Efficacy and Safety of Two Different Doses of Human Leukocyte Interferon Alpha for Treatment of Hepatitis C Virus Infection: A Pilot Study

The purpose of this pilot study was to assess the efficacy and safety of a 6-month course of 6 million units (MU) of leukocyte interferon alfa (IFN-α) 3 times a week (TIW) in naive patients with chronic hepatitis C virus (HCV) infection. Nine patients were treated with leukocyte IFN-α at a dose of 6 MU TIW; a control group of 30 patients received the standard regimen of leukocyte IFN-α 3 MU TIW. All patients were treated for 6 months and followed up for an additional 6 months. Biochemical (alanine aminotransferase [ALT] values) and virologic (HCV-RNA) responses to treatment were assessed. At the end of the treatment period, 6 (67%) of 9 patients treated with IFN-α 6 MU showed normal ALT levels compared with 14 (47%) of 30 patients treated with 3 MU. The complete (biochemical and virologie) response was slightly greater in patients treated with 6 MU (3/9, 33%) than in those treated with 3 MU (7/30, 23%), both at the end of treatment or after 6 months of follow-up. Both of the IFN regimens were well tolerated. Results of this pilot study suggest that treatment with 6 MU of leukocyte IFN-α TIW for 6 months is associated with a slightly better biochemical and virologic response than is treatment with the standard regimen of 3 MU TIW for 6 months. These results, however, should be confirmed in a larger trial with a high power.