CLINICAL TRIALS PROFILE FOR TIVICAY

All Clinical Trials for Tivicay

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00537966 ↗	Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study	Recruiting	University of Zurich	N/A	2002-01-01	Aim of the study: To describe the epidemiology, longitudinally follow, test the effect of early antiretroviral treatment and investigate early events of virus-host interactions in patients with documented acute or recent HIV-1 infection in Zurich. Study design: This is an open label, non-randomized, observational, single center study at the University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology. We aim at enrolling approximately 300 patients over a 10 year period. All patients who fulfill the inclusion criteria of a documented acute or recent HIV infection can participate in the study. Patients are offered early combination antiretroviral treatment (cART), if treatment start falls within 90 days after diagnosis of acute HIV-infection. After one year of suppressed HIV-plasma viremia (< 50 copies/ml) patients can chose to stop cART. Patients who have not chosen to undergo early-cART, respectively will stop cART after one year will be followed for a total of 5 years. Viral setpoints reached after treatment interruptions will be compared to historic controls and to the control group not having received cART during acute infection. A battery of virological and immunological assays will be performed on blood samples obtained to better understand early virus-host interactions, which are thought to play a key role in HIV-pathogenesis research. Summary: In summary, this study will provide comprehensive knowledge on early HIV-infection with regard to epidemiology, impact of early-cART on the course of disease and forms the base for a variety of translational research projects addressing early key pathogenesis events between virus and host, relevant for the course of disease, for transmission, for development of vaccines and new treatment strategies. - Trial with medicinal product
NCT00796263 ↗	Antiretroviral Therapy for Acute and Chronic HIV Infection	Recruiting	Gilead Sciences	Phase 3	2009-04-01	This is a protocol designed to randomize subjects with acute HIV infection to receive standard HAART or mega-HAART for subject who are enrolled in SEARCH 010 study (protocol title: Establish and characterize an acute HIV infection cohort in a Thai high risk population. To describe the impact of standard HAART versus mega-HAART initiated during the acute HIV infection period on immunological and virological outcomes.
NCT00796263 ↗	Antiretroviral Therapy for Acute and Chronic HIV Infection	Recruiting	Merck Sharp & Dohme Corp.	Phase 3	2009-04-01	This is a protocol designed to randomize subjects with acute HIV infection to receive standard HAART or mega-HAART for subject who are enrolled in SEARCH 010 study (protocol title: Establish and characterize an acute HIV infection cohort in a Thai high risk population. To describe the impact of standard HAART versus mega-HAART initiated during the acute HIV infection period on immunological and virological outcomes.

Clinical Trial Conditions for Tivicay

Condition Name

Condition Name for Tivicay
Intervention	Trials
HIV	8
HIV Infections	5
HIV-1 Infection	5

Condition MeSH

Condition MeSH for Tivicay
Intervention	Trials
HIV Infections	15
Acquired Immunodeficiency Syndrome	10
Infections	6

Clinical Trial Locations for Tivicay

Trials by Country

Trials by Country for Tivicay
Location	Trials
United States	24
Brazil	7
United Kingdom	5
South Africa	5
Argentina	4

Trials by US State

Trials by US State for Tivicay
Location	Trials
California	4
Texas	3
North Carolina	2
Georgia	2
Florida	2

Clinical Trial Progress for Tivicay

Clinical Trial Phase

Clinical Trial Phase for Tivicay
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	7
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Tivicay
Clinical Trial Phase	Trials
Completed	14
Recruiting	4
Active, not recruiting	4

Clinical Trial Sponsors for Tivicay

Sponsor Name

Sponsor Name for Tivicay
Sponsor	Trials
ViiV Healthcare	10
National Institute of Allergy and Infectious Diseases (NIAID)	6
St Stephens Aids Trust	3

Sponsor Type

Sponsor Type for Tivicay
Sponsor	Trials
Other	38
Industry	20
NIH	7

TIVICAY (Dolutegravir): Clinical Trials, Market Analysis, and Projections

Introduction to TIVICAY

TIVICAY, developed by ViiV Healthcare, is an antiretroviral medication containing the active ingredient dolutegravir, an integrase inhibitor. It has been a cornerstone in the treatment of HIV-1 since its FDA approval in 2013. Here, we delve into the clinical trials, market analysis, and future projections for TIVICAY.

Clinical Trials Overview

Phase III Clinical Trials

TIVICAY's approval was based on data from four pivotal Phase III clinical trials that involved 2,557 adults and children aged 12 years and older. These trials evaluated the efficacy and safety of dolutegravir in various patient populations, including treatment-naive and treatment-experienced patients, as well as those with resistance to multiple classes of HIV medicines[3].

• Treatment-Naive Patients: Trials compared dolutegravir-based regimens to other antiretroviral therapies, showing superior or non-inferior efficacy in achieving viral suppression.
• Treatment-Experienced Patients: Studies like VIKING-3 evaluated dolutegravir's effectiveness in patients with resistance to multiple classes of HIV drugs, demonstrating significant reductions in viral loads[3].

Ongoing and Recent Trials

Recent clinical trials continue to assess the long-term efficacy and safety of TIVICAY. For example:

• Phase 4 Trials: These trials, such as those conducted by the Frederick National Laboratory for Cancer Research, focus on real-world outcomes and long-term resistance patterns[5].

Growing Resistance to TIVICAY

Global HIV Drug Resistance Report

The World Health Organization (WHO) has flagged growing resistance to TIVICAY in some countries. Surveys from Uganda, Ukraine, Malawi, and Mozambique indicate resistance rates ranging from 3.9% to 8.6%, with a notable 19.6% resistance rate in treatment-experienced patients in Mozambique who switched to TIVICAY while having high viral loads[1][2].

• WHO Recommendations: The WHO emphasizes the need for increased vigilance, optimized HIV care delivery, and strict surveillance of resistance, particularly in pregnant and breastfeeding women and newborns[1].

Market Analysis

Current Market Position

TIVICAY has been recommended by the WHO since 2018 as a preferred first- and second-line treatment for HIV-1 across all population groups due to its efficacy, safety profile, and ease of administration. This broad endorsement has led to widespread adoption globally[1][2].

Market Challenges

The growing resistance to TIVICAY poses a significant challenge to its market position. Countries are advised to enhance their monitoring and reporting systems to mitigate this issue. Additionally, the implementation of pre-exposure prophylaxis (PrEP) treatments, accompanied by strict resistance surveillance, is recommended[1].

Patent and Exclusivity

TIVICAY's patents are set to expire in June 2030, which could lead to generic competition. However, this date may be influenced by patent challenges or licensing agreements[5].

Market Projections

Generic Entry

The potential entry of generic versions of dolutegravir in 2030 could significantly impact TIVICAY's market share. Generic competition often leads to reduced prices and increased accessibility, but it may also affect the brand's market dominance[5].

Continued Use and Adaptation

Despite growing resistance, TIVICAY is likely to remain a crucial component of HIV treatment regimens due to its overall efficacy and favorable side effect profile. Efforts to optimize treatment protocols and enhance resistance surveillance will be key to maintaining its effectiveness[1][2].

Emerging Trends

The integration of TIVICAY into combination therapies and the use of PrEP will continue to shape the HIV treatment landscape. The WHO's recommendations on strict surveillance and optimized care delivery will be pivotal in managing resistance and ensuring the long-term viability of TIVICAY and similar antiretroviral medications[1].

Key Takeaways

• Clinical Trials: TIVICAY's approval was based on robust Phase III trials, and ongoing Phase 4 trials continue to monitor its long-term efficacy and safety.
• Growing Resistance: The WHO has flagged increasing resistance to TIVICAY, emphasizing the need for enhanced surveillance and optimized care.
• Market Position: TIVICAY remains a preferred treatment globally, but faces challenges from growing resistance and impending generic competition.
• Future Projections: The drug is expected to remain crucial in HIV treatment, with a focus on optimizing protocols and managing resistance.

FAQs

What is TIVICAY, and how does it work?

TIVICAY is an antiretroviral medication containing dolutegravir, an integrase inhibitor that blocks the HIV virus from integrating its DNA into host cells, thus disrupting its replication cycle[1].

Why is there growing resistance to TIVICAY?

Resistance is increasing due to factors such as uncontrolled viral loads in some patient groups and the transition of treatment-experienced patients to TIVICAY while still having high viral loads[1][2].

What are the WHO's recommendations to manage resistance to TIVICAY?

The WHO recommends increased vigilance, optimized HIV care delivery, strict surveillance of resistance, and the implementation of PrEP treatments with resistance monitoring[1].

When do the patents for TIVICAY expire?

The patents for TIVICAY are set to expire in June 2030, which could lead to the entry of generic versions[5].

How will generic competition affect TIVICAY's market position?

Generic competition is likely to reduce prices and increase accessibility but may also erode TIVICAY's market share and dominance[5].

What is the current market position of TIVICAY?

TIVICAY is widely recommended and used as a first- and second-line treatment for HIV-1 globally due to its efficacy, safety, and ease of administration[1][2].

Sources

1. Biospace: WHO Warns of Growing Resistance in Individuals to GSK, ViiV's HIV Drug Tivicay[1].
2. FiercePharma: WHO flags increasing resistance to GSK's HIV med Tivicay in some countries[2].
3. GSK: ViiV Healthcare announces U.S. approval of Tivicay (dolutegravir) for the treatment of HIV-1[3].
4. Prime Therapeutics: FDA Decisions Expected: January 2025[4].
5. DrugPatentWatch: When do the TIVICAY patents expire, and when will generic versions be available?[5].

Last updated: 2025-01-01