Thirty-six children with chronic hepatitis B were entered into a randomized controlled trial of recombinant human interferon-a. 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-a 2b/m2 body surface area three times a week (group I); 12 children received 5 MU/mZ under the same conditions (group 11); and 12 children served as controls (group 111). 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 < 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-a was well tolerated and all children finished therapy. These findings indicate that a 6-mo course of interferon-a is effective in inducing a serological, biochemical and histological remission of disease in approximately 50% of children with chronic hepatitis B. (HEPATOLOCY 1991;13 1035-1039.) Chronic HBV infection can be divided into two clinical and serological phases: (a) an initial phase during which HBV replication is active, HBV DNA is readily detected in serum and liver damage progresses and (b) a second, later phase during which HBV replication is low or absent, HBV DNA is not detected in serum by conventional techniques and liver injury ceases (1, 2).
Children with chronic HBV infection often have high levels of circulating virus, generally have chronic hepatitis and may have cirrhosis (3, 4) or hepatoma (5). An efficient treatment for children with chronic hepatitis B is needed.
The effectiveness of interferon-a as treatment of chronic hepatitis B in adults has been well documented in several studies (6,7). The role of interferon in treating