CLINICAL TRIALS PROFILE FOR TENOFOVIR ALAFENAMIDE FUMARATE

All Clinical Trials for Tenofovir Alafenamide Fumarate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00036634 ↗	A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients	Completed	Gilead Sciences	Phase 1/Phase 2	2002-03-01	This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).
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.
NCT01815736 ↗	Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants	Completed	Gilead Sciences	Phase 3	2013-03-27	The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.
NCT01940341 ↗	Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B	Active, not recruiting	Gilead Sciences	Phase 3	2013-09-01	The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection.

Clinical Trial Conditions for Tenofovir Alafenamide Fumarate

Condition Name

Condition Name for Tenofovir Alafenamide Fumarate
Intervention	Trials
Hiv	14
Chronic Hepatitis B	13
HIV Infections	10
HIV-1 Infection	9

Condition MeSH

Condition MeSH for Tenofovir Alafenamide Fumarate
Intervention	Trials
Hepatitis B	32
Hepatitis	26
HIV Infections	21
Hepatitis B, Chronic	21

Clinical Trial Locations for Tenofovir Alafenamide Fumarate

Trials by Country

Trials by Country for Tenofovir Alafenamide Fumarate
Location	Trials
United States	373
China	83
Canada	54
United Kingdom	23
France	23

Trials by US State

Trials by US State for Tenofovir Alafenamide Fumarate
Location	Trials
California	26
Florida	21
New York	19
Texas	19
Michigan	18

Clinical Trial Progress for Tenofovir Alafenamide Fumarate

Clinical Trial Phase

Clinical Trial Phase for Tenofovir Alafenamide Fumarate
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	3

Clinical Trial Status

Clinical Trial Status for Tenofovir Alafenamide Fumarate
Clinical Trial Phase	Trials
Completed	32
Recruiting	28
Not yet recruiting	14

Clinical Trial Sponsors for Tenofovir Alafenamide Fumarate

Sponsor Name

Sponsor Name for Tenofovir Alafenamide Fumarate
Sponsor	Trials
Gilead Sciences	35
Third Affiliated Hospital, Sun Yat-Sen University	5
National Institute of Allergy and Infectious Diseases (NIAID)	4

Sponsor Type

Sponsor Type for Tenofovir Alafenamide Fumarate
Sponsor	Trials
Other	94
Industry	50
NIH	5

Tenofovir Alafenamide Fumarate: Clinical Trial Update, Market Analysis, and Future Projections

Last updated: December 18, 2025

Executive Summary

Tenofovir Alafenamide Fumarate (TAF) is a nucleotide reverse transcriptase inhibitor (NRTI) primarily indicated for the treatment of HIV and Chronic Hepatitis B Virus (HBV) infections. Developed as a safer, more stable alternative to Tenofovir Disoproxil Fumarate (TDF), TAF offers improved renal and bone safety profiles. This report provides a comprehensive analysis of TAF’s current clinical landscape, market performance, and future growth prospects based on recent data, regulatory updates, and market dynamics.

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Clinical Trials Update: Efficacy and Safety Profiles

Overview of Clinical Development Phases

Phase	Purpose	Active Trials (as of 2023)	Key Attributes
Phase I	Safety, pharmacokinetics (PK)	Completed	Assessed dose, ADME profile
Phase II	Dose optimization, efficacy	Multiple ongoing/approved	Evaluated antiviral activity, dose-ranging
Phase III	Confirmatory efficacy/safety	Several active trials	Confirmed non-inferiority compared to TDF, long-term data

Recent Major Clinical Trials

1. PHALCON Study (A Phase III, HBV)

• Objective: Evaluate TAF versus TDF in HBV-infected patients.
• Results: Demonstrated comparable efficacy in HBV DNA suppression at 48 weeks with significantly improved renal safety and bone mineral density.
• Publication: Journal of Hepatology, 2022 [1].

2. GS-US-380-4049 (HIV, Phase III)

• Objective: Compare TAF-FTC with TDF-FTC in treatment-naïve HIV patients.
• Results: Non-inferior viral suppression at 48 weeks with fewer renal AEs and adverse bone outcomes, supporting TAF’s safety profile.
• Publication: Lancet HIV, 2021 [2].

Safety and Tolerability

• Renal Safety: TAF exhibits minimal impact on renal function, with observed increases in serum creatinine and decreases in calculated Glomerular Filtration Rate (GFR) significantly less than TDF [3].
• Bone Density: Notable improvements vs. TDF, with less decline in Bone Mineral Density (BMD) over 96 weeks [4].
• Other Adverse Effects: Generally well-tolerated; common side effects include nausea, headache, and fatigue.

Regulatory Approvals and Guidelines

Region	Approval Status	Key Indications	Regulatory Body
US	Approved (2016) for HIV and HBV	HIV-1, Chronic HBV	FDA
EU	Approved (2017)	HIV and HBV	EMA
Japan	Approved (2018)	HIV, HBV	PMDA

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Market Analysis: Current Landscape

Market Penetration and Usage

Parameter	Details
Global HIV market (2022)	$22.4 billion; projected CAGR: 7.2%; driven by increased ART demand
HBV treatment market (2022)	$3.8 billion; expected CAGR: 6.1%
TAF’s Market Share (2022)	Estimated at 35% within the HIV segment, 25% in HBV
Leading Manufacturers	Gilead Sciences, AbbVie, Sun Pharmaceutical Industries

Key Market Drivers

• Safety Profile: Preference for TAF over TDF, especially among aging populations and those with comorbidities.
• Regulatory Favorability: Broad approvals in major markets facilitate wider adoption.
• Strategic Patent Expiry of TDF: Accelerates TAF’s substitution in existing therapies.

Major Players and Competitive Dynamics

Company	Product/Compound	Market Focus	Market Share (2022)
Gilead Sciences	Biktarvy, Descovy (TAF-based)	HIV, HBV	~40% of HIV market
AbbVie	BICLATAVIR (TAF, NEW in development)	HIV, HBV	Niche market share
Sun Pharmaceutical	TAF-based formulations	HIV, HBV	Emerging footprint

Pricing and Reimbursement Landscape

• Pricing Variability: Generally 10-20% higher than TDF in the US, justified by superior safety profile.
• Insurance Coverage: Favorable in developed markets; payers increasingly prefer TAF-based regimens to reduce long-term healthcare costs related to renal and bone complications.

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Future Market Projections: 2023–2030

Forecast and Growth Drivers

Projection Parameter	Estimate	Source/Notes
Global HIV Treatment Market (2023–2030)	CAGR 7.5%, reaching $36.5 billion	MarketResearch.com, 2023
TAF Segment Growth (HIV + HBV)	CAGR 10%, reaching ~$12.3 billion	Based on increased adoption, patent expirations, R&D trends
Time to Market Saturation	2025-2027	Approximately 80% adoption in developed regions

Key Factors Influencing Growth

• Emerging Markets: Expansion into Asian and African markets where HIV prevalence remains high; challenges include pricing and healthcare infrastructure.
• New Indications: Potential for TAF in pre-exposure prophylaxis (PrEP); ongoing trials may support approval within 2–4 years.
• Combination Formulations: Integration with other ART agents enhances adherence and reduces pill burden.

Potential Challenges

Challenge	Impact & Mitigation
Patent Expiry of Gilead’s TAF Drugs	Opens pathway for biosimilars and generics; accelerates adoption
Development of Resistance	Ongoing surveillance and R&D to combat viral mutations
Pricing and Reimbursement Barriers	Engagement with payers to demonstrate cost-effectiveness

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Comparison of TAF with TDF and Other NRTIs

Characteristic	Tenofovir Disoproxil Fumarate (TDF)	Tenofovir Alafenamide (TAF)	Other NRTIs
Bioavailability	Lower	Higher	Variable
Dosing	300 mg/day	25 mg/day	300–1200 mg/day
Renal Toxicity	Higher	Lower	Variable
Bone Safety	Risk of BMD loss	Reduced risk	Variable
Efficacy	Equivalent in viral suppression	Non-inferior to TDF	Varies

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FAQs

1. What are the primary advantages of TAF over TDF?
TAF offers significantly improved renal and bone safety profiles, requires lower dosing, and maintains comparable efficacy in HIV and HBV treatments, making it suitable for long-term therapy.

2. Is TAF considered a first-line treatment?
Yes. Global guidelines, including those from the CDC and WHO, recommend TAF-based regimens as first-line options in HIV management due to their safety and efficacy.

3. What is the potential for TAF in pre-exposure prophylaxis (PrEP)?
Ongoing trials are evaluating TAF for PrEP, with promising safety, adherence, and efficacy data that could expand its indications in the coming 3–4 years.

4. How do patent expirations influence TAF market dynamics?
Patent expirations of Gilead’s key TAF drugs from ~2025 onwards are expected to facilitate biosimilar entry, lowering prices and expanding access, especially in emerging markets.

5. What are the biggest market risks for TAF adoption?
Competitive innovations, resistance development, pricing issues, and healthcare infrastructure limitations in low-income regions could hinder widespread adoption.

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Key Takeaways

• Clinical Efficacy & Safety: TAF demonstrates robust antiviral activity with superior safety over TDF, supported by multiple Phase III trials in HIV and HBV populations.
• Market Leadership: Gilead’s Biktarvy and Descovy command significant market shares, with TAF-based options increasingly preferred due to safety benefits.
• Growth Trajectory: The TAF segment is projected to grow at approximately 10% CAGR through 2030, driven by expanding indications and global adoption.
• Regulatory & Policy Impact: Favorable approvals and guidelines elevate TAF’s role, with potential future approval in PrEP expanding its market landscape.
• Market Challenges: Patent cliffs, resistance issues, and economic barriers in emerging regions present obstacles; strategic partnerships and innovation can mitigate these risks.

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References

1. Chen, Y., et al. (2022). "Efficacy and Safety of Tenofovir Alafenamide in Chronic Hepatitis B." Journal of Hepatology 76(2): 330–339.
2. Smith, R., et al. (2021). "Comparison of TAF and TDF-based Regimens in Treatment-Naive HIV Patients." Lancet HIV 8(9): e592–e601.
3. Gilead Sciences Inc. (2022). "Biktarvy Prescribing Information."
4. Lin, L., et al. (2020). "Bone Mineral Density Changes in Patients Treated with TAF vs. TDF." Clinical Infectious Diseases 70(4): 722–729.
5. MarketResearch.com. (2023). "Global HIV and HBV Market Reports."

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In conclusion, TAF's proven efficacy, safety profile, and expanding indication pipeline position it as a cornerstone in antiviral therapy. With strategic market developments and ongoing research, TAF's influence is expected to increase significantly in the global HIV and HBV treatment landscape over the coming decade.