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CLINICAL TRIALS PROFILE FOR TRIUMEQ

All Clinical Trials for triumeq

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

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for triumeq

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for triumeq

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for triumeq

Sponsor Name

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

Sponsor Type

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

Triumeq Market Analysis and Financial Projection

Triumeq: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Triumeq

Triumeq, a fixed-dose combination medication developed by ViiV Healthcare, is composed of abacavir, dolutegravir, and lamivudine. It is indicated for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 10 kg. This medication works by interfering with the action of two enzymes, reverse transcriptase and integrase, to prevent the virus from replicating and further infecting cells[1].

Clinical Trials and Efficacy

Triumeq has undergone extensive clinical trials to establish its safety and efficacy. One notable study, the SINGLE trial, was a randomized, double-blind trial that compared Triumeq to a regimen of Reyataz/Truvada/Norvir. The results showed that Triumeq had a statistically superior treatment difference, with 71% of patients achieving a viral load of HIV-1 RNA <50 copies/mL compared to 63% for the comparator regimen. Additionally, the average increase in CD4 cell count was higher for Triumeq (378 cells/mm³) than for the comparator regimen (234 cells/mm³)[3].

Pediatric Indications

The safety and efficacy of Triumeq for pediatric patients have also been evaluated. The FDA approved Triumeq PD, a dispersible tablet formulation, for children weighing at least 10 kg. Clinical reviews supported the extension of the indication to children in this weight range based on the known safety and efficacy profile and pharmacokinetic data of the individual components[5].

Market Analysis

Market Size and Forecast

The Triumeq market is significant and growing. As of 2023, the market size was valued at USD 34.10 billion and is projected to reach USD 66.16 billion by 2031, growing at a CAGR of 6.21% during the forecast period 2024-2031[2].

Market Drivers

Several factors drive the demand for Triumeq:

• Innovations in Drug Formulation: Enhancements in drug formulation and delivery systems can improve the effectiveness and tolerability of treatments, expanding the market.
• Generic Competition: The introduction of generic versions can impact pricing and market dynamics, leading to increased access and patient switching.
• Regional Market Dynamics: Demand varies by region due to factors such as healthcare infrastructure, insurance coverage, and cultural attitudes toward HIV treatment.
• Side Effect Profiles and Patient Preferences: Triumeq's favorable side effect profile compared to other treatments can drive patient and physician preference.
• Public Health Initiatives: Efforts to reduce stigma and promote treatment as prevention (TasP) can increase the utilization of antiretroviral therapies[2].

Market Segmentation

The Triumeq market is segmented by indication and geography:

• By Indication: The market is primarily categorized into treatment-naive patients and treatment-experienced patients. Triumeq simplifies treatment regimens and improves adherence among both groups[2].
• By Geography: The market spans various regions, including North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America. Each region exhibits distinct trends influenced by healthcare policies, patient demographics, and socio-economic factors[2].

Key Players

The major players in the Triumeq market include:

• ViiV Healthcare: The developer and primary marketer of Triumeq.
• Gilead Sciences: A significant competitor in the HIV treatment market with its own antiretroviral therapies.
• Bristol-Myers Squibb, Merck & Co., Johnson & Johnson, AbbVie, and Mylan are other key players in the broader HIV treatment landscape[2].

Regulatory Challenges and Market Access Issues

The pharmaceutical industry, including the Triumeq market, faces several regulatory and market access challenges:

• Generic Competition: As patents expire, generic versions can enter the market, impacting sales.
• Pricing Pressure: Increasing pressure from health authorities and insurers to reduce drug prices can affect profit margins.
• Market Access Issues: Differences in healthcare systems and reimbursement policies can limit market access in certain regions.
• Evolving Treatment Guidelines: Changes in clinical guidelines and the development of new therapies could lead to decreased demand for Triumeq[2].

Safety and Side Effects

Triumeq is associated with several warnings and precautions, including serious hypersensitivity reactions, exacerbations of hepatitis B virus (HBV), hepatotoxicity, lactic acidosis, and severe hepatomegaly with steatosis. Common adverse reactions include insomnia, headache, and fatigue[1].

Projections and Future Outlook

The future outlook for Triumeq is positive, driven by the growing need for effective HIV treatments and the medication's favorable efficacy and safety profile. However, the market will need to navigate challenges such as generic competition, pricing pressure, and evolving treatment guidelines.

Emerging Trends and Competitors

Gilead Sciences, a major competitor, continues to innovate with new treatments like Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), which has shown promising long-term efficacy and safety in clinical trials. Gilead's pipeline also includes investigational treatments like GS-1720, a novel once-weekly integrase strand transfer inhibitor (INSTI), and a once-weekly oral combination regimen of islatravir and lenacapavir[4].

Key Takeaways

• Triumeq is a highly effective fixed-dose combination medication for the treatment of HIV-1 infection, with a strong clinical trial record.
• The market is growing, with a projected value of USD 66.16 billion by 2031.
• Key drivers include innovations in drug formulation, favorable side effect profiles, and public health initiatives.
• Regulatory challenges and generic competition are significant factors that will shape the market.
• Triumeq faces competition from other antiretroviral therapies, such as those developed by Gilead Sciences.

FAQs

What is Triumeq and how does it work?

Triumeq is a fixed-dose combination medication containing abacavir, dolutegravir, and lamivudine. It works by interfering with the action of two enzymes, reverse transcriptase and integrase, to prevent the HIV virus from replicating and further infecting cells[1].

When was Triumeq approved by the FDA?

Triumeq was first approved by the FDA on August 22, 2014, for the treatment of HIV-1 infection in adults. It has since been approved for pediatric patients weighing at least 10 kg[1].

What are the common side effects of Triumeq?

Common adverse reactions to Triumeq include insomnia, headache, and fatigue. It also carries a boxed warning for serious hypersensitivity reactions and exacerbations of hepatitis B virus (HBV)[1].

How does the market for Triumeq project to grow?

The Triumeq market is projected to grow from USD 34.10 billion in 2023 to USD 66.16 billion by 2031, at a CAGR of 6.21% during the forecast period 2024-2031[2].

Who are the major players in the Triumeq market?

The major players include ViiV Healthcare, Gilead Sciences, Bristol-Myers Squibb, Merck & Co., Johnson & Johnson, AbbVie, and Mylan[2].

What are the key challenges facing the Triumeq market?

Key challenges include generic competition, pricing pressure, market access issues, and evolving treatment guidelines. Additionally, regulatory changes and new safety concerns can impact the market[2].

Sources

1. Drugs.com: Triumeq (abacavir, dolutegravir and lamivudine) FDA Approval History.
2. Verified Market Research: Triumeq Market Size, Share, Scope, Trends, Growth and Analysis.
3. ViiV Healthcare: MOVING FORWARD - Triumeq.
4. Gilead Sciences: Gilead to Present Late Breaking Data Highlighting Antiviral Portfolio.
5. FDA: Clinical Review of Original NDA and Efficacy Supplement (Triumeq).