CLINICAL TRIALS PROFILE FOR EMTRIVA

All Clinical Trials for Emtriva

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00016718 ↗	Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2	2001-08-01	Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study was to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who had taken few or no anti-HIV drugs.
NCT00016718 ↗	Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2	2001-08-01	Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study was to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who had taken few or no anti-HIV drugs.
NCT00051831 ↗	Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults	Completed	AIDS Clinical Trials Group	N/A	2003-10-01	HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00051831 ↗	Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	2003-10-01	HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00112047 ↗	Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects	Completed	Gilead Sciences	Phase 3	2003-07-01	The purpose of Study GS-01-934 was to assess the efficacy and safety of two simplified antiretroviral treatment (ART) regimens in ART-naive, human immunodeficiency virus, type 1 (HIV-1) infected participants. The primary objective of the study was to assess noninferiority of emtricitabine (FTC) and tenofovir disoproxil fumarate (tenofovir DF; TDF) in combination with efavirenz (EFV) relative to Combivir (CBV) in combination with EFV in the treatment of HIV-1 infected ART-naive participants, determined by the achievement and maintenance of confirmed HIV-1 ribonucleic acid (RNA) < 400 copies/mL (c/mL) through Week 48, as defined by the United States (US) Food and Drug Administration (FDA) time-to-loss-of-virologic-response (TLOVR) algorithm.
NCT00344981 ↗	Safety and Durability ofTenofovir and a Cell Cycle Agent for Viral Suppression	Completed	University of Maryland	N/A	2003-06-01	Study Hypothesis Evaluation of the durability of the combination Tenofovir and Hydroxyurea to maintain viral suppression below 50 copies/ml in volunteers who have achieved viral suppression on a standard HAART regimen.

Clinical Trial Conditions for Emtriva

Condition Name

Condition Name for Emtriva
Intervention	Trials
HIV Infections	8
HIV Infection	2
Acute HIV Infection	1
AIDS	1

Condition MeSH

Condition MeSH for Emtriva
Intervention	Trials
HIV Infections	11
Infections	5
Acquired Immunodeficiency Syndrome	4
Infection	4

Clinical Trial Locations for Emtriva

Trials by Country

Trials by Country for Emtriva
Location	Trials
United States	77
Puerto Rico	5
Peru	2
Canada	2
Uganda	1

Trials by US State

Trials by US State for Emtriva
Location	Trials
North Carolina	6
New York	6
California	6
Massachusetts	5
District of Columbia	5

Clinical Trial Progress for Emtriva

Clinical Trial Phase

Clinical Trial Phase for Emtriva
Clinical Trial Phase	Trials
Phase 3	2
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Emtriva
Clinical Trial Phase	Trials
Completed	10
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for Emtriva

Sponsor Name

Sponsor Name for Emtriva
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	5
AIDS Clinical Trials Group	4
Alzheimer's Association	1

Sponsor Type

Sponsor Type for Emtriva
Sponsor	Trials
Other	17
NIH	8
Industry	5

Emtriva: Clinical Trials, Market Analysis, and Projections

Last updated: December 31, 2024

Introduction

Emtriva, also known as emtricitabine, is a nucleoside reverse transcriptase inhibitor (NRTI) used in the treatment of HIV-1 infection. Here, we will delve into the clinical trials, market analysis, and future projections for this crucial antiretroviral medication.

Clinical Trials and Efficacy

Comparative Efficacy with Other Antiretrovirals

In clinical trials, Emtriva has demonstrated comparable efficacy to other NRTIs. For instance, in Trial 303, Emtriva and lamivudine (3TC) showed similar efficacy, safety, and resistance patterns when used as part of multidrug regimens[3].

Combination Therapies

Emtriva is often used in combination with other antiretroviral drugs. The fixed-dose combination of Emtriva and tenofovir disoproxil fumarate, known as Truvada, has been extensively studied. These studies have supported the use of Truvada for the treatment of HIV-1 infection in treatment-naive adults, with efficacy and safety profiles comparable to other combination therapies[3].

Adverse Reactions

Clinical trials have identified common adverse reactions associated with Emtriva, including headache, diarrhea, nausea, rash, and fatigue. These reactions are generally mild to moderate, with approximately 1% of subjects discontinuing participation due to these events. Notably, skin discoloration, manifested by hyperpigmentation on the palms or soles, was reported more frequently in the Emtriva-treated group, though it was typically mild and asymptomatic[1][3].

Market Analysis

Global Market Size and Growth

The global market for Emtriva and its combination formulations, such as emtricitabine and tenofovir alafenamide fumarate tablets, is significant and growing. The market size for these tablets was estimated to be in the millions in 2023, with a projected compound annual growth rate (CAGR) from 2024 to 2031. This growth is driven by increasing demand for effective HIV treatments and the expanding global healthcare market[2].

Regional and Country Analysis

The market for Emtriva and its combinations is segmented into major regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region has its own trends and growth rates, with detailed analysis provided in market reports to help understand the current and future market dynamics[2].

Competitive Analysis

The market for antiretroviral medications is competitive, with several key players including Gilead Sciences, ViiV Healthcare, and others. The competitive landscape is influenced by factors such as product efficacy, safety profiles, pricing, and regulatory approvals. Market reports provide competitor analysis, including SWOT analysis and Porter's Five Forces analysis, to give a comprehensive view of the market[2].

Market Projections

Forecasted Growth

The market for Emtriva and its combination tablets is expected to grow significantly from 2025 to 2031. This growth is forecasted based on historical trends, current market size, and future demand. The reports provide detailed forecasts at the global, regional, and country levels, helping stakeholders understand future market opportunities and challenges[2].

Application and End-Use Analysis

Emtriva and its combinations are used in various applications, primarily for the treatment of HIV-1 infection. The demand for these medications is driven by the need for effective antiretroviral therapies. Market reports analyze the demand across different end-use industries, providing insights into the segments that are expected to be most lucrative in the near future[2].

Key Trends and Opportunities

Technological Advancements

Advancements in antiretroviral therapy, including the development of new formulations and combination therapies, are driving the market forward. For example, the transition from tenofovir disoproxil fumarate to tenofovir alafenamide fumarate has improved the safety profile of these medications[2].

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in the market for Emtriva and its combinations. Market reports include analysis of regulatory factors that influence market growth and opportunities[2].

COVID-19 Impact

The COVID-19 pandemic has had various impacts on the healthcare sector, including disruptions in supply chains and changes in consumer behavior. Market reports provide COVID-19 analysis to help understand the short-term and long-term effects on the market for Emtriva and its combinations[2].

Conclusion

Emtriva, as an antiretroviral medication, has a strong clinical foundation and a growing market presence. Its efficacy and safety profile, as demonstrated in clinical trials, make it a valuable component of HIV treatment regimens. The global market for Emtriva and its combination tablets is projected to grow significantly, driven by increasing demand for effective HIV treatments and technological advancements.

Key Takeaways

• Clinical Efficacy: Emtriva has shown comparable efficacy to other NRTIs in clinical trials.
• Adverse Reactions: Common adverse reactions include headache, diarrhea, nausea, and rash, with skin discoloration reported more frequently in Emtriva-treated groups.
• Market Growth: The global market for Emtriva and its combinations is expected to grow significantly from 2025 to 2031.
• Regional Analysis: The market is segmented into major regions, each with its own trends and growth rates.
• Technological Advancements: New formulations and combination therapies are driving market growth.

FAQs

What are the common adverse reactions associated with Emtriva?

Common adverse reactions include headache, diarrhea, nausea, rash, and fatigue, with skin discoloration reported more frequently in Emtriva-treated groups[1][3].

How does Emtriva compare to other antiretroviral medications in clinical trials?

Emtriva has demonstrated comparable efficacy and safety profiles to other NRTIs, such as lamivudine, in clinical trials[3].

What is the projected market growth for Emtriva and its combination tablets?

The market is expected to grow significantly from 2025 to 2031, driven by increasing demand for effective HIV treatments and technological advancements[2].

What regions are driving the growth of the Emtriva market?

The market is segmented into North America, Europe, Asia Pacific, Middle East & Africa, and Latin America, each with its own growth trends and rates[2].

How has the COVID-19 pandemic impacted the market for Emtriva?

The pandemic has caused disruptions in supply chains and changes in consumer behavior, with detailed analysis provided in market reports to understand the short-term and long-term effects[2].

Sources

1. Gilead Sciences, "EMTRIVA (emtricitabine) Capsules", [PDF].
2. Cognitive Market Research, "Global Emtricitabine And Tenofovir Alafenamide Fumarate Tablets Market Report 2024".
3. Gilead Sciences, "Gilead Provides Update on Development of Fixed-Dose Regimen of Truvada and Sustiva".
4. Open Forum Infectious Diseases, "Results Through Week 144 of the SIMPL'HIV Trial".
5. ViiV Healthcare, "ViiV Healthcare to announce data from largest head-to-head, randomised clinical trial of the 2-drug regimen Dovato".