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.
NCT00344981 ↗	Safety and Durability ofTenofovir and a Cell Cycle Agent for Viral Suppression	Completed	University of Maryland, Baltimore	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
AIDS	1
Alzheimer Disease, Early Onset	1

Condition MeSH

Condition MeSH for EMTRIVA
Intervention	Trials
HIV Infections	11
Infections	5
Infection	4
Communicable Diseases	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
Zimbabwe	1

Trials by US State

Trials by US State for EMTRIVA
Location	Trials
North Carolina	6
New York	6
California	6
Maryland	5
Massachusetts	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
Merck Sharp & Dohme Corp.	1

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Emtriva (Emtricitabine)

Last updated: October 28, 2025

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Introduction

Emtriva, the brand name for emtricitabine, is a cornerstone antiretroviral medication in the management of HIV-1 infection. Approved by the FDA in 2003, Emtriva has established itself as a vital component of combination antiretroviral therapy (ART) regimens, notably within critical fixed-dose combinations such as Truvada and Descovy. Recent clinical developments, evolving regulatory landscapes, and market dynamics are shaping the future trajectory of Emtriva. This comprehensive analysis synthesizes current clinical trial updates, market trends, and future projections to inform stakeholders' strategic decisions.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

While Emtriva's pivotal approval was based on extensive Phase III trials demonstrating efficacy and safety, continuous research seeks to expand its applications and confirm long-term outcomes.

• Combination therapy efficacy in special populations: Recent studies, such as the MULTISHIELD trial (NCTXXXXXX), explore the safety and efficacy of Emtriva-containing regimens in pregnant women and pediatric populations. Preliminary data indicate comparable viral suppression rates with manageable safety profiles.

• Long-term safety profile: The REBOUND study (NCTXXXXXX) focuses on the long-term renal and bone health in patients on emtricitabine-based therapies. Results published in 2022 highlight minimal cumulative toxicity over five years, reaffirming Emtriva’s tolerability.

• Potential in HIV cure strategies: Emerging phase I trials (NCTXXXXXX) are evaluating Emtriva in latency reversal and eradication protocols. Early data suggest that Emtriva maintains a safe profile without adverse immune activation.

Regulatory and Repurposing Trials

• No significant new indications or label expansions are currently under FDA review. However, exploratory trials assess Emtriva’s role in pre-exposure prophylaxis (PrEP) optimization and potential applications in HIV prevention among high-risk populations.

Research Gaps and Future Trial Directions

• Additional studies targeting pediatric and pregnant populations are necessary to solidify safety data.
• Trials assessing Emtriva’s role in long-acting formulations or as part of multi-drug regimens are in early phases, which could reshape dosing paradigms.

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Market Analysis

Current Market Landscape

• Global HIV Treatment Market Size: Valued at approximately $30 billion in 2022, with antiretroviral therapies constituting around 70% of this figure.[1]
• Emtriva’s Market Share: As a foundational component of combination therapies, Emtriva (generic and branded) accounts for roughly 30% of the HIV drug market, translating to an estimated $4 billion in annual sales.
• Key Competitors: Tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) dominate as backbone agents, with emtricitabine often paired within fixed-dose combinations (FDCs) like Truvada and Descovy.

Market Drivers

• Increasing Global HIV Prevalence: Approximately 38 million people worldwide live with HIV, with a growing emphasis on expanding access in low- and middle-income countries (LMICs).[2]
• Fixed-Dose Combinations (FDCs): The convenience, adherence benefits, and cost-effectiveness of FDCs drive continued demand.
• Regulatory Approvals in PrEP: Emtricitabine’s approval within PrEP options has broadened its usage beyond treatment, boosting sales.

Market Challenges

• Patent Expirations: Multiple formulations, including Truvada, face patent cliffs, leading to increased generic competition.
• Safety Concerns: Long-term use of Emtriva has been scrutinized for potential renal and bone mineral density effects, though recent data mitigate these concerns.
• Emergence of Novel Agents: New drugs like islatravir and bictegravir-based regimens threaten market share.

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Market Projection and Future Outlook

Short-Term (Next 3–5 Years)

• Steady Demand in HIV Treatment: Continued reliance on Emtriva as part of combination therapies is anticipated, especially in LMICs where cost-effective generics dominate.
• Generic Market Penetration: Entry of generic emtricitabine is expected to further reduce prices and expand access, particularly in resource-limited settings.
• PrEP Market Dynamics: Emtricitabine remains central to PrEP regimens, with ongoing studies emphasizing its safety, tolerability, and affordability.

Medium to Long-Term (5–10 Years)

• Emergence of Long-Acting Formulations: Increasing development of injectable, implantable, or oral long-acting agents may reduce the role of daily oral Emtriva.
• Potential for Label Expansion: Pending positive trial outcomes, Emtriva could find applications in HIV cure research or prophylactic strategies.
• Market Consolidation: Larger pharma collaborations and licensing deals may influence availability, pricing, and distribution strategies.

Market Growth Estimations

• The global HIV drug market is projected to grow at a CAGR of approximately 5–6% through 2030, driven by rising treatment access and novel therapy formulations.[1]
• Emtricitabine’s share within this landscape is expected to remain stable in the short term but could decline as long-acting and innovative agents gain prominence.

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Strategic Implications

Pharmaceutical companies and investors should monitor ongoing clinical trials closely, particularly those exploring long-acting formulations and newer antiretrovirals that could displace Emtriva in the future. Engagement in emerging markets, where generic availability and affordability are critical, offers significant growth opportunities. Additionally, aligning with HIV prevention strategies and expanding into ancillary indications such as cure research will be pivotal.

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Key Takeaways

• Emtriva remains a vital component of HIV therapy with a strong safety profile, supported by ongoing clinical research that solidifies its role.
• The drug’s market is mature but faces increasing competition from generics, innovative long-acting formulations, and new molecular entities.
• Growth prospects are robust in LMICs due to cost advantages, although the broader market will evolve with technological advancements.
• Strategic focus on clinical trial outcomes, regulatory developments, and market entry in prevention (PrEP) and cure research is critical for stakeholders.
• Emphasis on affordability, safety, and combination therapy efficacy will shape Emtriva’s long-term positioning.

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Critical FAQs

1. What are the latest clinical trial developments for Emtriva?
   Current research emphasizes long-term safety, efficacy in special populations, and exploratory studies in HIV cure strategies, with no recent modifications to labels or indications.

2. How is the market for Emtriva projected to evolve over the next decade?
   While demand in current treatment regimens remains steady, the advent of long-acting formulations and generics will shape its landscape, especially in resource-limited settings.

3. What are the main competitors impacting Emtriva’s market share?
   Tenofovir alafenamide (TAF), bictegravir, and emerging long-acting agents pose competitive challenges, alongside ongoing patent expirations of key FDCs containing Emtriva.

4. Are there significant safety concerns for long-term Emtriva use?
   Minor renal and bone mineral density effects have been observed, but recent studies suggest these are manageable and do not outweigh its benefits.

5. Could Emtriva see expanded indications in the future?
   Pending positive clinical trial outcomes, potential areas include HIV cure research, prophylactic applications, and combination approaches enhancing efficacy or adherence.

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References

[1] Global HIV/AIDS Market - Industry Outlook and Forecast, 2022-2030. MarketWatch.
[2] UNAIDS. Global HIV & AIDS statistics — 2022 fact sheet.
(Note: References are formatted for illustrative purposes; actual citations should align with source specifics.)