CLINICAL TRIALS PROFILE FOR EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE

All Clinical Trials for Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00039741 ↗	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2/Phase 3	2002-08-01	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	PENTA Foundation	Phase 2/Phase 3	2002-08-01	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2/Phase 3	2002-08-01	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00084136 ↗	Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 4	2005-05-01	This study compared 3 different three-drug combinations in HIV infected individuals starting their first HIV treatment regimens. Participants were recruited from resource-limited areas in Africa, Asia, South America, Haiti, and also from the United States. The study hypothesis was each of the once daily combinations (PI based, or NNRTI based) would not have inferior efficacy compared to the twice daily NNRTI based combination.

Clinical Trial Conditions for Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate

Condition Name

Condition Name for Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate
Intervention	Trials
HIV Infections	18
HIV-1 Infection	7
HIV	5
HIV Infection	3

Condition MeSH

Condition MeSH for Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate
Intervention	Trials
HIV Infections	26
Acquired Immunodeficiency Syndrome	9
Immunologic Deficiency Syndromes	6
Hepatitis C	3

Clinical Trial Locations for Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate

Trials by Country

Trials by Country for Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate
Location	Trials
United States	232
Canada	16
Germany	11
South Africa	10
United Kingdom	9

Trials by US State

Trials by US State for Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate
Location	Trials
California	15
Florida	13
North Carolina	12
New York	12
Illinois	12

Clinical Trial Progress for Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate

Clinical Trial Phase

Clinical Trial Phase for Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	16
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate
Clinical Trial Phase	Trials
Completed	29
Withdrawn	3
Active, not recruiting	2

Clinical Trial Sponsors for Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate

Sponsor Name

Sponsor Name for Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate
Sponsor	Trials
Gilead Sciences	15
National Institute of Allergy and Infectious Diseases (NIAID)	11
AIDS Clinical Trials Group	5

Sponsor Type

Sponsor Type for Efavirenz, Emtricitabine, And Tenofovir Disoproxil Fumarate
Sponsor	Trials
Industry	34
Other	25
NIH	14

Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate: Clinical Trials, Market Analysis, and Projections

Introduction

Efavirenz, emtricitabine, and tenofovir disoproxil fumarate is a widely used antiretroviral therapy (ART) for the treatment of HIV-1 infection. This combination drug has been a cornerstone in HIV management, but its landscape is evolving with new clinical trials, market dynamics, and emerging therapies.

Mechanism of Action

To understand the significance of this combination, it's crucial to grasp its mechanism of action. Efavirenz inhibits HIV-1 reverse transcriptase through noncompetitive inhibition. Emtricitabine is phosphorylated to its active form, which competes with the natural substrate deoxycytidine 5'-triphosphate and terminates the viral DNA chain. Tenofovir disoproxil fumarate is converted to tenofovir diphosphate, which inhibits reverse transcriptase by competing with deoxyadenosine 5'-triphosphate and causing DNA chain termination[1].

Clinical Trials and Efficacy

Viral Suppression and Safety

Recent clinical trials have compared the efficacy and safety of this combination with newer regimens. For instance, a study involving participants who were virally suppressed on efavirenz, emtricitabine, and tenofovir disoproxil fumarate for at least 6 months showed that switching to a regimen of rilpivirine, emtricitabine, and tenofovir alafenamide maintained viral suppression in 90% of participants at week 48, which was non-inferior to the original regimen[4].

ADVANCE Trial

The ADVANCE trial, a randomized, open-label, noninferiority trial, compared three World Health Organization-recommended first-line regimens, including a fixed-dose combination of tenofovir disoproxil fumarate (TDF) / emtricitabine (FTC) / efavirenz (EFV). The trial demonstrated the noninferiority and safety of dolutegravir (DTG)- and tenofovir alafenamide (TAF)-containing regimens over 192 weeks, highlighting the potential benefits of newer drugs in terms of safety and efficacy[5].

Market Analysis and Projections

Market Size and Forecast

The market for the efavirenz, tenofovir, and emtricitabine combination drug is expected to grow at a compound annual growth rate (CAGR) of 3 to 5 percent from 2021 to 2031. This growth is driven by increasing demand in various healthcare settings such as hospitals, clinics, and drug centers across different geographical regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[2].

Geographical Segmentation

The market is segmented based on application and geographical regions. North America and Europe are significant markets due to advanced healthcare infrastructure and higher awareness of HIV treatments. However, the Asia-Pacific region is expected to show substantial growth due to increasing healthcare expenditure and a large patient population[2].

Competitive Landscape

The HIV therapeutics market is evolving with the introduction of novel therapies. While efavirenz, emtricitabine, and tenofovir disoproxil fumarate remain a staple, drugs like lenacapavir, islatravir, and vocabria (cabotegravir LA) are gaining traction for their innovative dosing regimens and improved safety profiles. For example, lenacapavir, with its biannual dosing, is expected to capture a significant market share by 2025[3].

Safety and Tolerability

Adverse Events

Clinical trials have highlighted the safety profile of efavirenz, emtricitabine, and tenofovir disoproxil fumarate. However, there are concerns about the long-term use of tenofovir disoproxil fumarate, which can lead to bone and renal risks. The switch to tenofovir alafenamide has shown to reduce these risks significantly while maintaining efficacy[4].

Bone and Renal Risks

Tenofovir alafenamide reduces tenofovir plasma concentrations by 90% compared to tenofovir disoproxil fumarate, thereby decreasing the risk of bone and renal adverse events. This has made it a preferred option in newer regimens[4].

Emerging Therapies and Market Impact

Novel Antiretrovirals

The HIV therapeutics market is witnessing the emergence of novel antiretrovirals with improved safety and efficacy profiles. Drugs like dolutegravir and tenofovir alafenamide are becoming preferred choices due to their lower risk of adverse events and better tolerability[5].

Market Share and Projections

The market share of efavirenz, emtricitabine, and tenofovir disoproxil fumarate is expected to be impacted by the increasing adoption of these newer therapies. However, its established presence and generic availability will continue to make it a significant player in the HIV treatment market[2].

Regulatory and Manufacturing Considerations

Generic Production

The potential for lower manufacturing costs if scaled up in generic production is a significant factor in the market dynamics. Regimens containing dolutegravir and tenofovir alafenamide are designed to be more cost-effective, which could influence market share in the future[5].

Patient and Healthcare Provider Perspectives

Treatment Preferences

Healthcare providers and patients are increasingly looking for regimens with better safety profiles and easier dosing schedules. The emergence of biannual and monthly dosing options is likely to influence treatment preferences and market trends[3].

Key Takeaways

• Efficacy and Safety: Efavirenz, emtricitabine, and tenofovir disoproxil fumarate remain effective in viral suppression, but newer regimens offer improved safety profiles.
• Market Growth: The market is expected to grow at a CAGR of 3 to 5 percent from 2021 to 2031, driven by increasing demand and geographical expansion.
• Emerging Therapies: Novel antiretrovirals like dolutegravir and tenofovir alafenamide are gaining traction due to their better safety and efficacy.
• Regulatory and Manufacturing: Generic production and lower manufacturing costs are key factors influencing market dynamics.

FAQs

What is the mechanism of action of efavirenz, emtricitabine, and tenofovir disoproxil fumarate?

Efavirenz inhibits HIV-1 reverse transcriptase noncompetitively, emtricitabine competes with deoxycytidine 5'-triphosphate and terminates the viral DNA chain, and tenofovir disoproxil fumarate inhibits reverse transcriptase by competing with deoxyadenosine 5'-triphosphate and causing DNA chain termination[1].

What are the potential risks associated with long-term use of tenofovir disoproxil fumarate?

Long-term use of tenofovir disoproxil fumarate can lead to bone and renal risks, which can be mitigated by switching to tenofovir alafenamide[4].

How is the market for efavirenz, emtricitabine, and tenofovir disoproxil fumarate expected to grow?

The market is expected to grow at a CAGR of 3 to 5 percent from 2021 to 2031, driven by increasing demand and geographical expansion[2].

What are some emerging therapies that could impact the market share of efavirenz, emtricitabine, and tenofovir disoproxil fumarate?

Emerging therapies include lenacapavir, islatravir, and vocabria (cabotegravir LA), which offer improved safety profiles and innovative dosing regimens[3].

How do newer regimens like dolutegravir and tenofovir alafenamide compare to efavirenz, emtricitabine, and tenofovir disoproxil fumarate?

Newer regimens offer better safety profiles, particularly in reducing bone and renal risks, and are designed to be more cost-effective in generic production[5].

Sources

1. eMPR.com: Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate.
2. Market Research Intellect: Global Efavirenz Tenofovir Emtricitabine Combination Drug Market Size and Forecast.
3. DelveInsight: Top Drugs To Watch in HIV (2025).
4. PubMed: Switching from efavirenz, emtricitabine, and tenofovir disoproxil fumarate.
5. Oxford Academic: Final 192-Week Efficacy and Safety Results of the ADVANCE Trial.