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Last Updated: January 14, 2025

CLINICAL TRIALS PROFILE FOR EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE


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505(b)(2) Clinical Trials for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00641641 ↗ The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection Completed Merck Sharp & Dohme Corp. N/A 2008-03-01 The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.
New Combination NCT00641641 ↗ The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection Completed Kirby Institute N/A 2008-03-01 The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.
New Formulation NCT02583464 ↗ Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg. Completed Laboratorio Elea Phoenix S.A. Phase 1 2014-09-01 Objective: To evaluate the relative bioavailability of a new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare this formulation with the branded formulation (R) to meet regulatory criteria for marketing the test product in Argentina.
New Formulation NCT02583464 ↗ Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg. Completed Laboratorio Elea S.A.C.I.F. y A. Phase 1 2014-09-01 Objective: To evaluate the relative bioavailability of a new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare this formulation with the branded formulation (R) to meet regulatory criteria for marketing the test product in Argentina.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00039741 ↗ Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2/Phase 3 2002-08-01 Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗ Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Completed PENTA Foundation Phase 2/Phase 3 2002-08-01 Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗ Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2/Phase 3 2002-08-01 Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00051831 ↗ Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults Completed AIDS Clinical Trials Group N/A 2003-10-01 HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00051831 ↗ Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 2003-10-01 HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00055120 ↗ When to Start Anti-HIV Drugs in Patients With Opportunistic Infections Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 4 2003-03-01 The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI.
NCT00076791 ↗ Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1 2004-03-01 Most infants infected with HIV through mother-to-child transmission (MTCT, or perinatal transmission) become infected during labor and delivery. The purpose of this study is to test the safety and tolerability of a single dose of tenofovir disoproxil fumarate (TDF) or emtricitabine/TDF (FTC/TDF) given at the time of labor to HIV infected pregnant women and to their newborn infants.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Condition Name

Condition Name for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Intervention Trials
HIV Infections 66
HIV 25
HIV-1 Infection 18
HIV Infection 13
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Condition MeSH

Condition MeSH for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Intervention Trials
HIV Infections 103
Acquired Immunodeficiency Syndrome 41
Infections 25
Immunologic Deficiency Syndromes 24
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Clinical Trial Locations for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Trials by Country

Trials by Country for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Location Trials
United States 907
Canada 86
Spain 52
United Kingdom 47
South Africa 45
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Trials by US State

Trials by US State for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Location Trials
California 67
Florida 51
New York 51
Texas 48
North Carolina 47
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Clinical Trial Progress for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Clinical Trial Phase

Clinical Trial Phase for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Clinical Trial Phase Trials
Phase 4 39
Phase 3 58
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Clinical Trial Phase Trials
Completed 129
Active, not recruiting 12
Recruiting 12
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Clinical Trial Sponsors for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Sponsor Name

Sponsor Name for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor Trials
Gilead Sciences 70
National Institute of Allergy and Infectious Diseases (NIAID) 44
AIDS Clinical Trials Group 12
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Sponsor Type

Sponsor Type for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor Trials
Other 177
Industry 119
NIH 57
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EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE Market Analysis and Financial Projection

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

Introduction

Emtricitabine and tenofovir disoproxil fumarate, commonly known by the brand name Truvada, are crucial components in the prevention and treatment of HIV/AIDS and chronic hepatitis B. This article delves into the latest clinical trials, market analysis, and future projections for this combination therapy.

Clinical Trials Update

PURPOSE Program

One of the most significant recent developments is the PURPOSE program conducted by Gilead Sciences. This comprehensive program includes several clinical trials evaluating the efficacy and safety of various HIV prevention strategies. The PURPOSE 1 trial, a Phase 3 study, compares the efficacy of twice-yearly subcutaneous lenacapavir with once-daily oral Descovy (emtricitabine/tenofovir alafenamide) and once-daily oral Truvada (emtricitabine/tenofovir disoproxil fumarate) in over 5,300 cisgender women and adolescent girls. The trial demonstrated 100% efficacy for lenacapavir, but it also highlighted the continued effectiveness of Truvada as a comparator[1].

ADVANCE Trial

The ADVANCE trial, another significant study, compared different antiretroviral regimens including those containing tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF). This trial aimed to assess the noninferiority and safety of dolutegravir (DTG)-based regimens combined with TDF or TAF. The results up to 192 weeks showed high efficacy and safety of these regimens, although they noted substantial weight gain associated with DTG-containing regimens[3].

Market Analysis

Market Size and Growth

The market for tenofovir disoproxil fumarate is projected to grow at a Compound Annual Growth Rate (CAGR) of around 4.5% from 2022 to 2027. This growth is driven by increasing cases of hepatitis B and HIV, particularly among women, and global efforts to achieve viral suppression against HIV[2].

End User Segments

The pregnant women segment holds a significant share in the tenofovir disoproxil fumarate market, with a CAGR of 3.9% during the forecast period. This is due to the drug's role in preventing the transmission of HIV from mothers to their babies during pregnancy and childbirth. According to the Joint United Nations Programme on HIV/AIDS, in 2020, 85% of pregnant women with HIV received antiretroviral therapy, which includes tenofovir disoproxil fumarate[2].

Regional Market

North America, particularly the United States, is a key region for the tenofovir disoproxil fumarate market. Companies like Gilead Sciences Inc., a leading producer of tenofovir disoproxil fumarate, contribute significantly to the market. The increase in HIV and hepatitis B cases in the region has led to higher sales, with HIV product sales in the US increasing by 7% to $4.5 billion in Q4 2021 compared to the same period in 2020[2].

Market Drivers

Growing Number of Hepatitis B Patients

Hepatitis B, a serious liver infection caused by the hepatitis B virus (HBV), is a significant driver for the tenofovir disoproxil fumarate market. According to the World Health Organization, in 2019, 296 million people were living with chronic hepatitis B infection, resulting in an estimated 820,000 deaths. This high prevalence of hepatitis B increases the demand for tenofovir disoproxil fumarate, which is used to prevent the spread of the virus and protect the liver from further infection[2].

Increase in Number of Female HIV Patients

Women are more vulnerable to HIV infection, and the growing number of female HIV patients is another key driver. Tenofovir disoproxil fumarate is recommended for pregnant women to prevent the transmission of HIV to their babies and to protect their own health. The growing awareness and efforts to prevent HIV transmission among women have positively impacted the usage of tenofovir disoproxil fumarate[2].

Side Effects and Safety Concerns

While tenofovir disoproxil fumarate is generally well-tolerated, it can have side effects such as nausea, rash, diarrhea, headache, pain, and depression. These side effects can restrict its usage in some cases. However, clinical trials like the PURPOSE program have shown that new formulations and regimens, such as lenacapavir, are being developed to address these concerns and offer better safety profiles[1][2].

Future Projections

Continued Dominance in HIV Prevention

Truvada, containing emtricitabine and tenofovir disoproxil fumarate, is expected to remain a cornerstone in HIV pre-exposure prophylaxis (PrEP) due to its established efficacy and safety profile. Despite the emergence of new drugs like lenacapavir, Truvada will likely continue to be a preferred option for many patients and healthcare providers[1].

Generic Availability

The availability of generic versions of tenofovir disoproxil fumarate is expected to increase accessibility and affordability, particularly in regions with high HIV and hepatitis B prevalence. This could further boost the market growth as more patients gain access to these life-saving medications[2].

Innovation in Formulations

The development of new formulations, such as the twice-yearly lenacapavir, indicates a shift towards more convenient and less frequent dosing regimens. This innovation is likely to enhance patient compliance and overall treatment outcomes, potentially expanding the market for HIV and hepatitis B treatments[1].

Key Takeaways

  • Clinical Trials: Recent trials like the PURPOSE program and ADVANCE trial have reinforced the efficacy and safety of emtricitabine and tenofovir disoproxil fumarate, while also introducing new treatment options.
  • Market Growth: The market for tenofovir disoproxil fumarate is projected to grow at a CAGR of around 4.5% driven by increasing cases of HIV and hepatitis B.
  • Regional Focus: North America, particularly the US, is a key market due to the presence of major pharmaceutical companies like Gilead Sciences.
  • Safety and Side Effects: While generally well-tolerated, the drug can have side effects, but new formulations aim to address these concerns.
  • Future Projections: Truvada is expected to remain a dominant player in HIV prevention, with generic availability and innovative formulations set to expand market reach.

FAQs

What is the current market size and growth rate for tenofovir disoproxil fumarate?

The market size for tenofovir disoproxil fumarate is estimated to grow at a CAGR of around 4.5% from 2022 to 2027[2].

What are the primary drivers for the tenofovir disoproxil fumarate market?

The primary drivers include the growing number of hepatitis B patients and the increase in female HIV patients, along with global efforts to achieve viral suppression against HIV[2].

What are the common side effects of tenofovir disoproxil fumarate?

Common side effects include nausea, rash, diarrhea, headache, pain, and depression[2].

How does the PURPOSE program impact the market for tenofovir disoproxil fumarate?

The PURPOSE program, while introducing new treatment options like lenacapavir, also reinforces the efficacy and safety of tenofovir disoproxil fumarate, ensuring it remains a viable option for HIV prevention[1].

What role does generic availability play in the market for tenofovir disoproxil fumarate?

Generic availability is expected to increase accessibility and affordability, particularly in regions with high HIV and hepatitis B prevalence, thereby boosting market growth[2].

Sources

  1. Gilead Sciences. Gilead's Twice Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada for HIV Prevention. [June 20, 2024].
  2. IndustryARC. Tenofovir Disoproxil Fumarate Market Size Report, 2022-2027.
  3. Oxford Academic. Final 192-Week Efficacy and Safety Results of the ADVANCE Trial. [March 25, 2024].

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