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 chronic hepatitis C virus (HCV) infection has been studied in 33 HCV-RNA positive patients with chronic hepatitis C. Patients were randomly allocated 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, responder patients stopped treatment, whereas nonresponders received 12 additional 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 baseline values (140 +/- 63 vs. 70 +/- 30 IU/L). At the end of treatment (24 weeks), the mean ALT level (80 +/- 50 IU/L) continued significantly lower (P < .001) than the baseline one, and 24% of patients normalized 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 levels decreased during treatment, but in none of the patients became undetectable. All patients had a local reaction at the injection site with induration, erythema, and swelling, which was dose-related. The dose of 5.4 MIU was poorly tolerated and was reduced to 3.6 MIU in 4 of 11 patients. No changes in hematological parameters were observed. At the end of follow-up (6 months) four of eight responder patients continued with normal ALT. In conclusion, IL-2 treatment for chronic hepatitis C induced a biochemical response in 8 of 33 (24%) patients at the end of therapy while at the end of follow-up, 4 of 33 (8%) patients remained with normal ALT. The dose of 1.8 MIU is well tolerated and seems to be the most efficacious.
Pardo
M
M
Department of Hepatology, Fundación Jiménez Díaz, Madrid, Spain.
Castillo
I
I
Oliva
H
H
Fernández-Flores
A
A
Bárcena
R
R
de Peuter
M A
MA
Carreño
V
V
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000201:enzymology / Q000628:therapy* / Q000821:virology; D006801:Humans; D007376:Interleukin-2 / Q000009:adverse effects / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D008875:Middle Aged; D010865:Pilot Projects; D012367:RNA, Viral / Q000032:analysis; D011897:Random Allocation; D011994:Recombinant Proteins / Q000627:therapeutic use; D012867:Skin / Q000187:drug effects
D007376:Interleukin-2; D012367:RNA, Viral; D011994:Recombinant Proteins; D000410:Alanine Transaminase