A PILOT-STUDY OF RECOMBINANT INTERLEUKIN-2 FOR TREATMENT OF CHRONIC HEPATITIS-C

The optimal and safer interleukin-2 (IL-2) dose for treatment of chron ic hepatitis C virus (HCV) infection has been studied in 33 HCV-RNA po sitive patients with chronic hepatitis C. Patients were randomly alloc ated to receive 5 days per week during 12 weeks IL-2 doses of: 0.9 MIU (n = 10), 1.8 MIU (n = 10), or 3.6 MIU (n = 13), After 12 weeks, resp onder patients stopped treatment, whereas nonresponders received 12 ad ditional weeks of IL-2 at the next higher dose: 1.8, 3.6, or 5.4 MIU, As a whole, after the first 12 weeks of IL-2 alanine aminotransferase (ALT) levels significantly decreased (P < .001) with respect to the ba seline values (140 +/- 63 vs. 70 +/- 30 IU/L), At the end of treatment (24 weeks), the mean ALT level (80 +/- 50 IU/L) continued significant ly lower (P < .001) than the baseline one, and 24% of patients normali zed ALT levels; according to dosage, ALT normalization was: 0% for 0.9 MIU, 25% for 1.8 MIU, 5% for 3.6 MIU, and 18% for 5.4 MIU. HCV-RNA le vels decreased during treatment, but in none of the patients became un detectable. All patients had a local reaction at the injection site wi th induration, erythema, and swelling, which was dose-related. The dos e of 5.4 MIU was poorly tolerated and was reduced to 3.6 MIU in 4 of 1 1 patients, No changes in hematological parameters were observed. At t he end of follow-up (6 months) four of eight responder patients contin ued with normal ALT. In conclusion, IL-2 treatment for chronic hepatit is C induced a biochemical response in 8 of 33 (24%) patients at the e nd of therapy while at the end of follow-up, 4 of 33 (8%) patients rem ained with normal ALT, The dose of 1.8 MIU is well tolerated and seems to be the most efficacious.