Stakeholder Insight: HIV - A way of life

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

• About the Infectious Disease pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

• Scope of the analysis
• Datamonitor insight into the HIV market

CHAPTER 2 INTRODUCTION AND SCOPE

• Coverage of the Stakeholder Insight Survey
  • Epidemiology
  • Diagnosis and treatment rates
  • Antiretroviral prescriptions
  • Prescription choice
• Country level treatment trees

CHAPTER 3 COUNTRY TREATMENT TREES

• US
• Japan
• France
• Germany
• Italy
• Spain
• UK
• Seven major markets

CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION

• Disease definition and classification
  • The HIV lifecycle - numerous steps has created severaltherapeutic targets
  • HIV subtypes - diversity throughout the world
• HIV epidemiology - changing demographics creating newunmet needs
  • A growing proportion of women are affected by HIV/AIDS
  • The aging of the HIV population has created newtherapeutic issues
• Key patient segmentations
  • Newly diagnosed versus follow-up patients
  • Multi-drug resistant patients
  • Hepatitis co-infection
  • Pregnancy
• Routes of transmission

CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS

• Presentation and diagnosis
  • Perception of risk drives HIV testing
  • HIV diagnostics are effective and easy to use
    • ELISA
    • PCR
    • Others
    • Advances in diagnostics has led to quicker and easier HIVtests
• Treatment guidelines
• Treatment rates
• Treatment options
  • Class overviews

CHAPTER 6 PRESCRIBING TRENDS AND INFLUENCING FACTORS

• First-line therapy
  • Prescription choice
    • FDC backbones dominate first-line therapy
  • Switching from first- to second-line therapy
    • Factors affecting patient quality of life are key driversof regime changes
    • The M184V mutation is the most common in first-linepatients, but NNRTI resistance is also a frequent driver of switching
• Second-line therapy
  • Prescription choice
    • PI usage is more predominant in second-line therapy
  • Switching from second- to third-line therapy
    • Tenofovir- and PI-associated mutations are more common insecond-line patients
• Third- and later-line therapy
  • Prescription choice
    • Fuzeon is increasingly being used in third- andlater-lines of therapy
• Factors influencing prescription choice
  • Patient quality of life issues are playing an increasinglyimportant role
  • Although a growing concern, cost rarely plays a part inthe physician decision
    • The increasing importance of cost in prescriptiondecisions
    • How cost-effective is HAART?
    • Cost of first-line therapy in the US and the UK - acomparison

CHAPTER 7 IMPROVING TREATMENT OUTCOMES

• Treatment outcomes
  • Advances in therapy mean fewer patients progress to AIDS
  • Morbidity and mortality have declined significantly overthe last decade
    • HIV accounts for a small proportion of total deaths in thedeveloped world
    • Antiretroviral therapy has led to significant gains interms of survival years and a reduced incidence of opportunisticinfections
• Unmet needs
  • Resistance to currently available therapy is a major unmetneed for certain classes
  • Although there have been considerable improvements intherapy, important unmet needs remain

CHAPTER 8 OPINION LEADER AND STAKEHOLDER TRANSCRIPTS

• French key opinion leader
  • Section 1 - Epidemiology
  • Section 2 - Presentation and diagnosis
  • Section 3 - Treatment practices
  • Section 4 - Prescription choice
  • Section 5 - Resistance issues
  • Section 6 - Unmet Needs
  • Section 7 - Pipeline products
• Italian key opinion leader
  • Section 1 - Epidemiology
  • Section 2 - Presentation and diagnosis
  • Section 3 - Treatment practices
  • Section 4 - Prescription choice
  • Section 5 - Resistance issues
  • Section 6 - Unmet Needs
  • Section 7 - Pipeline products
• German key opinion leader
  • Section 1 - Epidemiology
  • Section 2 - Presentation and diagnosis
  • Section 3 - Treatment practices
  • Section 4 - Prescription choice
  • Section 5 - Resistance issues
  • Section 6 - Unmet Needs
  • Section 7 - Pipeline products
• US key opinion leader
  • Section 1 - Epidemiology
  • Section 2 - Presentation and diagnosis
  • Section 3 - Treatment practices
  • Section 4 - Prescription choice
  • Section 5 - Resistance issues
  • Section 6 - Unmet Needs
  • Section 7 - Pipeline products
• Spanish key opinion leader
  • Section 1 - Epidemiology
  • Section 2 - Presentation and diagnosis
  • Section 3 - Treatment practices
  • Section 4 - Prescription choice
  • Section 5 - Resistance issues
  • Section 6 - Unmet Needs
  • Section 7 - Pipeline products
• UK key opinion leader
  • Section 1 - Epidemiology
  • Section 2 - Presentation and diagnosis
  • Section 3 - Treatment practices
  • Section 4 - Prescription choice
  • Section 5 - Resistance issues
  • Section 6 - Unmet Needs
  • Section 7 - Pipeline products
• US key opinion leader (cost efficiency expert)
  • Section 1 - Current cost of antiretroviral therapy
  • Section 2 - Pricing antiretrovirals

APPENDIX A - ADDITIONAL DATA

Pacific Rim definition

APPENDIX B - BIBLIOGRAPHY

• Journal articles
• Conference abstracts
• Press Releases
• Websites
• Guidelines
• Epidemiological data

APPENDIX C

• Physician research methodology
  • Physician sample breakdown
  • US
  • Japan
  • France
  • Germany
  • Italy
  • Spain
  • UK

APPENDIX D

• The survey questionnaire
  • Section 1: Epidemiology
  • Section 2: Diagnosis and treatment rates
  • Section 3: Antiretroviral prescriptions
  • Section 4: Prescription choice
• The opinion leader discussion guide
  • Section 1 - Epidemiology
  • Section 2 - Presentation and diagnosis
  • Section 3 - Treatment practices
  • Section 4 - Prescription choice
  • Section 5 - Resistance issues
  • Section 6 - Unmet needs
  • Section 7 - Pipeline products
• Disclaimer

List of Tables

• Table 1: Total number of patients treated by the SIphysician sample compared to the total number of treated patients in eachof the seven major markets
• Table 2: HIV pipeline, 2005
• Table 3: HIV prevalence and incidence numbers and rates,seven major markets, 2003
• Table 4: Number of women, aged between 15 and 49, withHIV/AIDS, 2002 and 2004
• Table 5: Incidence of new opportunistic infections andtumors according to age group (rate/1,000 person-years)
• Table 6: Total number of newly diagnosed and follow-upHIV patients, seven major markets*, 2005
• Table 7: Rate of problem drug use** in the five majorEuropean markets
• Table 8: Total number of HIV patients with hepatitis B Cinfection, seven major markets, 2005
• Table 9: Hepatotoxicity of antiretrovirals
• Table 10: Reasons for seeking HIV testing among adultsin the US, 1998 and 2002
• Table 11: Total diagnosed HIV patient population in theseven major markets, 2005
• Table 12: HIV treatment guidelines available for theseven major markets
• Table 13: Examples of changes in the US DHHS guidelinessince 1998
• Table 14: Overview of the antiretrovirals available forthe treatment of HIV
• Table 15: Fixed-dose combinations: key facts
• Table 16: Top five first-line antiretroviral regimes bypatient numbers in the seven major markets, 2005, as reported by the SIphysician sample
• Table 17: Key safety concerns for Epzicom and Truvada
• Table 18: Key antiretroviral side effects
• Table 19: Reasons for missing antiretroviral doses
• Table 20: Costs, clinical benefits and costeffectiveness of triple-drug antiretroviral regimes
• Table 21: Cost per year of first-line antiretroviraltherapy in the US, as recommended by the DHHS guidelines
• Table 22: Cost per year of first-line antiretroviraltherapy in the UK, as recommended by the BHIVA guidelines
• Table 23: Survival benefits of antiretroviral therapy inthe US
• Table 24: Key pricing data for antiretrovirals in theUS, 2004
• Table 25: Key pricing data for antiretrovirals in theUK, 2005
• Table 26: US physician sample breakdown
• Table 27: Japan physician sample breakdown
• Table 28: France physician sample breakdown
• Table 29: Germany physician sample breakdown
• Table 30: Italy physician sample breakdown
• Table 31: Spain physician sample breakdown
• Table 32: UK physician sample breakdown

List of Figures

• Figure 1: Treatment trees calculation methodology
• Figure 2: Calculation methodology for total number ofpatients on every regime for each line of therapy
• Figure 3: HIV prevalence, diagnosis and treatment rates,and the proportion of patients on each line of therapy in the US
• Figure 4: The percentage of patients on the top fiveantiretroviral regimes for each line of therapy in the US
• Figure 5: HIV prevalence, diagnosis and treatment rates,and the proportion of patients on each line of therapy in Japan
• Figure 6: The percentage of patients on the top fiveantiretroviral regimes for each line of therapy in Japan
• Figure 7: HIV prevalence, diagnosis and treatment rates,and the proportion of patients on each line of therapy in France
• Figure 8: The percentage of patients on the top fiveantiretroviral regimes for each line of therapy in France
• Figure 9: HIV prevalence, diagnosis and treatment rates,and the proportion of patients on each line of therapy in Germany
• Figure 10: The percentage of patients on the top fiveantiretroviral regimes for each line of therapy in Germany
• Figure 11: HIV prevalence, diagnosis and treatmentrates, and the proportion of patients on each line of therapy in Italy
• Figure 12: The percentage of patients on the top fiveantiretroviral regimes for each line of therapy in Italy
• Figure 13: HIV prevalence, diagnosis and treatmentrates, and the proportion of patients on each line of therapy in Spain
• Figure 14: The percentage of patients on the top fiveantiretroviral regimes for each line of therapy in Spain
• Figure 15: HIV prevalence, diagnosis and treatmentrates, and the proportion of patients on each line of therapy in the UK
• Figure 16: The percentage of patients on the top fiveantiretroviral regimes for each line of therapy in the UK
• Figure 17: HIV prevalence, diagnosis and treatmentrates, and the proportion of patients on each line of therapy in the sevenmajor markets
• Figure 18: Total AIDS cases per year, seven majormarkets, 1993-2003
• Figure 19: The HIV replication process
• Figure 20: The classification and geographicdistribution of HIV subtypes
• Figure 21: Total HIV/AIDS patients by gender, sevenmajor markets, 2001 and 2005
• Figure 22: Age distribution of the HIV patientpopulation, seven major markets, 2005
• Figure 23: Total HIV diagnoses per year by age group,US, 2000-03
• Figure 24: Percentage of newly diagnosed and follow-upHIV patients, seven major markets, 2005
• Figure 25: Patients with phenotypic antiretroviralresistance, US
• Figure 26: Triple class resistance in the UK, 1999-2002
• Figure 27: Percentage of HIV patients with hepatitis Bor C infection, seven major markets, 2005
• Figure 28: Percentage of HIV patients acquiring theinfection through intravenous drug use, seven major markets, 2005
• Figure 29: Routes of HIV transmission in the seven majormarkets, 2005
• Figure 30: New HIV infections acquired via sexualcontact in the UK, 1990-2005
• Figure 31: Usual test centers for HIV diagnosis, US
• Figure 32: Diagnosis rate in the seven major markets,2001 and 2005
• Figure 33: Treatment guidelines recommendations forinitial antiretroviral therapy
• Figure 34: Treatment status of the diagnosed HIVpopulation in the seven major markets, 2005
• Figure 35: Antiretroviral market share (percentage ofsales) by class, seven major markets, 2004
• Figure 36: Antiretroviral market share (percentage ofsales) by product, seven major markets, 2004
• Figure 37: Total treated HIV patients on each line oftherapy, seven major markets
• Figure 38: Percentage of patients on each regimen,first-line therapy, as reported by the SI physician sample
• Figure 39: The NRTI pill burden has been significantlyreduced following the introduction of the FDCs
• Figure 40: Percentage of first-line patients on eachNRTI FDC, seven major markets, as reported by the SI physician sample
• Figure 41: Factors leading to switching from first- tosecond-line antiretroviral therapy
• Figure 42: Quality of life factors leading to switchingfrom first- to second-line therapy
• Figure 43: Frequency of tolerability issues and adverseeffects leading to switching from first- to second-line therapy
• Figure 44: The PIs most frequently cause adverse lipideffects in first-line therapy
• Figure 45: Simple, personalized pill reminders can beprovided on a pager, with two-way communication and information provisionavailable on the more sophisticated devices
• Figure 46: The Crixivan website provides a personalizedpill planner for HIV/AIDS patients who are starting a new regime,including the option for selecting reminder activities
• Figure 47: Percentage of patients switching from first-to second-line therapy due to resistance development, seven major markets
• Figure 48: Prevalence of HIV drug resistance in the US
• Figure 49: Resistance mutations commonly leading toswitching from first- to second-line therapy
• Figure 50: Percentage of patients on each regimen,second-line therapy, as reported by the SI physician sample
• Figure 51: Percentage of second-line patients on NNRTI-and PI-based regimes and on each PI, as reported by the SI physiciansample
• Figure 52: Factors leading to switching from second- tothird-line antiretroviral therapy
• Figure 53: Resistance development exerts a greaterinfluence in switching decisions for later-lines of therapy
• Figure 54: The incidence of tenofovir- and PI-relatedmutations increases for second-line therapy
• Figure 55: Percentage of patients on each regimen,third- and fourth/later-line therapy, as reported by the SI physiciansample
• Figure 56: Factors driving first-line antiretroviralprescription choice in the seven major markets
• Figure 57: Factors affecting patient quality of lifeexert a strong influence over first-line prescription choice
• Figure 58: Impact of product attributes on adherence
• Figure 59: Cost is a relatively low priority in terms ofinfluencing prescription choice
• Figure 60: Timeline of the development of the HIV market
• Figure 61: Total AIDS cases per year, seven majormarkets, 1991-2004
• Figure 62: Total AIDS deaths per year in the US and UK,1991-2005*
• Figure 63: Infectious diseases as proportion of alldeaths, 2001
• Figure 64: Main causes of death in the UK, 2003 and theUS, 2002