Thymalfasin for the treatment of chronic hepatitis C infection

References

• Fried MW, Shiffman ML, Rajender Reddy K et al. Peginterferon-α2a plus ribavirin for chronic hepatitis C virus infection. N. Engl. J. Med. 347, 975–982 (2002).
   PubMed Web of Science ®Google Scholar
• Gish RG. Treating hepatitis C: the state of the art. Gastroenterol. Clin. North Am. 33(1 Suppl.), S1–S9 (2004).
   PubMedGoogle Scholar
• Moscarella S, Buzzelli G, Romanelli RG et al. Interferon and thymosin combination therapy in naive patients with chronic hepatitis C: preliminary results. Liver 18, 366–369 (1998).
   PubMedGoogle Scholar
• Hepburn MJ, Hepburn LM, Cantu NS, Lapeer MG, Lawitz EJ. Differences in treatment outcome for hepatitis C among ethnic groups. Am. J. Med. 117, 163–168 (2004).
   PubMed Web of Science ®Google Scholar
• Dantzler TE, Lawitz EJ. Treatment of chronic hepatitis C in nonresponders to previous therapy. Curr. Gastroenterol. Rep. 5, 78–85 (2003).
   PubMedGoogle Scholar
• Shiffman ML, Hoffman CM, Contos MJ et al. A randomized, controlled trial of maintenance interferon therapy for patients with chronic hepatitis C virus and persistent viremia. Gastroenterology 117, 1164–1172 (1999).
   PubMed Web of Science ®Google Scholar
• Sherman KE, Sjogren M, Creager RL et al. Combination therapy with thymosin α1 and interferon for the treatment of chronic hepatitis C infection: a randomized, placebo-controlled double-blind trial. Hepatology 27, 1128–1135 (1998).
   PubMed Web of Science ®Google Scholar
• Poo JL, Sanchez-Avila F, Kershenobich D, Garcia-Samper X, Gongora J, Uribe M. Triple combination of thymalfasin, peginterferon-α2a and ribavirin in patients with chronic hepatitis C who have failed prior interferon and ribavirin treatment: 24-week interim results of a pilot study. J. Gastroenterol. Hepatol. 19, S79–S81 (2004).
   Google Scholar
• Pockros PJ. Developments in the treatment of chronic hepatitis C. Expert Opin. Investig. Drugs 11, 515–528 (2002).
   PubMed Web of Science ®Google Scholar
• McHutchison JG, Gordon SC, Schiff ER et al. Interferon-α2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. N. Engl. J. Med. 339, 1485–1492 (1998).
   PubMed Web of Science ®Google Scholar
• Roferon-A® package insert. Hoffmann-LaRoche Inc., NJ, USA (2003).
   Google Scholar
• Dusheiko G, Main J, Thomas H et al. Ribavirin treatment for patients with chronic hepatitis C: results of a placebo-controlled study. J. Hepatol. 25, 591–598 (1996).
   PubMed Web of Science ®Google Scholar
• Manns MP, McHutchison JG, Gordon SC et al. Peginterferon-α2b plus ribavirin compared with interferon-α2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 358, 958–965 (2001).
   PubMed Web of Science ®Google Scholar
• Gish RG, Arora S, Nelson D et al. End-of-treatment (EOT) response in therapy-naive patients treated for chronic hepatitis C with viramidine in combination with pegylated interferon. Presented at 55^th annual meeting of the American Association for the Study of Liver Diseases. October 29–November 2, MA, USA (2004).
   Google Scholar
• Bacon B. Safety, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of CPG 10101 (Actilon), a novel TLR9 agonist: comparison in normal volunteers and HCV infected individuals. Dig. Dis. Week May 14–19, IL, USA (2005).
   Google Scholar
• Afdhal N, Godofsky E, Dienstag J et al. Final Phase I/II trial results for NM 283, a new polymerase inhibitor for hepatitis C: antiviral efficacy and tolerance in patients with HCV infection, including previous interferon failures. Presented at 55th Annual Meeting of the American Association for the Study of Liver Diseases. October 29–November 2, MA, USA (2004).
   Google Scholar
• Reesink H. Initial results of a Phase 1B, multiple-dose study of VX- 950, a hepatitis C virus protease inhibitor. Dig. Dis. Week IL, USA, May 14–19 (2005).
   Google Scholar
• Lawrence M. A Phase 1, single-blind, dose-escalating study of the safety and pharmacokinetics of a single injection of pegylated interferon alfacon-1 in healthy volunteers. Dig. Dis. Week IL,USA, May 14–19 (2005).
   Google Scholar
• Balasubramanian S. Angiotensin receptor blockage as an antifibrotic intervention in patients with chronic viral hepatitis C – a pilot study. Dig. Dis. Week IL, USA, May 14–19 (2005).
   Google Scholar
• Rost KL, Wierich W, Masayuki F, Tuthill CW, Horwitz DL, Herrmann WM. Pharmacokinetics of thymosin α1 after subcutaneous injection of three different formulations in healthy volunteers. Int. J. Clin. Pharmacol. Ther. 37, 51–57 (1999).
   PubMed Web of Science ®Google Scholar
• Giuliani C, Napolitano G, Mastino A et al. Thymosin-α1 regulates MHC class I expression in FRTL-5 cells at transcriptional level. Eur. J. Immunol. 30, 778–786 (2000).
   PubMed Web of Science ®Google Scholar
• Zhang P, Chan J, Dragoi A-M et al. Activation of IKK by thymosin α1 requires the TRAF6 signalling pathway. EMBO J. 6, 531–537 (2005).
   Google Scholar
• Romani L, Bistoni F, Graziano R et al. Thymosin α1 activates dendritic cells for fungal Th1 resistance through Toll-like receptor signaling. Blood 103, 4232–4239 (2004).
   PubMed Web of Science ®Google Scholar
• Knutsen AP, Freeman JJ, Mueller KR et al. Thymosin-α1 stimulates maturation of CD34+ stem cells into CD3+4+ cells in an in vitro thymic epithelia organ coculture model. Int. J. Immunopharmacol. 21, 15–26 (1999).
   PubMed Web of Science ®Google Scholar
• Andreone P, Cursaro C, Gramenzi A et al. A double-blind, placebo-controlled pilot trial of thymosin alpha 1 for the treatment of chronic hepatitis C. Liver 16, 207–210 (1996).
   PubMedGoogle Scholar
• Baumann CA, Badamchian M, Goldstein AL. Thymosin α1 is a time and dose-dependent antagonist of dexamethasone-induced apoptosis of murine thymocytes in vitro. Int. J. Immunopharmacol. 22, 1057–1066 (2000).
   PubMed Web of Science ®Google Scholar
• Colledge D. Paper presented at Second International Conference on Therapies for Viral Hepatitis, HI, USA (1997).
   Google Scholar
• Rasi G, DiVirgilio D, Mutchnick MG et al. Combination thymosin α1 and lymphoblastoid interferon treatment in chronic hepatitis C. Gut 39, 679–683 (1996).
   PubMed Web of Science ®Google Scholar
• Andreone P, Gramenzi A, Cursaro C et al. Thymosin-α1 plus interferon-α for naive patients with chronic hepatitis C: results of a randomized controlled pilot trial. J. Viral. Hepat. 11, 69–73 (2004).
   PubMed Web of Science ®Google Scholar
• Rustgi V. Combination therapy of thymalfasin (thymosin-α1) and peginterferon-α2a in patients with chronic hepatitis C virus infection who are non-responders to standard treatment. J. Gastroenterol. Hepatol. 19, S76–S78 (2004).
   Google Scholar
• Poo JL, Sanchez-Avila F, Kershenobich D et al. A pilot trial of thymalfasin (thymosin α1) in combination with peginterferon-α2a (PEG-IFN-α2a) and ribavirin in HCV non-responders: 48-week (end of therapy) results. Hepatology 40(Suppl. 1), 91A (2004).
   Google Scholar
• Poo JL, Kershenobich D, Samper XG et al. Thymalfasin (thymosin α1), peg-interferon-α2a (PEG-IFN-α2a) and ribavirin in patients with chronic viral hepatitis C not responding to prior treatment: clinical experience with 40 Mexican patients. Presented at 2nd Annual Congress of the Mexican Association of Hepatology. Yucatan, Mexico, June 21–24 (2005).
   Google Scholar
• SciClone Pharmaceuticals – data on file.
   Google Scholar