Citations & References

Western (Allopathic) Medicine

Chapter 9, Section 4

The Future of Western Treatment for Hepatitis C

1. Xu ZX, Hoffman J, Patel I, Joubert P. Single-dose safety/tolerability and pharmacokinetics/ pharmacodynamics (PK/PD) following administration of ascending subcutaneous doses of pegylated-interferon (PEG-IFN) and interferon alpha-2a (IFN alpha-2a) to healthy subjects. Hepatology. 1998;28:A702.

2. Heathcote EJ, Fried MW, Bain MA, DePamphilis J, Modi M. The pharmacokinetics of pegylated-40K interferon alpha-2A (PEG-IFN) in chronic hepatitis C (CHC) patients with cirrhosis. Gastroenterology 1999;116:A735.

3. Reddy KR. Controlled-release, pegylation, liposomal formulations: new mechanisms in the delivery of injectable drugs. Ann Pharmacother. 2000; 34(7-8):915-923.

4. Healthcote EJ, Shiffman ML, Cooksley WG, et al. Peginterferon alfa-2a in patients with chronic hepatitis C and cirrhosis. N Engl J Med. 2000;343(23):1673-1680.

5. Kozlowski A, Harris JM. Improvements in protein PEGylation: pegylated interferons for treatment of hepatitis C. J Control Release. 2001; 72(1-3):217-224.

6. Jen JF, Glue P, Ezzet F, Chung C, Gupta SK, Jacobs S et al. Population pharmacokinetic analysis of pegylated interferon alfa-2b and interferon alfa-2b in patients with chronic hepatitis C. Clin Pharmacol Ther. 2001; 69(6):407-421.

7. Lindsay KL, Trepo C, Heintges T, et al. A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C. Hepatology. 2001;34(2):395-403.

8. Bailon P, Palleroni A, Schaffer CA, Spence CL, Fung WJ, Porter JE et al. Rational design of a potent, long-lasting form of interferon: a 40 kDa branched polyethylene glycol-conjugated interferon alpha-2a for the treatment of hepatitis C. Bioconjug Chem. 2001; 12(2):195-202.

9.Glue P, Fang JW, Rouzier-Panis R, Raffanel C, Sabo R, Gupta SK et al. Pegylated interferon-alpha2b: pharmacokinetics, pharmacodynamics, safety, and preliminary efficacy data. Hepatitis C Intervention Therapy Group. Clin Pharmacol Ther. 2000; 68(5):556-567

10. Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL, Jr. et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002; 347(13):975-982.

11. Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001; 358(9286):958-965.

12. McHutchison JG, Manns M, Patel K, Poynard T, Lindsay KL, Trepo C et al. Adherence to combination therapy enhances sustained response in genotype-1-infected patients with chronic hepatitis C. Gastroenterology. 2002; 123(4):1061-1069.

13. Zeuzem S. Treatment of chronic hepatitis C virus infection in patients with cirrhosis. J Viral Hepat. 2000; 7(5):327-334.

14. Zeuzem S, Herrmann E, Lee JH, et al. Viral kinetics in patients with chronic hepatitis C treated with standard or peginterferon alpha-2a. Gastroenterology. 2001;120(6):1438-1447.

15. Davis GL, et al. A phase I study to evaluate the pharmacokinetics, safety, and tolerability of escalating doses of a novel recombinant human albumin-interferon-a fusion protein (Albuferon™) in subjects with chronic hepatitis C. Abstract 490. 53rd Annual Meeting of the American Association for the Study of Liver Diseases. November 2002. Boston, Massachusetts.

16. Abrignani S, Houghton M, Hsu HH. Perspectives for a vaccine against hepatitis C virus. J Hepatology 1999;31(Suppl 1):259-263.

17. Hsu HH, Abrignani S, Houghton M. Prospects for a hepatitis C virus vaccine. Clin Liver Dis. 1999; 3(4):901-915.

18. Lechmann M, Liang TJ. Vaccine development for hepatitis C. Semin Liver Dis. 2000; 20(2):211-226.

19. Rosenberg S. Recent advances in the molecular biology of hepatitis C virus. J Mol Biol. 2001; 313(3):451-464.

20. Beyene A, Basu A, Meyer K, Ray R. Hepatitis C virus envelope glycoproteins and potential for vaccine development. Vox Sang. 2002; 83 Suppl 1:27-32.

21. Inchauspe G, Feinstone S. Development of a hepatitis C virus vaccine. Clin Liver Dis. 2003; 7(1):243-59

22. Tyrell DL, et al. Development of a mouse model to support hepatitis C viral replication. Frontiers for Drug Development. Abstract 024. HepDART 2001. Maui, Hawaii. 2001.

23. Innogenetics Press Release, March 25, 2004. [At the time of publication, the referenced press release was available on the Innogenetics Internet site at www.innogenetics.be/site/news.html.]

24. Charlton M. Hepatitis C infection in liver transplantation. Am J Transplant. 2001; 1(3):197-203.

25. Fattovich G, Giustina G, Alberti A, et al. A randomized controlled trial of thymopentin therapy in patients with chronic hepatitis B. J Hepatol. 1994;21:361-366.

26. Eichberg JW, Seeff LB, Lawlor DL, et al. Effect of thymosin immunostimulation with and without corticosteroid immunosuppression on chimpanzee hepatitis B carriers. J Med Virol. 1987;21(1):25-37.

27. Davis GL. Treatment of chronic hepatitis B. Hepatology. 1991;14(3):567-569.

28. Mutchnick MG, Lindsay KL, Schiff ER, et al. Thymosin a-1 treatment of chronic hepatitis B: a multicenter randomized, placebo-controlled double blind study. Gastroenterology. 1995;108:A1127.

29. Saruc M, Ozden N, Turkel N, Ayhan S, Hock LM, Tuzcuoglu I, Yuceyar H. Long-term outcomes of thymosin-alpha 1 and interferon alpha-2b combination therapy in patients with hepatitis B e antigen (HBeAg) negative chronic hepatitis B. J Pharm Sci. 2003;92(7):1386-95.

30. Rasi G, DiVirgilio D, Mutchnick MG, et al. Combination thymosin alpha 1 and lymphoblastoid interferon treatment in chronic hepatitis C. Gut. 1996;39(5):679-683.

31. Andreone P, Gramenzi A, Cursaro C, et al. Thymosin-alpha 1 plus interferon-alpha for naive patients with chronic hepatitis C: results of a randomized controlled pilot trial. J Viral Hepat. 2004;11(1):69-73.

32. Penin F, Dubuisson J, Rey FA, Moradpour D, Pawlotsky JM. Structural biology of hepatitis C virus. Hepatology. 2004;39(1):5-19.

33. Love RA, Parge HE, Yu X, et al. Crystallographic identification of a noncompetitive inhibitor binding site on the hepatitis C virus NS5B RNA polymerase enzyme. J Virol. 2003;77(13):7575-81. Erratum in: J Virol. 2003;77(18):10176.

34. Lamarre D, Anderson PC, Bailey M, Beaulieu P, Bolger G, Bonneau P et al. An NS3 protease inhibitor with antiviral effects in humans infected with hepatitis C virus. Nature. 2003; 426(6963):186-189.

35. Dias N, Stein CA. Antisense oligonucleotides: basic concepts and mechanisms. Mol.Cancer Ther. 2002;1:347-355.

36. Witherell GW. ISIS-14803 (Isis Pharmaceuticals). Curr Opin Investig Drugs. 2001; 2(11):1523-1529.

37. McHutchison JG, Pockros PJ, Patel K, et al. A phase 1B dose escalation trial of ISIS 14803, an antisense inhibitor of HCV, in patients with chronic HCV: final report. Hepatology. 2002;36(4 Pt 2):303A.

38. Lee PA, Blatt LM, Blanchard KS, Bouhana KS, Pavco PA, Bellon L et al. Pharmacokinetics and tissue distribution of a ribozyme directed against hepatitis C virus RNA following subcutaneous or intravenous administration in mice. Hepatology. 2000;32:640-646.

39. Kapadia SB, Brideau-Andersen A, Chisari FV. Interference of hepatitis C virus RNA replication by short interfering RNAs. Proc Natl Acad Sci U S A. 2003;100(4):2014-2018.

40. Leevy CB, Ramaraju G, Chalmers CP, Blatt LM. Interim results of a pilot study of the combination of type 1 (IFN alfacon-1) and type 2 (IFN gamma-1b) interferons in chronic hepatitis C patients who have failed to respond to peg-interferon alpha 2 plus ribavirin. Abstract 107455. DDW. May 2004. New Orleans, Louisiana.

41. Gish, R. Clinical study of viramidine in treatment of hepatitis C supports RBC-sparing mechanism of action (abstract). European Association for the Study of the Liver. April 2004. Berlin, Germany.

42. Idenix Pharmaceutical Press Release, April 2003. [At the time of publication, the referenced press release was available on the Idenix Internet site at www.idenix.com/press/030409.html.

43. Shapiro D, Schiff E, Pockros P, et al. Oral IDN-6556, the first caspase inhibitor of apoptosis lowers liver enzymes in HCV patients. HepDART 2003. December 2003. Kauai, Hawaii.