CLINICAL TRIALS PROFILE FOR EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

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.

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.

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

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

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

Trials by US State

Trials by US State for Emtricitabine And Tenofovir Disoproxil Fumarate
Location	Trials
California	67
New York	51
Florida	51
Texas	48
North Carolina	47

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

Clinical Trial Status

Clinical Trial Status for Emtricitabine And Tenofovir Disoproxil Fumarate
Clinical Trial Phase	Trials
Completed	129
Active, not recruiting	12
Recruiting	12

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

Sponsor Type

Sponsor Type for Emtricitabine And Tenofovir Disoproxil Fumarate
Sponsor	Trials
Other	177
Industry	119
NIH	57

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

Introduction

Emtricitabine and tenofovir disoproxil fumarate, commonly known by the brand name Truvada, is a combination antiretroviral medication used for the treatment and prevention of HIV/AIDS and the treatment of chronic hepatitis B. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

PANCOVID Study

One of the notable clinical trials involving tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) is the PANCOVID study. This open-label, double-randomized, phase 3 pragmatic clinical trial was conducted in Spain to evaluate the efficacy of TDF/FTC in patients at high risk for severe COVID-19. The study included adults with symptomatic COVID-19 and at least two comorbidities or aged 60 years or older. Patients were randomized to receive TDF/FTC or no TDF/FTC, and those with hypoxemia and systemic inflammation were further randomized to receive baricitinib plus dexamethasone or dexamethasone alone. The trial was stopped early due to a decrease in COVID-19 cases and lower-than-expected mortality rates, but it provided valuable insights into the potential use of TDF/FTC in COVID-19 management[1].

HIV Prevention Trials

A significant clinical trial compared the efficacy and safety of emtricitabine and tenofovir alafenamide (TAF) versus emtricitabine and tenofovir disoproxil fumarate (TDF) for HIV pre-exposure prophylaxis (PrEP). This blinded phase 3 study found that emtricitabine and TAF were non-inferior to emtricitabine and TDF in preventing HIV infection, with both regimens showing low rates of adverse events leading to discontinuation. This study highlighted the efficacy and safety profile of both formulations, with TAF offering improved renal and bone safety compared to TDF[4].

Market Analysis

Market Size and Growth

The global 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/AIDS, as well as efforts to achieve viral suppression in HIV patients. The market is also influenced by the availability of generic versions of the drug, which has expanded access and affordability[2].

End User Segments

The market for tenofovir disoproxil fumarate is segmented by end users, with significant shares held by pregnant women, individuals with HIV/AIDS, and those with chronic hepatitis B. Pregnant women, in particular, benefit from this medication to prevent the transmission of HIV 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 Performance

North America is the fastest-growing region in the tenofovir disoproxil fumarate market, driven by the presence of major pharmaceutical companies like Gilead Sciences Inc. in the United States. The region saw a significant increase in sales of HIV and hepatitis B products, with HIV product sales 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

The increasing prevalence of hepatitis B globally is a key 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 number of active cases and deaths due to hepatitis B has increased the demand for tenofovir disoproxil fumarate[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 significant market driver. The awareness and treatment initiatives for HIV among women have positively impacted the usage of tenofovir disoproxil fumarate. For instance, in 2020, 85% of pregnant women with HIV received antiretroviral therapy to prevent HIV transmission to their babies[2].

Side Effects and Safety Profile

Common Side Effects

Tenofovir disoproxil fumarate is associated with several side effects, including nausea, rash, diarrhea, headache, pain, and depression. These side effects can restrict its usage in some medical contexts but are generally manageable with appropriate medical supervision[2].

Renal and Bone Safety

The safety profile of tenofovir disoproxil fumarate has been a subject of ongoing research. Tenofovir alafenamide, a newer formulation, has shown improved renal and bone safety compared to tenofovir disoproxil fumarate, making it a preferred option in some clinical scenarios[4].

Future Projections

Market Growth

The market for tenofovir disoproxil fumarate is expected to continue growing, driven by the increasing global burden of HIV/AIDS and hepatitis B. The CAGR of around 4.5% from 2022 to 2027 indicates a steady and significant growth trajectory[2].

New Formulations and Innovations

The development of new formulations, such as tenofovir alafenamide, is expected to further boost the market. These newer formulations offer improved safety profiles and could expand the patient base for antiretroviral therapy[4].

Regulatory Approvals

Regulatory approvals play a crucial role in the market growth of any pharmaceutical product. The positive opinion from the European Medicines Agency (EMA) for the marketing authorization of emtricitabine and tenofovir disoproxil fumarate has facilitated its widespread use in the EU/EEA region[5].

Key Takeaways

• Clinical Trials: Recent trials like the PANCOVID study and the comparison of TAF and TDF for HIV PrEP have provided valuable insights into the efficacy and safety of emtricitabine and tenofovir disoproxil fumarate.
• Market Growth: The global market is projected to grow at a CAGR of around 4.5% from 2022 to 2027, driven by increasing cases of HIV/AIDS and hepatitis B.
• End User Segments: Pregnant women, individuals with HIV/AIDS, and those with chronic hepatitis B are significant end-user segments.
• Regional Performance: North America, particularly the United States, is a key region driving market growth.
• Market Drivers: Growing cases of hepatitis B and HIV/AIDS, along with increased awareness and treatment initiatives, are major market drivers.
• Safety Profile: While tenofovir disoproxil fumarate has common side effects, newer formulations like tenofovir alafenamide offer improved safety profiles.

FAQs

What is the primary use of emtricitabine and tenofovir disoproxil fumarate?

Emtricitabine and tenofovir disoproxil fumarate are primarily used for the treatment and prevention of HIV/AIDS and the treatment of chronic hepatitis B.

What are the common side effects of tenofovir disoproxil fumarate?

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

How does the market for tenofovir disoproxil fumarate project to grow?

The market is projected to grow at a CAGR of around 4.5% from 2022 to 2027.

What are the key drivers of the tenofovir disoproxil fumarate market?

Key drivers include the growing number of hepatitis B patients, the increase in female HIV patients, and efforts to achieve viral suppression in HIV patients.

Are there any new formulations of tenofovir disoproxil fumarate?

Yes, tenofovir alafenamide is a newer formulation that offers improved renal and bone safety compared to tenofovir disoproxil fumarate.

Sources

1. PANCOVID Study: "Tenofovir Disoproxil Fumarate/Emtricitabine and Baricitinib for COVID-19" - Clinical Infectious Diseases[1].
2. Market Report: "Tenofovir Disoproxil Fumarate Market Size Report, 2022-2027" - IndustryARC[2].
3. Gilead Sciences Update: "Gilead Provides Update on Development of Fixed Dose Regimen of Truvada" - Gilead Sciences[3].
4. Clinical Trial Results: "Primary results from a randomised, double-blind, multicentre, active-controlled trial" - PubMed[4].
5. EMA Assessment Report: "Assessment report - Emtricitabine/Tenofovir disoproxil Krka" - European Medicines Agency[5].