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Chapter 2.5 110 for patients with and without SR, including age, gender, HBV genotype, serum ALT, HBV DNA and HBsAg levels and liver necroinfl ammatory and fi brosis scores (Table 1). Table 1. Baseline characteristics according to SR Characteristics All patients SR + SR – P value (n=107) (n=24) (n=83) Mean (SD) age, years 42 (10) 41 (11) 42 (10) 0.59 Male (%) 77 (72.0) 16 (66.7) 61 (73.5) 0.51 Ethnicity (%) 0.73 Caucasian 102 (95.3) 23 (95.8) 79 (95.2) Other 5 (4.7) 1 (4.2) 4 (4.8) HBV genotype (%) 0.13 A 15 (14.0) 0 15 (18.1) D 85 (79.4) 23 (95.8) 62 (74.7) Other/mixed 7 (6.5) 1 (4.2) 6 (7.2) Median (IQR) ALT* 2.3 (1.6-4.1) 2.0 (1.7-3.9) 2.3 (1.6-4.1) 0.82 Mean (SD) HBV DNA, log copies/mL 6.8 (1.2) 6.9 (1.2) 6.7 (1.2) 0.52 Mean (SD) HBsAg, log IU/mL 3.8 (0.5) 3.8 (0.4) 3.8 (0.6) 0.80 Median (IQR) liver necroinfl ammation 5 (4-7) 5 (4-6) 5 (4-7) 0.52 Median (IQR) liver fi brosis 3 (1-3) 2 (1-3) 3 (1-3) 0.57 Cirrhosis† (%) 3 (2.8) 0 3 (3.6) 1.0 *Multiples of upper limit of the normal range †Ishak fi brosis score 5-6 Serum HBsAg and HBV DNA levels during treatment and follow-up Overall, the mean serum HBsAg concentration decreased signifi cantly after 48 weeks of therapy (mean change compared to baseline -0.47 log IU/mL, p
Early on-treatment prediction of response to PEG 111 Serum HBsAg and HBV DNA levels according to response Mean HBsAg declines from baseline for sustained responders and non-responders are shown in fi gure 1A. During the fi rst 8 weeks of therapy mean serum HBsAg levels remained stable in both patient groups (Fig. 1A). From week 8 onwards however, HBsAg levels markedly decreased among the 24 patients who developed SR, whereas only a modest decrease in HBsAg level was observed in patients who failed to achieve SR (p
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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
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 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 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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