CLINICAL TRIALS PROFILE FOR EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

All Clinical Trials for Efavirenz; Emtricitabine; 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.
NCT00084136 ↗	Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings	Completed	AIDS Clinical Trials Group	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.
NCT00087464 ↗	Three Month Course of Anti-HIV Medications for People Recently Infected With HIV	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	Short-term therapy may reduce the amount of HIV in the blood of adults recently infected with HIV. The purpose of this study is to see whether it is better for people to take a short course of anti-HIV drugs when they are first infected or if it is better to wait until the HIV infection causes health problems before taking anti-HIV drugs.

Clinical Trial Conditions for Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate

Condition Name

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

Condition MeSH

Condition MeSH for Efavirenz; Emtricitabine; 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; Tenofovir Disoproxil Fumarate

Trials by Country

Trials by Country for Efavirenz; Emtricitabine; 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; Tenofovir Disoproxil Fumarate
Location	Trials
California	15
Florida	13
North Carolina	12
New York	12
Illinois	12

Clinical Trial Progress for Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate

Clinical Trial Phase

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Withdrawn	3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

Clinical Trial Sponsors for Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate

Sponsor Name

Sponsor Name for Efavirenz; Emtricitabine; 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; Tenofovir Disoproxil Fumarate
Sponsor	Trials
Industry	34
Other	25
NIH	14

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

Introduction

The combination of efavirenz, emtricitabine, and tenofovir disoproxil fumarate (EFV/FTC/TDF) is a widely used antiretroviral therapy (ART) for the treatment of HIV-1 infection. This article will delve into recent clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Overview

Safety and Efficacy Studies

A significant clinical trial, a Phase 3B randomized, open-label study, compared the safety and efficacy of a single-tablet regimen of emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) with the EFV/FTC/TDF regimen in antiretroviral treatment-naive adults. This study aimed to evaluate the efficacy and safety of these regimens over a 96-week period, with an option for extended treatment in the FTC/RPV/TDF arm until the drug became commercially available or development was terminated[1].

Alternate-Day Dosing

Another clinical trial investigated the noninferiority of the TDF/FTC/EFV fixed-dose combination administered on alternate days versus the standard daily regimen in virologically suppressed patients. This study sought to improve adherence, reduce toxicity, and lower costs by leveraging the long half-lives of these antiretrovirals[5].

Market Analysis

Global HIV Drugs Market

The global HIV drugs market was valued at $32.8 billion in 2022 and is projected to reach $51.1 billion by 2032, growing at a CAGR of 4.5% from 2023 to 2032. This growth is driven by the increasing prevalence of HIV, advancements in antiretroviral therapies, and public-private partnerships aimed at improving access to these medications[4].

Market Share and Demand

By 2025, efavirenz (EFV) and tenofovir disoproxil fumarate (TDF) are expected to remain significant players in the ART regimen, with 10 million and 16 million patients using these drugs, respectively. However, newer antiretrovirals like tenofovir alafenamide (TAF) and dolutegravir (DTG) are forecasted to become major components of ART regimens, with 8 million and 15 million patients using these drugs by 2025[3].

Regulatory Approvals and Generic Versions

Marketing Authorization

The EFV/FTC/TDF combination has received marketing authorization in various regions. For instance, Glenmark Arzneimittel GmbH obtained approval for their generic version of EFV/FTC/TDF in the European Economic Area (EEA) based on a bioequivalence study comparing their product with the reference product Atripla by Gilead Sciences[2].

Future Projections

Anticipated Demand and Supply

The demand for EFV and TDF is expected to continue, especially in low- and middle-income countries (LMICs), where these drugs are crucial for maintaining access to effective ART. However, the introduction of lower-dose antiretrovirals like TAF and DTG may impact the production capacities of generics manufacturers, which are currently geared towards higher-dose formulations[3].

Public-Private Partnerships

Recent public-private partnerships, such as those announced by Gilead Sciences, are focused on accelerating the development of new formulations, including pediatric formulations of TAF and emtricitabine/tenofovir alafenamide (F/TAF), which will further expand the treatment options for HIV patients[4].

Challenges and Considerations

Safety and Efficacy During Pregnancy and TB/HIV Co-infection

There are ongoing debates about the safety and efficacy of newer antiretrovirals like DTG and TAF during pregnancy and in patients co-infected with TB who are using rifampicin. This underscores the need for continuous monitoring and research to ensure the optimal use of these medications[3].

Ensuring Continuous Supply

The scale-up of ART is predicted to increase significantly, emphasizing the importance of ensuring continuous supplies of both existing and new antiretrovirals. This includes maintaining the production capacities for higher-dose formulations like EFV and TDF, alongside the introduction of lower-dose alternatives[3].

Key Takeaways

• Clinical Trials: Recent studies have compared the safety and efficacy of EFV/FTC/TDF with other antiretroviral regimens and explored alternate-day dosing to improve adherence.
• Market Analysis: The global HIV drugs market is growing, with EFV and TDF expected to remain significant, while newer antiretrovirals like TAF and DTG are gaining prominence.
• Regulatory Approvals: Generic versions of EFV/FTC/TDF have been approved, ensuring broader access to these medications.
• Future Projections: Public-private partnerships are driving innovation, and there is a need to balance the supply of existing and new antiretrovirals to meet increasing demand.

FAQs

Q: What is the purpose of the Phase 3B clinical trial comparing EFV/FTC/TDF with FTC/RPV/TDF?

A: The trial aims to evaluate the safety and efficacy of these single-tablet regimens in antiretroviral treatment-naive adults over a 96-week period[1].

Q: How does the market demand for EFV and TDF look by 2025?

A: By 2025, it is projected that 10 million patients will be using EFV and 16 million patients will be using TDF[3].

Q: What are the challenges associated with the introduction of newer antiretrovirals like TAF and DTG?

A: There are concerns about their safety and efficacy during pregnancy and in TB/HIV co-infected patients using rifampicin, and the need to ensure continuous supplies of existing antiretrovirals[3].

Q: What public-private partnerships are relevant to the development of new HIV treatments?

A: Gilead Sciences has announced partnerships to accelerate the development of pediatric formulations of F/TAF and to eliminate bitterness in these formulations[4].

Q: Why is it important to maintain production capacities for higher-dose antiretrovirals?

A: Ensuring continuous supplies of higher-dose formulations like EFV and TDF is crucial as they remain essential components of ART regimens, especially in LMICs[3].

Sources

1. Stanford Health Care: Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults.
2. Geneesmiddeleninformatiebank: Public Assessment Report - Efavirenz/Emtricitabine/Tenofovir disoproxil Glenmark 600 mg/200 mg/245 mg film-coated tablets.
3. PubMed: Projected Uptake of New Antiretroviral (ARV) Medicines in Adults in Low- and Middle-Income Countries.
4. Allied Market Research: HIV Drugs Market Size, Share and Growth Analysis | Report, 2032.
5. PubMed: Randomized clinical trial on efficacy of fixed-dose efavirenz/tenofovir/emtricitabine on alternate days versus continuous treatment.