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Long term study of treatment with recombinant alpha 2b-interferon in the chronic active hepatitis B virus in the children and adolescent

Abstract:

To assess the efficacy of recombinant alpha 2b-interferon treatment 'Heberon alpha R' in children with chronic active hepatitis (CAH) B virus, we conducted a long-term study (three years) in 22 children infected with hepatitis B virus (17 males and 5 females), age range 3 to 15 years. Diagnostic criteria included the clinical picture, laboratory tests, virus markers (H BeAg, HBsAg), laparoscopy and liver biopsy. Children under 12 years received 3 million IU of interferon per day whereas those older than 12 years received 6 million IU of interferon per day by intramuscular injection, three times per week for four months. Alanine aminotransferase (ALT) levels had been elevated for six months in all patients and hepatitis B viral infection was replicative. A variance analysis was made to evaluate ALT response to interferon administration and the Mc Nemar test was used to analyze HBeAg/anti-HBe behavior. Seventeen (77%) out of 22 patients responded to treatment (clearance of HBeAg and ALT levels returned to normal. HBeAg seroconversion (anti-HBe) occurred in 36% of patients during the first year (p < 0,01) and it increased to 50% by the third year follow-up. ALAT levels also decreased and the difference ws statistically significant (p < 0,01). This occurred during and after treatment with a steady and increasing tendency to return to normal levels within the first and third year. Side effects were scarse, transient and tolerable and they only appeared during the initial phase of treatment; symptoms were mainly influenza-like and they disappeared very soon. There were no late side effects such as modular depression, renal toxicity and glycemia alterations. The therapeutic regime, that is, dose and time of administration proved to be effective in all cases. Because of its antiviral action againts viral replication, recombinant alpha 2b-interferon 'Heberon alpha R' reported beneficial effects in CAH B virus patients, together with an improvement in liver damage. We insist that follow-up must be prolonged up to three years and if viral activity persists new treatment schedules must be repeated.