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Efficacy and Safety of Peginterferon Alfa-2a (40KD) in Children With Chronic Hepatitis B: The PEG-B-ACTIVE Study

Stefan Wirth1, Hongfei Zhang2, Winita Hardikar3

  • 1Department of Pediatrics, Helios Medical Center Wuppertal, Witten-Herdecke University, Germany.

Hepatology (Baltimore, Md.)
|April 25, 2018
PubMed

Insights

Peginterferon alfa-2a effectively treats chronic hepatitis B in children, showing higher rates of hepatitis B surface antigen clearance and viral DNA suppression. This treatment is well-tolerated, offering a vital new option for pediatric patients.

Area of Science:

  • Hepatology
  • Pediatric Gastroenterology
  • Virology

Background:

  • Chronic hepatitis B (CHB) in children presents unique challenges due to increased long-term risks and limited treatment options.
  • Pediatric CHB patients face a higher lifetime risk of sequelae compared to adults.
  • Existing therapies for CHB in children are scarce, highlighting an unmet medical need.

Purpose of the Study:

  • To evaluate the efficacy and safety of peginterferon (PegIFN) alfa-2a in children aged 3 to <18 years with CHB.
  • To assess treatment outcomes including hepatitis B e antigen (HBeAg) seroconversion, hepatitis B surface antigen (HBsAg) clearance, and viral load reduction.
  • To compare outcomes in children receiving PegIFN alfa-2a with untreated controls and evaluate safety profiles.

Main Methods:

  • The phase III PEG-B-ACTIVE study randomized 161 HBeAg-positive, immune-active CHB patients without advanced fibrosis to PegIFN alfa-2a or no treatment.
  • A separate group (Group C) of 10 patients with advanced fibrosis received PegIFN alfa-2a.
  • Treatment involved 48 weeks of PegIFN alfa-2a administration based on body surface area (BSA).

Main Results:

  • Significantly higher HBeAg seroconversion rates were observed in the PegIFN alfa-2a group (25.7% vs. 6%, P = 0.0043).
  • Hepatitis B surface antigen (HBsAg) clearance (8.9% vs. 0%, P = 0.03) and viral DNA suppression (HBV DNA <2,000 IU/mL: 28.7% vs. 2.0%, P < 0.001) were significantly improved.
  • Alanine aminotransferase (ALT) normalization occurred in 51.5% of treated patients versus 12% in controls (P < 0.001).

Conclusions:

  • Peginterferon alfa-2a is an effective and well-tolerated treatment for children in the immune-active phase of CHB.
  • The study demonstrated superior efficacy in achieving HBsAg clearance compared to adult treatment data.
  • PegIFN alfa-2a offers a significant advancement in therapeutic options for pediatric chronic hepatitis B.

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