Pediatric issues in new therapies for hepatitis B and C
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1Department of Pediatric Gastroenterology and Nutrition, Johns Hopkins Children's Center, 600 North Wolfe Street, Brady 320, Baltimore, MD 21287, USA. kschwarz@jhmi.edu
Insights
Two FDA-approved antiviral treatments exist for pediatric hepatitis B virus (HBV) infection: interferon-alpha (IFN) and lamivudine. Both show efficacy in reducing viral load and HBeAg, but lamivudine use is associated with drug resistance.
Area of Science:
- Pediatric Hepatology
- Viral Hepatitis Treatment
- Pharmacology
Background:
- Hepatitis B virus (HBV) and hepatitis C virus (HCV) are significant pediatric health concerns.
- Limited FDA-approved antiviral therapies exist for children with HBV infection.
- No FDA-approved treatments are available for pediatric HCV infection.
Purpose of the Study:
- To review current FDA-approved antiviral treatments for pediatric HBV infection.
- To discuss reported treatment outcomes and challenges for HBV and HCV in children.
- To highlight the need for further research and clinical trials in pediatric viral hepatitis.
Main Methods:
- Review of FDA-approved antiviral treatments for pediatric HBV: interferon-alpha (IFN) and lamivudine.
- Analysis of published data on treatment efficacy, including viral DNA negativity and HBeAg seroconversion.
- Examination of treatment approaches for pediatric HCV, including IFN monotherapy and combination therapy.
Main Results:
- Interferon-alpha (IFN) achieved HBV DNA negativity in 26-58% and HBeAg negativity in up to 38% of pediatric patients.
- Lamivudine demonstrated comparable HBeAg to anti-HBe seroconversion rates and HBV DNA clearance in 50-65% of children.
- Lamivudine treatment led to YMDD mutant development in 16-32% of patients annually; loss of surface antigen was rare (<5%).
- HCV treatment in children involves IFN monotherapy or combination therapy with ribavirin, with ongoing trials for PEG-IFN.
Conclusions:
- Both IFN and lamivudine are viable options for pediatric HBV, each with specific efficacy and resistance profiles.
- Optimal treatment strategies for pediatric HCV are still under investigation, emphasizing the need for randomized controlled trials.
- Further research is crucial to establish evidence-based guidelines for treating viral hepatitis in children.
Abstract:
Two antiviral treatments have been approved for hepatitis B virus (HBV) infection by the US Food and Drug Administration (FDA) for use in children: interferon (IFN)-alpha, 6 MU/m(2) three times a week subcutaneously for 6 months, and lamivudine, 3 mg/kg/d orally for 12 months. Twenty-six percent to 58% of children treated with IFN become HBV DNA negative, and up to 38% become negative to hepatitis B e antigen (HBeAg). Lamivudine, a nucleoside analogue that blocks viral replication by inhibition of the HBV polymerase, has been associated with comparable rates of seroconversion of HBeAg to anti-HBe. Loss of surface antigen occurs in less than 5% of patients treated with lamivudine, compared with 3% to 33% in those treated with IFN-alpha. Fifty percent to 65% of children treated with lamivudine clear HBV DNA after 12 months of therapy, but relapse rates have not been clarified. Patients treated with lamivudine develop drug-resistant (YMDD) mutants in the HBV polymerase at the rate of 16% to 32% per year. No treatments for children with hepatitis C virus (HCV) have been approved by the FDA. However, published reports describe treatment with IFN monotherapy and combination therapy with IFN and ribavirin. Trials of PEG-IFN alone or in combination with ribavirin are in progress. Given the lack of data regarding treatment of HCV in children, it is generally agreed among pediatric hepatologists that the optimal treatment is within the context of randomized, controlled trials.
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