Placebo-controlled trial of recombinant alpha 2-interferon in Chinese HBsAg-carrier children

Lancet. 1987 Oct 17;2(8564):877-80. doi: 10.1016/s0140-6736(87)91371-7.


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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Carrier State / therapy*
  • Child, Preschool
  • Clinical Trials as Topic
  • DNA, Viral / analysis
  • DNA-Directed DNA Polymerase / analysis
  • Female
  • Follow-Up Studies
  • Hepatitis B / therapy*
  • Hepatitis B Surface Antigens / analysis*
  • Hepatitis B virus / enzymology
  • Hong Kong
  • Humans
  • Infant
  • Injections, Intramuscular
  • Interferon Type I / administration & dosage
  • Interferon Type I / therapeutic use*
  • Male
  • Prospective Studies
  • Random Allocation
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / therapeutic use


  • DNA, Viral
  • Hepatitis B Surface Antigens
  • Interferon Type I
  • Recombinant Proteins
  • DNA-Directed DNA Polymerase