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-al pha) 3 times a week (TIW) in naive patients with chronic hepatitis C virus (HCV) infection, Nine patients were treated with leukocyte IFN-alpha at a d ose of 6 MU TIW; a control group of 30 patients received the standard regim en of leukocyte IFN-alpha 3 MU TIW. All patients were treated for 6 months and followed up for an additional 6 months. Biochemical (alanine aminotrans ferase [ALT] values) and virologic (HCV-RNA) responses to treatment were as sessed. At the end of the treatment period, 6 (67%) of 9 patients treated w ith IFN-alpha 6 MU showed normal ALT levels compared with 14 (47%) of 30 pa tients treated with 3 MU, The complete (biochemical and virologic) response was slightly greater in patients treated with 6 MU (3/9, 33%) than in thos e treated with 3 MU (7/30, 23%), both at the end of treatment or after 6 mo nths 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-alpha T IW for 6 months is associated with a slightly better biochemical and virolo gic 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.