Pilot interferon-beta trial in children with chronic hepatitis B who had previously not responded to interferon-alpha therapy

Background. Recombinant interferon alpha (IFN-alpha) treatment is useful in 40% of children with chronic hepatitis B. However, nonresponder children continue to have viral replication and a progressive disease. Objective. To administer natural IFN-beta to hepatitis B virus chronic carrier children who had not responded to a previous IFN-alpha cycle. Methods. Twenty-two children with chronic hepatitis B, nonresponders to a previous IFN-alpha cycle, were retreated with 5 MU/m(2) of body surface of natural IFN-beta, administered intramuscularly, three times per week for 24 weeks. Results. At the end of treatment, 9 (41%) of 22 children became hepatitis B virus DNA negative. Hepatitis B e antibodies (anti-HBe) developed in 5 of these children, and 6 had normal alanine aminotransferase values. At the end of the posttreatment follow-up (21 months from the beginning of the study), 10 (45%) of 22 children were viral DNA negative, 7 (32%) of 22 were anti-HBe positive (none of them had viral DNA in serum), and 11 (50%) of 22 had normal alanine aminotransferase levels (10 without detectable viral DNA and 7 anti-HBe positive). Conclusion. IFN-beta seems to be an effective retreatment therapy for children with chronic hepatitis B who are nonresponders to a first IFN-alpha cycle; however, a controlled study should be performed to confirm these results.