Contents:

TABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the HIV, HCV and co-infection markets 4 HCV is the most prevalent chronic infection within the HIV cohort, infecting over 30% of HIV positive individuals. However, the HIV/HCV co-infected population is primarily comprised of difficult-to-treat patient groups, such as intravenous drug users (IDUs). Companies wishing to enter this market need to balance investment in patient targeting campaigns against a potential increase in product uptake, which may be limited in scope 4 HIV/HCV patient potential is limited by poor compliance and low prevalence rates, limiting the incentive for novel product development. However, penetration of the co-infected market will enable companies to leverage their products into the wider HIV or HCV mono-infected populations 6 Treatment of HIV/HCV co-infected patients is complicated by drug-drug interactions and the hepatotoxic side effects of certain HIV products. The design and development of a treatment package with proven efficacy in the co-infected population would provide physicians with a convenient treatment strategy. In addition, it would facilitate collaboration between HIV and HCV companies, to the benefit of both 6 Summary 8 Key metrics 9 CHAPTER 2 PATIENT POTENTIAL 15 Introduction 15 Epidemiology 16 HIV prevalence 16 Disease progression 16 HCV prevalence 19 Disease progression 19 HIV/HCV co-infection 21 High-risk populations 22 Impact of HIV on HCV progression 24 Impact of HCV on HIV progression 24 Summary 24 CHAPTER 3 TREATMENT OVERVIEW 26 Current treatment options 26 HIV 26 Nucleoside reverse transcriptase inhibitors (NRTIs) 27 Non-nucleoside reverse transcriptase inhibitors (NNRTI) 29 Protease inhibitors (PIs) 30 Entry (fusion) inhibitors (EIs) 31 Key treatment strategies 32 HCV 33 Key treatment strategies 34 HIV/HCV co-infected patients 35 Current treatment strategies 36 Unmet needs in the HCV/HIV co-infection market 38 Poor compliance rates 39 Drug-drug interactions 40 Inefficacy of HCV therapy in co-infected patients 40 Diagnosis rates 41 CHAPTER 4 HIV/HCV MARKET PENETRATION STRATEGIES 42 Key companies 42 HIV 42 HCV 45 Expansion into HCV 46 Clinical trials 47 Case study: Fuzeon 47 Case study: Viread and Emtriva 48 Drugs with dual activity 49 Case study: Epivir and Hepsera 49 Can a cross-activity strategy be adopted for HIV/HCV treatment? 50 Entry into the HCV market 50 Case study: BI 51 Opportunities for company collaboration 55 Expansion into HIV 55 Entry into the HIV market 55 Case study: Roche 57 Summary 59 APPENDIX A 60 Contributing experts 60 List of tables 60 List of figures 61 Bibliography 62 Epidemiology 62 Clinical trial data 65 General 67 Websites 69 Company websites 70 Appendix B 72 About Datamonitor 72 About Datamonitor Healthcare 72 Datamonitor Healthcare’s research and analysis methodologies 73 Datamonitor Healthcare’s therapy area capabilities 73 About the Infectious Disease analysis team 74 Datamonitor Healthcare’s Consulting expertise 75 Datamonitor’s Therapeutic Consulting expertise 76 Key therapy team members 76 John Savopoulos , Director of Infectious Diseases 76 David Abramson, Therapeutic Lead Consultant 77 Disclaimer 78