Randomized Trial of Interferon-Alpha plus Ursodeoxycholic Acid versus Interferon plus Placebo in Patients with Chronic Hepatitis C Resistant to Interferon

References

• References
   Google Scholar
• Serfaty L, Giral P, Loria A, Andréani T, Legendre C, Poupon R. Factors predictive of the response to interferon in patients with chronic hepatitis C. J Hepatol 1994;21:12–7.
   Google Scholar
• Pagliaro L, Craxi A, Cammaa C, Tine F, Di Marco V, Lo Jacono O, et al. Interferon-alpha for chronic hepatitis C: an analysis of pretreatment clinical predictors of response. Hepatology 1994;19:820–8.
   Google Scholar
• Lau JYN, Davis GL, Kniffen J, Qian KP, Urdea MS, Chan CS, et al. Significance of serum hepatitis C virus RNA levels in chronic hepatitis C. Lancet 1993;341:1501–4.
   PubMed Web of Science ®Google Scholar
• Nousbaum JB, Pol S, Nalpas B, Landais P, Berthelot P, Bréchot C, et al. Hepatitis C virus type 1b (II) infection in France and Italy. Ann Intern Med 1995;122: 161–8.
   Google Scholar
• Martinot-Peignoux M, Marcellin P, Pouteau M, Castelnau C, Boyer N, Poliquen M, et al. Pretreatment serum hepatitis C virus RNA levels and hepatitis C genotype are the main and independent prognostic factors of sustained response to alpha interferon therapy in chronic hepatitis C. Hepatology 1995;22:1050–6.
   Google Scholar
• Pawlotsky JM, Roudot-Thoraval F, Bastie A, Darthuy F, Rémiré J, Métreau JM, et al. Factors affecting treatment responses to interferon-α in chronic hepatitis C. J Infect Dis 1996;174:1–7.
   PubMed Web of Science ®Google Scholar
• Davis GL, Lau JYN. Factors predictive of a beneficial response to therapy of hepatitis C. Hepatology 1997;26 Suppl:112–27.
   Google Scholar
• Richtsmeier WJ, Grossberg SE. Intact mitochondrial functions are required for the full expression of the antiviral actions of interferon α and γ. J Interf Res 1989;9:87–96.
   PubMedGoogle Scholar
• Podevin P, Calmus Y, Bonnefis MT, Veyrunes C, Chereau C, Poupon R. Effect of cholestasis and bile acids on interferon- induced 2′, 5′-adenylate synthetase and NK cell activities. Gastroenterology 1995;108:1192–8.
   PubMed Web of Science ®Google Scholar
• Poupon R, Poupon RE. Ursodeoxycholic acid therapy of chronic cholestatic conditions in adults and children. Pharmacol Ther 1995;66:1–15.
   PubMed Web of Science ®Google Scholar
• Yamanaka M. Study of curative effect of ursodeoxycholic acid for chronic hepatitis by double blind trial. Diagn Treat 1976; 64:2150.
   Google Scholar
• Bellentani S, Tabarroni G, Barchi T, Ferretti I, Fratti N, Villa E, et al. Effect of ursodeoxycholic acid treatment on alanine aminotransferase and γ–glutamyltranspeptidase serum levels in patients with hypertransamisemia. J Hepatol 1989;8:7–12.
   PubMed Web of Science ®Google Scholar
• Podda M, Ghezzi C, Battezzati PM, Crosignani A, Zuin M, Roda A. Effects of ursodeoxycholic acid on serum liver enzymes and bile acids in chronic hepatitis. Gastroenterology 1990;98:1044–50.
   PubMed Web of Science ®Google Scholar
• Rolandi E, Franceschini R, Cataldi A, Cichetti V, Carati L, Barreca T. Effects of ursodeoxycholic acid (UDCA) on serum liver damage indices in patients with chronic active hepatitis. A double-blind controlled study. Eur J Clin Invest 1991;40:473–6.
   Google Scholar
• Portincasa P, Palmieri V, Doronzo F, Vendemiale G, Altomare E, Sabba C, et al. Effect of tauroursodeoxycholic acid on serum liver enzymes and dyspeptic symptoms in patients with chronic active hepatitis. Curr Ther Res 1993;53:521–31.
   Web of Science ®Google Scholar
• Bellentani S, Podda M, Tiribelli C, Callea F, Marazzi M, Sodde M, et al. Ursodiol in the long-term treatment of chronic hepatitis: a double-blind multicenter clinical trial. J Hepatol 1993;19:459–64.
   PubMed Web of Science ®Google Scholar
• Boucher E, Jouanolle H, Andre P, Ruffault A, Guyader D, Moirand R, et al. Interferon and ursodeoxycholic acid combined therapy in the treatment of chronic viral C hepatitis: results from a controlled randomized trial in 80 patients. Hepatology 1995;21:322–7.
   PubMed Web of Science ®Google Scholar
• Angelico M, Gandin C, Pescamorna E, Rapicetta M, Del Vecchio C, Bini A, et al. Recombinant interferon-alpha and ursodeoxycholic acid versus interferon-alpha alone in the treatment of chronic hepatitis C: a randomized clinical trial with long-term follow-up. Am J Gastroenterol 1995;90:263–9.
   PubMed Web of Science ®Google Scholar
• Tanaka K, Kondo M, Sagaguchi T, Saito S, Arata S, Ikeda M, et al. Efficacy of ursodeoxycholic acid in combination with interferon-α in treating chronic hepatitis C: results of a longterm follow-up trial. J Gastroenterol Hepatol 1996;11:1155–60.
   PubMed Web of Science ®Google Scholar
• Setchell KDR, Matsui A. Serum bile acid analysis. Clin Chim Acta 1982;127:164–71.
   Web of Science ®Google Scholar
• Stellaard F, Schubert R, Paumgartner G. Measurement of bile acid kinetics in human serum using labeled chenodeoxycholic acid and capillary gas chromatography electron impact mass spectrometry. Biomed Mass Spectrom 1983;10:187–91.
   Google Scholar
• The French METAVIR Cooperative Study Group. Intraobserver and interobserver variations in liver biopsy interpretation in patients with chronic hepatitis C. Hepatology 1994;20:15–20.
   PubMed Web of Science ®Google Scholar
• Knodell RG, Ishak KG, Black WC, Chen TS, Craig R, Kaplowitz N, et al. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology 1981;5:431–5.
   Web of Science ®Google Scholar
• Offensperger W-B, Offensperger S, Stoll B, Gerok W, Haüssinger D. Effects of anisotonic exposure on duck hepatitis B virus replication. Hepatology 1994;10:1–7.
   Google Scholar
• Beuers U, Rust C, Paumgartner G. Mechanisms of action of ursodeoxycholic acid. In: Manns MP, Boyer JL, Jansen PLM, Reichen J, editors. Cholestatic liver diseases. Dordrecht: Kluwer Academic Publishers; 1998. p. 262–70.
   Google Scholar
• Häussinger D, Hallbrucker C, Saha N, Lang F, Gerok W. Cell volume and bile acid excretion. Biochem J 1992;288:681–9.
   Google Scholar
• Krähenbuhl S, Fischer S, Talos C, Reichen J. Ursodeoxycholate protects oxidative mitochondrial metabolism from bile toxicity: dose-response study in isolated rat liver mitochondria. Hepatology 1994;20:1595–601.
   Google Scholar
• Botla R, Spivey JR, Aguilar H, Bronk SF, Gores GJ. Ursodeoxycholate (UDCA) inhibits the mitochondrial membrane permeability transition induced by glycochenodeoxycho- late: a mechanism of UDCA protection. J Pharmacol Exp Ther 1995;272:930–8.
   Google Scholar
• Rodrigues CMP, Fan G, Wong PY, Kren BT, Steer CJ. Ursodeoxycholic acid may inhibit deoxycholic acid-induced apoptosis by modulating mitochondrial transmembrane potential and reactive oxygen species production. Mol Med 1998;4:165–78.
   Google Scholar
• Calmus Y, Guechot J, Podevin P, Bonnefis MT, Giboudeau J, Poupon R. Differential effects of chenodeoxycholic and ursodeoxycholic acids on interleukin 1, interleukin 6 and tumor necrosis factor-α production by monocytes. Hepatology 1992; 16:719–23.
   PubMed Web of Science ®Google Scholar
• Tanaka H, Makino Y, Miura T, Hirano F, Okamoto K, Komura K, et al. Ligand-independent activation of the glucocorticoid receptor by ursodeoxycholic acid. Repression of IFN-γ-induced MHC class II gene expression via a glucocorticoid receptor- dependent pathway. J Immunol 1996;156:1601–8.
   Google Scholar
• Rodrigues CM, Fan G, Ma X, Kren BT, Steer CJ. A novel role for ursodeoxycholic acid in inhibiting apoptosis by modulating mitochondrial membrane perturbation. J Clin Invest 1998;101:2790–9.
   Google Scholar
• Yoshikawa M, Matsui Y, Umemoto N, Yamao J, Kuriyama S, Fukui H, et al. Effects of ursodeoxycholic acid on target apoptosis induced by an antigen-specific CD4H+−T cell line. Int Hepatol Comm 1996;4:268–76.
   Web of Science ®Google Scholar
• Invernezzi P, Salzman AL, Czabo C, Ueta I, O’Connor M, Setchell KDR. Ursodeoxycholate inhibits induction of NOS in human intestinal epithelial cells and in vivo. Am J Physiol 1997;273:G131–8.
   Google Scholar