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Mil U Ottawa mil u Ottawa L'Univereite canadienne Canada's university TTTTT FACULTE DES ETUDES SUPERIEURES i^s FACULTY OF GRADUATE AND ET POSTOCTORALES u Ottawa POSDOCTORAL STUDIES L'Unneisite c aiidiiieiuiu Canada's university Madzouka Bwesse Kokolo M.Sc. (Epidemiology) _._„„„„__„__. Department of Epidemiology and Community Medicine HIV Oral Pre-Exposure Prophylaxis (PrEP) Trails: A Systematic Review and Systematic Ethics Appraisal TITRE DE LA THESE / TITLE OF THESIS Dean Fergusson „„.„„„„„.__ William Cameron __„„„„„„__„„„:_.„™ David Moher Ineke Neutel Gary W. Slater Le Doyen de la Faculte des etudes superieures et postdoctorales / Dean of the Faculty of Graduate and Postdoctoral Studies HIV ORAL PRE-EXPOSURE PROPHYLAXIS (PrEP) TRIALS: A SYSTEMATIC REVIEW AND SYSTEMATIC ETHICS APPRAISAL MADZOUKA B. KOKOLO Thesis submitted to the Faculty of Graduate and Postdoctoral Studies In partial fulfillment of the requirements For the Master in Science Degree in Epidemiology Epidemiology and Community Medicine Faculty of Medicine University of Ottawa © Madzouka Kokolo, Ottawa, Canada, 2010 Library and Archives Bibliotheque et 1*1 Canada Archives Canada Published Heritage Direction du Branch Patrimoine de I'edition 395 Wellington Street 395, rue Wellington Ottawa ON K1A 0N4 Ottawa ON K1A 0N4 Canada Canada Your file Votre reference ISBN: 978-0-494-73761-3 Our file Notre reference ISBN: 978-0-494-73761-3 NOTICE: AVIS: The author has granted a non­ L'auteur a accorde une licence non exclusive exclusive license allowing Library and permettant a la Bibliotheque et Archives Archives Canada to reproduce, Canada de reproduire, publier, archiver, publish, archive, preserve, conserve, sauvegarder, conserver, transmettre au public communicate to the public by par telecommunication ou par I'lntemet, preter, telecommunication or on the Internet, distribuer et vendre des theses partout dans le loan, distribute and sell theses monde, a des fins commerciales ou autres, sur worldwide, for commercial or non­ support microforme, papier, electronique et/ou commercial purposes, in microform, autres formats. paper, electronic and/or any other formats. The author retains copyright L'auteur conserve la propriete du droit d'auteur ownership and moral rights in this et des droits moraux qui protege cette these. Ni thesis. Neither the thesis nor la these ni des extraits substantiels de celle-ci substantial extracts from it may be ne doivent etre imprimes ou autrement printed or otherwise reproduced reproduits sans son autorisation. without the author's permission. In compliance with the Canadian Conformement a la loi canadienne sur la Privacy Act some supporting forms protection de la vie privee, quelques may have been removed from this formulaires secondaires ont ete enleves de thesis. cette these. While these forms may be included Bien que ces formulaires aient inclus dans in the document page count, their la pagination, il n'y aura aucun contenu removal does not represent any loss manquant. of content from the thesis. 1*1 Canada ABSTRACT BACKGROUND. Pre-exposure prophylaxis (PrEP) is an experimental HIV prevention approach whereby antiretroviral pills are used before anticipated exposure. It is unclear how ethical considerations have been addressed by investigators. METHODS. A systematic review of PrEP controlled prospective studies was conducted. Pre-determined data items were extracted from registries, protocols, reports, and consent forms. Study characteristics, methods, and ethics considerations were synthesized. RESULTS. Among sixteen studies included, twelve involved resource-limited countries. Quality scores were generally high and overall risk of bias was low. Considerations for social value were the least reported whereas considerations for the fair selection of study population were the most reported. More ethics considerations tend to be reported with time. No meta-analysis was performed, as few data were available. CONCLUSION. As critical as clinical data generation is for scientific progress, ethics should be monitored and adequately reported, lest lack of consideration for key principles be uncovered after the facts. ii ACKNOWLEDGEMENTS I would like to express my warmest thanks to: My thesis supervisors, Dr. Dean A. Fergusson and Dr. D. William Cameron, for their sustained support, their sound advice, their diplomatic attitude, and their inspiring mentorship. My second reviewers, Ms. Louise Le Bel and Mr. Danny Monsour, for their enthusiasm, their self-motivation and their diligent work. My research assistantship supervisor, Dr. Alan Tinmouth, and my OHRI colleagues, for their amazing kindness, their cheerful encouragements, their precious comments, and their good spirit. HIV oral PrEP investigators and sponsors, for kindly sharing the study documents without which this work could not have been done. Countless local, national and international experts, for sharing their experience, expertise, and insights. Last but definitely not least: my parents and friends, overseas and in Canada, for their love, their care, their thoughtfulness, and their patience. hi TABLE OF CONTENTS 1.0 ABBREVIATIONS 1 2.0 STATEMENT OF THE PROBLEM 2 3.0 BACKGROUND 3 3.1. A modern plague named HIV/AIDS 3 3.2. Modern bioethics 5 3.3. HIV pre-exposure prophylaxis (PrEP) 8 3.4. Relevance of thesis 11 4.0 OBJECTIVES 13 5.0 METHODS 13 5.1. Systematic review question 13 5.2. Eligibility criteria 14 5.3. Information sources 15 5.4. Search 15 5.5. Study selection 17 5.6. Data collection process 17 5.7. Data items 18 5.8. Quality assessment 27 5.9. Additional analyses 29 5.10. Synthesis of results 30 5.11. Amendments to original protocol 31 6.0 RESULTS 32 6.1. Study selection 32 6.2. Data collection process 32 6.3. Data analysis 33 6.4. Quality assessment 55 6.5. Additional analyses 58 iv 6.6. Synthesis of results 61 6.7. Risk of bias assessment 64 7.0 DISCUSSION 65 7.1. Discussion on Objective 1: identification of PrEP trials 65 7.2. Discussion on Objective 2: methods in PrEP trials 72 7.3. Discussion on Objective 3: ethics appraisal of PrEP trials 79 7.4. Discussion on Objective 4: synthesis of evidence 96 7.5. Challenges & limitations 97 8.0 CONCLUSION 103 9.0 DISSEMINATION 106 10.0 LIST OF ATTACHMENTS 107 Attachment! Reviewer's Brochure 107 Attachment 2. Data Extraction Form 107 Attachments. PrEP Ethics 101 Checklist 107 Attachment 4. Consent Content Analysis Form 107 11.0 TABLES 108 Table 1. List of studies included in the review (16 studies) 108 Table 2. Reported reasons for premature closures (4 studies) 109 Table 3. HIV oral PrEP trials' host countries (16 studies) 110 Table 4. Design features of HIV oral PrEP trials (16 studies) 111 Table 5. Eligibility criteria for HIV exposure (15 studies) 112 Table 6. Primary questions and phases of studies (16 trials) 113 Table 7. Main sources of financial or in-kind support (16 studies) 114 Table 8. Follow-up characteristics (15 studies) 115 Table 9. HIV detection features (15 studies) 116 Table 10. Number of trials reporting each ethics checklist item (14 studies) 117 Table 11. Exploring heterogeneity: outliers in ethics appraisal 123 Table 12. Risk of bias analysis at study level (15 studies) 124 Table 13. Risk of bias analysis at outcome level (15 studies) 124 12.0 FIGURES 125 Figure! Study selection flow diagram 125 V Figure 2. World map of countries considered for hosting PrEP trials 126 Figure 3. Primary analysis: ethics appraisal (14 studies) 127 Figure 4. Primary analysis: variations in ethics sub-scores & time trends (14 trials) 128 Figure 5. Sub-group analyses: quality scores (15 trials) 129 Figure 6. Sub-group analysis: studies with 3-4 sources (11 studies) 130 Figure 7. Sub-group analysis: studies outside of the USA (10 studies) 131 Figure 8. Sub-group analysis: efficacy/effectiveness as a primary question (9 studies) 132 Figure 9. Sub-group analysis: study sites closed early (4 studies) 133 Figure 10. Correlation ethics scores - Jadad scores (14 studies) 134 Figure 11. Synthesis: time trends for ethics scores and Jadad scores 135 Figure 12. Synthesis: past, current, and planned HIV oral PrEP trials (16 studies) 136 13.0 OTHER APPENDICES 137 Appendix! Search strategies 137 Appendix 2. List of key informants contacted 142 Appendix 3. Ethics guidance documents screened 143 Appendix 4. Reference documents for ethical analysis framework 144 Appendix 5. Emanuel et al.'s ethical principles and benchmarks 145 Appendix 6. "Modified" Jadad 5 point-scale 147 Appendix 7. Other reviews of HIV oral PrEP trials 148 Appendix 8. HIV oral PrEP trials mentioned in previous reviews 151 Appendix 9. Hypothetical validation process for ethics checklist 152 Appendix 10. Glossary 154 14.0 REFERENCE LIST 156 VI 1.0 ABBREVIATIONS AIDS acquired immuno-deficiency syndrome AST aspartamine aminotransferase CASI computer-assisted self-interview DMC data monitoring committee DSMB data safety and monitoring board FTC emtricitabine GGT glutamyl transpeptidase HBsAg hepatitis B surface antigen HCV hepatitis C virus HIV human immunodeficiency virus IC50 concentration needed to reduce population growth of HIV by 50%, in vitro IOM Institute of Medicine IQR interquartile range ml millimetre ng nanogram (109 g) NIH United States National Institutes of Health NVP nevirapine PI principal investigator PEP post-exposure prophylaxis PrEP pre-exposure prophylaxis RCT randomized clinical trial TDF tenofovir disoproxil fumarate IU/I international unit per litre UNAIDS Joint United Nations Programme on HIV and AIDS USA United States of America WHO World Health Organization 1 2.0 STATEMENT OF THE PROBLEM HIV prevention research includes trials using antiretrovirals before an anticipated exposure, for persons considered at higher risk. This experimental approach is called pre-exposure prophylaxis or PrEP. "Given (...) the potentially universal benefits of effective biomedical HIV prevention tools, there is an ethical imperative for global support to develop these modal'rties"\ And several research teams have undertaken to scientifically demonstrate the clinical value of HIV oral PrEP. But that endeavour presents considerable methodological challenges. Concerns have been expressed by the public about HIV oral PrEP trials conducted in developing countries, on bioethics grounds.
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