CLINICAL TRIALS PROFILE FOR EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

All Clinical Trials for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02251236 ↗	Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals	Completed	Gilead Sciences	N/A	2016-01-01	The project will have two tracks, one for participants who are currently taking elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or E/C/F/tenofovir alafenamide (E/C/F/TDF or E/C/F/TAF) single-tablet regimen* (STR) (Track A) and one for participants who will begin therapy with E/C/F/TDF or E/C/F/TAF STR during the study (Track B). Participants will take E/C/F/TDF and/or E/C/F/tenofovir alafenamide fumarate (E/C/F/TAF) STR** (if available) for 24 weeks. *Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate. **Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide fumarate.
NCT02121795 ↗	Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF	Completed	Gilead Sciences	Phase 3	2014-05-06	This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF. This study will consist of a 96 week double-blind treatment period. After Week 96, all participants will continue on blinded study drug treatment and attend visits every 12 weeks until treatment assignments are unblinded. All participants will return for an unblinding visit and will be given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical development program.
NCT01797445 ↗	Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 3	2013-03-12	The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.
NCT01780506 ↗	Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 3	2012-12-26	The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.
NCT01565850 ↗	D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults	Completed	Gilead Sciences	Phase 2	2012-04-01	This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24.
NCT01497899 ↗	Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 2	2011-12-28	The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Clinical Trial Conditions for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Condition Name

Condition Name for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Intervention	Trials
Hiv	9
HIV-1 Infection	9
HIV Infections	7
HIV-1-infection	5

Condition MeSH

Condition MeSH for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Intervention	Trials
HIV Infections	16
Acquired Immunodeficiency Syndrome	9
Immunologic Deficiency Syndromes	5
Infections	3

Clinical Trial Locations for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Trials by Country

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−

Trials by Country for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Location	Trials
United States	293
Canada	39
France	17
United Kingdom	17
Spain	14

Trials by US State

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−

Trials by US State for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Location	Trials
California	18
Florida	17
Texas	15
Georgia	15
North Carolina	14

Clinical Trial Progress for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Clinical Trial Phase

Clinical Trial Phase for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	19
Phase 2	6

Clinical Trial Status

Clinical Trial Status for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Clinical Trial Phase	Trials
Completed	22
Not yet recruiting	7
Recruiting	6

Clinical Trial Sponsors for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Sponsor Name

Sponsor Name for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Sponsor	Trials
Gilead Sciences	25
National Institute of Allergy and Infectious Diseases (NIAID)	3
University of California, San Diego	2

Sponsor Type

Sponsor Type for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Sponsor	Trials
Other	41
Industry	29
NIH	3

Emtricitabine and Tenofovir Alafenamide Fumarate: Clinical Trials, Market Analysis, and Projections

Introduction

Emtricitabine and Tenofovir Alafenamide Fumarate (F/TAF) is a combination antiretroviral therapy widely used for the treatment of HIV/AIDS and chronic hepatitis B virus (HBV) infection. This article delves into the current clinical trials, market analysis, and future projections for this critical medication.

Clinical Trials Update

Ongoing Studies

One of the significant ongoing clinical trials is the Phase 3 study evaluating the safety and efficacy of the fixed-dose combination of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in HIV-1 and HBV co-infected adults. This study aims to assess the efficacy of B/F/TAF in treatment-naive patients, focusing on viral suppression and safety profiles[1].

Previous Findings

Previous studies have demonstrated the non-inferior efficacy of emtricitabine and tenofovir alafenamide compared to emtricitabine and tenofovir disoproxil fumarate for HIV prevention. A blinded phase 3 study showed that F/TAF had comparable efficacy to F/TDF but with superior renal and bone safety profiles. This study highlighted that F/TAF is a safer option with favorable effects on bone mineral density and renal biomarkers[5].

Market Analysis

Market Size and Growth

The market for emtricitabine and tenofovir alafenamide fumarate tablets was valued at approximately USD 3.5 billion in 2023 and is anticipated to reach around USD 6.2 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 6.1% from 2024 to 2033. This growth is driven by the increasing prevalence of HIV/AIDS, expanding treatment access, and advancements in drug delivery technologies[2].

Market Drivers

The primary driver of this market is the rising global prevalence of HIV/AIDS. According to the World Health Organization (WHO), approximately 37.7 million people were living with HIV/AIDS in 2020. The efficacy, tolerability, and reduced side effects of F/TAF tablets make them a preferred choice in HIV/AIDS management, contributing significantly to market growth[2].

Regional Analysis

The market exhibits regional variations influenced by healthcare infrastructure, disease prevalence, and regulatory frameworks. North America holds a dominant market share due to high healthcare expenditure and early adoption of F/TAF tablets. Europe is also a growing market driven by supportive healthcare policies and increasing awareness. The Asia Pacific region is rapidly expanding due to rising HIV/AIDS prevalence and improving healthcare access[2].

Market Opportunities

Expansion in Emerging Markets

Emerging markets offer significant opportunities for growth due to increasing healthcare infrastructure development, rising healthcare expenditure, and government initiatives to combat HIV/AIDS. These factors create a fertile ground for the expansion of F/TAF tablets in regions that previously had limited access to advanced antiretroviral therapies[2].

Pipeline Advancements

Ongoing research and development efforts to enhance drug formulations, develop novel drug combinations, and explore new indications for F/TAF tablets offer substantial growth potential. These advancements are expected to improve treatment adherence and patient outcomes, further driving market growth[2].

Patient-Centric Approaches

The adoption of patient-centric drug delivery systems, such as long-acting formulations and combination therapies, is expected to improve treatment adherence and patient outcomes. This shift towards more patient-friendly treatments is likely to boost the market for F/TAF tablets[2].

Future Outlook

Next-Generation Therapies

The future outlook for F/TAF tablets is promising, with a focus on developing next-generation antiretroviral therapies. These new therapies aim to target drug-resistant HIV strains, improve treatment adherence, and reduce long-term side effects. Such advancements will continue to drive the market forward[2].

Precision Medicine

Personalized treatment approaches using genomic testing, biomarker profiling, and therapeutic monitoring are expected to optimize HIV/AIDS management and outcomes. This precision medicine approach will likely enhance the efficacy and safety of F/TAF tablets, making them even more appealing to healthcare providers and patients[2].

Global Health Initiatives

Global health initiatives aimed at achieving HIV/AIDS eradication goals, reducing viral transmission, and improving the quality of life for individuals living with HIV/AIDS will continue to support the market growth for F/TAF tablets. Collaborative efforts among governments, NGOs, and pharmaceutical companies will be crucial in this endeavor[2].

Market Segmentation

By Patient Demographics

The market is segmented by patient demographics, including adult and pediatric patients. The adult segment is currently the largest due to the higher prevalence of HIV/AIDS in this age group. However, there is a growing need for pediatric formulations, which presents an opportunity for market expansion[2].

By Indications

The market is also segmented by indications, primarily focusing on HIV/AIDS treatment and chronic HBV infection treatment. The efficacy of F/TAF in both indications has been well-documented, making it a versatile treatment option[2].

Key Takeaways

• Clinical Trials: Ongoing studies are evaluating the safety and efficacy of F/TAF in various patient populations, including those co-infected with HIV and HBV.
• Market Growth: The market for F/TAF tablets is expected to grow significantly, driven by increasing HIV/AIDS prevalence and advancements in drug delivery technologies.
• Regional Variations: The market is influenced by regional healthcare infrastructure, disease prevalence, and regulatory frameworks.
• Future Outlook: Next-generation therapies, precision medicine, and global health initiatives will continue to drive the market forward.
• Market Segmentation: The market is segmented by patient demographics and indications, with a focus on both HIV/AIDS and chronic HBV infection treatment.

FAQs

What is the current market size of emtricitabine and tenofovir alafenamide fumarate tablets?

The current market size of emtricitabine and tenofovir alafenamide fumarate tablets was valued at approximately USD 3.5 billion in 2023[2].

What is the projected growth rate for the F/TAF tablets market?

The market is anticipated to grow at a CAGR of 6.1% from 2024 to 2033[2].

What are the primary drivers of the F/TAF tablets market?

The primary drivers include the increasing prevalence of HIV/AIDS, expanding treatment access, and advancements in drug delivery technologies[2].

How do F/TAF tablets compare to F/TDF tablets in terms of safety and efficacy?

F/TAF tablets have been shown to be non-inferior to F/TDF tablets in terms of efficacy but offer superior renal and bone safety profiles[5].

What are the key regions driving the growth of the F/TAF tablets market?

North America, Europe, and the Asia Pacific region are the key drivers of market growth due to their healthcare infrastructure, disease prevalence, and regulatory frameworks[2].

Sources

1. Gilead Clinical Trials: "A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults (Alliance)".
2. DataHorizon Research: "Emtricitabine And Tenofovir Alafenamide Fumarate Tablets Market".
3. Market Research Intellect: "Tenofovir Alafenamide Fumarate Market Size, Scope And Forecast".
4. NATAP: "Comparative Pricing of Branded Tenofovir Alafenamide ... - NATAP".
5. PubMed: "Primary results from a randomised, double-blind, multicentre, active ...".