You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR TRUVADA


✉ Email this page to a colleague

« Back to Dashboard


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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Truvada

Condition Name

Condition Name for Truvada
Intervention Trials
HIV Infections 80
HIV 55
HIV Infection 21
HIV Prevention 10
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Truvada
Intervention Trials
HIV Infections 128
Acquired Immunodeficiency Syndrome 47
Infections 36
Infection 28
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Truvada

Trials by Country

Trials by Country for Truvada
Location Trials
United States 535
Canada 61
South Africa 58
United Kingdom 40
France 37
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Truvada
Location Trials
California 52
Florida 34
Texas 33
North Carolina 33
Massachusetts 31
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Truvada

Clinical Trial Phase

Clinical Trial Phase for Truvada
Clinical Trial Phase Trials
Phase 4 78
Phase 3 51
Phase 2/Phase 3 8
[disabled in preview] 33
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Truvada
Clinical Trial Phase Trials
Completed 162
Unknown status 15
Recruiting 13
[disabled in preview] 11
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Truvada

Sponsor Name

Sponsor Name for Truvada
Sponsor Trials
Gilead Sciences 59
Merck Sharp & Dohme Corp. 36
National Institute of Allergy and Infectious Diseases (NIAID) 29
[disabled in preview] 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Truvada
Sponsor Trials
Other 350
Industry 152
NIH 50
[disabled in preview] 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Gilead's Lenacapavir and the Evolving Landscape of HIV Pre-Exposure Prophylaxis (PrEP): Implications for Truvada

Introduction

The landscape of HIV pre-exposure prophylaxis (PrEP) is undergoing a significant transformation with the emergence of new, long-acting treatments. Gilead Sciences' investigational drug, lenacapavir, has shown remarkable efficacy in clinical trials, potentially redefining the market and impacting existing treatments like Truvada.

Background on Truvada

Truvada, developed by Gilead Sciences, was the first drug approved for HIV PrEP in 2012. It is a once-daily oral tablet containing emtricitabine and tenofovir disoproxil fumarate (F/TDF). Since its approval, Truvada has been a cornerstone in HIV prevention, but it has its limitations, particularly in terms of adherence and convenience[1].

The Rise of Lenacapavir

Lenacapavir, Gilead's twice-yearly injectable HIV-1 capsid inhibitor, has demonstrated unprecedented efficacy in clinical trials. Here are the key findings:

Clinical Trial Results

  • The PURPOSE 1 trial, which enrolled over 5,300 individuals, showed that lenacapavir achieved 100% efficacy in preventing HIV infections among cisgender women. This trial met its primary and secondary endpoints, leading the independent Data Monitoring Committee to recommend stopping the blinded phase and offering open-label lenacapavir to all participants[3][4].
  • The trial results were so compelling that no infections were observed in the lenacapavir group, while the Truvada and Descovy groups recorded incidence rates of 1.69 and 2.02 per 100 person-years, respectively[2][3].

Adherence and Tolerability

  • Adherence to lenacapavir was high, with 91.5% of participants receiving on-time injections at week 26 and 92.8% at one year. This contrasts with the lower adherence rates seen with daily oral PrEP drugs like Truvada and Descovy[2].
  • Lenacapavir was generally well tolerated, with no new safety concerns identified[2].

Market Analysis and Projections

The success of lenacapavir in clinical trials has significant implications for the HIV PrEP market and specifically for Truvada.

Market Impact

  • Lenacapavir's twice-yearly dosing regimen addresses critical gaps in uptake and adherence, which have been challenges for daily oral PrEP drugs. This could lead to a shift in market share, with lenacapavir potentially capturing a significant portion of the PrEP market[3].
  • Analysts predict that lenacapavir could achieve global peak sales of around $3 billion to $4 billion, depending on regulatory approvals and market dynamics[3].

Competitive Landscape

  • The introduction of lenacapavir will increase competition in the PrEP market, where Truvada, Descovy, and Apretude (the first injectable PrEP approved in 2021) currently dominate. Apretude, given every two months, may also face competition from lenacapavir's more convenient twice-yearly dosing[1][3].

Regulatory and Access Considerations

  • Gilead plans to use data from both the PURPOSE 1 and PURPOSE 2 trials to support global regulatory filings, aiming for launches in 2025. This includes prioritizing access in high-incidence, resource-limited countries[2][4].

Future of Truvada

Given the emergence of lenacapavir and other long-acting PrEP options, the future of Truvada is likely to be impacted in several ways:

Continued Use but Reduced Market Share

  • While Truvada will likely remain an option for HIV prevention, its market share may decline as patients and healthcare providers opt for the more convenient and potentially more effective lenacapavir[3].

Generic Competition

  • Truvada already faces competition from generic versions, which could further erode its market share. However, Gilead's brand loyalty and the established trust in Truvada may help it maintain some market presence[1].

Evolution of Treatment Guidelines

  • Treatment guidelines may evolve to include lenacapavir as a preferred or alternative option for PrEP, potentially reducing the recommendation for Truvada in certain patient populations[2].

Key Takeaways

  • Lenacapavir has shown 100% efficacy in preventing HIV infections in clinical trials, outperforming Truvada and Descovy.
  • The twice-yearly dosing regimen of lenacapavir addresses adherence issues associated with daily oral PrEP drugs.
  • Lenacapavir is expected to significantly impact the HIV PrEP market, potentially capturing a substantial market share.
  • Truvada's market share is likely to decline with the introduction of lenacapavir and other long-acting PrEP options.
  • Regulatory filings and global launches for lenacapavir are anticipated in 2025.

FAQs

Q: What is lenacapavir, and how does it differ from Truvada?

A: Lenacapavir is a twice-yearly injectable HIV-1 capsid inhibitor, whereas Truvada is a once-daily oral tablet containing emtricitabine and tenofovir disoproxil fumarate. Lenacapavir has shown superior efficacy and adherence compared to Truvada in clinical trials.

Q: How effective is lenacapavir in preventing HIV infections?

A: Lenacapavir demonstrated 100% efficacy in preventing HIV infections in the PURPOSE 1 trial, with no infections observed among participants receiving the drug[3][4].

Q: What are the implications of lenacapavir for the HIV PrEP market?

A: Lenacapavir's success could lead to a significant shift in the market, potentially reducing the market share of existing PrEP drugs like Truvada and Apretude. It addresses critical gaps in adherence and could become a preferred option for many patients[3].

Q: When is lenacapavir expected to be available?

A: Gilead plans to begin global regulatory filings by the end of 2024, with anticipated launches in 2025[1][4].

Q: How does lenacapavir's safety profile compare to Truvada?

A: Lenacapavir, Descovy, and Truvada were generally well tolerated in clinical trials, with no new safety concerns identified for lenacapavir[2].

Sources

  1. MMIT Network: "Twice-Yearly PrEP Shows Promise in Clinical Trials"
  2. Gilead Sciences: "Full Efficacy and Safety Results for Gilead Investigational Twice-Yearly Lenacapavir for HIV Prevention Presented at AIDS 2024"
  3. FiercePharma: "Watch out, GSK. Gilead's twice-yearly PrEP drug shows 100% efficacy in HIV prevention"
  4. Gilead Sciences: "Gilead’s Twice Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada for HIV Prevention"

More… ↓

⤷  Free Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.