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"Combination therapy with pegylated interferon (Pegasys or PegIntron) plus ribavirin has improved treatment for chronic hepatitis C, but many patients -- especially those with genotype 1 HCV -- fail to achieve sustained virological response. Such individuals could benefit from therapies that reduce liver inflammation and fibrosis, even if they do not produce virological suppression.
As reported in the June 25, 2007 advance online edition of Gut, researchers from the University of Tokyo assessed the effect of oral ursodeoxycholic acid (UDCA) on serum biomarkers in non-responders to prior interferon-based therapy. Chronic hepatitis C patients with elevated alanine aminotransferase (ALT) levels were randomly assigned to receive UDCA at doses of 150 mg/day (n = 199), 600 mg/day (n = 200), or 900 mg/day (n = 197) for 24 weeks. Changes in ALT, aspartate aminotransferase (AST), and gamma-glutamyl transpeptidase (GGT) were measured.
• ALT, AST, and GGT levels decreased at week 4, then remained constant for the remainder of the drug administration period.
• The median changes in the UDCA 150, 600, and 900 mg/day dose groups, respectively, were:
- ALT: -15.3%, -29.2%, and -36.2%;
- AST: -13.6%, -25.0%, and -29.8%%;
- GGT: -22.4%, -41.0%, and -50.0%.
• All 3 biomarkers decreased significantly less in the UDCA 150 mg/day arm compared with the 2 higher dose groups.
• While changes in ALT and AST did not differ between the 600 and 900 mg/day dose groups, GGT was significantly lower in the 900 mg/day group.
• In a subgroup analysis, ALT decreased significantly in the 900 mg/day group when baseline GGT exceeded 80 IU/L.
• Serum HCV RNA levels did not change in any group.
• Adverse side effects were reported by 19.1% of the patients, with no differences between the 3 dose groups.
In conclusion, the authors wrote, "A 600 mg/day UDCA dose was optimal to decrease ALT and AST levels in chronic hepatitis C patients. The 900 mg/day dose decreased GGT levels further, and may be preferable in patients with prevailing biliary injuries."
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