建立基于聚乙二醇干扰素α治疗的 HBeAg 阴性慢性乙型肝炎患者功能性治愈的多参数预测模型及基于应答指导治疗策略的决策流程。

Establishment of a multi-parameter prediction model for the functional cure of HBeAg-negative chronic hepatitis B patients treated with pegylated interferonα and decision process based on response-guided therapy strategy.

机构信息

Department of Infectious Diseases, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678, Hefei, 230601, Anhui, China.

Department of Infectious Diseases, The First Affiliated Hospital of Anhui Medical University, Hefei, China.

出版信息

BMC Infect Dis. 2023 Jul 10;23(1):456. doi: 10.1186/s12879-023-08443-1.

BACKGROUND & AIMS: This study aimed to establish multivariate prediction models according to a response-guided therapy (RGT) based strategy at baseline and week 12 and 24 of follow-up to predict the functional cure for HBeAg-negative patients with chronic hepatitis B (CHB) treated with pegylated interferonα (PEG-IFNα).

METHODS

A total of 242 HBeAg-negative patients with CHB were treated with PEG-IFNα for 52 weeks and followed up for 24 weeks. Responses at the end of follow-up (EOF) were defined as hepatitis B surface antigen (HBsAg) loss, and patients were defined as either responders or non-responders.

RESULTS

The three most meaningful predictors were an age ≤ 40 years, alanine aminotransferase (ALT) levels ≤ 40 U/L, and HBsAg levels ≤ 100 IU/mL at baseline; ALT levels ≥ 80 U/L, anti-HBc levels ≤ 8.42 S/CO, and HBsAg levels ≤ 50 IU/mL at week 12; and ALT levels ≥ 40 U/L, anti-HBc levels ≤ 8.46 S/CO, and HBsAg levels ≤ 0.2 IU/mL at week 24. The response rates of patients with a score of 0-1 and 4-5 at baseline, week 12, and 24 were 13.5%, 7.8%, and 11.7%; and 63.6%, 68.1%, and 98.1%, respectively. At week 12, the cumulative scores were 0-2, 3-4, 5-7, and 8-10 (response rates 5.0%, 18.9%, 41.3%, and 71.4%, respectively). At week 24, the cumulative scores were 0-3, 4-6, 7-10, and 11-15 (response rates: 1.3%, 12.3%, 37.0%, and 92.5%, respectively). At baseline, patients with scores of 0-1 were slightly recommended; at week 12, patients with 0-1 or 0-2 cumulative scores were recommended to stop treatment. At week 24, patients with a score of 0-1 or a cumulative score of 0-6 were recommended to stop treatment.

CONCLUSION

We established a multi-parameter prediction model for the functional cure of HBeAg-negative patients with CHB treated with PEG-IFNα.

背景与目的

本研究旨在根据基于应答指导治疗（RGT）的策略，建立基线、随访 12 周和 24 周的多变量预测模型，以预测接受聚乙二醇干扰素α（PEG-IFNα）治疗的 HBeAg 阴性慢性乙型肝炎（CHB）患者的功能性治愈。

方法

242 例 HBeAg 阴性 CHB 患者接受 PEG-IFNα 治疗 52 周，并随访 24 周。随访结束时的应答（EOF）定义为乙型肝炎表面抗原（HBsAg）丢失，将患者定义为应答者或无应答者。

结果

三个最有意义的预测因素是基线时年龄≤40 岁、丙氨酸氨基转移酶（ALT）水平≤40 U/L 和 HBsAg 水平≤100 IU/mL；第 12 周时 ALT 水平≥80 U/L、抗-HBc 水平≤8.42 S/CO 和 HBsAg 水平≤50 IU/mL；第 24 周时 ALT 水平≥40 U/L、抗-HBc 水平≤8.46 S/CO 和 HBsAg 水平≤0.2 IU/mL。基线、第 12 周和第 24 周时评分分别为 0-1 和 4-5 的患者的应答率分别为 13.5%、7.8%和 11.7%；63.6%、68.1%和 98.1%。第 12 周时，累积评分分别为 0-2、3-4、5-7 和 8-10（应答率分别为 5.0%、18.9%、41.3%和 71.4%）。第 24 周时，累积评分分别为 0-3、4-6、7-10 和 11-15（应答率分别为 1.3%、12.3%、37.0%和 92.5%）。基线时，评分 0-1 的患者略有推荐；第 12 周时，推荐评分 0-1 或 0-2 的患者停止治疗。第 24 周时，推荐评分 0-1 或累积评分 0-6 的患者停止治疗。