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
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.
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.
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.
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.
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.
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.
NCT02251236 ↗	Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals	Completed	University at Buffalo	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.

Clinical Trial Conditions for emtricitabine; tenofovir alafenamide fumarate

Condition Name

Condition Name for emtricitabine; tenofovir alafenamide fumarate
Intervention	Trials
HIV-1 Infection	9
HIV	9
HIV Infections	7
HIV-1-infection	5

Condition MeSH

Condition MeSH for emtricitabine; tenofovir alafenamide fumarate
Intervention	Trials
HIV Infections	17
Acquired Immunodeficiency Syndrome	10
Immunologic Deficiency Syndromes	5
Infections	3

Clinical Trial Locations for emtricitabine; tenofovir alafenamide fumarate

Trials by Country

Trials by Country for emtricitabine; tenofovir alafenamide fumarate
Location	Trials
United States	293
Canada	39
United Kingdom	17
France	17
Spain	14

Trials by US State

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
PHASE3	1
PHASE2	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for emtricitabine; tenofovir alafenamide fumarate
Clinical Trial Phase	Trials
Completed	22
RECRUITING	8
Not yet recruiting	7

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
Radboud University Medical Center	2

Sponsor Type

Sponsor Type for emtricitabine; tenofovir alafenamide fumarate
Sponsor	Trials
Other	47
Industry	31
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Emtricitabine; Tenofovir Alafenamide Fumarate

Last updated: October 28, 2025

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Introduction

Emtricitabine (FTC) and Tenofovir Alafenamide Fumarate (TAF) form a cornerstone of modern antiretroviral therapy (ART) for HIV management. This combination has been integrated into various therapeutic regimens due to its high efficacy, favorable safety profile, and improved dosing convenience. As HIV treatment evolves, understanding current clinical trial developments, market dynamics, and future projections is critical for pharmaceutical stakeholders, investors, and healthcare providers.

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Clinical Trials Update

Recent Developments in Clinical Research

Recent years have seen intensified clinical evaluations of FTC and TAF, reflecting their expanding therapeutic applications beyond HIV. Multiple Phase III and IV trials focus on optimizing dosing regimens, evaluating long-term safety, and expanding indications, including pre-exposure prophylaxis (PrEP) and treatment of hepatitis B virus (HBV) co-infections.

Key Trials and Outcomes

• Long-acting formulations: Trials like HPTN 083 and HPTN 084 continue to evaluate injectable formulations of TAF-based regimens, aiming to improve adherence by reducing dosing frequency from daily to monthly or bi-monthly injections. Early phase data suggest promising pharmacokinetics and patient acceptance.

• HIV Prevention: The landmark DISCOVER trial reinforced TAF/FTC’s role as a preferred PrEP regimen, demonstrating high efficacy with a favorable safety profile. Subsequent studies assess the durability of protection and incidence in diverse populations.

• Hepatitis B applications: TAF’s efficacy in suppressing HBV replication is being further explored in Phase II/III trials, with preliminary results indicating comparable or superior outcomes to tenofovir disoproxil fumarate (TDF), with reduced renal and bone toxicity.

• Combination therapies: Ongoing research looks into novel fixed-dose combinations (FDCs) to simplify regimens, with multiple trials comparing TAF-based FDCs against existing standards of care.

Safety and Tolerability

Long-term data from clinical trials, including GS-7340 (an earlier formulation of TAF) studies, affirm the reduced renal and bone marrow side effects relative to TDF. Monitoring of lipid profiles and renal function remains integral in ongoing trials.

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Market Analysis

Market Size and Segmentation

The global market for antiretroviral drugs, particularly those targeting HIV, is substantial and projected to grow. In 2022, the HIV therapeutics market was valued at approximately $30 billion, with TAF-based regimens accounting for a significant share due to their recommended status in current treatment guidelines.

Segment Breakdown:

• HIV Treatment: Dominates the TAF/FTC market segment due to widespread use as first-line therapy.
• HIV Prevention (PrEP): Rapidly growing, driven by increased awareness and prophylactic guidelines.
• HBV Treatment: Niche but expanding segment, especially with favorable safety profiles.

Key Players and Market Penetration

Major pharmaceutical companies include:

• Gilead Sciences: Pioneers in TAF development; their Descovy (TAF/FTC) remains a leading PrEP and treatment option.
• GlaxoSmithKline (GSK): Offers Dovato (Dolutegravir + Lamivudine) with TAF in some formulations.
• ViiV Healthcare: Has introduced Cabotegravir, a long-acting injectable competing with TAF-based injectables.

Gilead remains dominant, leveraging patents and established clinical data. However, patent expirations and biosimilar development threaten market share continuity.

Regulatory Status

• U.S.: TAF/FTC (Descovy) approved for ART and PrEP.
• Europe: Regulatory agencies have approved similar formulations.
• Emerging Markets: Adoption limited owing to cost and patent complexities but gradually expanding as generics proliferate.

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Market Projection and Future Outlook

Growth Drivers

• Increased adoption of long-acting formulations: Injectable TAF regimens are expected to transform adherence, forecasted to represent over 20% of HIV treatment sales by 2028.
• Expanding indications: Use in HBV and potential in curing HIV will broaden the therapeutic scope.
• Global HIV burden: With an estimated 38 million people living with HIV worldwide (UNAIDS, 2022), long-term management options remain in high demand.

Forecast Data

The HIV antiretroviral market is projected to grow at a CAGR of 7-9% over the next five years. The TAF/FTC segment is anticipated to sustain a CAGR of 8-10%, driven primarily by innovations in delivery and expanding indications.

Challenges to Growth

• Patent cliff and generic entry: Patent expirations in key markets could disrupt revenue streams, especially in low- and middle-income countries.
• Pricing pressures: Cost reduction initiatives and healthcare access disparities may impact profit margins.
• Competition: Long-acting injectables from rivals like ViiV's Cabotegravir and emerging oral agents could erode market share.

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Strategic Opportunities

• Development of combined long-acting formulations for HIV and HBV.
• Expanding access through partnerships in emerging markets.
• Investing in clinical trials focusing on sustained-release injectables to address compliance issues.

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Conclusion

The landscape for Emtricitabine and Tenofovir Alafenamide Fumarate remains robust with ongoing clinical innovations and expanding market opportunities. Their pivotal role in HIV therapy, combined with technological advances in delivery systems, supports continued growth. However, patent expirations, pricing initiatives, and competitive dynamics necessitate strategic agility for stakeholders aiming to capitalize on this evolving market.

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Key Takeaways

• Clinical progress favors long-acting injectable formulations, potentially revolutionizing adherence and long-term management.
• Market dominance by Gilead persists, yet patent expirations and biosimilar proliferation could reshape competitive dynamics.
• Market growth forecasts indicate sustained expansion, with long-acting therapies and broadening indications at the forefront.
• Pricing and access remain critical, particularly in middle- and low-income regions, influencing future adoption trajectories.
• Investment in R&D is essential to develop next-generation formulations that address compliance, safety, and resistance concerns.

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FAQs

1. What are the latest advancements in long-acting TAF formulations?
Recent Phase I and II trials indicate promising pharmacokinetics and patient acceptance for injectable TAF-based regimens, aiming for dosing intervals of one to two months, potentially improving adherence and reducing pill burden.

2. How does TAF compare to TDF in safety profiles?
Clinical data demonstrate that TAF offers comparable antiviral efficacy with substantially reduced renal toxicity and bone mineral density loss, making it preferable in long-term management.

3. What is the outlook for TAF in hepatitis B treatment?
Emerging clinical trials suggest TAF effectively suppresses HBV replication with fewer side effects than TDF, broadening its application base and market potential in HBV management.

4. How will patent expirations impact the TAF market?
Patent cliffs could lead to increased generic competition, lowering prices and expanding access, particularly in emerging markets. Companies are investing in new formulations to prolong market relevance.

5. What are the competitive threats to Gilead’s TAF offerings?
New long-acting injectables from competitors, advances in oral therapies with improved convenience, and potential biosimilar entrants could challenge Gilead’s market share in the coming years.

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References

1. UNAIDS. Global HIV & AIDS statistics — 2022 fact sheet.
2. Gilead Sciences. FDA approvals and clinical trial data publications.
3. ClinicalTrials.gov. Recent phase III and IV studies on TAF-based regimens.
4. MarketResearch.com. HIV therapeutics market projections.
5. ViiV Healthcare. Competitive landscape analysis.