Long term effect of alpha interferon in children with chronic hepatitis B

Background/aims-The purpose of this study was to better define the long ter m prognosis of infection and disease in children with chronic hepatitis B t reated with interferon (IFN) alpha. Patients-A total of 107 children chronic hepatitis B who received IFN alpha for three or six months in two clinical trials were followed for a mean pe riod of 69 (17) months. Response to treatment was defined as loss of hepati tis B e antigen (HBeAg) within 12 months after stopping treatment. A contro l group of 59 patients was also followed for a shorter mean time (46 (19) m onths). Results-Sixteen (15%) treated children responded during therapy and 18 (17% ) during post-treatment follow up; 31 (29%) non-responders lost HBeAg durin g subsequent years. High pretreatment levels of transaminases and a greater histological activity index were predictors of response. Kaplan-Meier esti mates of cumulative HBeAg clearance rates at five years were similar betwee n treated patients (60%) and controls (65%). After HBeAg clearance, all cas es lost hepatitis B virus DNA and 94% had normal transaminase levels. Loss of hepatitis B surface antigen (HBsAg) occurred in four (25%) patients who responded during treatment but in none of the other treated or untreated pa tients. Conclusions-After five years' observation, the proportion of treated childr en with sustained HBeAg clearance comprised an equal number of responders a nd non-responders and did not differ from that observed in untreated contro ls, suggesting that IFN simply accelerated a spontaneous event. However, IF N significantly improved the rate of HBsAg loss in cases with more prominen t disease activity who were early responders, and may be particularly usefu l in this type of patient.