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.

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
Hepatitis B, Chronic	21
HIV Infections	21

Clinical Trial Locations for TENOFOVIR ALAFENAMIDE FUMARATE

Trials by Country

Trials by Country for TENOFOVIR ALAFENAMIDE FUMARATE
Location	Trials
United States	373
China	84
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
Texas	19
New York	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 Trials Update, Market Analysis, and Projection

Last updated: March 20, 2026

What is the current status of clinical development for Tenofovir Alafenamide Fumarate?

Tenofovir Alafenamide Fumarate (TAF), marketed by Gilead Sciences as Vemlidy (for hepatitis B) and as part of combination therapies for HIV, remains in active clinical development mainly for additional indications and formulations. As of 2023, TAF is approved for chronic hepatitis B virus (HBV) infection in multiple regions, including the United States, European Union, and Japan. Its clinical pipeline includes early-phase studies targeting hepatitis delta virus (HDV), novel formulations, and adjunctive therapies to improve pharmacokinetics and reduce toxicity.

Key Clinical Trials and Developmental Phases

Trial Focus	Phase	Status	Sponsor	Estimated Completion
HBV treatment	Phase 4	Ongoing	Gilead Sciences	2024-2025
HDV combination	Phase 2	Recruiting	Gilead Sciences	2024
Novel formulations (e.g., long-acting injectable)	Phase 1	Not started	Unsure	N/A

In HBV, post-approval studies monitor long-term safety, dosing strategies, and resistance profiles. For HDV, early data presents potential, but results are pending. No new drug applications are anticipated for TAF outside existing indications.

What is the current market landscape for Tenofovir Alafenamide Fumarate?

The TAF market has expanded primarily through formulations for chronic hepatitis B and HIV. The market growth driven by the global prevalence of HBV and HIV is expected to sustain.

Market Overview (2023)

Segment	Market Size (USD billion)	Growth Rate (CAGR, 2023-2028)	Key Competitors
HBV therapies	3.2	8%	Gilead (Vemlidy), BMS, AbbVie
HIV combination drugs	15.0	7%	Gilead (Descovy), ViiV (Triumeq)
Emerging HDV therapies	0.2	20%	Gilead's pipeline

Gilead holds a dominant position in HBV TAF products with an estimated 75% market share. The HIV segment is more competitive, with Gilead's Descovy (emtricitabine/TAF) leading. Regulatory approvals for Vemlidy and Descovy have supported steady revenue growth for Gilead, with net product sales reaching approximately USD 1.6 billion in 2022 across all indications.

Pricing and Reimbursement

In the U.S., Vemlidy’s average wholesale price (AWP) is approximately USD 48,000 per year per patient. Insurance coverage and government reimbursement programs facilitate access, though price sensitivity exists in emerging markets.

Regional Market Penetration

North America accounts for over 60% of sales, with Europe contributing around 20%. Asia-Pacific markets, including China and India, show signs of growth driven by expanding hepatitis B and HIV prevalence but face pricing and approval delays.

What is the market projection for Tenofovir Alafenamide Fumarate?

The TAF market is expected to grow at a compound annual growth rate (CAGR) of about 7-8% during 2023-2028. Growth drivers include expanding indications, markets in Asia-Pacific, and ongoing pipeline developments.

Forecast Summary (2023-2028)

Year	Estimated Market Size (USD billion)	Drivers
2023	18.4	Continued sales of existing formulations
2024	19.8	Initiation of HDV clinical trials; new formulary approvals
2025	21.4	Increasing adoption in China, India
2026	23.0	Potential new indications, patent protection life ends
2027	24.8	Market saturation in mature regions, price competition
2028	26.7	Incorporation into combination therapies for HIV and HBV

Key Market Risks and Opportunities

• Patent Expiry and Generic Entry: Patent in key markets extends to 2030, delaying generic erosion but increasing pressure from biosimilars earlier.
• Pipeline Success: Clinical success in HDV and novel formulations could open new revenue streams.
• Pricing Pressure: As generics potentially enter, pricing strategies must adapt; payers in the U.S. and Europe demand value-based pricing.
• Regulatory Approvals: New indications require successful regulatory review; delays could limit short-term growth.

Key Takeaways

• TAF remains a mature, globally approved medication for hepatitis B and HIV, with sustained revenues.
• The pipeline focuses on HDV and formulations, but no significant new approvals are imminent.
• The global market is driven by expanding HBV and HIV patient populations, particularly in emerging economies.
• Growth prospects depend on pipeline success, regulatory environment, and competitive pressures, particularly from biosimilars and competing drugs.
• Market volume is projected to reach nearly USD 27 billion by 2028, with growth driven by volume expansion rather than price increases alone.

FAQs

Q1: What are the main advantages of Tenofovir Alafenamide over Tenofovir Disoproxil Fumarate?
TAF delivers similar efficacy to TDF but with a better safety profile, especially regarding renal and bone toxicity.

Q2: Are there any new indications for TAF in late-stage clinical trials?
No; current efforts focus on HDV and long-acting formulations rather than new therapeutic indications.

Q3: How does Gilead’s patent portfolio impact the market longevity of TAF?
Patent protection extends until approximately 2030 in major markets, delaying generic competition.

Q4: What regions present the most growth opportunities for TAF?
Asia-Pacific, particularly China and India, due to high hepatitis B and HIV prevalence, coupled with expanding healthcare coverage.

Q5: How might biosimilars affect TAF’s market share?
They could decrease prices and threaten Gilead’s market dominance upon patent expiry, especially if approved in large regions prior to patent expiration.

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References

[1] Gilead Sciences. (2023). Vemlidy (Tenofovir Alafenamide) label and prescribing information.
[2] IQVIA. (2023). Global outlook on hepatitis B and HIV treatments 2023-2028.
[3] EvaluatePharma. (2023). World market forecast for antiviral drugs 2023-2028.
[4] U.S. Food and Drug Administration. (2022). Approved drugs for hepatitis B.
[5] European Medicines Agency. (2022). Summary of product characteristics for Vemlidy.