BACKGROUND/AIMS: This study analyzed the response of two selected groups of asymptomatic chronic hepatitis B patients, treated either with Interferon or with Prednisone plus the same regimen of Interferon, on finalizing treatment and after a long-term follow-up. PATIENTS AND METHODS: Twelve patients received Interferon over 6 months (group I) and 7 patients Prednisone plus Interferon with the same regimen (group II). Both groups were homogeneous in age, sexual preferences, serum ALT levels, liver histology and Knodell's index. Patients with decompensated liver disease, ongoing drug abuse, active alcoholism or viral superinfections were excluded. RESULTS: On finalizing treatment, no statistical differences were observed in either group, except for clearance of HBsAg, found to be better in group II. Both treatments improved hepatic histology. These results were comparable with those reported for both therapeutical regimens in the literature. After a mean follow-up period of 1.8 years for group I and 3.5 years for group II, no patient included in group II relapsed and 2 additionally cleared their replication markers; thus, a complete response was achieved in 6 (86%) out of 7 patients. In group I, however, 3 patients relapsed and 4 presented no change, obtaining a complete response in 3 (27%) out of 11 followed-up patients. When statistically studied, this improved response in the Prednisone plus Interferon group was significant in clearing HBV DNA, HBeAg and HBsAg and, also, in normalizing ALT levels. CONCLUSIONS: In spite of the few number of cases studied, these results could indicate an improved long-term evolution after a short course of steroids prior to Interferon in selected chronic hepatitis B patients.
RCT Entities:
BACKGROUND/AIMS: This study analyzed the response of two selected groups of asymptomatic chronic hepatitis Bpatients, treated either with Interferon or with Prednisone plus the same regimen of Interferon, on finalizing treatment and after a long-term follow-up. PATIENTS AND METHODS: Twelve patients received Interferon over 6 months (group I) and 7 patientsPrednisone plus Interferon with the same regimen (group II). Both groups were homogeneous in age, sexual preferences, serum ALT levels, liver histology and Knodell's index. Patients with decompensated liver disease, ongoing drug abuse, active alcoholism or viral superinfections were excluded. RESULTS: On finalizing treatment, no statistical differences were observed in either group, except for clearance of HBsAg, found to be better in group II. Both treatments improved hepatic histology. These results were comparable with those reported for both therapeutical regimens in the literature. After a mean follow-up period of 1.8 years for group I and 3.5 years for group II, no patient included in group II relapsed and 2 additionally cleared their replication markers; thus, a complete response was achieved in 6 (86%) out of 7 patients. In group I, however, 3 patients relapsed and 4 presented no change, obtaining a complete response in 3 (27%) out of 11 followed-up patients. When statistically studied, this improved response in the Prednisone plus Interferon group was significant in clearing HBV DNA, HBeAg and HBsAg and, also, in normalizing ALT levels. CONCLUSIONS: In spite of the few number of cases studied, these results could indicate an improved long-term evolution after a short course of steroids prior to Interferon in selected chronic hepatitis Bpatients.