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Chapter 2.4 102 References 1. Janssen HL, van Zonneveld M, Senturk H, Zeuzem S, Akarca US, Cakaloglu Y, Simon C, So TM, Gerken G, de Man RA, Niesters HG, Zondervan P, Hansen B, Schalm SW. Pegylated interferon alfa-2b alone or in combination with lamivudine for HBeAg-positive chronic hepatitis B: a randomised trial. Lancet 2005;365:123-9. 2. Lau GK, Piratvisuth T, Luo KX, Marcellin P, Thongsawat S, Cooksley G, Gane E, Fried MW, Chow WC, Paik SW, Chang WY, Berg T, Flisiak R, McCloud P, Pluck N. Peginterferon Alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. N Engl J Med 2005;352:2682-95. 3. van Zonneveld M, Flink HJ, Verhey E, Senturk H, Zeuzem S, Akarca US, Cakaloglu Y, Simon C, So TM, Gerken G, de Man RA, Hansen BE, Schalm SW, Janssen HL. The safety of pegylated interferon alpha-2b in the treatment of chronic hepatitis B: predictive factors for dose reduction and treatment discontinuation. Aliment Pharmacol Ther 2005;21:1163-71. 4. van Nunen AB, Hansen BE, Suh DJ, Lohr HF, Chemello L, Fontaine H, Heathcote J, Song BC, Janssen HL, de Man RA, Schalm SW. Durability of HBeAg seroconversion following antiviral therapy for chronic hepatitis B: relation to type of therapy and pretreatment serum hepatitis B virus DNA and alanine aminotransferase. Gut 2003;52:420-4. 5. ter Borg MJ, van Zonneveld M, Zeuzem S, Senturk H, Akarca US, Simon C, Hansen BE, Haagmans BL, de Man RA, Schalm SW, Janssen HL. Patterns of viral decline during PEGinterferon alpha-2b therapy in HBeAg-positive chronic hepatitis B: relation to treatment response. Hepatology 2006;44:721-7. 6. Flink HJ, Sprengers D, Hansen BE, van Zonneveld M, de Man RA, Schalm SW, Janssen HL. Flares in chronic hepatitis B patients induced by the host or the virus? Relation to treatment response during Peg-interferon {alpha}-2b therapy. Gut 2005;54:1604-9. 7. Hansen BE, Buster EH, Steyerberg EW, Lesaffre E, Janssen HL. Prediction of the response to peg-interferon-alfa in patients with HBeAg positive chronic hepatitis B using decline of HBV DNA during treatment. J Med Virol 2010;82:1135-42. 8. Mauryama NT, F. Takeuchi M. Prediction of an outcome using trajectories estimated from a linear mixed model. Journal of Biopharmaceutical Statistics 2009;19:779-790. 9. Brant LJ, Sheng SL, Morrell CH, Verbeke GN, Lesaffre E, Carter HB. Screening for prostate cancer by using random-effects models. Journal of the Royal Statistical Society Series A - Statistics in Society 2003;166(part 1):51-62. 10. Morrell CH, Brant LJ, Sheng S. Comparing approaches for predicting prostate cancer from longitudinal data, In Proceedings of the American Statistical Association, Alexandria, American Statistica Association, 2007. 11. Steyerberg EW. Clinical Prediction Models. Springer, 2009. 12. Hernan MA, Brumback B, Robins JM. Marginal structural models to estimate the causal effect of zidovudine on the survival of HIV-positive men. Epidemiology 2000;11:561-70.
Dynamic prediction of response using longitudinal profi les 103 13. Buster EH, Hansen BE, Zeuzem S, Schalm SW, Steyerberg EW, Janssen HL. Predicting sustained hepatitis B virus eAg loss after treatement with peginterferon alpha-2b: development and validation of a pratical model European Journal of Gastroenterology & Hepatology Jul, 2008;20:A69-A70. 14. Buster EH, Hansen BE, Lau GK, Piratvisuth T, Zeuzem S, Steyerberg EW, Janssen HL. Factors that predict response of patients with hepatitis B e antigen-positive chronic hepatitis B to peginterferon-alfa. Gastroenterology 2009;137:2002-9. 15. Fieuws S, Verbeke G, Maes B, Vanrenterghem Y. Predicting renal graft failure using multivariate longitudinal profi les. Biostatistics 2008;9:419-31. 16. Fieuws S, Verbeke G, Brant LJ. Classifi cation of longitudinale profi les using nonlinear mixedeffects models.Technical report 0356. IAP Statistics Network. 17. Komárek A, Hansen BE, Kuiper EM, van Buuren HR, Lesaffre E. Discriminant analysis using a multivariate linear mixed model with a normal mixture in the random effects distribution. Statistics in Medicine 2010;in press. 18. Brant LJ, Sheng SL, Morrell CH, Zonderman AB. Data from a longitudinal study provided measurements of cognition to screen for Alzheimer’s disease. J Clin Epidemiol 2005;58:701-7. Acknowledgement The authors would like to thank Marek Molas, department of Biostatistics, Erasmus MC, Rotterdam , the Netherlands who wrote the SAS program for the adjustment of the predictions in the direct approach using the pattern approach. Foundation for Liver Research (SLO), Rotterdam, The Netherlands (HBV9901), Ministry of Education, Youth and Sports of the Czech Republic (MSM 0021620839), Czech Science Foundation (GAČR 201/09/P077), Belgian State – Federal Office for Scientific, Technical and Cultural Affairs (Interuniversity Attraction Poles Program P6/03).
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Statistical Models of Treatment Eff
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ISBN: 978-90-8559-069-9 © Bettina
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PROMOTIECOMMISSIE Promotor: Prof.dr
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CONTENTS Chapter 1. Introduction 11
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Cha pter 1 Introduction
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Chapter 1 14 Epidemiology Worldwide
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Chapter 1 16 Prediction models with
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Chapter 1 18 standard method fails
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Chapter 1 20 The extended non-linea
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Chapter 1 22 References 1. Blumberg
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Cha pter 2 Prediction of response t
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Chapter 2.1 28 ABSTRACT The aim of
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Chapter 2.1 30 been hepatitis B sur
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Chapter 2.1 32 HBV DNA decline The
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Chapter 2.1 34 Figure 2 continued.
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Chapter 2.1 36 Figure 4. Estimated
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Chapter 2.1 38 DNA was observed in
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Chapter 2.1 40 15. Kao JH. Role of
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Chapter 2.2 44 ABSTRACT Background:
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Chapter 2.2 46 low baseline HBV DNA
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Chapter 2.2 48 patient subgroups wa
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Chapter 2.2 50 p=0.002). Previous I
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Page 56 and 57: Chapter 2.2 54 PEG-IFN, the proport
Page 58 and 59: Chapter 2.2 56 References 1. Lavanc
Page 60 and 61: Chapter 2.2 58 26. Bonino F, Lau GK
Page 63 and 64: Chap ter 2.3 Prediction of the resp
Page 65 and 66: INTRODUCTION Dynamic prediction of
Page 67 and 68: Statistical analysis Dynamic predic
Page 69 and 70: Dynamic prediction of response to P
Page 77 and 78: References Dynamic prediction of re
Page 81 and 82: Cha pter 2.4 Dynamic prediction of
Page 83 and 84: INTRODUCTION Dynamic prediction of
Page 85 and 86: For the indirect approach we rewrit
Page 87 and 88: logit pi,j = logit Pr(Ri =1|visit =
Page 89 and 90: Dynamic prediction of response usin
Page 101 and 102: Table 1. Results of different stopp
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Page 108 and 109: Chapter 2.5 106 ABSTRACT Peginterfe
Page 110 and 111: Chapter 2.5 108 and placebo daily.
Page 112 and 113: Chapter 2.5 110 for patients with a
Page 114 and 115: Chapter 2.5 112 Mean HBV DNA declin
Page 116 and 117: Chapter 2.5 114 peginterferon and n
Page 118 and 119: Chapter 2.5 116 hepatocellular carc
Page 120 and 121: Chapter 2.5 118 13. Werle-Lapostoll
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Page 127 and 128: Chap ter 3.1 Long-term clinical out
Page 129 and 130: INTRODUCTION Glycyrrhizin for IFN-n
Page 131 and 132: Statistics Glycyrrhizin for IFN-non
Page 133 and 134: Glycyrrhizin for IFN-non responders
Page 135 and 136: Table 2. Time dependent Cox regress
Page 143 and 144: Cha pter 3.2 Discriminant analysis
Page 145 and 146: Introduction Discriminant analysis
Page 147 and 148: Discriminant analysis using a MLMM
Page 149 and 150: Estimation Discriminant analysis us
Page 151 and 152: Discriminant analysis using a MLMM
Page 153 and 154: where wi,k(y i, θ) = (k =1,...,K).
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Discriminant analysis using a MLMM
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Appendix Discriminant analysis usin
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Cha pter 4 Statistical models of ea
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Chapter 4.1 176 ABSTRACT Nucleoside
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Chapter 4.1 178 at day 1 at t =0 an
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Chapter 4.1 180 Table 1. Baseline c
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Chapter 4.1 182 Figure 1.
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Chapter 4.1 184 Figure 1. Viral dec
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Chapter 4.1 186 suppression in seru
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Chapter 4.1 188 13. Seifer M, Hamat
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Cha pter 4.2 Viral dynamics during
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INTRODUCTION Viral dynamics during
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Viral dynamics during tenofovir the
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log HBV DNA (copies/mL) 10.0 9.0 8.
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Chap ter 4.3 Modelling of early vir
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INTRODUCTION HBV viral kinetics dur
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HBV viral kinetics during PEG-IFN 2
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SUMMARY AND CONCLUSION Summary and
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Summary and conclusion 233 The mode
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Summary and conclusion 235 The infe
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Summary and conclusion 237 Early st
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SAMENVATTING EN CONCLUSIE Samenvatt
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Samenvatting en conclusie 243 Er we
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Samenvatting en conclusie 245 Data
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Samenvatting en conclusie 247 Behan
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Dan kwoord
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Dankwoord 254 Lieve Marion en Margr
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BIBLI OGRAPHY Bibliography 257 1. K
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Bibliography 259 Interferon-ribavir
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Bibliography 261 Long term clinical
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Bibliography 263 Flares in chronic
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Bibliography 265 Genetic characteri
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Bibliography 267 106. Reijnders JG,
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