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Chapter 4.1 188 13. Seifer M, Hamatake RK, Colonno RJ, Standring D. In vitro inhibition of hepadnavirus polymerases by the triphosphates of BMS-200465 and lobucavir. Antimicrob Agents Chem 1998;42:3200–3208. 14. Genovesi EV, Lamb L, Medina I, Taylor D, Seifer M, Innaimo S, et al. Efficacy of the carbocyclic 2 0 -deoxyguanosine nucleoside BMS 200475 in the woodchuck model of hepatitis B virus infection. Anti microb Agents Chemother 1998;42:3209–3217. 15. Colonno R, Medina I, Lamb C, Genovesi E, Clark J. Maintenance of viral suppression in chronically infected woodchucks with weekly dosing of BMS-200475. Hepatology 1998;28:488A. 16. Colonno RJ, Genovesi EV, Median I, Lamb L, Durham S, Corey L, et al. Long-term therapy with entecavir (BMS-200475) in the wood chuck model of chronic hepatitis infection. Abstract 172 of the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, Canada, 2000. 17. Tsiang M, Rooney JF, Toole JJ, Gibbs C. Biphasic clearance kinetics of hepatitis B virus from patients during adefovir dipivoxil therapy. Hepatology 1999;29:1863–1869. 18. Wolters LMM, Hansen BE, Niesters HGM, Zeuzem S, Schalm SW, de Man RA. Viral dynamics in chronic hepatitis B patients during lamivudine therapy Liver. 2002 Apr;22(2):121-6 19. Heermann KH, Gerlich WH, Chudy M, Schaefer S, Thomssen R. Quantitative detection of hepatitis B virus DNA in two international reference plasma preparations. EUROHEP Pathobiology Group. J Clin Microbiol 1999;37:68–73. 20. Stuyver L, van Geyt C, de Gendt S, van Reybroeck G, Zoulim F, Leroux-Roels G, et al. Line probe assay for monitoring during resis tance in hepatitis B virus-infected patients during antiviral therapy. J Clin Microbiol 2000;38:702–707. 21. Neumann AU, Lam NP, Dahari H, Gretch DR, Wiley TE, Layden TJ, et al. Hepatitis C viral dynamics in vivo and the antiviral efficacy of Interferon-a therapy. Science 1998;282:103–107. 22. Nowak MA, Bonhoeffer S, Hill AM, Boehme R, Thomas HC, McDade H. Viral dynamics in hepatitis B virus infection. Proc Natl Acad Sci USA 1996;93:4398–4402. 23. Buti M, Jardi R, Cotrina M, Rodriguez-Frias F, Cruz de Castro E, Costa X, et al. Two years of lamivudine therapy in patients with chronic hepatitis B. Analysis of efficacy and emergence of HBV genomic variations (abstract). J Hepatol 2000;2(Suppl):111. 24. Liaw YF, Leung NW, Chang TT, Guan R, Tai D, Ng K, et al. Effects of extended lamivudine therapy in Asian patients with chronic hepa titis B. Gastroenterology 2000;119(1):172–180. 25. Leung NW, Lai CL, Chang TT, Guan R, Lee CM, Ng KY, et al. Extended lamivudine treatment in patients with chronic hepatitis B enhances hepatitis B e antigen seroconversion rates: results after 3 years of therapy. Hepatology 2001;33(6):1527–1532. 26. de Man RA, Wolters LMM, Nevens F, Chua D, Sherman M, Lai CL, et al. A study of oral entecavir given for 28 days in both treatment-naive and pre-treated subjects with chronic hepatitis. Hepatology 2001;34(3):578–582.
Viral dynamics during and after entecavir therapy 189 27. Wolters LMM, Hansen BE, Niesters HGM, Levi-Drummer RS, Neumann AU, Schalm SW, et al. The influence of baseline characteristics on viral dynamic parameters in chronic hepatitis B patients treated with lamivudine. J Hepatol 2002 Aug;37(2):253-8. 28. Nevens F, Main J, Honkoop P, Tyrrell DL, Barber J, Sullivan MT, et al. Lamivudine therapy for chronic hepatitis B: a six-month rando mized dose-ranging study. Gastroenterology 1997;113:1258–1263.
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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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Chapter 2.2 52 Application of the m
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Chapter 2.2 54 PEG-IFN, the proport
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Chapter 2.2 56 References 1. Lavanc
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Chapter 2.2 58 26. Bonino F, Lau GK
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Chap ter 2.3 Prediction of the resp
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INTRODUCTION Dynamic prediction of
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Statistical analysis Dynamic predic
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Dynamic prediction of response to P
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References Dynamic prediction of re
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Cha pter 2.4 Dynamic prediction of
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INTRODUCTION Dynamic prediction of
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For the indirect approach we rewrit
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logit pi,j = logit Pr(Ri =1|visit =
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Dynamic prediction of response usin
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Table 1. Results of different stopp
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Chapter 2.5 106 ABSTRACT Peginterfe
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Chapter 2.5 108 and placebo daily.
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Chapter 2.5 110 for patients with a
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Chapter 2.5 112 Mean HBV DNA declin
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Chapter 2.5 114 peginterferon and n
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Chapter 2.5 116 hepatocellular carc
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Chapter 2.5 118 13. Werle-Lapostoll
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Chapter 2.5 120 Greece - G Germanid
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Chap ter 3.1 Long-term clinical out
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INTRODUCTION Glycyrrhizin for IFN-n
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Statistics Glycyrrhizin for IFN-non
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Glycyrrhizin for IFN-non responders
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Table 2. Time dependent Cox regress
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Glycyrrhizin for IFN-non responders
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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 153 and 154: where wi,k(y i, θ) = (k =1,...,K).
Page 171 and 172: Appendix Discriminant analysis usin
Page 175: Cha pter 4 Statistical models of ea
Page 178 and 179: Chapter 4.1 176 ABSTRACT Nucleoside
Page 180 and 181: Chapter 4.1 178 at day 1 at t =0 an
Page 182 and 183: Chapter 4.1 180 Table 1. Baseline c
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Page 186 and 187: Chapter 4.1 184 Figure 1. Viral dec
Page 188 and 189: Chapter 4.1 186 suppression in seru
Page 193 and 194: Cha pter 4.2 Viral dynamics during
Page 195 and 196: INTRODUCTION Viral dynamics during
Page 197 and 198: Viral dynamics during tenofovir the
Page 201 and 202: log HBV DNA (copies/mL) 10.0 9.0 8.
Page 211 and 212: Chap ter 4.3 Modelling of early vir
Page 213 and 214: INTRODUCTION HBV viral kinetics dur
Page 215 and 216: HBV viral kinetics during PEG-IFN 2
Page 229: HBV viral kinetics during PEG-IFN 2
Page 233 and 234: SUMMARY AND CONCLUSION Summary and
Page 235 and 236: Summary and conclusion 233 The mode
Page 237 and 238: Summary and conclusion 235 The infe
Page 239: 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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