聚乙二醇干扰素的功效和安全性 慢性乙型肝炎患儿的Alfa-2a（

StephenW

Efficacy and Safety of Peginterferon  
Alfa-2a (40KD) in Children With Chronic
Hepatitis B: The PEG-B-ACTIVE Study
Stefan Wirth,1
* Hongfei Zhang,2
* Winita Hardikar,3
Kathleen B. Schwarz,4
Etienne Sokal,5
Weibo Yang,6
Huimin Fan,7  
Vyacheslav Morozov,8
Qing Mao,9
Hong Deng,10
Yang Huang,11
Lei Yang,11
Nicolas Frey,12
Clare Nasmyth-Miller,13  
Vedran Pavlovic,13
and Cynthia Wat
13
Children with chronic hepatitis B (CHB) represent an area of unmet medical need, attributed to increased lifetime risk of
CHB sequelae and limited therapeutic options compared with adult CHB patients. The PEG-B-ACTIVE (NCT01519960)
phase III study evaluated peginterferon (PegIFN) alfa-2a treatment in children aged 3 to <18 years with CHB. A total of 161
hepatitis B e antigen (HBeAg)-positive immune-active patients without advanced fibrosis (AF)/cirrhosis were randomized
(2:1) to PegIFN alfa-2a (Group A, n = 101) or no treatment (Group B, n = 50); patients with AF were assigned to PegIFN alfa-
2a (Group C, n = 10). PegIFN alfa-2a was administered for 48 weeks by body surface area (BSA) category, based on  
180 µg/1.73 m2. HBeAg seroconversion rates at 24 weeks posttreatment were significantly higher in Group A (25.7% vs. 6%;  
P = 0.0043), as were the rates of hepatitis B surface antigen (HBsAg) clearance (8.9% vs. 0%; P = 0.03), hepatitis B virus
(HBV) DNA <2,000 IU/mL (28.7% vs. 2.0%; P < 0.001) or undetectable (16.8% vs. 2.0%; P = 0.0069), and alanine ami-
notransferase (ALT) normalization (51.5% vs. 12%; P < 0.001). Safety, including incidence of ALT flares and neutropenia,
was comparable to the established PegIFN alfa-2a profile in HBV-infected adults or hepatitis C virus-infected children.
Changes in growth parameters were minimal during treatment and comparable to those in untreated patients. Safety and  
efficacy outcomes in Group C were in line with Group A. Conclusion: PegIFN alfa-2a treatment of children in the immune-
active phase of CHB was efficacious and well tolerated, and associated with higher incidence of HBsAg clearance than in
adults. This represents an important advance to the treatment options for children with CHB. (Hepatology 2018;00:1-14)

StephenW

聚乙二醇干扰素的功效和安全性
慢性乙型肝炎患儿的Alfa-2a（40KD）
乙型肝炎：PEG-B-ACTIVE研究
斯蒂芬沃斯，
1
* Hongfei Zhang，
2
* Winita Hardikar，
3
Kathleen B. Schwarz，
4
Etienne Sokal，
五
杨微博，
6
范惠民，
7
  
维亚切斯拉夫莫罗佐夫，
8
清毛，
9
洪登，
10
杨黄，
11
雷阳
11
尼古拉斯·弗雷
12
克莱尔·纳西米 - 米勒，
13
  
Vedran Pavlovic，
13
和辛西娅·笏
13
患有慢性乙型肝炎（CHB）的儿童代表了医疗需求未得到满足的领域，这归因于终身患病风险增加
与成人CHB患者相比，CHB后遗症和有限的治疗选择。 PEG-B-ACTIVE（NCT01519960）
III期研究评估了聚乙二醇干扰素（PegIFN）α-2a治疗患有CHB的3岁至18岁儿童。共161个
无晚期纤维化（AF）/肝硬化的乙型肝炎和抗原（HBeAg）阳性免疫活性患者随机分组
（2：1）PegIFNα-2a（A组，n = 101）或不处理（B组，n = 50）; AF患者被分配到PegIFN alfa-
2a（C组，n = 10）。 PegIFNα-2a按体表面积（BSA）类别给药48周，基于
180微克/1.73米
2
。 A组治疗后24周HBeAg血清转换率显着升高（25.7％vs。6％;
P = 0.0043），乙型肝炎病毒表面抗原（HBsAg）清除率（8.9％对0％; P = 0.03），乙型肝炎病毒
（HBV）DNA <2,000 IU / mL（28.7％vs。2.0％; P <0.001）或检测不到（16.8％vs。2.0％; P = 0.0069），丙氨酸氨基酸
非转移酶（ALT）正常化（51.5％对比12％，P <0.001）。安全性，包括ALT发作和中性粒细胞减少的发生率，
与HBV感染的成人或丙型肝炎病毒感染的儿童中已建立的PegIFNα-2a谱相当。
治疗期间生长参数的变化最小，与未治疗患者相当。安全和
C组的结果与A组一致。结论：PegIFNα-2a治疗儿童免疫 -
CHB的活性期有效且耐受性良好，并且与HBsAg清除率相比具有更高的发生率
成年人。这代表了CHB患儿治疗方案的重要进展。 （H2018; 00：1-14）

StephenW

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