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A large-scale, multicentre, double-blind trial of ursodeoxycholic acid in patients with chronic hepatitis C
  1. Masao Omata (omata-2im{at}
  1. University of Tokyo, Japan
    1. Haruhiko Yoshida (yoshida-2im{at}
    1. Tokyo University Graduate School of Medicine, Japan
      1. Joji Toyota ({at}
      1. Sapporo Kosei General Hospital, Japan
        1. Eiichi Tomita (etomita_jp{at}
        1. Gifu Municipal Hospital, Japan
          1. Shuhei Nishiguchi (nishiguc{at}
          1. Hyogo College of Medicine, Japan
            1. Norio Hayashi
            1. Osaka University Graduate School of, Japan
              1. Shiro Iino (kanen{at}
              1. Seizankai Kiyokawa Hospital, Japan
                1. Isao Makino (imakino{at}
                1. Hokushinkai Megumino Hospitals, Japan
                  1. Kiwamu Okita (icb68895{at}
                  1. Social Insurance Shimonoseki Kosei Hospital, Japan
                    1. Gotaro Toda (goutarou_toda{at}
                    1. Sempo Tokyo Takanawa Hospital, Japan
                      1. Kyuichi Tanikawa (tanikawa{at}
                      1. International Institute for Liver Research, Japan
                        1. Hiromitsu Kumada (kumahiro{at}
                        1. Toranomon Hospital, Japan


                          Background: Combined pegylated interferon and ribavirin has improved chronic hepatitis C (CH-C) therapy, however sustained virologic response is achieved in about half of patients with a 1b genotype infection. We assessed oral ursodeoxycholic acid (UDCA) on serum biomarkers as a possible treatment for interferon nonresponders.

                          Methods: CH-C patients with elevated alanine aminotransferase (ALT) were assigned randomly to 150 (n = 199), 600 (n = 200), or 900 mg/day (n = 197) UDCA intake for 24 weeks. Changes in ALT, aspartate aminotransferase (AST), and gamma-glutamyl transpeptidase (GGT) were assessed. This study is registered at, NCT00200343.

                          Results: ALT, AST, and GGT decreased at week 4 then remained constant during drug administration. The median changes (respectively 150, 600, and 900 mg/day) 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%. These biomarkers decreased significantly less in the 150 mg/day than in the other two groups. Although changes in ALT and AST did not differ between the 600 and 900 mg/day groups, GGT was significantly lower in the 900 mg/day group. In subgroup analysis, ALT decreased significantly in the 900 mg/day group when the baseline GGT exceeded 80 IU/L. Serum HCV-RNA did not change in any group. Adverse effects were reported by 19.1% of the patients, with no differences between groups.

                          Conclusions: A 600 mg/day UDCA dose was optimal to decrease ALT and AST levels in CH-C patients. The 900 mg/day dose decreased GGT levels further, and may be preferable in patients with prevailing biliary injuries.

                          • alanine aminotransferase
                          • aspartate aminotransferase
                          • gamma-glutamyl transpeptidase
                          • hepatitis C
                          • ursodeoxycholic acid

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