Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center of Digestive Diseases, Beijing, China.
Clinical Epidemiology & EBM Unit, Beijing Friendship Hospital, Capital Medical University; National Clinical Research Center for Digestive Diseases, Beijing, China.
J Viral Hepat. 2024 Dec;31(12):898-902. doi: 10.1111/jvh.14012. Epub 2024 Oct 7.
Low-level viraemia (LLV) occurs in chronic hepatitis B (CHB) patients despite antiviral treatment, which may cause failed histological regression. Our study aimed to investigate the impact of different LLV types on fibrosis regression. The prospective study enrolled CHB patients with paired liver biopsies before and after 260 weeks of entecavir treatment. Fibrosis regression was defined by the Ishak score or P-I-R system. Patients were grouped as the SVR (HBV DNA < 20 IU/mL persistently) or LLV (HBV DNA between 20 and 2000 IU/mL), which were further grouped as very low-level viraemia (VLLV, HBV DNA < 50 IU/mL), occasionally LLV (OLLV, HBV DNA ≥ 50 IU/mL only once) and multiple LLV (MLLV, HBV DNA ≥ 50 IU/mL more than once). Logistic regression models were used to calculate the adjusted odds ratios (aORs) and 95% confidence intervals (CIs). The analysis included 111 CHB patients. In the SVR group (n = 54), 39 (72.2%) patients had fibrosis regression, which was higher than the LLV (56.1%, p = 0.080). The fibrosis regression rates for VLLV (30 patients), OLLV (17 patients) and MLLV (10 patients) were 70.0%, 52.9% and 30.0%, respectively. Compared with SVR, VLLV (aOR = 0.78; 95% CI: 0.28-2.21; p = 0.644) was not associated with fibrosis regression, but patients with non-VLLV (aOR = 0.27; 95% CI: 0.09-0.85; p = 0.025), especially with MLLV (aOR = 0.19; 95% CI: 0.04-0.97; p = 0.046) is significantly associated with hindered fibrosis regression. Our study suggests that patients with detectable serum HBV DNA levels higher than 50 IU/mL need to be monitored carefully, especially in those with more than once. Trial Registration: ClinicalTrials.gov identifiers NCT01938781 and NCT01938820.
低水平病毒血症（LLV）在慢性乙型肝炎（CHB）患者接受抗病毒治疗后仍然存在，这可能导致组织学缓解失败。本研究旨在探讨不同 LLV 类型对纤维化消退的影响。这项前瞻性研究纳入了接受恩替卡韦治疗 260 周前后进行配对肝活检的 CHB 患者。纤维化消退通过 Ishak 评分或 P-I-R 系统定义。患者分为 SVR（HBV DNA 持续<20IU/mL）或 LLV（HBV DNA 在 20 至 2000IU/mL 之间），进一步分为非常低水平病毒血症（VLLV，HBV DNA<50IU/mL）、偶尔 LLV（OLLV，HBV DNA 仅一次≥50IU/mL）和多次 LLV（MLLV，HBV DNA 多次≥50IU/mL）。使用逻辑回归模型计算调整后的优势比（aOR）和 95%置信区间（CI）。该分析包括 111 名 CHB 患者。在 SVR 组（n=54）中，39 名（72.2%）患者的纤维化得到缓解，高于 LLV 组（56.1%，p=0.080）。VLLV（30 例）、OLLV（17 例）和 MLLV（10 例）的纤维化缓解率分别为 70.0%、52.9%和 30.0%。与 SVR 相比，VLLV（aOR=0.78；95%CI：0.28-2.21；p=0.644）与纤维化缓解无关，但非 VLLV 患者（aOR=0.27；95%CI：0.09-0.85；p=0.025），特别是 MLLV 患者（aOR=0.19；95%CI：0.04-0.97；p=0.046）与纤维化缓解受阻显著相关。本研究表明，需要密切监测血清 HBV DNA 水平高于 50IU/mL 的患者，特别是那些多次出现该水平的患者。
ClinicalTrials.gov 标识符 NCT01938781 和 NCT01938820。
