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Aus Der Fachrichtung Infektionsmedizin Aus der Fachrichtung Infektionsmedizin Abteilung für Transplantations- und Infektionsimmunologie Der Medizinischen Fakultät der Universität des Saarlandes, Homburg Saar Assessment & analysis of HIV/MTB epidemiology and diagnostics as a basis for evidence- based guideline development & priority setting in Europe Dissertation zur Erlangung des Grades eines Doktors der Theoretischen Medizin der Medizinischen Fakultät der UNIVERSITÄT DES SAARLANDES 2012 vorgelegt von Claudia Giehl geboren am 12.12.1974 in Saarbrücken Content 1 Summary ............................................................................................................................. 5 Zusammenfassung ...................................................................................................................... 7 2 Introduction ........................................................................................................................ 7 2.1 The history of tuberculosis in Europe .......................................................................... 9 2.2 The pathogen ............................................................................................................. 11 2.3 Transmission, infection, and immune response........................................................ 12 2.4 Latency ....................................................................................................................... 13 2.5 TB diagnostics ............................................................................................................ 14 2.6 Emerging drug resistance .......................................................................................... 18 2.7 Co-infection with HIV ................................................................................................. 19 2.8 Surveillance ................................................................................................................ 21 2.9 Political and financial support ................................................................................... 23 2.10 Specific aims .............................................................................................................. 26 3 Materials and methods ..................................................................................................... 27 3.1 Abbreviations ............................................................................................................. 27 3.2 Epidemiological data ................................................................................................. 29 3.2.1 Data collection .................................................................................................... 29 3.2.2 Calculation of prevalence, incidence, and mortality.......................................... 29 3.3 Diagnostic standards and disease management ....................................................... 30 3.3.1 Data collection on diagnostic standards ............................................................ 30 3.3.2 Meta-analysis of data on diagnostic tests (TST and IGRAs) ............................... 31 3.4 Definition of research priorities within the EUCO-Net project ................................. 33 3.4.1 Selection of experts for preparation of the EUCO-Net Roadmap ...................... 33 3.4.2 Assessment of baseline situation and definition of focus topics ....................... 34 3.4.3 Online follow-up, consensus procedure, and writing of the Roadmap ............. 35 3.5 Funding analysis ......................................................................................................... 36 2 3.5.1 Global funding .................................................................................................... 36 3.5.2 HIV/AIDS and TB in FP7 ...................................................................................... 36 3.6 Short film production ................................................................................................ 37 4 Results ............................................................................................................................... 40 4.1 Epidemiology of TB and HIV/MTB co-infection in Europe ........................................ 40 4.1.1 TB Epidemiology ................................................................................................. 40 4.1.2 Epidemiology of HIV/MTB co-infection .............................................................. 45 4.2 Variability of TB diagnostic standards and availability of tests ................................. 48 4.3 Limited suitability of IGRAs for the diagnosis of active tuberculosis ........................ 52 4.4 Research priorities are not EU-specific ..................................................................... 57 4.4.1 Basic sciences ..................................................................................................... 58 4.4.2 Clinical sciences .................................................................................................. 60 4.4.3 Diagnostics ......................................................................................................... 61 4.4.4 Training and networking .................................................................................... 62 4.5 HIV/AIDS, TB, and co-infection in the global funding portfolio ................................ 64 4.5.1 Global funding for HIV/AIDS & for TB research ................................................. 64 4.5.2 HIV/AIDS and TB funding within FP7 .................................................................. 65 4.6 Outreach .................................................................................................................... 68 5 Discussion .......................................................................................................................... 71 5.1 Epidemiological data ................................................................................................. 71 5.2 Diagnostics ................................................................................................................. 75 5.3 Funding ...................................................................................................................... 78 5.4 Research priorities ..................................................................................................... 80 5.5 Outreach .................................................................................................................... 82 6 Cooperations ..................................................................................................................... 84 7 Publications and Acknowledgement................................................................................. 85 3 7.1 Publications ............................................................................................................... 85 7.2 Invited oral presentations ......................................................................................... 86 7.3 Acknowledgement ..................................................................................................... 87 8 References ........................................................................................................................ 88 9 Annexes ............................................................................................................................. 96 9.1 Annex I: List of 27 IGRA papers included in the meta-analysis ................................. 96 9.2 Annex II: List of extended group of EUCO-Net experts ............................................. 99 10 Curriculum Vitae .......................................................................................................... 101 4 Summary Tuberculosis (TB) and the Acquired Immunodeficiency Syndrome (AIDS) are the two leading deadly infectious diseases globally, and in combination represent a public health problem of particular complexity. Though highly different in history and pathogenesis (AIDS is a viral infection, while TB is caused by the bacterium M. tuberculosis; AIDS is recently emerging and TB very ancient) the two diseases exert considerable mutual interactions that require specific public health measures and targeted research initiatives. The aim of this thesis was to provide an overview of the epidemiology of TB and HIV/M. tuberculosis co-infection and current diagnostic standards in Europe, identify priority areas for future research activities, and communicate the results to relevant stakeholders. To prepare an evidence-base for research priority setting, data collected by the World Health Organization (WHO) and the European Centre for Disease Prevention and Care (ECDC) were combined to a comprehensive overview of the epidemiology of TB, drug- resistant TB, and co-infection with HIV in all 27 EU member states. This data collection was complemented by an assessment of diagnostic standards, looking both at the suitability of different test methods to actually diagnose active TB or latent infection, and at the availability and frequency of use of the respective tests. Modern blood-based Interferon-- release-assays (IGRAs) have been recently established as a more specific alternative to the classical tuberculin skin test (TST) for the diagnosis of latent TB infection, while their value for the diagnosis of active TB was unclear. This question was addressed in a systematic review and meta-analysis, and information on current clinical practice in Europe and non- European high
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