Liver Research Center, Beijing Key Laboratory of Translational Medicine On Liver Cirrhosis, Beijing Friendship Hospital, National Clinical Research Center of Digestive Diseases, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing, 100050, China.
Department of Pathology, Beijing You-an Hospital, Capital Medical University, Beijing, China.
Hepatol Int. 2021 Jun;15(3):611-620. doi: 10.1007/s12072-021-10162-1. Epub 2021 Mar 7.
Antiviral treatment with necleos(t)ide analogues contributes to histological improvement and virologic response in chronic hepatitis B (CHB) patients. However, whether adding pegylated interferon alpha2a (Peg-IFN-α-2a) can help additional clinical benefit, particularly on fibrosis regression was still unknown.
Chronic hepatitis B patients with pre-treatment biopsy-proven Ishak fibrosis score 2, 3 or 4 were randomly assigned to entecavir (ETV) alone or ETV plus Peg-IFN-α-2a (Peg-IFN-α-2a add-on) group (1:2 ratio). Post-treatment liver biopsy was performed at week 78. Fibrosis regression was defined as decrease in Ishak fibrosis score by ≥ 1 stage or predominantly regressive categorized by P-I-R score. Serum HBV DNA levels were assessed at baseline and every 26 weeks, while HBsAg and HBeAg were evaluated at baseline and every 52 weeks.
A total of 218 treatment-naive CHB patients were randomly assigned to ETV alone or Peg-IFN-α-2a add-on group. Totals of 155 patients (ETV alone: Peg-IFN-α-2a add-on, 47:108) were included in statistical analysis. Fibrosis regression rates were 68% (32/47) in the ETV alone and 56% (60/108) in Peg-IFN-α-2a add-on group (p = 0.144). Both groups showed a similar trend of virological suppression during the process of 104-week antiviral therapy (p = 0.132). HBeAg or HBsAg loss or seroconversion rates in the ETV alone group were lower than Peg-IFN-α-2a add-on group though without statistical significance.
Peg-IFN-α-2a add-on therapy did not yield additional fibrosis regression and virologic response than ETV alone therapy.
核苷（酸）类似物抗病毒治疗可改善慢性乙型肝炎（CHB）患者的组织学和病毒学应答。然而，加用聚乙二醇干扰素 α2a（Peg-IFN-α-2a）是否能带来额外的临床获益，尤其是在肝纤维化逆转方面，目前仍不清楚。
对治疗前肝活检证实为 Ishak 纤维化评分 2、3 或 4 的慢性乙型肝炎患者进行随机分组，分别接受恩替卡韦（ETV）单药治疗或 ETV 联合 Peg-IFN-α-2a（Peg-IFN-α-2a 加用）治疗（1:2 比例）。治疗 78 周时进行肝活检。纤维化缓解定义为 Ishak 纤维化评分降低≥1 级或按 P-I-R 评分主要为逆转。基线和每 26 周评估血清 HBV DNA 水平，基线和每 52 周评估 HBsAg 和 HBeAg。
共纳入 218 例初治 CHB 患者，随机分配至 ETV 单药或 Peg-IFN-α-2a 加用组。共有 155 例患者（ETV 单药组：Peg-IFN-α-2a 加用组，47:108）纳入统计分析。ETV 单药组的纤维化缓解率为 68%（32/47），Peg-IFN-α-2a 加用组为 56%（60/108）（p=0.144）。两组在 104 周抗病毒治疗过程中均显示出类似的病毒学抑制趋势（p=0.132）。尽管 ETV 单药组的 HBeAg 或 HBsAg 丢失或血清学转换率低于 Peg-IFN-α-2a 加用组，但无统计学意义。
与 ETV 单药治疗相比，加用 Peg-IFN-α-2a 治疗并未带来额外的肝纤维化缓解和病毒学应答。
