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

Published by: Datamonitor

Published: Jan. 9, 2004 - 89 Pages


Table of 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





Abstract

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.



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