2002 Volume 41 Issue 10 Pages 774-779
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.
Patients and 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.
Conclusion These findings suggest that suplatast tosilate promotes biochemical improvement in the patients with chronic hepatitis C.
(Internal Medicine 41: 774-779, 2002)
