Mak Lung-Yi, Wong Danny Ka-Ho, Cheung Ka-Shing, Seto Wai-Kay, Fung James, Yuen Man-Fung
Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Pokfulam Road 102,, Pok Fu Lam, Hong Kong.
State Key Laboratory of Liver Research, The University of Hong Kong, Pok Fu Lam, Hong Kong.
BMC Gastroenterol. 2021 Mar 17;21(1):123. doi: 10.1186/s12876-021-01711-x.
BACKGROUND: Serum hepatitis B core-related antigen (HBcrAg) is a potential surrogate marker for intra-hepatic covalently-closed circular DNA in chronic hepatitis B (CHB). We aimed to study the profiles of serum HBcrAg in CHB patients treated with first-line nucleos(t)ide analogues (NA): entecavir (ETV), tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF). METHOD: Serum HBcrAg was measured in 120 treatment-naïve CHB patients receiving one of the 3 NAs (ETV: TDF: TAF = 60: 26: 34) using the Lumipulse G HBcrAg assay in a Lumipulse G1200 analyzer (Fujirebio Inc, Toyko, Japan). Serum HBcrAg levels were measured at week 0, week 48 and week 96 of NA therapy. RESULTS: Among the 120 patients, 67 (55.8%) were hepatitis B e antigen (HBeAg) positive. Both tenofovir and ETV led to significantly lower serum HBcrAg at week 48 and week 96 compared to week 0. There were no significant differences for the magnitude of median HBcrAg decline at week 96 between tenofovir and ETV in HBeAg-positive (2.28 vs. 1.65 log U/mL, p > 0.05) and HBeAg-negative (0.83 vs. 0.54 log U/mL, p > 0.05) patients. TDF and TAF produced no significant differences in the magnitude of median HBcrAg decline at week 96 (HBeAg-positive: 2.63 vs. 1.83, respectively; HBeAg-negative: 1.04 vs. 0.40, respectively; both p > 0.05). CONCLUSION: Magnitude of reduction of HBcrAg levels after 2-year first-line treatment did not differ statistically among the current first-line NAs, although HBcrAg reduction was numerically greater in tenofovir-treated group. More long-term studies are essential to determine whether tenofovir exerts a more pronounced effect on HBcrAg.
背景：血清乙肝核心相关抗原（HBcrAg）是慢性乙型肝炎（CHB）肝内共价闭合环状DNA的潜在替代标志物。我们旨在研究接受一线核苷（酸）类似物（NA）治疗的CHB患者的血清HBcrAg情况，这些一线NA包括恩替卡韦（ETV）、富马酸替诺福韦二吡呋酯（TDF）或替诺福韦艾拉酚胺（TAF）。 方法：使用Lumipulse G HBcrAg检测法在Lumipulse G1200分析仪（日本东京富士瑞必欧株式会社）上对120例初治CHB患者进行血清HBcrAg检测，这些患者接受三种NA中的一种治疗（ETV：TDF：TAF = 60：26：34）。在NA治疗的第0周、第48周和第96周测量血清HBcrAg水平。 结果：120例患者中，67例（55.8%）乙肝e抗原（HBeAg）阳性。与第0周相比，替诺福韦和ETV在第48周和第96周均导致血清HBcrAg显著降低。在HBeAg阳性患者（2.28对1.65 log U/mL，p>0.05）和HBeAg阴性患者（0.83对0.54 log U/mL，p>0.05）中，第96周替诺福韦和ETV的HBcrAg中位数下降幅度无显著差异。TDF和TAF在第96周的HBcrAg中位数下降幅度无显著差异（HBeAg阳性：分别为2.63对1.83；HBeAg阴性：分别为1.04对0.40；均p>0.05）。 结论：尽管替诺福韦治疗组的HBcrAg降低数值更大，但在目前的一线NA中，经过2年一线治疗后HBcrAg水平降低幅度在统计学上无差异。需要更多长期研究来确定替诺福韦对HBcrAg是否有更显著的影响。
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