Market Report Source

Overview

Introduction
Despite several developments in efforts to tackle the spread of HIV, the total number of people living with HIV has continued to increase across the 6MM. However, significant advances in HIV disease understanding, treatment and management mean that the outlook for patients has considerably improved.

Scope of this report

• Current epidemiology of HIV in the six major markets, including prevalence, diagnosis rates and patients split by line of therapy and drug regimens
• A detailed examination of the patient numbers on each line of therapy, their drug regimens and preferences
• Evaluation of the factors determining prescription choices and their respective level of influence
• An assessment of the perception of new products in development and of key unmet needs within HIV

Research and analysis highlights
In the US and M5EU the total number of people living with HIV is continuing to increase. According to Datamonitor’s physician survey, the total number of diagnosed patients across the 6MM is 1.1 million, of which 18% are treatment-naïve and approx. 800.000 are currently receiving therapy

The complexity of HAART begins to increase as patients progress to later stages of therapy, with regimens consisting of up to 6 different drugs. Treatment also becomes much more individualized: Datamonitor’s research shows that the top 5 most popular regimens selected by physicians account for only 13% of patients in salvage therapy

Prescription choice is largely driven by patient and product-specific qualities, but the influence of these issues varies according to line of therapy. Efficacy and resistance profile exert an increasing influence as the patient becomes more treatment-experienced.

Key reasons to read this report

• Identify the key factors underlying prescription choice for treatment of HIV
• Examine the current unmet needs in the HIV market and identify opportunities for new product development
• Enhance your commercial positioning through an improved understanding of the HIV market dynamics

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY 3

Scope of the analysis 3

Datamonitor insight into the HIV market 4

Related reports 6

Upcoming reports 6

CHAPTER 2 INTRODUCTION AND SCOPE 8

Coverage of the Stakeholder Insight Survey 8

Disease definition & epidemiology 8

Diagnosis and treatment rates 8

Treatment options and trends 8

Key prescribing influences 9

Improving treatment outcomes and new product development 9

CHAPTER 3 COUNTRY TREATMENT TREES 10

Introduction 10

US 11

France 13

Germany 15

Italy 17

Spain 19

UK 21

CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION 23

Disease definition 23

Etiology 24

Disease prevalence 27

HIV prevalence in the six major markets 27

Epidemiological trends 27

Patient segmentation 30

By treatment experience – treatment-naïve and treatment-experienced population 30

Pre- or post-HAART patients 31

Number of resistance mutations 34

CHAPTER 5 DIAGNOSIS AND TREATMENT RATES 40

Presentation and diagnosis 40

Diagnostic tests 41

Genotypic and phenotypic testing for resistance 43

Genotypic assays 43

Phenotypic assays 44

Awareness campaigns have increased diagnosis rates 47

Treatment rates 48

CD4 T cell count 48

Viral load 50

Factors influencing the initiation of treatment 52

CHAPTER 6 TREATMENT OPTIONS AND TRENDS 55

Treatment options 55

Nucleoside reverse transcriptase inhibitors (NRTIs) 56

Non-nucleoside reverse transcriptase inhibitors 58

Protease inhibitors 59

Entry inhibitors 60

Prescribing trends 61

First-line therapy 63

Second-line therapy 69

Third-line therapy 72

Fourth-line therapy 76

Fifth-line to salvage therapy 78

Treatment failure and switching therapy 81

Resistance 84

Compliance issues 84

GI side effects 85

Adverse lipid effects 86

Lipodystrophy 86

Dyslipidemia 87

Renal dysfunction 87

CNS side effects 88

Drug interactions 88

Hyperbilirubinemia and jaundice 89

Pregnancy 89

CHAPTER 7 PRESCRIBING INFLUENCES AND BRAND ASSESSMENT 91

Factors influencing physician decision making 91

Efficacy 93

Patient resistance profile 94

Clinical trial data 95

Quality of life considerations 96

Pill burden and dosing frequency 96

Side effects 97

Treatment guidelines/hospital protocol 98

Preservation of options for later lines of therapy 101

Cost 102

Physician perception of key brands 103

Fixed dose combinations 103

Protease inhibitors 106

CHAPTER 8 IMPROVING TREATMENT OUTCOMES AND NEW PRODUCT DEVELOPMENT 112

Treatment outcomes 112

Unmet needs 113

Resistance remains the key unmet need for antiretroviral therapy 113

Toxicity 114

Unmet needs for FDCs and PIs 115

New product development 115

Awareness 116

TMC125 and TMC278 117

MK-0518 (raltegravir) 121

GS-9137 (elvitegravir) 124

Selzentry/Celsentri (maraviroc) 126

Vicriviroc 129

BIBLIOGRAPHY 133

Journals 133

Websites 136

Other 137

APPENDIX A 142

Physician research methodology 142

Physician sample breakdown 142

US 142

France 143

Germany 143

Italy 144

Spain 144

UK 145

Contributing experts 146

APPENDIX B 147

The survey questionnaire 147

Epidemiology and Patient Segmentation 147

Diagnosis 148

Treatment 149

Product Profiles 175

Products In Development 180

Demographics 182

Name of opinion leader 184

Hospital 184

Hospital City/Address 184

Disclaimer 185

List of Tables

Table 1: HIV infected population in the six major markets, 2005 27

Table 2: HIV infections by transmission category in the US, 2005 28

Table 3: Overview of the nucleoside reverse transcriptase inhibitors, 2007 57

Table 4: Overview of the NNRTIs, 2007 58

Table 5: Overview of currently marketed PIs, 2007 60

Table 6: Overview of the FDCs 65

Table 7: Overview of top five first-line regimens selected by physicians across the six major markets, 2007 68

Table 8: Overview of top five second-line regimens selected by physicians across the six major markets, 2007 71

Table 9: Overview of the top five drug regimens for third-line therapy, as selected by physicians, 2007 75

Table 10: Overview of the top five drug regimens for fourth-line therapy, as selected by physicians 2007 77

Table 11: Overview of the top five drug regimens for fifth-line-salvage therapy, as selected by physicians 2007 80

Table 12: HIV treatment guidelines available for the six major markets, 2007 99

Table 13: Level of awareness of developmental compounds, 2007 116

Table 14: Probable line of therapy upon launch for developmental compounds, 2007 117

Table 15: Probable line of therapy upon launch for TMC125, 2007 119

Table 16: Probable line of therapy upon launch for TMC278, 2007 121

Table 17: Probable line of therapy upon launch for raltegravir, 2007 124

Table 18: Probable line of therapy upon launch for elvitegravir, 2007 126

Table 19: Probable line of therapy upon launch for Selzentry, 2007 129

Table 20: Probable line of therapy upon launch for vicriviroc, 2007 132

Table 21: US physician sample breakdown, 2007 142

Table 22: France physician sample breakdown, 2007 143

Table 23: Germany physician sample breakdown, 2007 143

Table 24: Italy physician sample breakdown, 2007 144

Table 25: Spain physician sample breakdown, 2007 144

Table 26: UK physician sample breakdown, 2007 145

List of Figures

Figure 1: Treatment tree for US part A 11

Figure 2: Treatment tree for US part B 12

Figure 3: Treatment tree for France part A 13

Figure 4: Treatment tree for France part B 14

Figure 5: Treatment tree for Germany part A 15

Figure 6: Treatment tree for Germany part B 16

Figure 7: Treatment tree for Italy part A 17

Figure 8: Treatment tree for Italy part B 18

Figure 9: Treatment tree for Spain part A 19

Figure 10: Treatment tree for Spain part B 20

Figure 11: Treatment tree for UK part A 21

Figure 12: Treatment tree for UK part B 22

Figure 13: Regional HIV and AIDS overview, 2006 24

Figure 14: HIV lifecycle 25

Figure 15: Trends in routes of transmission in the US, 2001-05 28

Figure 16: Number of newly diagnosed cases of HIV infection by transmission group and year of report in Western Europe (13 countries), 1998-2005 29

Figure 17: Percentage of treatment-naïve and treatment-experienced HIV patients, 2007 30

Figure 18: Response to treatment in the first year of HAART, 1996-2002 32

Figure 19: United Kingdom CHIC study: extensive risk of failure 33

Figure 20: Primary drug resistance in the US: March 2003-October 2006 35

Figure 21: Mutations that affect susceptibility to NRTIs 36

Figure 22: Mutations that affect susceptibility to NNRTIs 37

Figure 23: Mutations that affect the susceptibility to PIs 38

Figure 24: PI resistance across the six major markets, 2007 39

Figure 25: Percentage of total HIV-infected population that is successfully diagnosed, 2007 41

Figure 26: Advantages and disadvantages of genotypic and phenotypic assays 45

Figure 27: Factors that influence resistance testing in patients, 2007 46

Figure 28: Resistance testing by country, 2007 47

Figure 29: Newly diagnosed patients versus follow-up, 2007 51

Figure 30: Percentage of treatment-naïve and treatment-experienced HIV patients, 2007 51

Figure 31: CD4 counts at which therapy is initiated, 2007 53

Figure 32: Other criteria used by physicians to initiate treatment, 2007 54

Figure 33: Overview of sales by class,2002-06 55

Figure 34: Timeline of the development of the HIV market, 1985-2015 56

Figure 35: Percentage of patients receiving each line of therapy, 2007 63

Figure 36: FDCs reduce pill burden 66

Figure 37: Mean percentage of patients receiving each first line regimen 69

Figure 38: Mean percentage of patients receiving each second-line regimen 72

Figure 39: Mean percentage of patients receiving each third-line regimen 76

Figure 40: Mean percentage of patients receiving each fourth-line regimen 78

Figure 41: Mean percentage of patients receiving each fourth-line regimen 81

Figure 42: Reasons for switching HIV therapy, 2007 83

Figure 43: Factors influencing prescription choice for first to third lines of therapy, 2007 92

Figure 44: Factors influencing prescription choice from fourth-line onwards, 2007 93

Figure 45: Overview of recommendations given by US and UK guidelines 100

Figure 46: Brand map for fixed dose combinations, 2007 104

Figure 47: Brand map for protease inhibitors, 2007 107

Figure 48: Combined brand map for protease inhibitors and fixed dose combinations, 2007 110

Figure 49: Drug classes most likely to be used in combination with TMC125, 2007 118

Figure 50: Drug classes most likely to be used in combination with TMC278, 2007 120

Figure 51: Drug classes most likely to be used in combination with raltegravir, 2007 122

Figure 52: Drug classes most likely to be used in combination with elvitegravir, 2007 126

Figure 53: Drug classes most likely to be used in combination with Selzentry 128

Figure 54: Drug classes most likely to be used in combination with vicriviroc, 2007 131