Improvement of alanine aminotransferase by administration of suplatast tosilate plus ursodeoxycholic acid in patients with resistance to ursodeoxycholic acid monotherapy on hepatitis C virus-related chronic liver disease.
OBJECTIVE
Inflammatory liver damage and viral persistence after hepatitis C virus (HCV) infection are known to be related in host immunity. Suplatast tosilate is an immunomodulator that selectively inhibits type 2 cytokine production by helper T cells. We investigated the efficacy and safety of the administration of suplatast tosilate for patients with HCV infection by examining the level of serum alanine aminotransferase (ALT) and viremia.


METHODS
Thirty-eight patients who had shown resistance to ursodeoxycholic acid (UDCA) therapy (600 mg/day tid) over 6 months for HCV-related chronic liver disease were randomized into two groups and received UDCA alone (600 mg/day tid) or UDCA (600 mg/day tid) plus suplatast tosilate (300 mg/day tid) by means of sealed envelopes.


RESULTS
After 24 weeks, serum ALT was decreased in the patients receiving UDCA plus suplatast tosilate, with the mean reduction being 40.2% (from 132 to 79 IU/l; p=0.001). In the patients receiving UDCA alone, ALT decreased by 8.3% (from 133 to 122 IU/l; ns). Multiple comparison of individual ALT changes showed that the UDCA plus suplatast tosilate achieved significantly greater improvement (p = 0.001). However, serum HCV RNA was unchanged in both groups. Two patients developed adverse reactions to suplatast tosilate, which resolved promptly after the discontinuation of the therapy.


CONCLUSIONS
These findings suggest that suplatast tosilate promotes biochemical improvement in the patients with chronic hepatitis C.
Matsuda
Yukihiko
Y
Division of Internal Medicine, Toyonaka Municipal Hospital.
Inada
Masami
M
Maeda
Hisanori
H
Matsuyama
Tatsuo
T
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000097:blood*; D001190:Arylsulfonates / Q000627:therapeutic use*; D002756:Cholagogues and Choleretics / Q000627:therapeutic use*; D016207:Cytokines / Q000037:antagonists & inhibitors; D051263:D-Alanine Transaminase; D004351:Drug Resistance; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000201:enzymology*; D006801:Humans; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D012449:Safety; D013452:Sulfonium Compounds / Q000627:therapeutic use*; D018418:Th2 Cells / Q000276:immunology; D016896:Treatment Outcome; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
D000276:Adjuvants, Immunologic; D001190:Arylsulfonates; D002756:Cholagogues and Choleretics; D016207:Cytokines; D013452:Sulfonium Compounds; D014580:Ursodeoxycholic Acid; C073028:suplatast tosilate; D000410:Alanine Transaminase; D051263:D-Alanine Transaminase