Efficacy of Peginterferon alfa-2b in Nucleoside Analogue Experienced Patients with Negative HBeAg and Low HBsAg: A Non-Randomized Clinical Trial,Infectious Diseases and Therapy

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Efficacy of Peginterferon alfa-2b in Nucleoside Analogue Experienced Patients with Negative HBeAg and Low HBsAg: A Non-Randomized Clinical Trial
Infectious Diseases and Therapy ( IF 4.7 ) Pub Date : 2021-07-25 , DOI: 10.1007/s40121-021-00497-5
Jun Chen _{1,

2} , Min Qi ₁ , Xue-Gong Fan _{1,

2} , Xing-Wang Hu _{1,

2} , Cheng-Jin Liao ₁ , Li-Yuan Long ₁ , Xiao-Ting Zhao ₁ , Min Tan ₁ , Hai-Fu Li ₁ , Ruo-Chan Chen _{1,

2} , Ze-Bing Huang _{1,

2} , Yan Huang _{1,

2}

Affiliation

Introduction

Hepatitis B surface antigen (HBsAg) clearance is the treatment goal for hepatitis B e antigen (HBeAg)-negative patients with chronic hepatitis B (CHB). However, its rate is extremely low with nucleoside (acid) analogues (NAs) monotherapy. Peginterferon could enhance HBsAg clearance. This study aimed to evaluate the efficacy of peginterferon alfa-2b (PegIFNα-2b) in NAs-experienced patients with CHB with negative HBeAg and low HBsAg level.

Methods

HBeAg-negative patients with CHB who had received NAs therapy over 24 weeks with HBsAg < 1500 IU/mL and HBV DNA < 100 IU/mL were enrolled. Patients received either PegIFNα-2b add-on therapy (n = 108) or continuous NAs monotherapy (n = 75). The primary endpoint was HBsAg clearance rate at week 48.

Results

At week 48, serum HBV DNA was undetectable among all PegIFNα-2b add-on therapy patients. Almost all patients maintained HBV DNA suppression in the PegIFNα-2b add-on group (100%, 108/108) and NAs monotherapy group (97.33%, 73/75). Only patients with PegIFNα-2b add-on therapy achieved HBsAg clearance (50.93%, 55/108) and HBsAg seroconversion (48.15%, 52/108) at week 48. Patients with baseline HBsAg < 100 IU/mL achieved the highest HBsAg clearance rate and HBsAg seroconversion rate at week 48 (60.87%, 28/46 and 58.70%, 27/46 respectively). HBsAg clearance and HBsAg seroconversion at week 72 had no significant difference with continuing or discontinuing PegIFNα-2b therapy after 48 weeks of treatment. PegIFNα-2b add-on therapy was well tolerated.

Conclusions

PegIFNα-2b add-on therapy increases HBsAg clearance rate and seroconversion rate for HBeAg-negative patients with CHB, particularly for those with lower HBsAg level. It would be unnecessary to prolong PegIFNα-2b duration after 48 weeks of PegIFNα-2b treatment.

中文翻译：

Peginterferon alfa-2b 对 HBeAg 阴性和低 HBsAg 的核苷类似物经验丰富的患者的疗效：一项非随机临床试验

介绍

乙型肝炎表面抗原（HBsAg）清除是乙型肝炎e抗原（HBeAg）阴性慢性乙型肝炎（CHB）患者的治疗目标。然而，核苷（酸）类似物（NAs）单一疗法的发生率极低。聚乙二醇干扰素可增强 HBsAg 清除率。本研究旨在评估聚乙二醇干扰素 alfa-2b (PegIFNα-2b) 在 HBeAg 阴性且 HBsAg 水平低的 NAs 经验型 CHB 患者中的疗效。

方法

HBeAg 阴性 CHB 患者接受 NAs 治疗超过 24 周，HBsAg < 1500 IU/mL 和 HBV DNA < 100 IU/mL。患者接受 PegIFNα-2b 附加治疗（n = 108）或连续 NAs 单药治疗（n = 75）。主要终点是第 48 周的 HBsAg 清除率。

结果

在第 48 周时，在所有 PegIFNα-2b 附加治疗患者中检测不到血清 HBV DNA。在 PegIFNα-2b 添加组 (100%, 108/108) 和 NAs 单药治疗组 (97.33%, 73/75) 中，几乎所有患者都保持了 HBV DNA 抑制。只有接受 PegIFNα-2b 附加治疗的患者在第 48 周达到 HBsAg 清除率（50.93%，55/108）和 HBsAg 血清学转换（48.15%，52/108）。基线 HBsAg < 100 IU/mL 的患者达到最高 HBsAg 清除率率和 HBsAg 血清学转换率在第 48 周（分别为 60.87%、28/46 和 58.70%、27/46）。治疗 48 周后，HBsAg 清除率和 HBsAg 血清学转换与继续或停止 PegIFNα-2b 治疗没有显着差异。PegIFNα-2b 附加疗法的耐受性良好。