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

• Published in: The Lancet (British edition) Vol. 2; no. 8564; p. 877
• Main Authors: Lai, C L, Lok, A S, Lin, H J, Wu, P C, Yeoh, E K, Yeung, C Y
• Format: Journal Article
• Language: English
• Published: England 17.10.1987
• Subjects: 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; Hong Kong
• ISSN: 0140-6736
• 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.