PILOT-STUDY ON THE SAFETY AND EFFICACY OF INTRAVENOUS NATURAL INTERFERON-BETA THERAPY IN PATIENTS WITH CHRONIC HEPATITIS-C UNRESPONSIVE TO ALPHA-INTERFERON

Background. Since a large function of patients affected by chronic hep atitis C do not respond to alpha-interferon therapy, we planned a pilo t study of intravenous beta-interferon therapy in Italian patients non responsive to several courses of alpha-interferon. Methods. Ten Itali an patients with chronic hepatitis C Il ere treated intravenously with beta-interferon to assess the biochemical and virological responses. Each patient received intravenously 6 MU of beta-interferon daily for 7 days a week for a period of 2 months; in responders, this treatment was followed by intramuscular beta-interferon administration 6 MU thre e times a week for an additional 8 weeks. Results. All the patients we re infected by the genotype 1b of hepatitis C virus and had a high ser um concentration of HCV-RNA (4.1 +/- 3.3 x 10(7) copies/ml). During in travenous therapy, 4 patients (40%) showed a complete return to normal of alanino-aminotransferase and 3 cases became HCV-RNA negative. Duri ng intramuscular beta-interferon administration, two patients breakthr ough. At the end of the follow-up (six months after the end of the tre atment) two patients only showed return to normal of alanino-aminotran sferase, brit one of them remained HCV-RNA positive. Conclusions. Thes e results indicate that even genotype 1b of hepatitis C virus can be s uppressed bq intravenous beta-interferon therapy, as previously descri bed in similar cases in Japan. The rate of sustained biochemical and v irologic response was, however; low, suggesting that further studies a re needed to define the best regimen to achieve eradication of hepatit is C virus infection.