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Thématique :
- Foie
Originalité :
Réexamen
Solidité :
Intermédiaire
Doit faire évoluer notre pratique :
Dans certains cas
 
 
Nom du veilleur :
Professeur Christine SILVAIN
Coup de coeur :
 
 
Hepatology
  2018/11  
 
  2018 Nov;68(5):1681-1694.  
  doi: 10.1002/hep.30050  
 
  Efficacy and Safety of Peginterferon Alfa-2a (40KD) in Children With Chronic Hepatitis B: The PEG-B-ACTIVE Study.  
 
  Wirth S, Zhang H, Hardikar W, Schwarz KB, Sokal E, Yang W, Fan H, Morozov V, Mao Q, Deng H, Huang Y, Yang L, Frey N, Nasmyth-Miller C, Pavlovic V, Wat C  
  https://www.ncbi.nlm.nih.gov/pubmed/29689122  
 
 

Abstract

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 aminotransferase (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.

 

 
Question posée
 
Evaluation du traitement par interféron pégylé (PegIFN) alfa-2a pendant 48 semaines des enfants âgés de 3 à 18 ans ayant hépatite chronique virale B, AgHBe positif et sans fibrose sévère : randomisation traitement versus pas de traitement. Les enfants avec fibrose sévère étaient tous traités.
 
Question posée
 
A 24 semaines post-traitement, les taux de séroconversion AgHBe étaient plus élevés chez les enfants traités (25,7% vs. 6%) de même que la clearance de l’AgHBs (8,9% vs. 0%), l’ADN VHB<2,000 IU/mL (28,7% vs. 2,0%) ou non détectable (16,8% vs. 2,0%) et la normalisation de l’ALAT (51,5% vs. 12%). La tolérance était bonne sans conséquence sur la croissance.
 
Commentaires

Traitement à considérer chez les enfants ayant une hépatite chronique virale B à virus sauvage et fibrose hépatique.

 
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