Department of Medicine, Queen Mary Hospital, The University of Hong Kong, 4/F, Professorial Block, Pokfulam Road 102, Pok Fu Lam, Hong Kong.
State Key Laboratory of Liver Research, The University of Hong Kong, Pok Fu Lam, Hong Kong.
J Gastroenterol. 2021 May;56(5):479-488. doi: 10.1007/s00535-021-01780-5. Epub 2021 Mar 27.
We aimed to assess whether residual hepatitis B virus (HBV) viraemia is associated with HCC development.
This is a case-control study of 104 patients [52 HCC and 52 non-HCC (matched with age, gender, cirrhosis and treatment duration)] on ≥ 3 years entecavir (ETV) with unquantifiable HBV DNA by Cobas Taqman assay v2.0 (Roche Diagnostics; lower limit of quantification [LLOQ] 20 IU/mL). Serial sera within 1, 1-2, and > 2 years prior to HCC diagnosis or last follow-up (LFU) were measured for HBV DNA and pre-genomic (pg) RNA using a highly sensitive semi-quantitative PCR assay with lower limit of detection of 10 IU/mL and LLOQ of 51.5 IU/mL, respectively.
Among the 104 patients (80.8% male, median age 61.2 years old, 38.5% cirrhosis, median duration of ETV 45.5 months), 38.5% and 9.6% HCC patients had undetectable serum DNA and pgRNA, respectively, compared to 65.4% and 36.5% in non-HCC patients; P = 0.005 & 0.001, respectively, at the time of HCC diagnosis/LFU. Detectable HBV DNA and pgRNA were associated with a higher 2-year risk of HCC development (HR 2.79, 95% CI 1.424-5.468 & HR 4.544, 95% CI 1.07-19.289, respectively). No significant differences were observed for qHBsAg levels between HCC and non-HCC patients.
More than 50% CHB patients on ETV with HBV DNA < LLOQ by standard assay had persistent viraemia as determined by a more sensitive assay. Detectable HBV DNA or pgRNA by more sensitive assays was associated with HCC development. More potent viral suppression is required to further reduce the risk of HCC.
本研究旨在评估残余乙型肝炎病毒（HBV）血症是否与 HCC 发生有关。
这是一项病例对照研究，纳入了 104 名患者[52 名 HCC 患者和 52 名非 HCC 患者（与年龄、性别、肝硬化和治疗时间相匹配）]，他们在接受恩替卡韦（ETV）治疗≥3 年后，采用 Cobas Taqman 检测 v2.0 （罗氏诊断公司；定量下限 [LLOQ] 为 20IU/ml）检测不到 HBV DNA。在 HCC 诊断或最后一次随访（LFU）前 1、1-2 和 >2 年内，采用高灵敏度半定量 PCR 检测血清 HBV DNA 和前基因组（pg）RNA，该检测的检测下限为 10IU/ml，LLOQ 分别为 51.5IU/ml。
在 104 名患者中（80.8%为男性，中位年龄 61.2 岁，38.5%为肝硬化，ETV 中位治疗时间为 45.5 个月），与非 HCC 患者相比，分别有 38.5%和 9.6%的 HCC 患者在 HCC 诊断/LFU 时血清 DNA 和 pgRNA 无法检测到，而在非 HCC 患者中分别为 65.4%和 36.5%；P=0.005 和 0.001。在 HCC 诊断/LFU 时，检测到 HBV DNA 和 pgRNA 与 HCC 发生的 2 年风险增加相关（HR 2.79，95%CI 1.424-5.468 和 HR 4.544，95%CI 1.07-19.289）。HCC 患者与非 HCC 患者的 qHBsAg 水平无显著差异。
在接受标准检测时 HBV DNA<LLOQ 的 ETV 治疗的 CHB 患者中，有超过 50%的患者通过更敏感的检测存在持续病毒血症。更敏感的检测方法检测到 HBV DNA 或 pgRNA 与 HCC 发生相关。需要更有效的病毒抑制以进一步降低 HCC 风险。
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