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  4. > A Global Product and Pipeline Analysis of Antiretroviral Drug Development for the Treatment of HIV/AIDS

Antiretroviral Combinations Continue to Transform the Treatment Landscape

This research service focuses on antiviral/antiretroviral therapeutics for the treatment of HIV/AIDS. A product and pipeline assessment is provided for marketed and investigational products and combination regimens for the treatment of HIV infection. Segmentation by drug class is provided along with additional supporting information such as clinical trial timelines and results, historical and projected launch timelines, and global prevalence by region and country. Key market developments since Q1 2013 and key companies to watch are also included. This research service is an update of the 2013 research service titled Strategic Analysis of Antiviral Drug Development for Viral Hepatitis and HIV/AIDS.

Key Findings
Human Immunodeficiency Virus (HIV) Antiretrovirals
The 2006 launch of Atripla, the first single-tablet regimen (STR) for the treatment of HIV infection, marked an important advancement in antiretroviral therapy (ART), significantly enhancing efficacy and reducing pill burden. Research has continued to build on this innovation, and patients now have at their disposal a number of STRs that are highly effective and have good tolerability. Researchers are seeking to develop novel antiretroviral combinations that have a high barrier to resistance and a low cross-resistance with existing drugs, and that are easy to administer (ideally once-daily dosing).

Given the advancements in treatment, viral breakthrough is not uncommon. Keys to maintaining viral suppression are patient adherence, strategically guided treatment choices, and novel drug development.

Promising candidates in late trials include Tobira Therapeutics’ cenicriviroc with novel anti-inflammatory effects, and Gilead’s tenofovir alafenamide (TAF), which could overcome the safety concerns associated with tenofovir.

Methodology and Scope
-This research service focuses on antiretroviral therapeutics for the treatment of infection by HIV/AIDS. It does not cover vaccines.
-A product and pipeline assessment is provided for marketed and investigational products and combination regimens for the treatment of HIV infection. Segmentation by drug class is provided along with additional supporting information, such as clinical trial timelines and results, historical and projected launch timelines, and epidemiology.
-The information contained in this research service was derived from published sources, including the following: disease organization Web sites; public health organization Web sites; company publications including annual reports, SEC filings, and press releases; government public sources; and published articles in scientific journals.

HIV Overview
Human immunodeficiency virus, a bloodborne infectious disease, remains a major global health and development threat. Incidence and prevalence remain highest in Sub-Saharan Africa, with the region accounting for about % of the estimated million people living with HIV globally.

HIV infection weakens the immune system by destroying CD4 cells, and can eventually lead to acquired immune deficiency syndrome (AIDS). This is the most advanced stage of HIV infection and can take up to years to develop. Although carriers of the virus may not exhibit any symptoms, they can still transmit it.

HIV is transmitted by direct exposure to contaminated blood and other bodily fluids. Potential exposure routes include needle-stick injuries, needle sharing, blood transfusions, dialysis, tattoos and piercings, mother-to-fetus transmission, and sexual contact. High-risk populations include those with potential occupational exposure, including healthcare workers, dentists, and first responders; those practicing risky behaviors (e.g., intravenous drug users); and recipients of invasive therapeutic procedures such as blood transfusions and organ transplants (before 1985 in the United States).

ART is highly effective at suppressing the virus and boosting infected individuals’ immune systems, and at reducing the likelihood of transmission. Some million infected people are on ART; the global target is million by 2015. ART has recently been shown to be safe and effective for pre-exposure prophylaxis (PrEP) for HIV-negative people. It is not a cure, however, and must be taken for life due to the latent virus in reservoirs inaccessible to antiretrovirals.

Table Of Contents

A Global Product and Pipeline Analysis of Antiretroviral Drug Development for the Treatment of HIV/AIDS
1. EXECUTIVE SUMMARY

Executive Summary
Key Market Developments since Q1 2013
Key Findings
Evolution of Standard of Care for HIV
Key Companies to Watch

2. METHODOLOGY AND SCOPE

Methodology and Scope

3. INTRODUCTION

Introduction
HIV Overview
Prevalence of HIV/AIDS Globally and by Region
Market Segmentation

4. HIV/AIDS ANTIRETROVIRAL MARKET

HIV/AIDS Antiretroviral Market
HIV/AIDS Antiretroviral Market—Competitive Landscape ofMarketed Products
HIV/AIDS Antiretroviral Market—Competitive Landscape ofProducts in Development
HIV/AIDS Antiretroviral Market—Product Launch and Patent Expiration Timeline
HIV/AIDS Antiretroviral Market—Major Phase 3 Ongoing Trials
HIV/AIDS Antiretroviral Market—Recent Pivotal Trial Results
Marketed Product Synopsis—Multi-class FDC Products
Marketed Product Synopsis—Single-class FDC Products
Marketed Product Synopsis—Single-entity Products
Pipeline Synopsis—Late-stage Development Products
Pipeline Synopsis—Early Clinical Development Products
Pipeline Synopsis—Early Development Products

5. CONCLUSIONS AND RECOMMENDATIONS

Conclusions and Recommendations
Legal Disclaimer

6. APPENDIX

Appendix
Decision Support Database—Prevalence of HIV Infection

7. THE FROST and SULLIVAN STORY

The Frost and Sullivan Story
Value Proposition: Future of Your Company and Career
Global Perspective
Industry Convergence
360º Research Perspective
Implementation Excellence
Our Blue Ocean Strategy

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