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Chapter 2.2 58 26. Bonino F, Lau GKK, Marcellin P, Hadziyannis S, Kitis G, Jin R, Yao GB, Piratvisuth T, Germanidis G, Yurdaydin C, Diago M, Gurel S, Lai MY, McCloud P, Brunetto MR, Farci P. The fi rst detailed analysis of predictors of response in HBeAg-negative chronic hepatitis B: data from a multicenter, randomized, partially double-blind study of peginterferon-alfa-2a (4-KD) (Pegasys®) alone or in combination with lamivudine vs lamivudine alone. Hepatology 2004;40:A1142. 27. European Association For The Study Of The L. EASL Clinical Practice Guidelines: management of chronic hepatitis B. J Hepatol 2009;50:227-42. 28. 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. 29. Steyerberg EW, Eijkemans MJ, Harrell FE, Jr., Habbema JD. Prognostic modelling with logistic regression analysis: a comparison of selection and estimation methods in small data sets. Stat Med 2000;19:1059-79. 30. Steyerberg EW, Harrell FE, Jr., Borsboom GJ, Eijkemans MJ, Vergouwe Y, Habbema JD. Internal validation of predictive models: effi ciency of some procedures for logistic regression analysis. J Clin Epidemiol 2001;54:774-81. 31. Harrell FE. Regression Modeling Strategies with Applications to Linear Models, Logistic Regression, and Survival Analysis. Springer-Verlag New York, LLC, 2006. 32. de Franchis R, Hadengue A, Lau G, Lavanchy D, Lok A, McIntyre N, Mele A, Paumgartner G, Pietrangelo A, Rodes J, Rosenberg W, Valla D. EASL International Consensus Conference on Hepatitis B. 13-14 September, 2002 Geneva, Switzerland. Consensus statement (long version). J Hepatol 2003;39:S3-25. 33. Liaw YF, Leung N, Kao JH, Piratvisuth T, Gane E, Han KH, Guan R, Lau GK, Locarnini S. Asian- Pacifi c consensus statement on the management of chronic hepatitis B: a 2008 update. Hepatol Int 2008:DOI 10.1007/s12072-008-9080-3. 34. Zoulim F, Perrillo R. Hepatitis B: refl ections on the current approach to antiviral therapy. J Hepatol 2008;48 Suppl 1:S2-19. 35. Craxi A, Di Bona D, Camma C. Interferon-alpha for HBeAg-positive chronic hepatitis B. J Hepatol 2003;39 Suppl 1:S99-105. 36. Fried MW, Piratvisuth T, Lau GK, Marcellin P, Chow WC, Cooksley G, Luo KX, Paik SW, Liaw YF, Button P, Popescu M. HBeAg and hepatitis B virus DNA as outcome predictors during therapy with peginterferon alfa-2a for HBeAg-positive chronic hepatitis B. Hepatology 2008;47:428-34. 37. Buster EH, Hansen BE, Zeuzem S, Schalm SW, Steyerberg EW, Janssen HL. Predicting sustained HBeAg loss after treatment with peginterferon alpha-2b: development and validation of a practical model. Hepatology 2007;46:684A-685A. 38. Grandjacques C, Pradat P, Stuyver L, Chevallier M, Chevallier P, Pichoud C, Maisonnas M, Trepo C, Zoulim F. Rapid detection of genotypes and mutations in the pre-core promoter
Factors that predict response to PEG-IFN 59 and the pre-core region of hepatitis B virus genome: correlation with viral persistence and disease severity. J Hepatol 2000;33:430-9. 39. Lin SM, Yu ML, Lee CM, Chien RN, Sheen IS, Chu CM, Liaw YF. Interferon therapy in HBeAg positive chronic hepatitis reduces progression to cirrhosis and hepatocellular carcinoma. J Hepatol 2007;46:45-52. 40. Chen CJ, Yang HI, Su J, Jen CL, You SL, Lu SN, Huang GT, Iloeje UH. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA 2006;295:65-73. 41. Iloeje UH, Yang HI, Su J, Jen CL, You SL, Chen CJ. Predicting cirrhosis risk based on the level of circulating hepatitis B viral load. Gastroenterology 2006;130:678-86. 42. Marcellin P, Piratvisuth T, Brunetto MR, Bonino F, Lau GK, Farci P, Yurdaydin C, Wu J, Popescu M. Virological and biochemical response in patients with HBeAg-negative chronic hepatitis B treated with peginterferon alfa-2a (40kD) with or without lamivudine: results of 4-year follow-up. J Hepatol 2008;48:S46. Acknowledgment We thank Dr. Richard Batrla (Roche, Basel, Switzerland), Dr. Philip McCloud (Roche, Dee Why, Australia), Peter Button (Roche, Dee Why, Australia) and Schering-Plough International (Kenilworth, NJ, USA) for supporting this study. In addition, we thank all investigators of the Peginterferon Alfa-2a HBeAg-Positive Chronic Hepatitis B Study Group and the HBV99-01 Study Group. 10, 11
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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
Page 9 and 10: CONTENTS Chapter 1. Introduction 11
Page 13: Cha pter 1 Introduction
Page 16 and 17: Chapter 1 14 Epidemiology Worldwide
Page 18 and 19: Chapter 1 16 Prediction models with
Page 20 and 21: Chapter 1 18 standard method fails
Page 22 and 23: Chapter 1 20 The extended non-linea
Page 24 and 25: Chapter 1 22 References 1. Blumberg
Page 27: Cha pter 2 Prediction of response t
Page 30 and 31: Chapter 2.1 28 ABSTRACT The aim of
Page 32 and 33: Chapter 2.1 30 been hepatitis B sur
Page 34 and 35: Chapter 2.1 32 HBV DNA decline The
Page 36 and 37: Chapter 2.1 34 Figure 2 continued.
Page 38 and 39: Chapter 2.1 36 Figure 4. Estimated
Page 40 and 41: Chapter 2.1 38 DNA was observed in
Page 42: Chapter 2.1 40 15. Kao JH. Role of
Page 46 and 47: Chapter 2.2 44 ABSTRACT Background:
Page 48 and 49: Chapter 2.2 46 low baseline HBV DNA
Page 50 and 51: Chapter 2.2 48 patient subgroups wa
Page 52 and 53: Chapter 2.2 50 p=0.002). Previous I
Page 54 and 55: Chapter 2.2 52 Application of the m
Page 56 and 57: Chapter 2.2 54 PEG-IFN, the proport
Page 58 and 59: Chapter 2.2 56 References 1. Lavanc
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
Page 105: Dynamic prediction of response usin
Page 108 and 109: 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
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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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