Stakeholder Insight: HIV

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Publication Date: 2005-10-14

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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 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

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
- Country level treatment trees - page 12
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
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
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
- 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
- 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
- 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
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
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
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
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

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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Stakeholder Insight: HIV

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