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)作者: StephenW 时间: 2018-10-11 15:42