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Stakeholder Opinions: HIV/ HBV Co-infection - More Potency, More Policy


Description: Introduction Long-term usage of HAART for the management of HIV has reduced mortality in the HIV-infected population. However, this has consequently led to an increase in the prevalence of chronic co-infections such as Hepatitis B (HBV). Currently, HBV prevalence exceeds that of HIV and is estimated at 2 billion infected individuals worldwide, accounting for approximately 5% of the world’s population. Scope Key data and epidemiology of the seven major HIV therapeutic markets highlighting the HIV / HBV co-morbid population Overview of the limitations surrounding co-morbid management such as recognition of co infection, high-risk groups and lack of efficacious antivirals Report Highlights Concurrent early diagnosis of both HIV and HBV disease states is pivotal to increasing the lifespan of this co-morbid population. Effective treatment is currently hampered by poor patient compliance, HAART hepatotoxicity and lack of comprehensive treatment guidelines. Reasons to Purchase Effectively target this niche sector, through a complete understanding of the prevalence of the co-morbid population in the seven major markets Identify the most promising products in the HIV and HBV pipelines, and track how current players are seeking to optimize their market share Scope Analysis based on interviews with key opinion leaders in the major markets Report Highlights Lack of potency with current HBV therapeutics is an obvious gap in treating both mono and co-infected patients currently being addressed by companies such as Gilead and Idenix/Novartis. Commercial support for global implementation of HBV vaccination need not preclude a high volume/low cost business model for a new potent HBV antiviral.


Contents: Table of Contents CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the HIV/HBV co-morbid market 4 Increased longevity and shared epidemiological risk raises the likelihood that HIV infected individuals will contract HBV. Whilst HBV has little impact on HIV, HIV renders HBV more aggressive and frequent with co-infected individuals eight times more likely to die of liver damage related mortality. 4 Datamonitor research reveals that concurrent early diagnosis of both disease HIV and HBV states is pivotal to increasing the life span of this co-morbid population. Effective treatment is currently hampered by poor patient compliance, HAART hepatoxicity and lack of comprehensive treatment guidelines. Strong regional variance with regard to HAART modification was also observed. 6 Lack of potency with current HBV therapeutics is an obvious gap in treating both mono and co-infected patients currently being addressed by companies such as Gilead and Idenix/Novartis. Gilead is committed to maximizing commercial opportunity with broad spectrum antiviral compounds meeting the needs of all HIV and HBV patient groups; 7 Increased global implementation of HBV vaccination will affect the dynamics of the HIV/HBV co-morbid population in both developed and developing regions. Commercial support of this initiative need not preclude a high volume/low cost business model for a new potent HBV antiviral. 8 Summary 9 Key metrics 10 CHAPTER 2 NATURE OF THE HIV/HBV COINFECTED POPULATION 16 Introduction 16 Prognosis of HIV/HBV co-infection 17 HBV genotypes 19 HIV/HBV co-morbid population: estimates of prevalence 20 Case study: regional variation in Italy 23 Drivers and resistors to increasing HIV/HBV co-infection 24 Increased ‘high risk’ activity 25 CHAPTER 3 DIAGNOSTIC AND TREATMENT STRATEGIES FOR THE HIV/HBV COMORBID POPULATION 29 Overview 29 Diagnosis of HBV infection 31 HBV DNA detection 33 Diagnosis of HBV in HIV infected patients 37 Delta Hepatitis Infection 38 HIV /HBV co-infection management guidelines 39 Co-morbid patient treatment eligibility 40 Current HBV treatment options 41 Interferon a (IFN -a) 43 Lamivudine (Epivir-HBV / Zeffix) 44 HepSera (adefovir dipivoxil) 45 Differences in global treatment strategies 45 Key issues for HBV/HIV co-morbid therapy 47 Vaccination 47 HBV Vaccine choice 48 Vaccination of the HIV/HBV co-infected population 50 Substance abuse in the co-morbid population 52 Hepatoxicity 52 The effect of drug resistance on the co-morbid population 55 Dual-efficacy and drug resistance 56 Cross resistance and sanctuary sites 57 CHAPTER 4 COMPANY HBV THERAPEUTIC PORTFOLIOS 58 Pipeline HBV therapeutics 58 Tenofovir 61 Entecavir 61 Emtriva (emtricitabine/coviracil) 62 Telbivudine (LdT) 62 MIV-210 63 HIV/HBV co-infection therapeutic trials 63 Key commercial players in the HBV therapy market 65 CHAPTER 5 STRATEGIC RECOMMENDATIONS 68 HBV antiviral therapy: the need for potency 68 Case study: GSK life cycle management 69 Case study: Gilead in the HBV market 70 Case study: Idenix / Novartis collaboration 71 Key treatment issues of the HIV/HBV co-morbid population 72 Education and Training 72 Integration into HAART 73 Drug resistance 74 Alternative HBV antivirals 74 Generic co formulations: the knock on effect 75 HBV vaccination issues in the co-morbid population 75 Worldwide Hepatitis B vaccination 75 Hepatitis B Vaccination in the co-infected populace 76 New potent HBV antivirals: a high volume, low cost model 77 Capture of the HIV/HBV co-infected population 77 Governments in the major markets 77 Clinical targeting 78 Patient advocacy groups 78 Intercompany collaborations 79 Therapy-Therapy collaborations 79 Therapy-Diagnostic collaborations 79 APPENDIX A 80 Websites 83 Report methodology 84 Appendix B 85 About Datamonitor 85 About Datamonitor Healthcare 85 Datamonitor Healthcare’s research and analysis methodologies 86 Datamonitor Healthcare’s therapy area capabilities 86 About Infectious analysis team 87 Key therapy team members 88 Disclaimer 89




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