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

SUMMARY

Long-term usage of HAART for the management of HIV has reduced mortality inthe HIV-infected population. However, this has consequently led to an increasein the prevalence of chronic co-infections such as Hepatitis B (HBV). Currently,HBV prevalence exceeds that of HIV and is estimated at 2 billion infectedindividuals worldwide, accounting for approximately 5% of the world'spopulation.

Scope of this report

• Key data and epidemiology of the seven major HIV therapeutic marketshighlighting the HIV / HBV co-morbid population
• Overview of the limitations surrounding co-morbid management such asrecognition of co infection, high-risk groups and lack of efficaciousantivirals
• Analysis based on interviews with key opinion leaders in the major markets

Research and analysis highlights

Concurrent early diagnosis of both HIV and HBV disease states is pivotal toincreasing the lifespan of this co-morbid population. Effective treatment iscurrently hampered by poor patient compliance, HAART hepatotoxicity and lack ofcomprehensive treatment guidelines.

Lack of potency with current HBV therapeutics is an obvious gap in treatingboth mono and co-infected patients currently being addressed by companies suchas Gilead and Idenix/Novartis.

Commercial support for global implementation of HBV vaccination need notpreclude a high volume/low cost business model for a new potent HBV antiviral.

Key reasons to read this report

• Effectively target this niche sector, through a complete understanding ofthe prevalence of the co-morbid population in the seven major markets
• Identify the most promising products in the HIV and HBV pipelines, andtrack how current players are seeking to optimize their market share

TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the HIV/HBV co-morbid market

Increased longevity and shared epidemiological risk raises the likelihoodthat HIV infected individuals will contract HBV. Whilst HBV has littleimpact on HIV, HIV renders HBV more aggressive and frequent with co-infectedindividuals eight times more likely to die of liver damage relatedmortality.

Datamonitor research reveals that concurrent early diagnosis of both HIVand HBV disease states is pivotal to increasing the life span of thisco-morbid population. Effective treatment is currently hampered by poorpatient compliance, HAART hepatoxicity and lack of comprehensive treatmentguidelines. Strong regional variance with regard to HAART modification wasalso observed.

Lack of potency with current HBV therapeutics is an obvious gap intreating both mono and co-infected patients currently being addressed bycompanies such as Gilead and Idenix/Novartis. Gilead is committed tomaximizing commercial opportunity with broad spectrum antiviral compoundsmeeting the needs of all HIV and HBV patient groups;

Increased global implementation of HBV vaccination will affect thedynamics of the HIV/HBV co-morbid population in both developed anddeveloping regions. Commercial support of this initiative need not precludea high volume/low cost business model for a new potent HBV antiviral.

Summary

Key metrics

CHAPTER 2 NATURE OF THE HIV/HBV COINFECTED POPULATION

Introduction

Prognosis of HIV/HBV co-infection

HBV genotypes

HIV/HBV co-morbid population: estimates of prevalence

Case study: regional variation in Italy

Drivers and resistors to increasing HIV/HBV co-infection

Increased 'high risk'  activity

CHAPTER 3 DIAGNOSTIC AND TREATMENT STRATEGIES FOR THE HIV/HBV COMORBIDPOPULATION

Overview

Diagnosis of HBV infection

HBV DNA detection

Diagnosis of HBV in HIV infected patients

Delta Hepatitis Infection

HIV /HBV co-infection management guidelines

Co-morbid patient treatment eligibility

Current HBV treatment options

Interferon � (IFN �)

Lamivudine (Epivir-HBV / Zeffix)

HepSera (adefovir dipivoxil)

Differences in global treatment strategies

Key issues for HBV/HIV co-morbid therapy

Vaccination

Vaccination of the HIV/HBV co-infected population

Substance abuse in the co-morbid population

Hepatoxicity

The effect of drug resistance on the co-morbid population

CHAPTER 4 COMPANY HBV THERAPEUTIC PORTFOLIOS

Pipeline HBV therapeutics

HIV/HBV co-infection therapeutic trials

Key commercial players in the HBV therapy market

CHAPTER 5 STRATEGIC RECOMMENDATIONS

HBV antiviral therapy: the need for potency

Case study: GSK life cycle management

Case study: Gilead in the HBV market

Case study: Idenix / Novartis collaboration

Key treatment issues of the HIV/HBV co-morbid population

Education and Training

Integration into HAART

Drug resistance

Alternative HBV antivirals

Generic co formulations: the knock on effect

HBV vaccination issues in the co-morbid population

Worldwide Hepatitis B vaccination

Hepatitis B Vaccination in the co-infected populace

New potent HBV antivirals: a high volume, low cost model

Capture of the HIV/HBV co-infected population

Governments in the major markets

Clinical targeting

Patient advocacy groups

Intercompany collaborations

Therapy-Therapy collaborations

Therapy-Diagnostic collaborations

Websites

Report methodology

Appendix B

About Datamonitor

About Datamonitor Healthcare

Datamonitor Healthcare' s research and analysis methodologies

Datamonitor Healthcare' s therapy area capabilities

About Infectious analysis team

Key therapy team members

Disclaimer

List of Tables

Table 1: Prevalence of HBV/HIV co-infection across the seven major markets2002

Table 2: Summary of Prevalence of HBV in global regions

Table 3: Geographic distribution of HBV genotype

Table 4: Prevalence of HBV/HIV co-infection across the seven major markets2002

Table 5: US incidence of HIV/HBV co-morbidity, 2002-2010 (based on EpiCast2002 figures)

Table 6: Relative risks of HIV and HBV infection in the major transmissionsettings

Table 7: Estimates of prevalence, diagnosed and treated HIV/AIDS patientsin the US, 2001–10

Table 8: Key tests utilized in HBV diagnosis

Table 9: Comparison of HBV DNA quantification assays

Table 10: Interpretation of HBV diagnostic tests

Table 11: Serologic responses to HBV infection

Table 12: US and UK guidelines for treatment of HIV/HBV co-morbidpopulation

Table 13: Current FDA approved HBV therapeutics

Table 14: HIV/HBV co-morbid population treatment algorithms for the sevenmajor markets

Table 15: HBV vaccines available globally

Table 16: Current antiretrovirals on the market and their impact on HIV/HBVco-infection

Table 17: Sales forecasts for HBV drug sales comparing 2002 and 2010

Table 18: Novel HBV immunomodulators in development

Table 19: Developmental HBV antiviral therapeutics

Table 20: Latest key clinical trials of HIV/HBV co-morbid populationtherapeutic regimens

List of Figures

Figure 1: Optimal treatment strategies for HBV / HIV co-infection

Figure 2: Effect of HIV/HBV co-infection on liver-related mortality

Figure 3: Main drivers behind HIV/HBV co-infection

Figure 4: Key high risk groups for HBV infection

Figure 5: Variation in clinic presentation of the HIV/HBV co-morbidpopulation

Figure 6: Possible disease outcomes for HBV infection

Figure 7: Treatment guidelines for HBV mono infected individuals

Figure 8: Changes in global vaccination status of HBV infection(1996-2001)

Figure 9: Hepatitis B mono-infection rates and impact of HBV vaccinationbetween 1966 and 2000

Figure 10: Key players in the HBV therapeutic developmental market

Figure 11: Global HIV and HBV antivirals sales forecasts (2002 and 2010)

Figure 12: GSK' s lifecycle management of lamivudine (1996-2002)

Figure 13: Optimal treatment strategies for HBV / HIV co-infection