聚乙二醇干扰素 α-2b 在慢性乙型肝炎病毒感染优势人群中诱导的临床治愈：一项回顾性队列研究。
Clinical cure induced by pegylated interferon α-2b in the advantaged population of chronic hepatitis B virus infection: a retrospective cohort study.
机构信息
Department of Infectious Diseases, Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
出版信息
Front Cell Infect Microbiol. 2024 Jan 16;13:1332232. doi: 10.3389/fcimb.2023.1332232. eCollection 2023.
BACKGROUND
Among the advantaged population with clinical cure of chronic hepatitis B, chronic inactive hepatitis B virus carriers (IHCs) and nucleoside analog-experienced patients have similar serological manifestations. This study established non-interferon-treated groups as controls to compare the efficacy of pegylated interferon α-2b (Peg-IFNα-2b) in achieving clinical cure between IHCs and nucleoside analog (NA)-experienced patients.
METHOD
A total of 270 patients were enrolled in this observational study. The IHC cohort comprised 55 patients who received Peg-IFNα-2b (Peg-IFN group), and the other 70 patients did not receive any antiviral treatment (untreated group). Patients treated with NAs were divided into two groups: one group (70 patients) receiving NA add-on Peg-IFNα-2b therapy regimen (NA add-on Peg-IFN group) and another group (75 patients) receiving continuous NA monotherapy (NA group). The primary endpoints were hepatitis B surface antigen (HBsAg) clearance and HBsAg seroconversion at 48 weeks and 72 weeks.
RESULTS
At 48 weeks, 65.5% (36/55) and 52.9% (37/70) patients achieved HBsAg clearance in the Peg-IFN group and NA add-on Peg-IFN group, respectively (p = 0.156). HBsAg seroconversion was achieved in 47.3% (26/55) of the Peg-IFN group and 34.3% (24/70) of the NA add-on Peg-IFN group (p = 0.141). At the follow-up of 72 weeks, 36 patients in the Peg-IFN group achieved HBsAg loss (65.5%, 36/55), and 33 patients in the NA add-on Peg-IFN group achieved HBsAg clearance (47.1%, 33/70), which were significantly higher than in the Peg-IFN group (p = 0.041). The HBsAg seroconversion rates in the Peg-IFN group and NA add-on Peg-IFN group at 72 weeks were 45.5% (25/55) and 32.9% (23/70), respectively (p = 0.151). No patient achieved HBsAg clearance or seroconversion in the NA group and untreated group. Furthermore, the receiver operating characteristic curve showed baseline HBsAg< 72 IU/mL, and the decline of HBsAg of more than 80% and 98% from baseline to 12 and 24 weeks provided good predictions for HBsAg clearance. Meanwhile, 77% of patients with baseline HBsAg< 100 IU/mL achieved a clinical cure at 48 weeks.
CONCLUSION
Peg-IFNα-2b results in a high rate of HBsAg clearance and seroconversion in both IHCs and NA-experienced patients, especially for those patients who have HBsAg below 100 IU/mL.
背景
在慢性乙型肝炎临床治愈的优势人群中，慢性乙型肝炎病毒携带者（IHC）和核苷（酸）类似物经治患者具有相似的血清学表现。本研究建立未接受干扰素治疗的患者作为对照，比较聚乙二醇干扰素α-2b（Peg-IFNα-2b）在 IHC 和核苷（酸）类似物（NA）经治患者中实现临床治愈的疗效。
方法
共纳入 270 例患者进行这项观察性研究。IHC 队列包括 55 例接受 Peg-IFNα-2b 治疗的患者（Peg-IFN 组），另一组 70 例未接受任何抗病毒治疗（未治疗组）。NA 经治患者分为两组：一组（70 例）接受 NA 联合 Peg-IFNα-2b 治疗方案（NA 联合 Peg-IFN 组），另一组（75 例）接受连续 NA 单药治疗（NA 组）。主要终点为第 48 周和第 72 周时乙型肝炎表面抗原（HBsAg）清除和 HBsAg 血清学转换。
结果
第 48 周时，Peg-IFN 组和 NA 联合 Peg-IFN 组分别有 65.5%（36/55）和 52.9%（37/70）的患者达到 HBsAg 清除（p=0.156）。Peg-IFN 组和 NA 联合 Peg-IFN 组的 HBsAg 血清学转换率分别为 47.3%（26/55）和 34.3%（24/70）（p=0.141）。随访至第 72 周时，Peg-IFN 组有 36 例患者达到 HBsAg 丢失（65.5%，36/55），NA 联合 Peg-IFN 组有 33 例患者达到 HBsAg 清除（47.1%，33/70），均显著高于 Peg-IFN 组（p=0.041）。第 72 周时，Peg-IFN 组和 NA 联合 Peg-IFN 组的 HBsAg 血清学转换率分别为 45.5%（25/55）和 32.9%（23/70）（p=0.151）。NA 组和未治疗组均无患者达到 HBsAg 清除或血清学转换。此外，受试者工作特征曲线显示，基线 HBsAg<72 IU/ml，以及基线至 12 周和 24 周时 HBsAg 下降超过 80%和 98%，对 HBsAg 清除有良好的预测作用。同时，基线 HBsAg<100 IU/ml 的患者有 77%在第 48 周达到临床治愈。
结论
Peg-IFNα-2b 可使 IHC 和 NA 经治患者获得较高的 HBsAg 清除率和血清学转换率，尤其是 HBsAg 水平<100 IU/ml 的患者。
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