A Iarge-scale, multicentre, double-blind trial of ursodeoxycholic acid in patients with chronic hepatitis C

Omata, Masao; Yoshida, Haruhiko; Toyota, Joji; Tomita, Eiichi; Nishiguchi, Shuhei; Hayashi, Norlo; Lino, Shiro; Makino, Isao; Okita, Kiwamu; Toda, Gotaro; Tanikawa, Kyuichi; Kumada, Hiromitsu
December 2007
Gut;Dec2007, Vol. 56 Issue 12, p1747
Academic Journal
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 lU/I. 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 in juries.


Related Articles

  • Changes in Mood States and Biomarkers During Peginterferon and Ribavirin Treatment of Chronic Hepatitis C. Fontana, Robert J.; Kronfol, Ziad; Lindsay, Karen L.; Bieliauskas, Linas A.; Padmanabhan, Latha; Back-Madruga, Carla; Lok, Anna S. F.; Stoddard, Anne M. // American Journal of Gastroenterology;Nov2008, Vol. 103 Issue 11, p2766 

    OBJECTIVE: Depression is a frequent side effect of interferon therapy in patients with chronic hepatitis C (CHC). The aim of this study was to identify baseline and on-treatment predictors of depression in CHC patients receiving peginterferon and ribavirin. METHODS: In total, 201 prior...

  • Treatment of autoimmune thrombocytopenia in a case of chronic hepatitis C with ursodeoxycholic acid. Naz, Hasan; Aslan, Vahap // Journal of Infection in Developing Countries;2009, Vol. 3 Issue 8, p644 

    Pegylated interferon (PEG-IFN) alpha and ribavirin therapy has become the standard treatment in chronic hepatitis C virus (HCH)-infected patients. While thrombocytopenia associated with IFN use is frequently observed among these patients, autoimmune thrombocytopenia is one of the rarely observed...

  • Durability of Serological Remission in Chronic Hepatitis C Treated With Interferon-Alpha-2B. Sim, Howe; Yim, Colina; Krajden, Mel; Heathcote, Jenny // American Journal of Gastroenterology;Jan1998, Vol. 93 Issue 1, p39 

    Objective: We assessed the long-term effect of a course of interferon therapy on the biochemical and virological markers of Canadian patients with chronic hepatitis C. Methods: Thirty-six patients with chronic hepatitis C were treated with a median total dose of interferon-α-2B of 181.0...

  • Peginterferon alfa-2a (40KD) plus ribavirin in chronic hepatitis C patients who failed previous interferon therapy. Sherman, M.; Yoshida, E. M.; Deschenes, M.; Krajden, M.; Bain, V. G.; Peltekian, K.; Anderson, F.; Kaita, K.; Simonyi, S.; Baishaw, R.; Lee, S. S. // Gut;Nov2006, Vol. 55 Issue 11, p1631 

    Background: The management of patients with chronic hepatitis C who have relapsed or failed to respond to interferon based therapies is an important issue facing hepatologists. Aims: We evaluated the efficacy and safety of peginterferon alfa-2a (40KD) plus ribavirin in this population by...

  • Sustained virological response to interferon-α plus ribavirin decreases inflammation and endothelial dysfunction markers in HIV/HCV co-infected patients. Guzmán-Fulgencio, María; Berenguer, Juan; De Castro, Isabel Fernandez; Micheloud, Dariela; López, Juan Carlos; Cosín, Jaime; Miralles, Pilar; Lorente, Raquel; Aldamiz-Echevarría, Teresa; Muñoz-Fernández, M. Ángeles; Resino, Salvador // Journal of Antimicrobial Chemotherapy (JAC);Mar2011, Vol. 66 Issue 3, p645 

    Objectives Hepatitis C virus (HCV) antiviral therapy might lead to decreased chronic immune activation and endothelial dysfunction associated with cardiovascular risk. The aim was to evaluate the effect of HCV eradication on serum markers of inflammation and endothelial dysfunction markers in...

  • Biocortech Initiates Trial of Depression Blood Test. Etheridge, James // BioWorld International;4/15/2009, Vol. 14 Issue 15, p6 

    The article reports on the approval issued by the Comité de Protection des Personnes (CPP) for Biocortech to conduct a proof-of-concept clinical trial to validate a biological test for depression. The trial will include patients diagnosed with hepatitis C, who will be treated for the first...

  • Dynamics of regulatory T cells and plasmacytoid dendritic cells as immune markers for virological response in pegylated interferon-α and ribavirin therapy for chronic hepatitis C patients. Kanto, Tatsuya; Inoue, Michiyo; Oze, Tsugiko; Miyazaki, Masanori; Sakakibara, Mitsuru; Kakita, Naruyasu; Matsubara, Tokuhiro; Higashitani, Koyo; Hagiwara, Hideki; Iio, Sadaharu; Katayama, Kazuhiro; Mita, Eiji; Kasahara, Akinori; Hiramatsu, Naoki; Takehara, Tetsuo; Hayashi, Norio // Journal of Gastroenterology;Feb2012, Vol. 47 Issue 2, p169 

    Background: For the treatment of chronic hepatitis C, a combination of pegylated interferon-α (PEG-IFNα) and ribavirin has been widely used as a standard of care. Enhancement of immune response against hepatitis C virus (HCV) is known to be involved in the efficacy of the combination...

  • Current status and future directions in the management of chronic hepatitis C.  // Virology Journal;2012, Vol. 9 Issue 1, p57 

    The article presents a research which examines the several aspects related to current status and future directions in the management of chronic hepatitis C virus (HCV) which is endemic worldwide. It is reported that, the medical knowledge about the disease and its mechanisms is limited because...

  • Recombinant Interferon--α and Ursodeoxycholic Acid versus Interferon--α Alone in the Treatment of Chronic Hepatitis C: A Randomized Clinical Trial with Long--term Follow--up. Angelico, Mario; Gandin, Claudia; Pescarmona, Edoardo; Rapicetta, Mariella; Del Vecchio, Costanzo; Bini, Adriano; Spada, Enea; Baroni, Carlo D.; Capocaccia, Livio // American Journal of Gastroenterology;Feb1995, Vol. 90 Issue 2, p263 

    Objectives: The purpose of this study was to compare, within a randomized controlled trial, the efficacy of recombinant interferon-α in combination with ursodeoxycholic acid versus interferon-α alone in the treatment of chronic HCV hepatitis. Methods: Forty anti-HCV positive chronic...


Read the Article


Sign out of this library

Other Topics