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Prospective, randomized controlled trial of interferon-alpha in children with chronic hepatitis B
M Ruiz-Moreno1, M J Rua, J Molina
1Department of Pediatrics, Fundación Jiménez Díaz, Madrid, Spain.
Insights
Recombinant human interferon-alpha therapy effectively treated chronic hepatitis B in children. Fifty percent of treated children cleared hepatitis B virus DNA, showing significant improvement in liver health.
Area of Science:
- Hepatology
- Virology
- Pediatric Gastroenterology
Background:
- Chronic hepatitis B affects children worldwide.
- Recombinant human interferon-alpha is a potential therapeutic agent.
Purpose of the Study:
- To evaluate the efficacy of recombinant human interferon-alpha in treating chronic hepatitis B in children.
- To assess serological, biochemical, and histological outcomes.
Main Methods:
- A randomized controlled trial involving 36 children with chronic hepatitis B.
- Patients received either 10 MU/m2 or 5 MU/m2 of interferon-alpha 2b three times weekly for 6 months, or served as controls.
- Hepatitis B virus DNA, HBeAg, anti-HBe, aminotransferases, and liver histology were monitored.
Main Results:
- 50% of treated children (12/24) lost hepatitis B virus DNA from serum, compared to 17% (2/12) of controls.
- A statistically significant difference in response rate was observed between the higher dose interferon group and controls (p < 0.05).
- Treated patients who cleared HBV DNA showed HBeAg loss, anti-HBe seroconversion, improved liver histology, and normalization of ALT levels.
Conclusions:
- A 6-month course of interferon-alpha is effective in achieving remission in approximately 50% of children with chronic hepatitis B.
- Interferon-alpha therapy was well-tolerated in the pediatric population.
- The treatment induced significant serological, biochemical, and histological improvements.
Abstract:
Thirty-six children with chronic hepatitis B were entered into a randomized controlled trial of recombinant human interferon-alpha. All patients had hepatitis B virus DNA and increased levels of aminotransferases in serum for at least 1 yr. Twelve children received 10 MU of interferon-alpha 2b/m2 body surface area three times a week (group I); 12 children received 5 MU/m2 under the same conditions (group II); and 12 children served as controls (group III). During 6 mo of therapy, 12 of 24 (50%) treated patients (7 from group I, 58%, and 5 from group II, 42%) and 2 of 12 (17%) controls lost hepatitis B virus DNA from serum and subsequently remained negative. Comparison of the rate of response in group I vs. controls showed a statistically significant difference (p less than 0.05). Eleven of 12 (92%) treated patients who cleared hepatitis B virus DNA from serum lost HBeAg, seroconverted to anti-HBe and had improvement in liver histological findings with loss of hepatitis B virus DNA from liver. In 10, serum ALT levels became normal. Interferon-alpha was well tolerated and all children finished therapy. These findings indicate that a 6-mo course of interferon-alpha is effective in inducing a serological, biochemical and histological remission of disease in approximately 50% of children with chronic hepatitis B.