HIV 治療に関するステークホルダー分析

Abstract

Overview

Introduction

HIV is now considered a chronic, manageable disease. However the lifelong therapy required to control HIV means considerations such as patient quality of life and cost of therapy are becoming increasingly influential in product choice. Consequently the development of new products which offer limited improvements in efficacy but better convenience and tolerability has changed prescription practices

Scope

• Analysis of current treatment regimens and unmet needs, based on a survey of 180 physicians in the seven major pharma markets around the world
• Current epidemiology of HIV in the seven major markets, including prevalence, age and gender splits, with analysis of diagnosis and chain of care
• A detailed examination of the numbers of patients on each line of therapy, which drugs they are taking and for what reasons is provided
• An assessment of key unmet needs within HIV and the changes in mortality since the introduction of HAART is included

Report Highlights

Increasing transmission by heterosexual contact, as well as bearing hallmark to the old epidemic, suggests both an absence and/or ineffectiveness of HIV awareness and education programs. It also exposes more females to the HIV virus, leading to unique disease management issues.

The success of HAART in prolonging survival within the HIV population introduces new psychosocial challenges beyond pharmaceutical management. Age-related conditions, comorbidities and the desire to conceive call for a new multi-faceted pattern of patient care

Datamonitor physician research indicates that of 273,000 first-line treated individuals, globally 79% are now receiving fixed dosed combinations (FDCs). While guidelines and HIV specialists have embraced their convenience and simplicity, the unstructured nature of later lines of therapy requires increasing individualization

Reasons to Purchase

• Understand the unique disease management issues raised by increasing heterosexual transmission of HIV to females
• Identify opportunities for new patterns of patient care following the success of HAART in prolonging survival
• Explore unmet needs in HIV therapy, as identified by treating physicians, and including increased individualization in later-line therapy

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

Pacific Rim definition

APPENDIX B - BIBLIOGRAPHY

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

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

• 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