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Clinical trial of lamivudine in children with chronic hepatitis B

Maureen M Jonas1, Deirdre A Kelley, Jacek Mizerski

  • 1of Gastroenterology, Children's Hospital, Boston, MA 02115, USA.

The New England Journal of Medicine
|May 31, 2002
PubMed

Insights

Lamivudine treatment for children with chronic hepatitis B infection showed a higher virologic response rate compared to placebo over 52 weeks. This antiviral therapy was well-tolerated and effective in pediatric patients.

Area of Science:

  • Pediatric Hepatology
  • Viral Hepatitis Treatment
  • Antiviral Therapies

Background:

  • Chronic hepatitis B virus (HBV) infection affects children globally.
  • Lamivudine is an established treatment for adult chronic hepatitis B.
  • Pediatric efficacy and safety data for lamivudine were previously limited.

Purpose of the Study:

  • To evaluate the efficacy and tolerability of lamivudine in children with chronic HBV infection.
  • To determine the virologic response rate at 52 weeks of lamivudine treatment in pediatric patients.
  • To assess secondary endpoints including seroconversion and liver enzyme normalization.

Main Methods:

  • A randomized, double-blind, placebo-controlled trial was conducted.
  • Children with chronic hepatitis B were randomized to receive lamivudine or placebo for 52 weeks.
  • Virologic response was defined as the absence of hepatitis B e antigen and HBV DNA at week 52.

Main Results:

  • A total of 191 children received lamivudine and 97 received placebo.
  • Virologic response was significantly higher in the lamivudine group (23%) compared to placebo (13%) (P=0.04).
  • Lamivudine was well-tolerated and improved seroconversion rates, normalized ALT levels, and suppressed HBV DNA.

Conclusions:

  • Fifty-two weeks of lamivudine treatment significantly improved virologic response in children with chronic hepatitis B.
  • Lamivudine represents a safe and effective therapeutic option for pediatric chronic hepatitis B.
  • This study supports the use of lamivudine in managing chronic HBV infection in pediatric populations.
Abstract

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