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CLINICAL TRIALS PROFILE FOR TRIUMEQ PD

All Clinical Trials for triumeq pd

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02342769 ↗	Prospective Non-Interventional Observational Study of Use of TRIUMEQ and Corresponding Monitoring Measures in Clinical Practice in Germany	Completed	GlaxoSmithKline		2015-02-19	TRIUMPH is a prospective, non-interventional observational study on the use of the fixdose combination TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and the respective monitoring measures in the practice of HIV care in Germany. The primary study objective is a descriptive report of the incidence of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ therapy in everyday routine practice in Germany. The study is designed to enroll approximately 400 patients. There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 3 years or until premature discontinuation (i.e., discontinuation of TRIUMEQ, due to death, withdrawal of consent, lost to follow-up. TRIUMEQ is a registered trademark of the ViiV Healthcare group of companies.
NCT02342769 ↗	Prospective Non-Interventional Observational Study of Use of TRIUMEQ and Corresponding Monitoring Measures in Clinical Practice in Germany	Completed	ViiV Healthcare		2015-02-19	TRIUMPH is a prospective, non-interventional observational study on the use of the fixdose combination TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and the respective monitoring measures in the practice of HIV care in Germany. The primary study objective is a descriptive report of the incidence of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ therapy in everyday routine practice in Germany. The study is designed to enroll approximately 400 patients. There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 3 years or until premature discontinuation (i.e., discontinuation of TRIUMEQ, due to death, withdrawal of consent, lost to follow-up. TRIUMEQ is a registered trademark of the ViiV Healthcare group of companies.
NCT02354053 ↗	Evaluation of Switching From Current cART to Triumeq With Adherence Support Will Enhance HIV Control in Vulnerable Populations	Completed	CIHR Canadian HIV Trials Network	Phase 4	2015-11-01	Modern antiretroviral therapeutic regimens offer a vast array of choice that permits tailored therapy for HIV patients. While modern regimens have improved the rates of virologic suppression overall and reduced adverse effects of antiretroviral treatment, an important sub-group of HIV infected persons is unable to maintain adherence to their treatment regimens, fail to achieve long term virologic control and remain at risk for HIV related disease progression and transmission of HIV infection. Hypothesis: switching from current cART regimen to a Triumeq based regimen combined with adherence support will improve the rate of HIV suppression in vulnerable populations non-adherent to the their current cART as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24 post randomization.
NCT02354053 ↗	Evaluation of Switching From Current cART to Triumeq With Adherence Support Will Enhance HIV Control in Vulnerable Populations	Completed	ViiV Healthcare	Phase 4	2015-11-01	Modern antiretroviral therapeutic regimens offer a vast array of choice that permits tailored therapy for HIV patients. While modern regimens have improved the rates of virologic suppression overall and reduced adverse effects of antiretroviral treatment, an important sub-group of HIV infected persons is unable to maintain adherence to their treatment regimens, fail to achieve long term virologic control and remain at risk for HIV related disease progression and transmission of HIV infection. Hypothesis: switching from current cART regimen to a Triumeq based regimen combined with adherence support will improve the rate of HIV suppression in vulnerable populations non-adherent to the their current cART as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24 post randomization.
NCT02354053 ↗	Evaluation of Switching From Current cART to Triumeq With Adherence Support Will Enhance HIV Control in Vulnerable Populations	Completed	McGill University Health Center	Phase 4	2015-11-01	Modern antiretroviral therapeutic regimens offer a vast array of choice that permits tailored therapy for HIV patients. While modern regimens have improved the rates of virologic suppression overall and reduced adverse effects of antiretroviral treatment, an important sub-group of HIV infected persons is unable to maintain adherence to their treatment regimens, fail to achieve long term virologic control and remain at risk for HIV related disease progression and transmission of HIV infection. Hypothesis: switching from current cART regimen to a Triumeq based regimen combined with adherence support will improve the rate of HIV suppression in vulnerable populations non-adherent to the their current cART as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24 post randomization.
NCT02354053 ↗	Evaluation of Switching From Current cART to Triumeq With Adherence Support Will Enhance HIV Control in Vulnerable Populations	Completed	McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4	2015-11-01	Modern antiretroviral therapeutic regimens offer a vast array of choice that permits tailored therapy for HIV patients. While modern regimens have improved the rates of virologic suppression overall and reduced adverse effects of antiretroviral treatment, an important sub-group of HIV infected persons is unable to maintain adherence to their treatment regimens, fail to achieve long term virologic control and remain at risk for HIV related disease progression and transmission of HIV infection. Hypothesis: switching from current cART regimen to a Triumeq based regimen combined with adherence support will improve the rate of HIV suppression in vulnerable populations non-adherent to the their current cART as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24 post randomization.

Clinical Trial Conditions for triumeq pd

Condition Name

Condition Name for triumeq pd
Intervention	Trials
HIV Infections	6
HIV	4
HIV-1-infection	3
Infection, Human Immunodeficiency Virus	3

Condition MeSH

Condition MeSH for triumeq pd
Intervention	Trials
HIV Infections	9
Immunologic Deficiency Syndromes	4
Acquired Immunodeficiency Syndrome	4
Motor Neuron Disease	2

Clinical Trial Locations for triumeq pd

Trials by Country

Trials by Country for triumeq pd
Location	Trials
United States	12
Australia	8
Germany	8
Thailand	3
South Africa	2

Trials by US State

Trials by US State for triumeq pd
Location	Trials
Texas	2
California	2
Florida	2
Tennessee	1
Illinois	1

Clinical Trial Progress for triumeq pd

Clinical Trial Phase

Clinical Trial Phase for triumeq pd
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for triumeq pd
Clinical Trial Phase	Trials
Completed	10
Recruiting	3
Terminated	2

Clinical Trial Sponsors for triumeq pd

Sponsor Name

Sponsor Name for triumeq pd
Sponsor	Trials
ViiV Healthcare	11
Macquarie University, Australia	2
National Institute of Allergy and Infectious Diseases (NIAID)	2

Sponsor Type

Sponsor Type for triumeq pd
Sponsor	Trials
Other	29
Industry	16
NIH	5

Triumeq pd Market Analysis and Financial Projection

Triumeq PD: Clinical Trials, Market Analysis, and Projections

Introduction to Triumeq PD

Triumeq PD is a fixed-dose combination (FDC) medication developed by ViiV Healthcare, consisting of dolutegravir, abacavir, and lamivudine. It is designed for the treatment of HIV-1 infection and has been formulated to simplify treatment regimens, particularly for pediatric patients.

Clinical Trials Update

Pediatric Approval and Studies

Triumeq PD has undergone significant clinical trials to establish its safety and efficacy in pediatric patients. The FDA has approved Triumeq PD for children weighing at least 10 kg to less than 40 kg, based on pharmacokinetic data and clinical trials such as the ARROW and IMPAACT P1093 studies[1].

• IMPAACT P2019 Study: This study evaluated the pharmacokinetics, safety, and efficacy of Triumeq PD in HIV-infected pediatric patients. The results showed that the medication is safe, well-tolerated, and effective in controlling HIV when taken once daily. The study involved 57 children aged 1 to less than 12 years in Botswana, South Africa, Thailand, and the United States[3].
• EMA Approval: The European Medicines Agency (EMA) has approved Triumeq PD for infants and children as young as 3 months of age who weigh at least 6 kg, further expanding its use in younger populations[3].

Safety and Efficacy

Clinical trials have demonstrated that Triumeq PD provides durable virologic suppression in pediatric patients, similar to outcomes observed in adult trials. The safety profile of Triumeq PD in children is consistent with that of the individual components, with no new safety issues unique to the pediatric population identified in the ARROW and IMPAACT P1093 studies[1].

Market Analysis

Market Size and Forecast

The Triumeq market, which includes Triumeq PD, was valued at USD 34.10 billion in 2023 and is projected to reach USD 66.16 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.21% during the forecast period of 2024-2031[2].

Market Drivers

• Regulatory Approvals: The recent approvals for pediatric use, especially the EMA approval for infants and young children, have significantly expanded the market potential for Triumeq PD[3].
• Ease of Use: The single-pill regimen of Triumeq PD enhances treatment adherence, particularly in resource-limited settings, making it a favorable option in the competitive landscape of antiretroviral therapies[2].
• Global Health Initiatives: Increasing governmental initiatives and partnerships with global health organizations to enhance access to HIV treatments are driving market growth, especially in emerging markets like India and China[2].

Market Challenges

• Generic Competition: The impending expiration of patents and exclusivities (estimated generic launch date is June 8, 2030) could lead to the entry of generic versions, potentially impacting sales[4].
• Pricing Pressure: Increasing pressure from health authorities and insurers to reduce drug prices can affect profit margins for pharmaceutical companies[2].
• Market Access Issues: Differences in healthcare systems, reimbursement policies, and access to medications in various regions can limit the market for Triumeq PD[2].

Geographical Market Segmentation

North America and Europe

These regions have advanced healthcare infrastructures and high treatment adoption rates, contributing significantly to revenue generation. In North America, the United States and Canada are key markets, while in Europe, countries like Germany, France, and the UK have progressive treatment approaches and HIV management programs[2].

Asia-Pacific and Other Regions

The Asia-Pacific region is experiencing rapid growth due to rising HIV prevalence, improving healthcare systems, and increasing awareness and education about HIV treatment. Countries like India and China are emerging as significant markets driven by governmental initiatives and global health partnerships[2].

Key Players

The major players in the Triumeq market include ViiV Healthcare, Gilead Sciences, Bristol-Myers Squibb, Merck & Co., Johnson & Johnson, AbbVie, and Mylan. ViiV Healthcare, as the developer of Triumeq PD, holds a significant position in this market[2].

Patent and Exclusivity Status

Triumeq PD is protected by four US drug patents filed from 2022 to 2023, with none having expired yet. The last outstanding exclusivity is set to expire in 2026, which includes New Patient Population (NPP) and Pediatric Exclusivity (PED) codes[4].

Conclusion and Future Outlook

Triumeq PD has established itself as a critical component in the treatment of HIV-1 infection, particularly in pediatric patients. The medication's approval for younger age groups and its ease of use position it favorably in the market. However, the pharmaceutical industry's regulatory challenges, generic competition, and pricing pressures will continue to shape the market dynamics.

Key Takeaways

• Clinical Efficacy: Triumeq PD has demonstrated safety and efficacy in pediatric patients, with approvals for children as young as 3 months.
• Market Growth: The Triumeq market is projected to grow significantly, driven by regulatory approvals and global health initiatives.
• Challenges: Generic competition, pricing pressure, and market access issues are key challenges facing the market.
• Geographical Segmentation: North America, Europe, and the Asia-Pacific region are significant markets, each with unique dynamics.
• Patent Status: Triumeq PD is protected by patents and exclusivities until 2026.

Frequently Asked Questions (FAQs)

1. What are the active ingredients in Triumeq PD?

Triumeq PD contains dolutegravir, abacavir, and lamivudine.

2. What is the age and weight range for Triumeq PD approval?

Triumeq PD is approved for children as young as 3 months of age who weigh at least 6 kg, and for children weighing at least 10 kg to less than 40 kg[1][3].

3. What are the key market drivers for Triumeq PD?

Key market drivers include regulatory approvals, ease of use, and global health initiatives to enhance access to HIV treatments[2].

4. What are the major challenges facing the Triumeq PD market?

Challenges include generic competition, pricing pressure, and market access issues in different regions[2].

5. When are the patents and exclusivities for Triumeq PD set to expire?

The patents and exclusivities for Triumeq PD are set to expire in 2026, with the generic launch estimated for June 8, 2030[4].

Sources:

1. FDA Clinical Review of Original NDA and Efficacy Supplement (Triumeq)
2. Verified Market Research - Triumeq Market Size, Share, Scope, Trends, Growth and Analysis
3. IMPAACT Network - European Medicines Agency Approves Triumeq PD® for Infants and Young Children
4. Pharsight - Triumeq Pd patent expiration
5. European Medicines Agency - Triumeq