BACKGROUND:Combined pegylated interferon and ribavirin has improved chronic hepatitis C (CH-C) therapy; however, sustained virological response is achieved in only about half of the patients with a 1b genotype infection. We assessed oral ursodeoxycholic acid (UDCA) on serum biomarkers as a possible treatment for interferon non-responders. 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 ClinicalTrial.gov, identifier NCT00200343. RESULTS:ALT, AST and GGT decreased at week 4 and then remained constant during drug administration. The median changes (150, 600 and 900 mg/day, 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%. 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.
RCT Entities:
BACKGROUND: Combined pegylated interferon and ribavirin has improved chronic hepatitis C (CH-C) therapy; however, sustained virological response is achieved in only about half of the patients with a 1b genotype infection. We assessed oral ursodeoxycholic acid (UDCA) on serum biomarkers as a possible treatment for interferon non-responders. 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 ClinicalTrial.gov, identifier NCT00200343. RESULTS: ALT, AST and GGT decreased at week 4 and then remained constant during drug administration. The median changes (150, 600 and 900 mg/day, 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%. 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.
Authors: K Nakamura; M Yoneda; S Takamoto; Y Nakade; S Yokohama; K Tamori; K Aso; T Matui; Y Sato; M Aoshima; I Makino Journal: J Gastroenterol Hepatol Date: 1999-05 Impact factor: 4.029
Authors: H Yoshida; Y Shiratori; M Moriyama; Y Arakawa; T Ide; M Sata; O Inoue; M Yano; M Tanaka; S Fujiyama; S Nishiguchi; T Kuroki; F Imazeki; O Yokosuka; S Kinoyama; G Yamada; M Omata Journal: Ann Intern Med Date: 1999-08-03 Impact factor: 25.391
Authors: P Mathurin; J Moussalli; J F Cadranel; V Thibault; F Charlotte; P Dumouchel; A Cazier; J M Huraux; B Devergie; M Vidaud; P Opolon; T Poynard Journal: Hepatology Date: 1998-03 Impact factor: 17.425
Authors: Roman Müllenbach; Susanne N Weber; Marcin Krawczyk; Vincent Zimmer; Christoph Sarrazin; Frank Lammert; Frank Grünhage Journal: BMC Gastroenterol Date: 2012-06-08 Impact factor: 3.067
Authors: Carmen De Miguel; Randee Sedaka; Malgorzata Kasztan; Jeremie M Lever; Michelle Sonnenberger; Andrew Abad; Chunhua Jin; Pamela K Carmines; David M Pollock; Jennifer S Pollock Journal: Acta Physiol (Oxf) Date: 2018-12-23 Impact factor: 6.311