Stakeholder Insight: HIV
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious Disease pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the HIV market - page 3
- CHAPTER 2 INTRODUCTION AND SCOPE - page 11
- Coverage of the Stakeholder Insight Survey - page 11
- Epidemiology - page 11
- Diagnosis and treatment rates - page 11
- Antiretroviral prescriptions - page 11
- Prescription choice - page 12
- Country level treatment trees - page 12
- Coverage of the Stakeholder Insight Survey - page 11
- CHAPTER 3 COUNTRY TREATMENT TREES - page 15
- US - page 15
- Japan - page 17
- France - page 19
- Germany - page 21
- Italy - page 23
- Spain - page 25
- UK - page 27
- Seven major markets - page 29
- CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION - page 32
- Disease definition and classification - page 33
- The HIV lifecycle - numerous steps has created several therapeutic targets - page 34
- HIV subtypes - diversity throughout the world - page 37
- HIV epidemiology - changing demographics creating new unmet needs - page 38
- A growing proportion of women are affected by HIV/AIDS - page 39
- The aging of the HIV population has created new therapeutic issues - page 43
- Key patient segmentations - page 49
- Newly diagnosed versus follow-up patients - page 50
- Multi-drug resistant patients - page 51
- Hepatitis co-infection - page 54
- Pregnancy - page 60
- Routes of transmission - page 62
- Disease definition and classification - page 33
- CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS - page 66
- Presentation and diagnosis - page 66
- Perception of risk drives HIV testing - page 66
- HIV diagnostics are effective and easy to use - page 69
- ELISA - page 69
- PCR - page 70
- Others - page 71
- Advances in diagnostics has led to quicker and easier HIV tests - page 71
- Treatment guidelines - page 74
- Treatment rates - page 79
- Treatment options - page 82
- Class overviews - page 83
- Presentation and diagnosis - page 66
- CHAPTER 6 PRESCRIBING TRENDS AND INFLUENCING FACTORS - page 87
- First-line therapy - page 88
- Prescription choice - page 88
- FDC backbones dominate first-line therapy - page 89
- Switching from first- to second-line therapy - page 98
- Factors affecting patient quality of life are key drivers of regime changes - page 100
- The M184V mutation is the most common in first-line patients, but NNRTI resistance is also a frequent driver of switching - page 110
- Prescription choice - page 88
- Second-line therapy - page 115
- Prescription choice - page 115
- PI usage is more predominant in second-line therapy - page 115
- Switching from second- to third-line therapy - page 117
- Tenofovir- and PI-associated mutations are more common in second-line patients - page 118
- Prescription choice - page 115
- Third- and later-line therapy - page 121
- Prescription choice - page 121
- Fuzeon is increasingly being used in third- and later-lines of therapy - page 122
- Prescription choice - page 121
- Factors influencing prescription choice - page 123
- Patient quality of life issues are playing an increasingly important role - page 124
- Although a growing concern, cost rarely plays a part in the physician decision - page 127
- The increasing importance of cost in prescription decisions - page 128
- How cost-effective is HAART? - page 129
- Cost of first-line therapy in the US and the UK - a comparison - page 131
- First-line therapy - page 88
- CHAPTER 7 IMPROVING TREATMENT OUTCOMES - page 135
- Treatment outcomes - page 135
- Advances in therapy mean fewer patients progress to AIDS - page 135
- Morbidity and mortality have declined significantly over the last decade - page 139
- HIV accounts for a small proportion of total deaths in the developed world - page 139
- Antiretroviral therapy has led to significant gains in terms of survival years and a reduced incidence of opportunistic infections - page 142
- Unmet needs - page 144
- Resistance to currently available therapy is a major unmet need for certain classes - page 144
- Although there have been considerable improvements in therapy, important unmet needs remain - page 145
- Treatment outcomes - page 135
- CHAPTER 8 OPINION LEADER AND STAKEHOLDER TRANSCRIPTS - page 148
- French key opinion leader - page 148
- Section 1 - Epidemiology - page 148
- Section 2 - Presentation and diagnosis - page 149
- Section 3 - Treatment practices - page 151
- Section 4 - Prescription choice - page 153
- Section 5 - Resistance issues - page 156
- Section 6 - Unmet Needs - page 157
- Section 7 - Pipeline products - page 158
- Italian key opinion leader - page 161
- Section 1 - Epidemiology - page 161
- Section 2 - Presentation and diagnosis - page 163
- Section 3 - Treatment practices - page 164
- Section 4 - Prescription choice - page 166
- Section 5 - Resistance issues - page 171
- Section 6 - Unmet Needs - page 173
- Section 7 - Pipeline products - page 173
- German key opinion leader - page 176
- Section 1 - Epidemiology - page 176
- Section 2 - Presentation and diagnosis - page 178
- Section 3 - Treatment practices - page 180
- Section 4 - Prescription choice - page 182
- Section 5 - Resistance issues - page 186
- Section 6 - Unmet Needs - page 187
- Section 7 - Pipeline products - page 188
- US key opinion leader - page 191
- Section 1 - Epidemiology - page 191
- Section 2 - Presentation and diagnosis - page 192
- Section 3 - Treatment practices - page 195
- Section 4 - Prescription choice - page 196
- Section 5 - Resistance issues - page 200
- Section 6 - Unmet Needs - page 201
- Section 7 - Pipeline products - page 202
- Spanish key opinion leader - page 205
- Section 1 - Epidemiology - page 205
- Section 2 - Presentation and diagnosis - page 206
- Section 3 - Treatment practices - page 208
- Section 4 - Prescription choice - page 210
- Section 5 - Resistance issues - page 213
- Section 6 - Unmet Needs - page 214
- Section 7 - Pipeline products - page 214
- UK key opinion leader - page 217
- Section 1 - Epidemiology - page 217
- Section 2 - Presentation and diagnosis - page 218
- Section 3 - Treatment practices - page 220
- Section 4 - Prescription choice - page 222
- Section 5 - Resistance issues - page 225
- Section 6 - Unmet Needs - page 226
- Section 7 - Pipeline products - page 227
- US key opinion leader (cost efficiency expert) - page 230
- Section 1 - Current cost of antiretroviral therapy - page 230
- Section 2 - Pricing antiretrovirals - page 232
- French key opinion leader - page 148
- APPENDIX A - ADDITIONAL DATA - page 236
- Pacific Rim definition - page 241
- APPENDIX B - BIBLIOGRAPHY - page 242
- Journal articles - page 242
- Conference abstracts - page 248
- Press Releases - page 252
- Websites - page 254
- Guidelines - page 254
- Epidemiological data - page 255
- APPENDIX C - page 257
- Physician research methodology - page 257
- Physician sample breakdown - page 257
- US - page 257
- Japan - page 258
- France - page 258
- Germany - page 259
- Italy - page 259
- Spain - page 260
- UK - page 260
- Physician research methodology - page 257
- APPENDIX D - page 261
- The survey questionnaire - page 261
- Section 1: Epidemiology - page 261
- Section 2: Diagnosis and treatment rates - page 263
- Section 3: Antiretroviral prescriptions - page 265
- Section 4: Prescription choice - page 268
- The opinion leader discussion guide - page 278
- Section 1 - Epidemiology - page 278
- Section 2 - Presentation and diagnosis - page 278
- Section 3 - Treatment practices - page 279
- Section 4 - Prescription choice - page 280
- Section 5 - Resistance issues - page 281
- Section 6 - Unmet needs - page 282
- Section 7 - Pipeline products - page 282
- Disclaimer - page 284
- The survey questionnaire - page 261
- List of Tables
- Table 1: Total number of patients treated by the SI physician sample compared to the total number of treated patients in each of the seven major markets - page 31
- Table 2: HIV pipeline, 2005 - page 36
- Table 3: HIV prevalence and incidence numbers and rates, seven major markets, 2003 - page 38
- Table 4: Number of women, aged between 15 and 49, with HIV/AIDS, 2002 and 2004 - page 40
- Table 5: Incidence of new opportunistic infections and tumors according to age group (rate/1,000 person-years) - page 49
- Table 6: Total number of newly diagnosed and follow-up HIV patients, seven major markets*, 2005 - page 51
- Table 7: Rate of problem drug use** in the five major European markets - page 56
- Table 8: Total number of HIV patients with hepatitis B C infection, seven major markets, 2005 - page 57
- Table 9: Hepatotoxicity of antiretrovirals - page 58
- Table 10: Reasons for seeking HIV testing among adults in the US, 1998 and 2002 - page 67
- Table 11: Total diagnosed HIV patient population in the seven major markets, 2005 - page 74
- Table 12: HIV treatment guidelines available for the seven major markets - page 75
- Table 13: Examples of changes in the US DHHS guidelines since 1998 - page 77
- Table 14: Overview of the antiretrovirals available for the treatment of HIV - page 83
- Table 15: Fixed-dose combinations: key facts - page 89
- Table 16: Top five first-line antiretroviral regimes by patient numbers in the seven major markets, 2005, as reported by the SI physician sample - page 93
- Table 17: Key safety concerns for Epzicom and Truvada - page 96
- Table 18: Key antiretroviral side effects - page 102
- Table 19: Reasons for missing antiretroviral doses - page 106
- Table 20: Costs, clinical benefits and cost effectiveness of triple-drug antiretroviral regimes - page 130
- Table 21: Cost per year of first-line antiretroviral therapy in the US, as recommended by the DHHS guidelines - page 132
- Table 22: Cost per year of first-line antiretroviral therapy in the UK, as recommended by the BHIVA guidelines - page 134
- Table 23: Survival benefits of antiretroviral therapy in the US - page 142
- Table 24: Key pricing data for antiretrovirals in the US, 2004 - page 236
- Table 25: Key pricing data for antiretrovirals in the UK, 2005 - page 239
- Table 26: US physician sample breakdown - page 257
- Table 27: Japan physician sample breakdown - page 258
- Table 28: France physician sample breakdown - page 258
- Table 29: Germany physician sample breakdown - page 259
- Table 30: Italy physician sample breakdown - page 259
- Table 31: Spain physician sample breakdown - page 260
- Table 32: UK physician sample breakdown - page 260
- List of Figures
- Figure 1: Treatment trees calculation methodology - page 13
- Figure 2: Calculation methodology for total number of patients on every regime for each line of therapy - page 14
- Figure 3: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in the US - page 16
- Figure 4: The percentage of patients on the top five antiretroviral regimes for each line of therapy in the US - page 17
- Figure 5: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in Japan - page 18
- Figure 6: The percentage of patients on the top five antiretroviral regimes for each line of therapy in Japan - page 19
- Figure 7: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in France - page 20
- Figure 8: The percentage of patients on the top five antiretroviral regimes for each line of therapy in France - page 21
- Figure 9: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in Germany - page 22
- Figure 10: The percentage of patients on the top five antiretroviral regimes for each line of therapy in Germany - page 23
- Figure 11: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in Italy - page 24
- Figure 12: The percentage of patients on the top five antiretroviral regimes for each line of therapy in Italy - page 25
- Figure 13: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in Spain - page 26
- Figure 14: The percentage of patients on the top five antiretroviral regimes for each line of therapy in Spain - page 27
- Figure 15: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in the UK - page 28
- Figure 16: The percentage of patients on the top five antiretroviral regimes for each line of therapy in the UK - page 29
- Figure 17: HIV prevalence, diagnosis and treatment rates, and the proportion of patients on each line of therapy in the seven major markets - page 30
- Figure 18: Total AIDS cases per year, seven major markets, 1993-2003 - page 33
- Figure 19: The HIV replication process - page 34
- Figure 20: The classification and geographic distribution of HIV subtypes - page 37
- Figure 21: Total HIV/AIDS patients by gender, seven major markets, 2001 and 2005 - page 41
- Figure 22: Age distribution of the HIV patient population, seven major markets, 2005 - page 44
- Figure 23: Total HIV diagnoses per year by age group, US, 2000-03 - page 45
- Figure 24: Percentage of newly diagnosed and follow-up HIV patients, seven major markets, 2005 - page 50
- Figure 25: Patients with phenotypic antiretroviral resistance, US - page 53
- Figure 26: Triple class resistance in the UK, 1999-2002 - page 54
- Figure 27: Percentage of HIV patients with hepatitis B or C infection, seven major markets, 2005 - page 55
- Figure 28: Percentage of HIV patients acquiring the infection through intravenous drug use, seven major markets, 2005 - page 56
- Figure 29: Routes of HIV transmission in the seven major markets, 2005 - page 62
- Figure 30: New HIV infections acquired via sexual contact in the UK, 1990-2005 - page 63
- Figure 31: Usual test centers for HIV diagnosis, US - page 69
- Figure 32: Diagnosis rate in the seven major markets, 2001 and 2005 - page 72
- Figure 33: Treatment guidelines recommendations for initial antiretroviral therapy - page 76
- Figure 34: Treatment status of the diagnosed HIV population in the seven major markets, 2005 - page 79
- Figure 35: Antiretroviral market share (percentage of sales) by class, seven major markets, 2004 - page 85
- Figure 36: Antiretroviral market share (percentage of sales) by product, seven major markets, 2004 - page 86
- Figure 37: Total treated HIV patients on each line of therapy, seven major markets - page 87
- Figure 38: Percentage of patients on each regimen, first-line therapy, as reported by the SI physician sample - page 88
- Figure 39: The NRTI pill burden has been significantly reduced following the introduction of the FDCs - page 90
- Figure 40: Percentage of first-line patients on each NRTI FDC, seven major markets, as reported by the SI physician sample - page 92
- Figure 41: Factors leading to switching from first- to second-line antiretroviral therapy - page 99
- Figure 42: Quality of life factors leading to switching from first- to second-line therapy - page 101
- Figure 43: Frequency of tolerability issues and adverse effects leading to switching from first- to second-line therapy - page 103
- Figure 44: The PIs most frequently cause adverse lipid effects in first-line therapy - page 104
- Figure 45: Simple, personalized pill reminders can be provided on a pager, with two-way communication and information provision available on the more sophisticated devices - page 108
- Figure 46: The Crixivan website provides a personalized pill planner for HIV/AIDS patients who are starting a new regime, including the option for selecting reminder activities - page 109
- Figure 47: Percentage of patients switching from first- to second-line therapy due to resistance development, seven major markets - page 110
- Figure 48: Prevalence of HIV drug resistance in the US - page 112
- Figure 49: Resistance mutations commonly leading to switching from first- to second-line therapy - page 113
- Figure 50: Percentage of patients on each regimen, second-line therapy, as reported by the SI physician sample - page 115
- Figure 51: Percentage of second-line patients on NNRTI- and PI-based regimes and on each PI, as reported by the SI physician sample - page 116
- Figure 52: Factors leading to switching from second- to third-line antiretroviral therapy - page 117
- Figure 53: Resistance development exerts a greater influence in switching decisions for later-lines of therapy - page 118
- Figure 54: The incidence of tenofovir- and PI-related mutations increases for second-line therapy - page 119
- Figure 55: Percentage of patients on each regimen, third- and fourth/later-line therapy, as reported by the SI physician sample - page 121
- Figure 56: Factors driving first-line antiretroviral prescription choice in the seven major markets - page 124
- Figure 57: Factors affecting patient quality of life exert a strong influence over first-line prescription choice - page 125
- Figure 58: Impact of product attributes on adherence - page 126
- Figure 59: Cost is a relatively low priority in terms of influencing prescription choice - page 127
- Figure 60: Timeline of the development of the HIV market - page 136
- Figure 61: Total AIDS cases per year, seven major markets, 1991-2004 - page 137
- Figure 62: Total AIDS deaths per year in the US and UK, 1991-2005* - page 139
- Figure 63: Infectious diseases as proportion of all deaths, 2001 - page 140
- Figure 64: Main causes of death in the UK, 2003 and the US, 2002 - page 141
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