CLINICAL TRIALS PROFILE FOR TIVICAY PD

All Clinical Trials for Tivicay Pd

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.
NCT00796263 ↗	Antiretroviral Therapy for Acute and Chronic HIV Infection	Recruiting	Pfizer	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	Thai Red Cross AIDS Research Centre	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 Pd

Condition Name

Condition Name for Tivicay Pd
Intervention	Trials
HIV	8
HIV Infections	5
HIV-1 Infection	5
HIV-1-infection	4

Condition MeSH

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

Clinical Trial Locations for Tivicay Pd

Trials by Country

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

Trials by US State

Trials by US State for Tivicay Pd
Location	Trials
California	4
Texas	3
Georgia	2
Florida	2
Colorado	2

Clinical Trial Progress for Tivicay Pd

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Tivicay Pd

Sponsor Name

Sponsor Name for Tivicay Pd
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 Pd
Sponsor	Trials
Other	38
Industry	20
NIH	7

TIVICAY PD: Clinical Trials, Market Analysis, and Projections

Introduction to TIVICAY PD

TIVICAY PD, also known as dolutegravir, is a crucial antiretroviral medication developed by ViiV Healthcare for the treatment of HIV-1 infection. It is part of a class of drugs known as integrase strand transfer inhibitors (INSTIs). Here, we will delve into the clinical trials, market analysis, and future projections for TIVICAY PD.

Clinical Trials Overview

Pediatric Trials

TIVICAY PD has undergone extensive clinical trials to establish its safety and efficacy in pediatric patients. The IMPAACT P1093 trial, an ongoing multicenter, open-label, non-comparative trial, has been pivotal in this regard. This trial involves approximately 160 HIV-1-infected pediatric subjects aged 4 weeks to less than 18 years. The results from this trial have shown that the adverse reactions in pediatric patients are similar to those observed in adults, with primary safety concerns including severe hypersensitivity reactions, liver enzyme abnormalities, renal events, and psychiatric events[1].

Another significant trial is the ODYSSEY (Penta20) trial, a randomized control efficacy trial conducted by the Paediatric European Network for Treatment of AIDS (PENTA) and the Medical Research Council (MRC) Clinical Trials Unit. This trial is designed to support World Health Organization (WHO) guideline recommendations and provides data to support revised dosing for pediatric patients aged four weeks to 18 years[4].

Safety and Efficacy

The safety data from these trials indicate that TIVICAY PD is well-tolerated in pediatric patients. Grade 2 adverse drug reactions reported by more than one subject included decreased neutrophil count and diarrhea, but there were no Grade 3 or 4 drug-related adverse reactions, and no adverse reactions led to treatment discontinuation[1].

The pharmacokinetic parameters of TIVICAY PD in pediatric subjects were comparable to those of adults receiving the standard dose, further supporting its use in this population[1].

Market Analysis

Market Share and Competitors

ViiV Healthcare, the manufacturer of TIVICAY PD, holds a significant market share in the HIV-1 treatment market. In 2020, ViiV Healthcare had a 21% market share, with TIVICAY/TIVICAY PD and Triumeq being key contributors to this position[2].

The HIV-1 treatment market is evolving, with a shift from tenofovir disoproxil fumarate (TDF)-based regimens to tenofovir alafenamide (TAF)-based regimens. However, newer therapies like Biktarvy (INSTI + NRTI + NRTI) have been gaining traction, capturing market share from older TDF-based and TAF-based regimens. Despite this, TIVICAY PD remains a strong player in the market[2].

Emerging Therapies

The market is also seeing the emergence of new therapies such as lenacapavir and islatravir, which are being evaluated for various patient populations, including multi-drug resistant (MDR) HIV-1, treatment-naïve patients, and pre-exposure prophylaxis (PrEP). These new therapies could potentially impact the market dynamics, but TIVICAY PD's established safety and efficacy profile positions it well for continued market presence[2].

Market Projections

Future Market Size

Biktarvy, a competitor to TIVICAY PD, has seen rapid market growth, with its market size increasing from USD 1,144 million in its launch year to USD 6,095 million in 2020. It is projected to reach USD 10,673 million by 2024, potentially becoming the market leader. However, TIVICAY PD is expected to maintain its market share due to its strong clinical trial data and established patient base[2].

Generic Entry

The patent protection for TIVICAY PD is set to expire on June 8, 2030, which could lead to generic entry into the market. However, this date may change due to patent challenges or generic licensing agreements. The interest in generic launch is high, as indicated by the twenty-four patent litigation cases involving the patents protecting this drug[5].

Regulatory Approvals

Expanded Indications

TIVICAY PD has received several regulatory approvals that have expanded its indicated population. On June 12, 2020, the FDA approved TIVICAY PD tablets for oral suspension and expanded the indicated population to include pediatric patients aged at least 4 weeks and weighing at least 3 kg. This approval was based on data from the IMPAACT P1093 trial[1].

In the European Union, TIVICAY PD received marketing authorization for pediatric patients aged at least four weeks and weighing at least 3 kg, further solidifying its global presence[4].

Key Takeaways

• Clinical Trials: TIVICAY PD has demonstrated safety and efficacy in pediatric patients through trials like IMPAACT P1093 and ODYSSEY.
• Market Share: ViiV Healthcare holds a significant market share, with TIVICAY PD being a key contributor.
• Market Dynamics: The market is shifting towards newer therapies, but TIVICAY PD remains competitive.
• Future Projections: TIVICAY PD is expected to maintain its market presence despite the emergence of new therapies and potential generic entry.
• Regulatory Approvals: Expanded indications have broadened the use of TIVICAY PD in pediatric populations globally.

FAQs

What is TIVICAY PD used for?

TIVICAY PD is used for the treatment of HIV-1 infection in combination with other antiretroviral agents in adults and children aged at least 4 weeks and weighing at least 3 kg.

What are the key clinical trials for TIVICAY PD?

The key clinical trials include the IMPAACT P1093 trial and the ODYSSEY (Penta20) trial, which have established the safety and efficacy of TIVICAY PD in pediatric patients.

Who manufactures TIVICAY PD?

TIVICAY PD is manufactured by ViiV Healthcare, a global specialist HIV company majority-owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi Limited as shareholders.

What is the market projection for TIVICAY PD?

Despite the rise of newer therapies, TIVICAY PD is expected to maintain its market share due to its established safety and efficacy profile.

When does the patent protection for TIVICAY PD expire?

The patent protection for TIVICAY PD is set to expire on June 8, 2030, which could lead to generic entry into the market.

Sources

1. FDA: Dolutegravir Pediatric Postmarket Adverse Event Review 2023-03-21.
2. DelveInsight: Changing Dynamics of HIV-1 Treatment Market.
3. TGA: Australian public assessment report for Tivicay and Tivicay PD.
4. ViiV Healthcare: ViiV Healthcare receives EU Marketing Authorisation for the first dispersible formulation of dolutegravir for the treatment of HIV in children.
5. DrugPatentWatch: Tivicay Pd Drug Patent Profile.

Last updated: 2025-01-01