。

    PMID：33317247 DOI：10.3350 / cmh.2020.0216

抽象

背景：慢性乙型肝炎（CHB）患者的免疫耐受（IT）期通常不能指示抗病毒治疗（AVT）。我们评估并比较了由低纤维化4（FIB-4）指数严格定义的IT阶段与接受AVT的患者相比，肝细胞癌（HCC）的风险。

方法：2012年至2018年，在未经治疗的125例乙型肝炎e抗原阳性，HBV-DNA> 20,000 IU / ml，丙氨酸转氨酶水平正常的患者中，FIB-4指数<1.45的患者被分类为IT-组。使用Kaplan-Meier分析估计HCC的累积概率。对所有患者进行评估，直至HCC发生（意向性治疗[ITT]分析），而对怀疑患有CHB相变的患者使用按协议（PP）进行评估，并在相变时进行检查。

结果：与同期AFI治疗且FIB-4指数<1.45的AVT患者相比，IT组中1年，3年和5年HCC的累积概率为零，分别为0.2％，0.6％，和1.4％（ITT为P = 0.264，PP为P = 0.533）。在最初筛选的125名未经治疗的患者中，FIB-4指数≥1.45的患者与IT组相比具有更高的HCC风险（P = 0.005）。此外，在接受AVT治疗的患者中，FIB-4指数≥1.45的患者与相应患者相比具有更高的HCC风险（P <0.001）。

结论：在FIB-4指数低的严格定义的IT组中，HCC的风险可忽略不计。但是，考虑到未经治疗的FIB-4较高的患者存在较高的HCC风险，应建立适当的AVT标准。

关键字：抗病毒治疗； FIB-4指数；乙型肝炎；肝细胞癌；免疫耐受。

StephenW

https://www.e-cmh.org/upload/pdf/cmh-2020-0216.pdf