Interferon alfa-2b biosimilar(Center For Genetic Engineering And Biotechnology)

To assess the efficacy of recombinant alfa 2b-interferon treatment "Heberon alfa 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 (HBeAg, 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 was 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 scarce, 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 medullar depression, renal toxicity and glycemia alterations.(ABSTRACT TRUNCATED AT 250 WORDS)