Antiviral therapy in hepatitis B virus-infected children with immune-tolerant characteristics: A pilot open-label

Shishu Zhu1, Hongfei Zhang1, Yi Dong1

  • 1Pediatric Liver Diseases Therapy and Research Center, Beijing 302 Hospital, Beijing 100039, China.

Journal of Hepatology
|February 17, 2018
PubMed

Insights

Antiviral therapy using sequential interferon-α and lamivudine significantly improved outcomes for children with immune-tolerant chronic hepatitis B infection, leading to higher rates of undetectable HBV DNA and HBsAg loss.

Area of Science:

  • Hepatology
  • Virology
  • Pediatric Infectious Diseases

Background:

  • Chronic Hepatitis B Virus (HBV) infection in children, particularly the immune-tolerant phase (HBeAg positive, high viral load, normal ALT), presents a therapeutic challenge.
  • Optimal treatment strategies for immune-tolerant chronic hepatitis B (CHB) in pediatric populations remain largely undefined.
  • This study addresses the unmet need for effective antiviral interventions in this specific pediatric cohort.

Purpose of the Study:

  • To evaluate the efficacy and safety of antiviral therapy in children with immune-tolerant CHB.
  • To compare outcomes between children receiving sequential antiviral treatment and a control group.
  • To provide data on the benefits of interferon-α (IFN) and lamivudine (LAM) in this population.

Main Methods:

  • A pilot, open-label, randomized controlled study involving 69 treatment-naive children (1-16 years) with immune-tolerant CHB.
  • Random assignment in a 2:1 ratio to a treatment group (sequential IFN and LAM) or a control group.
  • Observation until week 96, with assessment of virological, serological, and clinical endpoints.

Main Results:

  • The treatment group showed significantly higher rates of undetectable serum HBV DNA (73.91%), HBeAg seroconversion (32.61%), and HBsAg loss (21.74%) compared to the control group.
  • No lamivudine (LAM) resistance was observed at week 96.
  • The control group had minimal spontaneous HBeAg seroconversion (4.35%) and no HBsAg clearance.

Conclusions:

  • Sequential antiviral therapy combining interferon-α (IFN) and lamivudine (LAM) is beneficial for children with immune-tolerant CHB.
  • This treatment regimen leads to significant improvements in viral suppression and serological markers.
  • The observed outcomes suggest a promising therapeutic approach for this challenging pediatric condition.
Abstract

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