A pharmacokinetic/viral kinetic model to evaluate the treatment effectiveness of danoprevir against chronic HCV

Antiviral Therapy

Volumn 20, Issue 5, 2015, Pages 469-477

  Canini, Laetitia ^a   Chatterjee, Anushree ^a,b,c   Guedj, Jeremie ^d,e   Lemenuel Diot, Annabelle ^f   Brennan, Barbara ^g   Smith, Patrick F ^h,i   Perelson, Alan S ^a  

^a LOS ALAMOS NATIONAL LABORATORY   (United States)

^b CENTER FOR NONLINEAR STUDIES   (United States)

^c University of Colorado at Boulder   (United States)

^d UNIVERSITÉ PARIS DIDEROT   (France)

^e UNIVERSITÉ PARIS DESCARTES   (France)

^f Pharma Development   (Switzerland)

^g Pharma Research and Early Development   (United States)

^h D3 Medicine LLC   (United States)

ⁱ UNIVERSITY AT BUFFALO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DANOPREVIR; MERICITABINE; PEGINTERFERON ALPHA; PLACEBO; RIBAVIRIN; VIRUS RNA; 2'-FLUORO-2'-METHYL-3',5'-DIISOBUTYRYLDEOXYCYTIDINE; ALPHA INTERFERON; ANTIVIRUS AGENT; DEOXYCYTIDINE; LACTAM; MACROGOL DERIVATIVE; NS-5 PROTEIN, HEPATITIS C VIRUS; PEGINTERFERON ALPHA2A; PROTEINASE INHIBITOR; RECOMBINANT PROTEIN; SULFONAMIDE; VIRAL PROTEIN;

ANTIVIRAL ACTIVITY; ARTICLE; CHRONIC HEPATITIS C; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; COHORT ANALYSIS; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG MEGADOSE; HEPATITIS C VIRUS; HUMAN; LOW DRUG DOSE; MATHEMATICAL MODEL; MONOTHERAPY; NONHUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT DURATION; VIRUS LOAD; ANALOGS AND DERIVATIVES; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; COMBINATION DRUG THERAPY; CONTROLLED STUDY; DOSE RESPONSE; DRUG EFFECTS; HEPACIVIRUS; HEPATITIS C, CHRONIC; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; THEORETICAL MODEL; TREATMENT OUTCOME; VIROLOGY;

ANTIVIRAL AGENTS; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG THERAPY, COMBINATION; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; INTERFERON-ALPHA; LACTAMS; MODELS, THEORETICAL; POLYETHYLENE GLYCOLS; PROTEASE INHIBITORS; RECOMBINANT PROTEINS; RIBAVIRIN; SULFONAMIDES; TREATMENT OUTCOME; VIRAL LOAD; VIRAL NONSTRUCTURAL PROTEINS;

EID: 84947254598     PISSN: 13596535     EISSN: 20402058     Source Type: Journal    
DOI: 10.3851/IMP2879     Document Type: Article

References (46)

1. Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology 2013; 57:1333-1342.
2. Pearlman BL, Traub N. Sustained virologic response to antiviral therapy for chronic hepatitis C virus infection: a cure and so much more. Clin Infect Dis 2011; 52:889-900.
3. Tencate V, Sainz B, Jr., Cotler SJ, Uprichard SL. Potential treatment options and future research to increase hepatitis C virus treatment response rate. Hepat Med 2010; 2010:125-145.
4. Ciesek S, von Hahn T, Manns MP. Second-wave protease inhibitors: choosing an heir. Clin Liver Dis 2011; 15:597-609.
5. Chayama K, Takahashi S, Toyota J, et al. Dual therapy with the nonstructural protein 5A inhibitor, daclatasvir, and the nonstructural protein 3 protease inhibitor, asunaprevir, in hepatitis C virus genotype 1b-infected null responders. Hepatology 2012; 55:742-748.
6. McHutchison JG, Everson GT, Gordon SC, et al. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med 2009; 360:1827-1838.
7. Pawlotsky J-M. Treatment of chronic hepatitis C: current and future. Hepatitis C Virus: From Molecular Virology to Antiviral Therapy. City: Springer 2013; p. 321-342.
8. Poordad F, McCone J, Jr., Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011; 364:1195-1206.
9. Forestier N, Larrey D, Guyader D, et al. Treatment of chronic hepatitis C patients with the NS3/4A protease inhibitor danoprevir (ITMN-191/RG7227) leads to robust reductions in viral RNA: a Phase 1b multiple ascending dose study. J Hepatol 2011; 54:1130-1136.
10. Seiwert SD, Andrews SW, Jiang Y, et al. Preclinical characteristics of the hepatitis C virus NS3/4A protease inhibitor ITMN-191 (R7227). Antimicrob Agents Chemother 2008; 52:4432-4441.
11. Gane EJ, Roberts SK, Stedman CA, et al. Oral combination therapy with a nucleoside polymerase inhibitor (RG7128) and danoprevir for chronic hepatitis C genotype 1 infection (INFORM-1): a randomised, double-blind, placebo-controlled, dose-escalation trial. Lancet 2010; 376:1467-1475.
12. Chatterjee A, Guedj J, Perelson AS. Mathematical modelling of HCV infection: what can it teach us in the era of directacting antiviral agents? Antivir Ther 2012; 17:1171-1182.
13. Guedj J, Dahari H, Pohl RT, Ferenci P, Perelson AS. Understanding silibinin's modes of action against HCV using viral kinetic modeling. J Hepatol 2012; 56:1019-1024.
14. Guedj J, Dahari H, Shudo E, Smith P, Perelson AS. Hepatitis C viral kinetics with the nucleoside polymerase inhibitor mericitabine (RG7128). Hepatology 2012; 55:1030-1037.
15. Guedj J, Perelson AS. Second-phase hepatitis C virus RNA decline during telaprevir-based therapy increases with drug effectiveness: implications for treatment duration. Hepatology 2011; 53:1801-1808.
16. Adiwijaya BS, Kieffer TL, Henshaw J, et al. A viral dynamic model for treatment regimens with direct-acting antivirals for chronic hepatitis C infection. PLOS Comput Biol 2012; 8:e1002339.
17. Adiwijaya BS, Herrmann E, Hare B, et al. A multi-variant, viral dynamic model of genotype 1 HCV to assess the in vivo evolution of protease-inhibitor resistant variants. PLOS Comput Biol 2010; 6:e1000745.
18. Guedj J, Dahari H, Rong L, et al. Modeling shows that the NS5A inhibitor daclatasvir has two modes of action and yields a shorter estimate of the hepatitis C virus half-life. Proc Natl Acad Sci U S A 2013; 110:3991-3996.
19. Gane EJ, Rouzier R, Stedman C, et al. Antiviral activity, safety, and pharmacokinetics of danoprevir/ritonavir plus PEG-IFN alpha-2a/RBV in hepatitis C patients. J Hepatol 2011; 55:972-979.
20. Dahari H, Lo A, Ribeiro RM, Perelson AS. Modeling hepatitis C virus dynamics: liver regeneration and critical drug efficacy. J Theor Biol 2007; 247:371-381.
21. Snoeck E, Chanu P, Lavielle M, et al. A comprehensive hepatitis C viral kinetic model explaining cure. Clin Pharmacol Ther 2010; 87:706-713.
22. Neumann AU, Lam NP, Dahari H, et al. Hepatitis C viral dynamics in vivo and the antiviral efficacy of interferonalpha therapy. Science 1998; 282:103-107.
23. Shudo E, Ribeiro RM, Perelson AS. Modeling HCV kinetics under therapy using PK and PD information. Expert Opin Drug Metab Toxicol 2009; 5:321-332.
24. Conway JM, Perelson AS. A hepatitis C virus infection model with time-varying drug effectiveness: solution and analysis. PLOS Comput Biol 2014; 10:e1003769.
25. Savic RM, Karlsson M. Importance of shrinkage in empirical Bayes estimates for diagnostics: problems and solutions. AAPS J 2009; 11:558-569.
26. Zhang L, Beal SL, Sheiner LB. Simultaneous vs. sequential analysis for population PK/PD data I: Best-case performance. J Pharmacokinet Pharmacodyn 2003; 30:387-404.
27. Burnham KP, Anderson DR. Model selection and multimodel inference: a practical information-theoretic approach. New York: Springer 2002.
28. Holford N. VPC: the visual predictive check superiority to standard diagnostic (Rorschach) plots. PAGE. 16-17 June 2005, Pamplona, Spain. Abstract 738.
29. McGivern DR, Masaki T, Williford S, et al. Kinetic analyses reveal potent and early blockade of hepatitis C virus assembly by NS5A inhibitors. Gastroenterology 2014; 147:453-462.
30. Rong L, Dahari H, Ribeiro RM, Perelson AS. Rapid emergence of protease inhibitor resistance in hepatitis C virus. Sci Trans Med 2010; 2:30ra32.
31. Dixit NM, Layden-Almer JE, Layden TJ, Perelson AS. Modelling how ribavirin improves interferon response rates in hepatitis C virus infection. Nature 2004; 432:922-924.
32. Adiwijaya BS, Hare B, Caron PR, et al. Rapid decrease of wild-type hepatitis C virus on telaprevir treatment. Antivir Ther 2009; 14:591-595.
33. Nguyen TH, Mentré F, Levi M, Yu J, Guedj J. A pharmacokinetic-viral kinetic model describes the effect of alisporivir monotherapy or in combination with peg-IFN on hepatitis C virologic response. Clin Pharmacol Ther 2014; 96:599-608.
34. Guedj J, Yu J, Levi M, et al. Modeling viral kinetics and treatment outcome during alisporivir interferon-free treatment in hepatitis C virus genotype 2 and 3 patients. Hepatology 2014; 59:1706-1714.
35. Herrmann E, Zeuzem S, Sarrazin C, et al. Viral kinetics in patients with chronic hepatitis C treated with the serine protease inhibitor BILN 2061. Antivir Ther 2006; 11:371-376.
36. Adiwijaya B, Kieffer T, Bartels D, et al. Modeling, clinical and virology data from Phase 2 and 3 studies support 12-week telaprevir duration in combination with 24-or 48-week peginterferon/ribavirin duration. J Hepatol 2011; 54 Suppl 1:S160.
37. Lewis H, Cunningham M, Foster G. Second generation direct antivirals and the way to interferon-free regimens in chronic HCV. Best Pract Res Clin Gastroenterol 2012; 26:471-485.
38. Lim SR, Qin X, Susser S, et al. Virologic escape during danoprevir (ITMN-191/RG7227) monotherapy is hepatitis C virus subtype dependent and associated with R155K substitution. Antimicrob Agents Chemother 2012; 56:271-279.
39. Rong L, Guedj J, Dahari H, et al. Analysis of hepatitis C virus decline during treatment with the protease inhibitor danoprevir using a multiscale model. PLOS Comput Biol 2013; 9:e1002959.
40. Kieffer TL, De Meyer S, Bartels DJ, et al. Hepatitis C viral evolution in genotype 1 treatment-naive and treatmentexperienced patients receiving telaprevir-based therapy in clinical trials. PLoS ONE 2012; 7:e34372.
41. Kuhn E, Lavielle M. Maximum likelihood estimation in nonlinear mixed effects models. Comput Stat Data Anal 2005; 49:1020-1038.
42. Gane EJ, Stedman CA, Hyland RH, et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med 2013; 368:34-44.
43. Feld JJ, Kowdley KV, Coakley E, et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014; 370:1594-1603.
44. Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med 2014; 370:1879-1888.
45. Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med 2014; 370:211-221.
46. Gane EJ, Pockros PJ, Zeuzem S, et al. Mericitabine and ritonavir-boosted danoprevir with or without ribavirin in treatment-naive HCV genotype 1 patients: INFORM-SVR study. Liver Int 2015; 35:79-89.