Premium
A pilot study of recombinant interleukin‐2 for treatment of chronic hepatitis C
Author(s) -
Pardo M,
Castillo I,
Oliva H,
FernandezFlores A,
Barcena R,
de Peuter M A,
Carreno V
Publication year - 1997
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.510260533
Subject(s) - recombinant dna , chronic hepatitis , medicine , virology , immunology , gastroenterology , biology , virus , biochemistry , gene
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.