Stakeholder Insight: Hiv Therapy Dynamics

Published by: Datamonitor

Published: Oct. 8, 2007 - 190 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Infectious diseases and Respriatory pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the HIV market

Related reports

Upcoming reports

CHAPTER 2 INTRODUCTION AND SCOPE

Coverage of the Stakeholder Insight Survey

Disease definition & epidemiology

Diagnosis and treatment rates

Treatment options and trends

Key prescribing influences

Improving treatment outcomes and new product development

CHAPTER 3 COUNTRY TREATMENT TREES

Introduction

US

France

Germany

Italy

Spain

UK

CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION

Disease definition

Etiology

Disease prevalence

HIV prevalence in the six major markets

Epidemiological trends

Patient segmentation

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

Pre- or post-HAART patients

Number of resistance mutations

CHAPTER 5 DIAGNOSIS AND TREATMENT RATES

Presentation and diagnosis

Diagnostic tests

Genotypic and phenotypic testing for resistance

Genotypic assays

Phenotypic assays

Awareness campaigns have increased diagnosis rates

Treatment rates

CD4 T cell count

Viral load

Factors influencing the initiation of treatment

CHAPTER 6 TREATMENT OPTIONS AND TRENDS

Treatment options

Nucleoside reverse transcriptase inhibitors (NRTIs)

Non-nucleoside reverse transcriptase inhibitors

Protease inhibitors

Entry inhibitors

Prescribing trends

First-line therapy

Second-line therapy

Third-line therapy

Fourth-line therapy

Fifth-line to salvage therapy

Treatment failure and switching therapy

Resistance

Compliance issues

GI side effects

Adverse lipid effects

Lipodystrophy

Dyslipidemia

Renal dysfunction

CNS side effects

Drug interactions

Hyperbilirubinemia and jaundice

Pregnancy

CHAPTER 7 PRESCRIBING INFLUENCES AND BRAND ASSESSMENT

Factors influencing physician decision making

Efficacy

Patient resistance profile

Clinical trial data

Quality of life considerations

Pill burden and dosing frequency

Side effects

Treatment guidelines/hospital protocol

Preservation of options for later lines of therapy

Cost

Physician perception of key brands

Fixed dose combinations

Protease inhibitors

CHAPTER 8 IMPROVING TREATMENT OUTCOMES AND NEW PRODUCT DEVELOPMENT

Treatment outcomes

Unmet needs

Resistance remains the key unmet need for antiretroviral therapy

Toxicity

Unmet needs for FDCs and PIs

New product development

Awareness

TMC125 and TMC278

MK-0518 (raltegravir)

GS-9137 (elvitegravir)

Selzentry/Celsentri (maraviroc)

Vicriviroc

BIBLIOGRAPHY

Journals

Websites

Other

APPENDIX A

Physician research methodology

Physician sample breakdown

US

France

Germany

Italy

Spain

UK

Contributing experts

APPENDIX B

The survey questionnaire

Epidemiology and Patient Segmentation

Diagnosis

Treatment

Product Profiles

Products In Development

Demographics

Name of opinion leader

Hospital

Hospital City/Address

Disclaimer

List of Tables

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

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

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

Table 4: Overview of the NNRTIs, 2007

Table 5: Overview of currently marketed PIs, 2007

Table 6: Overview of the FDCs

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

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

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

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

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

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

Table 13: Level of awareness of developmental compounds, 2007

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

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

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

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

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

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

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

Table 21: US physician sample breakdown, 2007

Table 22: France physician sample breakdown, 2007

Table 23: Germany physician sample breakdown, 2007

Table 24: Italy physician sample breakdown, 2007

Table 25: Spain physician sample breakdown, 2007

Table 26: UK physician sample breakdown, 2007

List of Figures

Figure 1: Treatment tree for US part A

Figure 2: Treatment tree for US part B

Figure 3: Treatment tree for France part A

Figure 4: Treatment tree for France part B

Figure 5: Treatment tree for Germany part A

Figure 6: Treatment tree for Germany part B

Figure 7: Treatment tree for Italy part A

Figure 8: Treatment tree for Italy part B

Figure 9: Treatment tree for Spain part A

Figure 10: Treatment tree for Spain part B

Figure 11: Treatment tree for UK part A

Figure 12: Treatment tree for UK part B

Figure 13: Regional HIV and AIDS overview, 2006

Figure 14: HIV lifecycle

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

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

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

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

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

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

Figure 21: Mutations that affect susceptibility to NRTIs

Figure 22: Mutations that affect susceptibility to NNRTIs

Figure 23: Mutations that affect the susceptibility to PIs

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

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

Figure 26: Advantages and disadvantages of genotypic and phenotypic assays

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

Figure 28: Resistance testing by country, 2007

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

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

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

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

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

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

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

Figure 36: FDCs reduce pill burden

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

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

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

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

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

Figure 42: Reasons for switching HIV therapy, 2007

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

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

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

Figure 46: Brand map for fixed dose combinations, 2007

Figure 47: Brand map for protease inhibitors, 2007

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

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

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

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

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

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

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

Abstract

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