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Chapter 4.3 224 References 1. Kane M. Global programme for control of hepatitis B infection. Vaccine 1995;13 Suppl 1:S47-9. 2. Lok AS, Lai CL, Leung N, Yao GB, Cui ZY, Schiff ER, Dienstag JL, Heathcote EJ, Little NR, Griffi ths DA, Gardner SD, Castiglia M. Long-term safety of lamivudine treatment in patients with chronic hepatitis B. Gastroenterology 2003;125:1714-22. 3. Fung SK, Chae HB, Fontana RJ, Conjeevaram H, Marrero J, Oberhelman K, Hussain M, Lok AS. Virologic response and resistance to adefovir in patients with chronic hepatitis B. J Hepatol 2006;44:283-90. 4. Sherman M, Yurdaydin C, Sollano J, Silva M, Liaw YF, Cianciara J, Boron-Kaczmarska A, Martin P, Goodman Z, Colonno R, Cross A, Denisky G, Kreter B, Hindes R. Entecavir for treatment of lamivudine-refractory, HBeAg-positive chronic hepatitis B. Gastroenterology 2006;130:2039-49. 5. Cooksley WG, Piratvisuth T, Lee SD, Mahachai V, Chao YC, Tanwandee T, Chutaputti A, Chang WY, Zahm FE, Pluck N. Peginterferon alpha-2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat 2003;10:298-305. 6. 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. 7. 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. 8. Marcellin P, Lau GK, Bonino F, Farci P, Hadziyannis S, Jin R, Lu ZM, Piratvisuth T, Germanidis G, Yurdaydin C, Diago M, Gurel S, Lai MY, Button P, Pluck N. Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2004;351:1206-17. 9. Chan HL, Leung NW, Hui AY, Wong VW, Liew CT, Chim AM, Chan FK, Hung LC, Lee YT, Tam JS, Lam CW, Sung JJ. A randomized, controlled trial of combination therapy for chronic hepatitis B: comparing pegylated interferon-alpha2b and lamivudine with lamivudine alone. Ann Intern Med 2005;142:240-50. 10. 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;44:721-727. 11. Neumann AU. Hepatitis B viral kinetics: a dynamic puzzle still to be resolved. Hepatology 2005;42:249-54.
HBV viral kinetics during PEG-IFN 225 12. Pas SD, Fries E, De Man RA, Osterhaus AD, Niesters HG. Development of a quantitative real-time detection assay for hepatitis B virus DNA and comparison with two commercial assays. J Clin Microbiol 2000;38:2897-901. 13. Powers KA, Dixit NM, Ribeiro RM, Golia P, Talal AH, Perelson AS. Modeling viral and drug kinetics: hepatitis C virus treatment with pegylated interferon alfa-2b. Semin Liver Dis 2003;23 Suppl 1:13-8. 14. Talal AH, Ribeiro RM, Powers KA, Grace M, Cullen C, Hussain M, Markatou M, Perelson AS. Pharmacodynamics of PEG-IFN alpha differentiate HIV/HCV coinfected sustained virological responders from nonresponders. Hepatology 2006;43:943-53. 15. Nowak MA, Bonhoeffer S, Hill AM, Boehme R, Thomas HC, McDade H. Viral dynamics in hepatitis B virus infection. Proc Natl Acad Sci U S A 1996;93:4398-402. 16. Sypsa VA, Mimidis K, Tassopoulos NC, Chrysagis D, Vassiliadis T, Moulakakis A, Raptopoulou M, Haida C, Hatzakis A. A viral kinetic study using pegylated interferon alfa-2b and/or lamivudine in patients with chronic hepatitis B/HBeAg negative. Hepatology 2005;42:77- 85. 17. Buti M, Sanchez-Avila F, Lurie Y, Stalgis C, Valdes A, Martell M, Esteban R. Viral kinetics in genotype 1 chronic hepatitis C patients during therapy with 2 different doses of peginterferon alfa-2b plus ribavirin. Hepatology 2002;35:930-6. 18. Formann E, Jessner W, Bennett L, Ferenci P. Twice-weekly administration of peginterferonalpha-2b improves viral kinetics in patients with chronic hepatitis C genotype 1. J Viral Hepat 2003;10:271-6. 19. Zeuzem S, Welsch C, Herrmann E. Pharmacokinetics of peginterferons. Semin Liver Dis 2003;23 Suppl 1:23-8. 20. Lindsay KL, Trepo C, Heintges T, Shiffman ML, Gordon SC, Hoefs JC, Schiff ER, Goodman ZD, Laughlin M, Yao R, Albrecht JK. A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C. Hepatology 2001;34:395-403. 21. Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001;358:958-65. 22. Chow WC, Manns M, Paik SW, Berg T, Piratvisuth T, Chang WY, Lau GKK, Marcellin P, Gane E, Pluck N. Effect of ethnicity, genotype, gender, age and bodyweight on sustained response in a large, randomised study of peginterferon (40KD) +/- lamivudine for HBeAG-positive chronic hepatitis B. Hepatology 2005;42 (Suppl. 1):576A. 23. Wolters LM, Hansen BE, Niesters HG, Levi-Drummer RS, Neumann AU, Schalm SW, de Man RA. The infl uence of baseline characteristics on viral dynamic parameters in chronic hepatitis B patients treated with lamivudine. J Hepatol 2002;37:253-8. 24. Tsiang M, Rooney JF, Toole JJ, Gibbs CS. Biphasic clearance kinetics of hepatitis B virus from patients during adefovir dipivoxil therapy. Hepatology 1999;29:1863-9.
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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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Cha pter 3.2 Discriminant analysis
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Introduction Discriminant analysis
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Discriminant analysis using a MLMM
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Estimation Discriminant analysis us
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where wi,k(y i, θ) = (k =1,...,K).
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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
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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 190 and 191: Chapter 4.1 188 13. Seifer M, Hamat
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 225: 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
Page 243 and 244: SAMENVATTING EN CONCLUSIE Samenvatt
Page 245 and 246: Samenvatting en conclusie 243 Er we
Page 247 and 248: Samenvatting en conclusie 245 Data
Page 249 and 250: Samenvatting en conclusie 247 Behan
Page 253: Dan kwoord
Page 256 and 257: Dankwoord 254 Lieve Marion en Margr
Page 259 and 260: BIBLI OGRAPHY Bibliography 257 1. K
Page 261 and 262: Bibliography 259 Interferon-ribavir
Page 263 and 264: Bibliography 261 Long term clinical
Page 265 and 266: Bibliography 263 Flares in chronic
Page 267 and 268: Bibliography 265 Genetic characteri
Page 269: Bibliography 267 106. Reijnders JG,
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