Human Immunodeficiency Virus (HIV) (Event Driven)

Decision Resources, Inc, December 2011, Pages: 185

The HIV market is highly dynamic, continually evolving in terms of new treatment options and practices. Major-market sales for HIV antiretrovirals reached $11.8 billion in 2010, and we expect sales to exceed $18 billion in 2020. Among the most promising products in the pipeline are Gilead’s Quad (elvitegravir/cobicistat/emtricitabine/tenofovir) and Shionogi/ViiV’s 572-Tri (dolutegravir/abacavir/lamivudine).

Both drugs are complete fixed-dose regimens in a once-daily pill with blockbuster potential. Introduction of Gilead’s blockbuster drug Atripla (efavirenz/emtricitabine/tenofovir) raised the bar for other HIV drug developers.

The launch of Quad and two new fixed-dose combinations codeveloped with BMS and Janssen, atazanavir/cobicistat and darunavir/cobicistat, respectively, will further solidify Gilead as the dominant force in HIV treatment.

Executive Summary
What are the key parameters of the HIV market?
What factors are driving the market for HIV therapies?
What factors are constraining the market for HIV therapies?
What are the drug development activities of note in HIV?
What do the experts say?
What key challenges and opportunities remain?

1 Etiology and Pathophysiology
Overview
Viral Structure
Viral Life Cycle and Drug Targets
Classification of HIV and Co-Receptor Tropism
HIV Disease Process
Treatment Life Cycle
Treatment-Naive Population
Maintenance Population
Salvage/Highly Treatment-Experienced Population
Patient Flows

2 Epidemiology and Patient Populations
Overview
Disease Definition
Methods
HIV Newly Diagnosed Cases
United States
Europe
Japan
HIV Total Prevalent Cases
United States and Europe
Japan
Prevalence Trends
Diagnosed and Drug-Treated Populations
Percentage Diagnosed
Percentage Drug-Treated

3 Current Therapies and Medical Practice
Treatment Providers
Goals of Treatment
Currently Marketed Products
Treatment-Naive Patients
Treatment-Experienced Patients
Treatment Guidelines and Factors Influencing Drug Selection
Treatment Algorithm
Country-Specific Trends

4 Unmet Needs
Overview
Agents Lacking Significant Long-Term Side Effects
Agents with High Barriers to Resistance
Follow-On Products with Activity Against Drug-Resistant Strains
Additional Therapeutic Options for Highly Treatment-Experienced Patients
Simpler Therapies for Treatment-Experienced Patients
Antiretrovirals with Additional Therapeutic Benefits

5 Emerging Therapies
Overview
Future Positioning of Key Competitors
Early-Stage Therapies
Non-Nucleoside Reverse Transcriptase Inhibitors
Overview
Mechanism of Action
Rilpivirine and Rilpivirine/emtricitabine/tenofovir
Lersivirine
2248761 (IDX-899)
Nucleoside/Nucleotide Reverse Transcriptase Inhibitors
Overview
Mechanism of Action
Elvucitabine
KP-1461
CCR5 Antagonists
Overview
Mechanism of Action
PRO-140
Integrase Inhibitors
Overview
Mechanism of Action
Elvitegravir
Elvitegravir/Cobicistat/Emtricitabine/Tenofovir (Quad)
Dolutegravir (1349572)
Pharmacokinetic Enhancers
Overview
Mechanism of Action
Cobicistat

6 Market Outlook
Overview
Drug-Class-Specific Trends
Protease Inhibitors
Non-Nucleoside Reverse Transcriptase Inhibitors
Nucleoside/Nucleotide Reverse Transcriptase Inhibitors
Entry Inhibitors
CCR5 Antagonists
Integrase Inhibitors
Pharmacokinetic Enhancers

Appendix A Bibliography—HIV

Appendix B Market Forecast Methodology
Bottom-Up Market Forecasting Overview
Patient Populations
Drug-Specific Assumptions
General Sources of Data
Agents Included in Our Market Analysis
Pricing, Dosing, Days of Therapy, and Compliance Assumptions
General Statements About Pricing
Dosing, Days of Therapy and Compliance
Generic Erosion
Emerging Therapy Prices

Appendix C Experts Interviewed

Appendix D Supplemental Epidemiology Bibliography

Tables and Figures

Table 1-1 Key Steps in the HIV Life Cycle

Table 1-2 AIDS-Defining Conditions According to the 1993 US Centers for Disease Control and Prevention AIDS Case Definition

Table 1-3 Key Challenges in HIV Treatment and Implications for Drug Development

Table 2-1 Number of Diagnosed Incident Cases of HIV in the Major Pharmaceutical Markets, 2010-2020

Table 2-2 Number of Total Prevalent Cases of HIV in the Major Pharmaceutical Markets, 2010-2020

Table 2-3 Number of Total, Diagnosed, and Drug-Treated Prevalent Cases of HIV in the Major Pharmaceutical Markets, 2010-2020

Table 2-4 Key Sources for Epidemiology Estimates—HIV/AIDS

Table 3-1 HIV Treatment Providers and Referral Patterns, by Market

Table 3-2 End Points Used in Clinical Trials for HIV

Table 3-3 HIV Antiretrovirals—Mechanism of Action

Table 3-4 Currently Marketed HIV Antiretrovirals

Table 3-5 Comparison of Clinical Efficacy of Select HIV Regimens in Treatment-Naive Patients

Table 3-6 Comparison of Clinical Efficacy of Select HIV Regimens in Treatment-Experienced Patients

Table 3-7 Comparison of Commonly Used HIV Regimens

Table 3-8 Expert Commentary: Leading Drugs in HIV

Table 3-9 HIV Treatment Guidelines, by Market

Table 3-10 Recommendations for Initiating Therapy for Treatment-Naive HIV Patients

Table 3-11 Factors Influencing Drug Selection in HIV

Table 3-12 HIV Prescribing Practices by Market

Table 3-13 Reimbursement Practices, by Market

Table 5-1 Select Emerging Therapies in Development for HIV

Table 5-2 Estimated Launch Dates for Key Emerging Therapies for the Treatment of HIV

Table 5-3 Early-Stage Emerging Therapies in Development for HIV

Table 5-4 Results of TMC-278-C204 Trial, a Phase IIb Trial, Week 48 and Week 96

Table 5-5 Current Phase III Trials of Rilpivirine in Treatment-Naive Patients: ECHO and THRIVE

Table 5-6 Results from Phase III Trials of Rilpivirine: ECHO and THRIVE, Week 48

Table 5-7 Results from Study A5271010, Day 8

Table 5-8 Results from Phase II Study of Elvucitabine (ACH443-015), Week 24 and Week 96

Table 5-9 Results from Phase IIa Study of IV PRO-140 in HIV Patients (Study PRO140-2301)

Table 5-10 Results from Phase IIa Study of Subcutaneous PRO-140 in HIV patients (Study PRO140-2101)

Table 5-11 Results from a Study of Ritonavir-Boosted Elvitegravir in Treatment-Experienced Patients with at Least One Primary PI Mutation, Week 24 and Week 48

Table 5-12 Results from a Phase II Study of Gilead’s Quad Compared with Gilead’s Atripla in Treatment-Naive Patients at Week 24

Table 5-13 Interim 24-Week Results from SPRING-1, a Phase IIb Study of ViiV’s Dolutegravir Compared with Efavirenz in Treatment-Naive Patients

Table 5-14 Results from a Phase II Study of Gilead’s Quad Compared with Gilead’s Atripla in Treatment-Naive Patients at Week 24

Table 6-1 Sales of Drugs to Treat Human Immunodeficiency Virus (All Populations) in the Major Pharmaceutical Markets, 2010-2020

Table 6-2 Timeline of Key Market Events for HIV

Table B-1 Sources for Drug Prices

Figure 1-1 Human Immunodeficiency Virus Structure

Figure 1-2 The Life Cycle of HIV-1

Figure 1-3 Factors Driving Disease Progression and Patient Flows Through the Treatment Life Cycle

Figure 2-1: Total Prevalent Cases (in thousands) of HIV in the Major Pharmaceutical Markets, 2010-2020

Figure 2-2: Newly Diagnosed Incident Cases of HIV by Transmission Category, 2010

Figure 3-1 HIV Diagnosis and Treatment Algorithm

Figure 4-1 Unmet Needs: Attainment and Remaining Opportunity in HIV

Figure 6-1 Timeline of Near-Term Events in Human Immunodeficiency Virus

Figure 6-2 Market Share of Drugs to Treat HIV, by Class, 2009 and 2019

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