CLINICAL TRIALS PROFILE FOR EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

All Clinical Trials for Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00013520 ↗	Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	The purpose of this study is to compare the effectiveness, safety, and tolerability of 3 anti-HIV combination treatments that do not use protease inhibitors (PIs). The current rule for starting treatment of HIV infection is to combine members from different classes of anti-HIV drugs, such as 2 nucleoside reverse transcriptase inhibitors (NRTIs) and either a PI or a nonnucleoside reverse transcriptase inhibitor (NNRTI). However, these combinations can be complicated and difficult to take, can cause a number of side effects, and may become ineffective. Combinations that are simpler, better tolerated, and more effective are needed. Because PIs can cause long-term side effects and because HIV can become resistant to many of them at the same time, anti-HIV combination treatments that do not use PIs are being tested.
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.
NCT00050895 ↗	Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	With new strategies and drugs available, many different regimens exist for the treatment of HIV. The purpose of this study is to compare three different anti-HIV drug regimens as first-time treatments for HIV infection.
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; Lamivudine; Tenofovir Disoproxil Fumarate

Condition Name

Condition Name for Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
Intervention	Trials
HIV Infections	11
HIV	3
HIV-1 Infection	3
HIV-1-infection	2

Condition MeSH

Condition MeSH for Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
Intervention	Trials
HIV Infections	17
Acquired Immunodeficiency Syndrome	8
Immunologic Deficiency Syndromes	5
Infection	3

Clinical Trial Locations for Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate

Trials by Country

Trials by Country for Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
Location	Trials
United States	123
Germany	8
South Africa	6
United Kingdom	5
Canada	5

Trials by US State

Trials by US State for Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
Location	Trials
New York	7
Illinois	7
Florida	7
California	7
North Carolina	7

Clinical Trial Progress for Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate

Clinical Trial Phase

Clinical Trial Phase for Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	14
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
Clinical Trial Phase	Trials
Completed	19
Recruiting	3
Unknown status	3

Clinical Trial Sponsors for Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate

Sponsor Name

Sponsor Name for Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	7
Gilead Sciences	6
Willem Daniel Francois Venter	3

Sponsor Type

Sponsor Type for Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
Sponsor	Trials
Other	33
Industry	16
NIH	8

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

Introduction

The combination of Efavirenz (EFV), Lamivudine (3TC), and Tenofovir Disoproxil Fumarate (TDF) is a widely used antiretroviral therapy (ART) regimen for the treatment of HIV-1. This article will delve into recent clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials: Efficacy and Safety

Non-Inferiority Trials

A recent phase 3 clinical trial compared the efficacy and safety of Ainuovirine (ANV) versus Efavirenz (EFV) when combined with Tenofovir Disoproxil Fumarate and Lamivudine (TDF+3TC). The trial, conducted over 48 weeks, found that ANV was non-inferior to EFV in achieving HIV RNA suppression. Additionally, the ANV group showed fewer adverse events related to liver toxicity, dyslipidemia, neuropsychiatric symptoms, and rash compared to the EFV group[1].

Long-Term Efficacy and Safety

The ADVANCE trial, a randomized, open-label, noninferiority trial, compared three World Health Organization (WHO)-recommended first-line regimens, including a fixed-dose combination of TDF/FTC/EFV. The trial reported final safety and efficacy data up to 192 weeks, demonstrating the noninferiority and safety of regimens containing Dolutegravir (DTG) and Tenofovir Alafenamide (TAF) compared to the TDF/FTC/EFV regimen. While DTG-containing regimens showed promising safety profiles, they were associated with substantial weight gain[5].

Market Analysis

Global Market Demand

By the end of 2020, over 25 million people in low- and middle-income countries were receiving antiretroviral therapy (ART). The global demand for ART is projected to increase, with estimates suggesting between 30.6 million and 35.6 million people receiving treatment by 2025, depending on the forecasting model used[3].

Market Trends and Forecast

The global market for Efavirenz/Lamivudine/Tenofovir compound drugs is expected to grow from 2025 to 2031. Market reports include detailed analyses such as market size, revenue share, forecasted CAGR, competitor analysis, and regional analysis. The base year for these calculations is 2023, with historical data from 2019 to 2023 and forecasted data from 2025 to 2031[2].

Regional Analysis

The demand for ARV medicines varies significantly across regions, with low- and middle-income countries accounting for a substantial portion of the global market. The WHO report highlights the need for accurate demand forecasting to enable suppliers to adjust their manufacturing capacity and processes accordingly[3].

Market Drivers and Opportunities

Increasing Prevalence of HIV

The ongoing need for effective ART due to the prevalence of HIV drives the demand for drugs like Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate. As more people are diagnosed and treated, the market for these medications is expected to expand.

Advancements in Treatment Regimens

Clinical trials like the ADVANCE trial and the PASO DOBLE study, which compare different treatment regimens, provide valuable insights into the efficacy and safety of various combinations. These studies can lead to the adoption of newer, more effective regimens, influencing market trends[4][5].

Market Restraints and Challenges

Resistance and Side Effects

The emergence of drug resistance, particularly to Efavirenz, and the side effects associated with long-term use of these medications are significant challenges. For instance, the ADVANCE trial highlighted the issue of weight gain associated with DTG-containing regimens, which could impact patient adherence and overall market demand[5].

Cost and Accessibility

The cost of antiretroviral medications remains a barrier in many low- and middle-income countries. Efforts to reduce manufacturing costs, such as scaling up generic production, are crucial for increasing accessibility and driving market growth[5].

Technological and Regulatory Trends

Generic Production

The potential for lower manufacturing costs if generic production is scaled up is a significant trend. This could make ARV medications more accessible and affordable, particularly in regions with limited resources[5].

Regulatory Approvals

Regulatory approvals and guidelines play a critical role in the market for ARV drugs. For example, the WHO's recommendations and guidelines influence the adoption of different treatment regimens globally[3].

Consumer Behavior and Preferences

Patient Adherence

Patient adherence to treatment regimens is a critical factor in the success of ART. Simplified regimens, such as the 2-drug regimen Dovato (dolutegravir/lamivudine), which showed less weight gain compared to 3-drug regimens, can improve adherence and influence market preferences[4].

Quality of Life

The quality of life for patients on long-term ART is a significant consideration. Medications with fewer side effects and better safety profiles are increasingly preferred, driving demand for newer, more tolerable treatments[1][5].

Conclusion

The combination of Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate remains a cornerstone in HIV treatment. Recent clinical trials have highlighted the efficacy and safety of this regimen while also pointing out areas for improvement. Market analysis indicates a growing demand driven by the increasing prevalence of HIV and advancements in treatment regimens. However, challenges such as drug resistance, side effects, and cost remain significant.

Key Takeaways

• Efficacy and Safety: Clinical trials show that the EFV/TDF/3TC regimen is effective but may have side effects that newer regimens can mitigate.
• Market Growth: The global market for ARV drugs is expected to grow, driven by increasing demand and advancements in treatment.
• Regional Variations: Demand varies significantly across regions, with low- and middle-income countries being key markets.
• Challenges: Drug resistance, side effects, and cost are significant challenges that need to be addressed.
• Technological Trends: Generic production and simplified regimens are key trends that could shape the future market.

FAQs

What are the main components of the EFV/TDF/3TC regimen?

The main components are Efavirenz (EFV), Lamivudine (3TC), and Tenofovir Disoproxil Fumarate (TDF).

What are the recent findings on the efficacy of EFV compared to other drugs?

Recent trials have shown that EFV is non-inferior to other drugs like Ainuovirine when combined with TDF and 3TC, but it may have more adverse effects[1].

How is the global market for ARV drugs projected to grow?

The market is projected to grow from 2025 to 2031, driven by increasing demand and advancements in treatment regimens[2].

What are the main challenges facing the market for ARV drugs?

The main challenges include drug resistance, side effects, and cost, particularly in low- and middle-income countries[3][5].

How do newer treatment regimens impact the market?

Newer regimens, such as the 2-drug regimen Dovato, can improve patient adherence and quality of life, influencing market preferences and driving demand for more tolerable treatments[4].

Sources

1. PubMed: "Week 48 results of a randomized controlled phase 3 clinical trial comparing the efficacy and safety of Ainuovirine versus Efavirenz in combination with two NRTIs."
2. Cognitive Market Research: "Efavirenz/Lamivudine/Tenofovir Compound Drugs Market Report."
3. WHO: "Antiretroviral medicines in low- and middle-income countries."
4. ViiV Healthcare: "ViiV Healthcare announces positive data demonstrating 2-drug regimen Dovato not just demonstrated the same efficacy as a 3-drug regimen, but also showed less weight gain."
5. Oxford Academic: "Final 192-Week Efficacy and Safety Results of the ADVANCE Trial."