CLINICAL TRIALS PROFILE FOR TRUVADA

505(b)(2) Clinical Trials for TRUVADA

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.

All Clinical Trials for TRUVADA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00074581 ↗	Preventing Sexual Transmission of HIV With Anti-HIV Drugs	Completed	HIV Prevention Trials Network	Phase 3	2005-02-01	This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.
NCT00074581 ↗	Preventing Sexual Transmission of HIV With Anti-HIV Drugs	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2005-02-01	This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.
NCT00090779 ↗	Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV	Terminated	Adult AIDS Clinical Trials Group	Phase 2	2005-01-01	Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in long-term benefits or harm. The purpose of this study is to learn whether or not people should take anti-HIV drugs when they are first infected.
NCT00090779 ↗	Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV	Terminated	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2005-01-01	Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in long-term benefits or harm. The purpose of this study is to learn whether or not people should take anti-HIV drugs when they are first infected.
NCT00090779 ↗	Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV	Terminated	AIDS Clinical Trials Group	Phase 2	2005-01-01	Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in long-term benefits or harm. The purpose of this study is to learn whether or not people should take anti-HIV drugs when they are first infected.

Clinical Trial Conditions for TRUVADA

Condition Name

Condition Name for TRUVADA
Intervention	Trials
HIV Infections	80
HIV	55
HIV Infection	21
HIV-1 Infection	10

Condition MeSH

Condition MeSH for TRUVADA
Intervention	Trials
HIV Infections	128
Acquired Immunodeficiency Syndrome	47
Infections	36
Infection	28

Clinical Trial Locations for TRUVADA

Trials by Country

Trials by Country for TRUVADA
Location	Trials
United States	538
Canada	61
South Africa	58
United Kingdom	41
France	38

Trials by US State

Trials by US State for TRUVADA
Location	Trials
California	53
Florida	34
Texas	33
North Carolina	33
Massachusetts	32

Clinical Trial Progress for TRUVADA

Clinical Trial Phase

Clinical Trial Phase for TRUVADA
Clinical Trial Phase	Trials
PHASE2	4
Phase 4	78
Phase 3	51

Clinical Trial Status

Clinical Trial Status for TRUVADA
Clinical Trial Phase	Trials
Completed	162
Unknown status	15
Recruiting	15

Clinical Trial Sponsors for TRUVADA

Sponsor Name

Sponsor Name for TRUVADA
Sponsor	Trials
Gilead Sciences	61
Merck Sharp & Dohme Corp.	36
National Institute of Allergy and Infectious Diseases (NIAID)	29

Sponsor Type

Sponsor Type for TRUVADA
Sponsor	Trials
Other	355
Industry	154
NIH	50

Clinical Trials Update, Market Analysis, and Projection for Truvada

Last updated: November 2, 2025

Introduction

Truvada (emtricitabine/tenofovir disoproxil fumarate) remains a cornerstone in HIV prevention and treatment since its approval by the FDA in 2004. With evolving indications, regulatory reviews, and biosimilar entries, understanding its current clinical status and market dynamics is crucial for stakeholders. This report offers a comprehensive update on recent clinical trials, market analysis, and future projections for Truvada, emphasizing strategic insights crucial for pharmaceutical companies, investors, and healthcare providers.

Clinical Trials Update

Ongoing and Recent Clinical Trials

Over the past year, several clinical trials involving Truvada have targeted both its established uses and new indications. Notably:

• Pre-exposure prophylaxis (PrEP) efficacy in diverse populations: Multiple studies (NCT04564259; NCT04563791) are evaluating Truvada's effectiveness among women in sub-Saharan Africa and adolescent populations, aiming to expand PrEP access and adherence strategies.

• Long-acting alternatives: Trials like the phase 3 study involving long-acting injectable formulations (e.g., cabotegravir) are indirectly impacting Truvada's market, as they may shift standard-of-care preferences.

• Safety and adherence enhancement: Trials assessing the safety profile of Truvada in combination regimens for hepatitis B virus (HBV) infection are ongoing or completed, reinforcing its role beyond HIV.

Regulatory and Labeling Developments

Recent regulatory activities include:

• No new FDA approvals specific to Truvada's indications but an emphasis on expanding access through updated CDC guidelines recommending PrEP for at-risk populations.

• The European Medicines Agency (EMA) recently reviewed Truvada's use in HIV prevention, emphasizing the importance of adherence and resistance monitoring.

Research Gaps and Opportunities

Despite extensive clinical research, ongoing issues include:

• Adherence Challenges: Studies (e.g., NCT03947507) focus on behavioral and technological interventions to improve compliance.

• Resistance Development: Monitoring for drug resistance in PrEP users remains a priority due to emerging data on breakthrough infections.

Market Analysis

Market Size and Revenue Dynamics

The global HIV therapeutics market was valued at approximately USD 24 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 6% through 2030, driven by increased PrEP adoption and aging populations with comorbidities.

Truvada's Role:

• As one of the earliest and most prescribed PrEP medications, Truvada dominates the PrEP segment, representing around 70% of the global PrEP market share.

• The drug's revenue peaked at USD 3.2 billion in 2018 but has seen a plateau due to patent expirations in key markets and the introduction of generic versions.

Patent Expiration and Generics Impact

In 2020, Gilead Sciences' patent on Truvada in the U.S. expired, leading to the emergence of generics, including Teva's generic emtricitabine/tenofovir disoproxil fumarate, which significantly reduced Truvada's pricing and profitability.

Impact:

• Market share shift toward generics decreased the brand's revenue by an estimated 45% in the last two years.

• Price erosion prompted Gilead and competitors to diversify their portfolios with long-acting injections (e.g., Cabenuva) and combination products.

Competitive Landscape

Apart from generics, key competitors include:

• Descovy (Gilead): A fixed-dose combination with tenofovir alafenamide (TAF), offering improved renal and bone safety profiles.

• Long-acting injectables: Cabotegravir (ViiV Healthcare), approved in 2021 for PrEP, position themselves as alternatives to daily oral Truvada.

Market Opportunities and Challenges

Opportunities:

• Expanding PrEP in underrepresented populations, especially in Asia-Pacific and Latin America, where HIV incidence remains high (UNAIDS).

• Developing combination regimens for co-infections such as hepatitis B and C, leveraging Truvada's antiviral activity.

Challenges:

• Pricing pressures post-generic entry.

• Consumer preference shifting towards long-acting formulations.

• Resistance concerns and adherence issues, affecting long-term market sustainability.

Market Projection

Future Market Trends

The following projections are based on current trajectories:

• Market retention and growth in HIV treatment will continue, with PrEP maintaining significant demand due to rising awareness and policy endorsements.

• Biosimilar and generic fluctuations will influence revenue streams, with Gilead shifting focus toward innovative therapies.

• Adoption of long-acting PrEP formulations is anticipated to outpace oral Truvada in the next 5-7 years, especially post-approval of cabotegravir.

Forecasted Revenue Trajectory

By 2030, it is estimated that:

• Truvada's total market revenue from the PrEP segment will decline to below USD 1 billion, primarily attributable to generics and brand erosion.

• Gilead's overall HIV portfolio, with innovations like Descovy and injectable regimens, will offset declines from Truvada.

• Emerging markets could counterbalance declines due to increased access initiatives, maintaining overall volume but at lower prices.

Strategic Outlook

Stakeholders should consider:

• Investing in long-acting formulations.

• Leveraging expanded indications (e.g., HBV, hepatitis C co-infections).

• Enhancing adherence technologies to maximize efficacy and market penetration.

Key Takeaways

• Clinical trials indicate ongoing efforts to optimize PrEP use, address resistance, and explore new indications, signifying continued relevance of Truvada in HIV management.

• Market dynamics are shifting due to patent expirations, generics, and the rise of alternative formulations, necessitating strategic diversification by Gilead and competitors.

• Future projections suggest a decline in Truvada's market share; however, its legacy and the expanding overall HIV market assure sustained, albeit reduced, revenues.

• Long-acting injectables and combination therapies will be primary growth drivers, potentially surpassing oral Truvada in adoption.

• Stakeholders should monitor regulatory developments, technological advances, and market access initiatives to optimize positioning.

FAQs

1. What are the current clinical trials involving Truvada?
   Multiple ongoing studies focus on expanding PrEP effectiveness among diverse populations, improving adherence, and exploring combination regimens for hepatitis B co-infection.

2. How does patent expiration affect Truvada's market share?
   Patent expirations in key markets have led to the entry of generics, significantly reducing pricing power and revenue, prompting Gilead to pursue new formulations and indications.

3. What are the main competitors to Truvada in HIV prevention?
   Descovy (Gilead), long-acting injectable cabotegravir (ViiV), and emerging biosimilars are primary competitors, with the latter impacting Truvada’s market share post-generic entry.

4. What is the future outlook for Truvada in the HIV landscape?
   While declining as a market leader due to generics and new formulations, Truvada remains relevant, especially in regions with limited access to advanced therapies, supported by ongoing clinical studies.

5. Are there new indications for Truvada beyond HIV?
   Yes, its activity against hepatitis B virus (HBV) and potential in hepatitis C co-infections are areas of active investigation, broadening its therapeutic scope.

References

[1] UNAIDS. Global HIV & AIDS statistics — 2022 factsheet.
[2] Gilead Sciences. Truvada product information; 2023.
[3] FDA. Truvada (emtricitabine/tenofovir disoproxil fumarate) approval history.
[4] MarketWatch. HIV therapeutics market analysis and forecasts; 2023.
[5] European Medicines Agency. Review of PrEP medications; 2022.