Modeling ribavirin-induced anemia in patients with chronic Hepatitis C Virus

CPT: Pharmacometrics and Systems Pharmacology

Volumn 5, Issue 2, 2016, Pages 65-73

  Wu, L S ^a   Jimmerson, L C ^b   Macbrayne, C E ^b   Kiser, J J ^b   D'Argenio, D Z ^a  

^a University of Southern California   (United States)

^b UNIVERSITY OF COLORADO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HEMOGLOBIN; INOSINE PHOSPHATE; INOSINE TRIPHOSPHATASE; INTERLEUKIN 28B; PEGINTERFERON ALPHA2A; RIBAVIRIN; TELAPREVIR; UNCLASSIFIED DRUG; ANTIVIRUS AGENT; IL28B PROTEIN, HUMAN; INORGANIC PYROPHOSPHATASE; INTERLEUKIN DERIVATIVE; ITPA PROTEIN, HUMAN;

ANEMIA; ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CELL SURVIVAL; CHRONIC HEPATITIS C; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DRUG EXPOSURE; DRUG MECHANISM; ERYTHROCYTE; FEEDBACK SYSTEM; FEMALE; GENETIC ANALYSIS; HEMOGLOBIN DETERMINATION; HEPATITIS C VIRUS; HEPATITIS C VIRUS GENOTYPE 1; HUMAN; INCIDENCE; MALE; NONHUMAN; PRIORITY JOURNAL; TREATMENT DURATION; WILD TYPE; BIOLOGICAL MODEL; CHEMICALLY INDUCED; COMPUTER SIMULATION; DOSE RESPONSE; DRUG EFFECTS; GENETICS; HEPATITIS C, CHRONIC;

ANEMIA; ANTIVIRAL AGENTS; COMPUTER SIMULATION; DOSE-RESPONSE RELATIONSHIP, DRUG; ERYTHROCYTES; HEPATITIS C, CHRONIC; HUMANS; INTERLEUKINS; MODELS, BIOLOGICAL; PYROPHOSPHATASES; RIBAVIRIN;

EID: 84959080561     PISSN: None     EISSN: 21638306     Source Type: Journal    
DOI: 10.1002/psp4.12058     Document Type: Article

References (43)

1. AASLD/IDSA/IAS-USA. Hepatitis C treatment guidelines.-www.hcvguidelines.org
2. Fried, M.W., et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N. Engl. J. Med. 347, 975-982 (2002
3. Manns, M.P., 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 358, 958-965 (2001
4. McHutchison, J.G., et al. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N. Engl. J. Med. 361, 580-593 (2009
5. Jacobson, I.M., et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N. Engl. J. Med. 364, 2405-2416 (2011
6. Poordad, F., et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N. Engl. J. Med. 370, 1973-1982 (2014
7. Zeuzem, S., et al. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N. Engl. J. Med. 370, 1604-1614 (2014
8. Feld, J.J., et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N. Engl. J. Med. 370, 1594-1603 (2014
9. Sovaldi [package insert]. Foster City, CA: Gilead Sciences, 2015
10. Hadziyannis, S.J., et al. Peginterferon-Alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann. Intern. Med. 140, 346-355 (2004
11. Reddy, K.R., et al. Impact of ribavirin dose reductions in hepatitis C virus genotype 1 patients completing peginterferon alfa-2a/ribavirin treatment. Clin. Gastroenterol. Hepatol. 5, 124-129 (2007
12. Page, T., & Connor, J.D. The metabolism of ribavirin in erythrocytes and nucleated cells. Int. J. Biochem. 22, 379-383 (1990
13. Jimmerson, L.C., et al. Effects of ribavirin on red blood cell concentrations of endogenous purines in patients with hepatitis C virus undergoing ribavirin-based treatment. 65th Annual Meeting of the American Association for the Study of Liver Diseases: the Liver Meeting, Boston, MA, 7-11 November 2014
14. De Franceschi, L., et al. Hemolytic anemia induced by ribavirin therapy in patients with chronic hepatitis C virus infection: role of membrane oxidative damage. Hepatology 31, 997-1004 (2000
15. Homma, M., Hosono, H., Hasegawa, Y., & Kohda Y. Morphological transformation and phosphatidylserine exposure in erythrocytes treated with ribavirin. Biol. Pharm. Bull. 32, 1940-1942 (2009
16. Canonico, P.G., Kastello, M.D., Spears, C.T., Brown, J.R., Jackson, E.A., & Jenkins, D.E. Effects of ribavirin on red blood cells. Toxicol. Appl. Pharmacol. 74, 155-162 (1984
17. Canonico, P.G., et al. Hematological and bone marrow effects of ribavirin in rhesus monkeys. Toxicol. Appl. Pharmacol. 74, 163-172 (1984
18. Ronzoni, L., et al. Ribavirin suppresses erythroid differentiation and proliferation in chronic hepatitis C patients. J. Viral Hepat. 21, 416-423 (2014
19. Virtue, M.A., Furne, J.K., Ho, S.B., & Levitt, M.D. Use of alveolar carbon monoxide to measure the effect of ribavirin on red blood cell survival. Am. J. Hematol. 76, 107-113 (2004
20. Krishnan, S.M., & Dixit, N.M. Estimation of red blood cell lifespan from alveolar carbon monoxide measurements. Transl. Res. 154, 15-17 (2009
21. Tod, M., et al. Pharmacokinetic/pharmacodynamic and time-To-event models of ribavirininduced anaemia in chronic hepatitis C. Clin. Pharmacokinet. 44, 417-428 (2005
22. Krishnan, S.M., & Dixit, N.M. Ribavirin-induced anemia in hepatitis C virus patients undergoing combination therapy. PLoS Comput. Biol. 7, e1001072 (2011
23. Krishnan, S.M., & Dixit, N.M. A formula to estimate the optimal dosage of ribavirin for the treatment of chronic hepatitis C: influence of ITPA polymorphisms. Antivir. Ther. 17, 1581-1592 (2012
24. Wu, L.S., et al. Population pharmacokinetic modeling of plasma and intracellular ribavirin concentrations in patients with chronic hepatitis C virus infection. Antimicrob. Agents Chemother. 59, 2179-2188 (2015
25. Thompson, A.J., et al. Variants in the ITPA gene protect against ribavirin-induced hemolytic anemia and decrease the need for ribavirin dose reduction. Gastroenterology 139, 1181-1189 (2010
26. Fellay, J., et al ITPA gene variants protect against anaemia in patients treated for chronic hepatitis C. Nature 464, 405-408 (2010
27. Ge, D., et al. Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance. Nature 461, 399-401 (2009
28. Thomas, D.L., et al. Genetic variation in IL28B and spontaneous clearance of hepatitis C virus. Nature 461, 798-801 (2009
29. Spada, E., et al. Role of IL28B gene polymorphism and cell-mediated immunity in spontaneous resolution of acute hepatitis C. Clin. Infect. Dis. 57, 803-811 (2013
30. Savic, R.M., & Karlsson, M.O. Importance of shrinkage in empirical bayes estimates for diagnostics: problems and solutions. AAPS J. 11, 558-569 (2009
31. Berlin, N.I., Waldmann, T.A., & Weissman, S.M. Life span of red blood cell. Physiol. Rev. 39, 577-616 (1959
32. D Argenio, D.Z., Schumitzky, A., & Wang, X. ADAPT 5 User s Guide: Pharmacokinetic/Pharmacodynamic Systems Analysis Software. (Biomedical Simulations Resource, Los Angeles, CA, 2009
33. Wahlby, U., Jonsson, E.N., & Karlsson, M.O. Comparison of stepwise covariate model building strategies in population pharmacokinetic-pharmacodynamic analysis. AAPS PharmSci. 4, E27 (2002
34. Giblett, E.R., Coleman, D.H., Pirziobiroli, G., Donohue, D.M., Motulsky, A.G., & Finch, C.A. Erythrokinetics: quantitative measurements of red cell production and destruction in normal subjects and patients with anemia. Blood 11, 291-309 (1956
35. De Nicoló, A., et al. Telaprevir-S isomer enhances ribavirin exposure and the ribavirin-related haemolytic anaemia in a concentration-dependent manner. Antiviral Res. 109, 7-14 (2014
36. Domingo, P., et al. Association of ITPA gene polymorphisms and the risk of ribavirininduced anemia in HIV/hepatitis C virus (HCV)-coinfected patients receiving HCV combination therapy. Antimicrob. Agents Chemother. 56, 2987-2993 (2012
37. Sumi, S., et al. Genetic basis of inosine triphosphate pyrophosphohydrolase deficiency. Hum. Genet. 111, 360-367 (2002
38. Hitomi, Y., et al. Inosine triphosphate protects against ribavirin-induced adenosine triphosphate loss by adenylosuccinate synthase function. Gastroenterology 140, 1314-1321 (2011
39. Li, M., Liu, X., Zhou, Y., & Su, S.B. Interferon-lambdas: the modulators of antivirus, antitumor, and immune responses. J. Leukoc. Biol. 86, 23-32 (2009
40. Zhang, L., et al. IL28B inhibits hepatitis C virus replication through the JAK-STAT pathway. J. Hepatol. 55, 289-298 (2011
41. Marcello, T., et al. Interferons alpha and lambda inhibit hepatitis C virus replication with distinct signal transduction and gene regulation kinetics. Gastroenterology 131, 1887-1898 (2006
42. Ganser, A., Carlo-Stella, C., Greher, J., Volkers, B., & Hoelzer, D. Effect of recombinant interferons alpha and gamma on human bone marrow-derived megakaryocytic progenitor cells. Blood 70, 1173-1179 (1987
43. Peck-Radosavljevic, M., et al. Rapid suppression of hematopoiesis by standard or pegylated interferon-Alpha. Gastroenterology 123, 141-151 (2002