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Placebo-controlled trial of recombinant alpha 2-interferon in Chinese HBsAg-carrier children
Insights
Recombinant alpha 2-interferon (r-IFN) treatment in Chinese children with chronic hepatitis B showed temporary reductions in viral markers. However, long-term benefits on hepatitis B surface antigen (HBsAg) carriage were not observed.
Area of Science:
- Hepatology
- Virology
- Pediatric Infectious Diseases
Background:
- Chronic hepatitis B virus (HBV) infection is a significant health concern in children.
- Hepatitis B e antigen (HBeAg) and HBV DNA polymerase (HBV DNAp) are key markers of viral replication.
- Recombinant alpha 2-interferon (r-IFN) has been explored as a treatment for chronic HBV.
Purpose of the Study:
- To evaluate the efficacy of r-IFN in treating chronic hepatitis B in Chinese children.
- To assess the impact of r-IFN on viral markers including HBeAg, HBV DNAp, and HBV DNA.
Main Methods:
- A randomized trial involving 24 Chinese children (1.5-5 years) positive for HBsAg, HBeAg, HBV DNAp, and HBV DNA.
- Children received either vitamin B complex (placebo) or intramuscular r-IFN (10 x 10^6 IU/m2 thrice weekly for 12 weeks).
- Viral markers were monitored for 18 months.
Main Results:
- r-IFN treatment led to a temporary decrease in HBV DNAp and HBV DNA levels in all treated children.
- These viral markers returned to pre-trial levels within 4 weeks of treatment cessation in most subjects.
- Sustained loss of HBV DNAp and HBV DNA was observed in 2 children receiving r-IFN and 2 in the placebo group; one child in each group lost HBeAg.
Conclusions:
- r-IFN at the tested dose was safe for Chinese children with chronic hepatitis B, with minimal side effects.
- The treatment did not demonstrate long-term beneficial effects on HBsAg carriage.
- Temporary suppression of viral replication occurred, but sustained viral clearance was not achieved.
Abstract:
24 Chinese children aged 1.5-5 years and positive for hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B virus DNA polymerase (HBV DNAp), and HBV DNA on at least three occasions in the 6 months before the trial were randomised to receive either vitamin B complex or intramuscular recombinant alpha 2-interferon (r-IFN) ('Roferon') 10 X 10(6) IU/m2 thrice weekly for 12 weeks. In all 12 subjects receiving r-IFN, HBV DNAp and HBV DNA levels fell during the course of r-IFN injections. Within 4 weeks of cessation of r-IFN injection, the HBV DNAp and HBV DNA returned to pre-trial levels except in 2 subjects, in whom loss of HBV DNAp and HBV DNA was sustained for up to 18 months from onset of the trial. 1 child lost HBeAg at 18 months. 2 of the 12 children in the placebo group also had a sustained loss of HBV DNAp and HBV DNA during the 18 months, with 1 child losing HBeAg at 18 months. All 24 subjects remained positive for HBsAg. r-IFN produced very slight side-effects except for pyrexia and the "flu" syndrome, both of which showed rapid tachyphylaxis. In the dose given r-IFN was safe but had no long-term beneficial effects on HBsAg carriage in Chinese children.