Clinical

Ursodeoxycholic acid might help in refractory HCV

Last Updated: 2007-12-11 13:41:03 -0400 (Reuters Health)

By David Douglas

NEW YORK (Reuters Health) - Ursodeoxycholic acid (UDCA) may be of use in treatment of patients with chronic hepatitis C virus (HCV) who do not respond to therapy with combined pegylated interferon and ribavirin, Japanese researchers report in the December issue of Gut.

Lead investigator Dr. Masao Omata told Reuters Health that in such patients, "UDCA therapy, which reduces serum aminotransferase levels, might prevent fibrosis progression and hepatocellular carcinoma development."

Dr. Omata, of the University of Tokyo Graduate School of Medicine, and colleagues note that HCV genotype 1b is the most common in Japan and can be refractory to even combination therapy. Only about 50% of patients show sustained virological response.

To investigate whether UDCA might be of help in nonresponding patients, the researchers studied 596 who had elevated alanine aminotransferase (ALT). They were randomized to treatment with 150, 600 or 900 mg per day of UDCA for 24 weeks.

ALT, aspartate aminotransferase (AST) and gamma-glutamyl transpeptidase (GGT) decreased at week 4 and then remained constant during drug administration.

Changes in ALT and AST did not differ in the 600 and 900 mg groups, but GCT was significantly lower in the 900 mg group. In patients with baseline GCT exceeding 80 IU/L who received this dosage, ALT also showed a significant decrease.

However, there was no change in serum HCV-RNA in any of the groups. Overall, 19.1% of patients reported adverse effects. There were no differences in such effects among groups.

Based on the findings, "there are not sufficient data to advise ursodeoxycholic acid treatment in hepatitis C," Dr. Raoul Poupon of Universite Pierre and Marie Curie in Paris, co-author of an accompanying editorial, told Reuters Health.

Gut 2007;56:1747-1753.