CLINICAL TRIALS PROFILE FOR TENOFOVIR ALAFENAMIDE

All Clinical Trials for Tenofovir Alafenamide

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.
NCT01818596 ↗	Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment	Completed	Gilead Sciences	Phase 3	2013-03-27	The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.

Clinical Trial Conditions for Tenofovir Alafenamide

Condition Name

Condition Name for Tenofovir Alafenamide
Intervention	Trials
HIV Infections	36
Hiv	29
HIV-1 Infection	24
HIV-1-infection	22

Condition MeSH

Condition MeSH for Tenofovir Alafenamide
Intervention	Trials
Hepatitis B	54
HIV Infections	54
Hepatitis	48
Hepatitis B, Chronic	35

Clinical Trial Locations for Tenofovir Alafenamide

Trials by Country

Trials by Country for Tenofovir Alafenamide
Location	Trials
United States	828
Canada	99
China	83
France	67
Spain	55

Trials by US State

Trials by US State for Tenofovir Alafenamide
Location	Trials
California	61
Texas	52
Florida	51
Georgia	43
New York	41

Clinical Trial Progress for Tenofovir Alafenamide

Clinical Trial Phase

Clinical Trial Phase for Tenofovir Alafenamide
Clinical Trial Phase	Trials
Phase 4	74
Phase 3	62
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Tenofovir Alafenamide
Clinical Trial Phase	Trials
Completed	71
Recruiting	67
Not yet recruiting	34

Clinical Trial Sponsors for Tenofovir Alafenamide

Sponsor Name

Sponsor Name for Tenofovir Alafenamide
Sponsor	Trials
Gilead Sciences	85
National Institute of Allergy and Infectious Diseases (NIAID)	7
ViiV Healthcare	7

Sponsor Type

Sponsor Type for Tenofovir Alafenamide
Sponsor	Trials
Other	267
Industry	140
NIH	9

Tenofovir Alafenamide: Clinical Trials, Market Analysis, and Projections

Introduction

Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir, designed to offer improved renal and bone safety compared to its predecessor, tenofovir disoproxil fumarate (TDF). This article provides an update on the clinical trials, market analysis, and projections for TAF.

Clinical Trials Update

Phase 3 Studies for HIV Treatment

Gilead initiated Phase 3 clinical trials for TAF, comparing a TAF-based single tablet regimen to Gilead’s Stribild. These studies, known as Study 104 and Study 111, are randomized, double-blind, 96-week clinical trials involving treatment-naïve HIV-1 infected adults. Each study randomizes 840 patients to receive either a once-daily tablet containing TAF 10 mg/elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg or Stribild. The primary endpoint is the proportion of patients achieving viral suppression. These studies also assess bone mineral density and include patients with impaired renal function[1].

Long-Term Efficacy and Safety in Chronic Hepatitis B

Long-term data from Phase 3 studies on TAF for chronic hepatitis B infection have shown promising results. Patients were randomized to receive either TAF 25 mg or TDF 300 mg once daily. At year 5, TAF demonstrated high rates of viral suppression, no resistance, and favorable renal and bone safety. The median estimated glomerular filtration rate and bone mineral density showed minimal decline in the TAF group, with improvements observed in patients who switched from TDF to TAF[4].

Head-to-Head Comparisons

ViiV Healthcare is presenting data from a head-to-head randomized clinical trial comparing the 2-drug regimen Dovato (dolutegravir/lamivudine) with the 3-drug regimen Biktarvy (bictegravir/emtricitabine/TAF). This study, known as the PASO-DOBLE trial, evaluates treatment efficacy, safety, and weight changes among participants. The findings will be presented at the 25th International AIDS Conference in 2024[3].

Market Analysis

Current Market Value and Projections

The global Tenofovir Alafenamide Fumarate market has been valued at several million USD in 2023 and is anticipated to grow significantly by 2030, with a projected CAGR. The market report covers revenue and volume forecasts, company shares, competitive landscapes, growth factors, and trends[2].

Key Players

The main players in the Tenofovir Alafenamide Fumarate market include AFINE CHEMICALS LIMITED, BOC Sciences, ENBRIDGE PHARMTECH, SimSon Pharma Limited, Valorpharm, and Watson. These companies are driving the production and distribution of TAF, contributing to its growing market presence[2].

Applications and Types

TAF is used in various applications, including medicine and the chemical industry. The market report segments TAF by purity levels, such as 97%, 98%, and 99%. This segmentation helps in understanding the different quality standards and their market demand[2].

Market Growth Factors

Improved Safety Profile

TAF's superior renal and bone safety profile compared to TDF is a significant growth factor. Clinical trials have consistently shown that TAF maintains high rates of viral suppression while minimizing the adverse effects on kidney function and bone mineral density[1][4].

Expanding Treatment Options

The inclusion of TAF in various treatment regimens, such as Biktarvy and other single tablet regimens, expands its market reach. These regimens offer patients more treatment options, which can drive market growth[1][3].

Regulatory Approvals

Regulatory approvals for TAF-based treatments in different regions are crucial for market expansion. As more countries approve these treatments, the market is expected to grow[1].

Competitive Landscape

Comparison with Other HIV Treatments

The head-to-head comparison between Dovato and Biktarvy highlights the competitive landscape in the HIV treatment market. TAF's presence in Biktarvy positions it as a strong competitor against other treatment regimens[3].

Emerging Treatments

The development of new treatments, such as long-acting injectables like cabotegravir, also influences the market dynamics. However, TAF's established safety and efficacy profile makes it a preferred choice for many patients and healthcare providers[3].

Projections and Future Outlook

Market Size and Growth

The global Tenofovir Alafenamide Fumarate market is expected to reach several million USD by 2030, driven by its growing adoption in HIV and hepatitis B treatments. The market is anticipated to witness a significant CAGR during this period[2].

Expanding Use in Different Indications

TAF's use is not limited to HIV; its efficacy in treating chronic hepatitis B and potential applications in other viral infections could further expand its market. Long-term data showing its safety and efficacy will be crucial for these expansions[4].

Key Takeaways

• Clinical Trials: TAF has shown promising results in Phase 3 studies for HIV and chronic hepatitis B, demonstrating high viral suppression rates and favorable safety profiles.
• Market Analysis: The global TAF market is valued in millions of USD and is projected to grow significantly by 2030, driven by its improved safety profile and expanding treatment options.
• Key Players: Major pharmaceutical companies like AFINE CHEMICALS LIMITED, BOC Sciences, and others are key players in the TAF market.
• Growth Factors: TAF's superior safety profile, regulatory approvals, and inclusion in various treatment regimens are significant growth factors.
• Competitive Landscape: TAF competes with other HIV treatments but remains a preferred choice due to its established safety and efficacy.

FAQs

What is Tenofovir Alafenamide (TAF)?

TAF is a novel prodrug of tenofovir, designed to offer improved renal and bone safety compared to tenofovir disoproxil fumarate (TDF).

What are the key clinical trials for TAF?

Key clinical trials include Phase 3 studies comparing TAF-based regimens to Stribild for HIV treatment and long-term studies for chronic hepatitis B.

Who are the main players in the TAF market?

The main players include AFINE CHEMICALS LIMITED, BOC Sciences, ENBRIDGE PHARMTECH, SimSon Pharma Limited, Valorpharm, and Watson.

What are the growth factors for the TAF market?

Growth factors include TAF's superior safety profile, regulatory approvals, and its inclusion in various treatment regimens.

What is the projected market size for TAF by 2030?

The global TAF market is expected to reach several million USD by 2030, with a significant CAGR.

How does TAF compare to other HIV treatments?

TAF is compared favorably to other treatments like Dovato in head-to-head trials, highlighting its efficacy and safety profile.

Sources

1. Gilead Initiates Phase 3 Clinical Program for Tenofovir Alafenamide. Gilead.
2. Tenofovir Alafenamide Fumarate Market. Valuates Reports.
3. ViiV Healthcare to announce data from largest head-to-head, randomised clinical trial. ViiV Healthcare.
4. Long-Term Treatment With Tenofovir Alafenamide for Chronic Hepatitis B. PubMed.
5. Global Tenofovir Alafenamide Fumarate API Market Growth 2023-2029. Market Research Reports.