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Stakeholder Opinions: HIV/ HBV Co-infection - More Potency, More Policy
Datamonitor, Sep 2004, Pages: 89
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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