CLINICAL TRIALS PROFILE FOR PREZISTA

All Clinical Trials for Prezista

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00381303 ↗	GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.	Completed	Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA	Phase 3	2006-11-01	The purpose of this study is to evaluate any differences in the effectiveness, safety, and tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day on virologic response (defined as a viral load (VL) of < 50 copies/mL) over a 48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV) agents will also be administered and will be chosen by the Investigator based on resistance testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).
NCT00381303 ↗	GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.	Completed	Tibotec, Inc	Phase 3	2006-11-01	The purpose of this study is to evaluate any differences in the effectiveness, safety, and tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day on virologic response (defined as a viral load (VL) of < 50 copies/mL) over a 48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV) agents will also be administered and will be chosen by the Investigator based on resistance testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).
NCT00421551 ↗	Study Comparing Efficacy and Safety of Darunavir Boosted With Ritonavir to HART With 2 NRTI and Darunavir Boosted With Ritonavir in HIV-1 Infected Patients ANRS136	Completed	Tibotec Pharmaceutical Limited	Phase 3	2007-03-01	The purpose of this study is to evaluate whether a monotherapy of boosted darunavir is able to maintain the virological success until 48 weeks in comparison to a standard therapy 2 INTI + darunavir/r in HIV infected patients with full viral suppression.

Clinical Trial Conditions for Prezista

Condition Name

Condition Name for Prezista
Intervention	Trials
HIV Infections	17
HIV-1 Infection	6
HIV	5

Condition MeSH

Condition MeSH for Prezista
Intervention	Trials
HIV Infections	30
Acquired Immunodeficiency Syndrome	12
Infections	10

Clinical Trial Locations for Prezista

Trials by Country

Trials by Country for Prezista
Location	Trials
United States	78
South Africa	7
Canada	6
Thailand	6
France	6

Trials by US State

Trials by US State for Prezista
Location	Trials
New York	7
California	7
Texas	6
North Carolina	6
Florida	5

Clinical Trial Progress for Prezista

Clinical Trial Phase

Clinical Trial Phase for Prezista
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Prezista
Clinical Trial Phase	Trials
Completed	31
Terminated	6
Unknown status	3

Clinical Trial Sponsors for Prezista

Sponsor Name

Sponsor Name for Prezista
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	5
Merck Sharp & Dohme Corp.	4
ViiV Healthcare	4

Sponsor Type

Sponsor Type for Prezista
Sponsor	Trials
Other	52
Industry	42
NIH	7

Clinical Trials, Market Analysis, and Projections for PREZISTA

Overview of PREZISTA

PREZISTA, marketed by Janssen Products, LP, is a protease inhibitor used in the treatment of HIV-1 infection. The drug, whose generic name is darunavir, is often co-administered with either low-dose ritonavir or cobicistat to enhance its pharmacokinetic properties[2][3].

Clinical Trials and Development

Current Indications and Usage

PREZISTA is currently indicated for the treatment of HIV-1 infection in adult and pediatric patients. For adults and adolescents (aged 12 years and older, weighing at least 40 kg), it is co-administered with cobicistat. For pediatric patients from the age of 3 years and at least 15 kg, it is co-administered with low-dose ritonavir[2].

Expanded Pediatric Indication

Johnson & Johnson has recently submitted a supplemental New Drug Application (sNDA) to the U.S. FDA and a type 2 variation application to the European Medicines Agency (EMA) to expand the indication of PREZCOBIX (darunavir/cobicistat) to include the treatment of HIV-1 infection in pediatric patients aged 6 and older, weighing at least 25 kg. This expansion is supported by data from clinical studies that established the bioequivalence and safety of the new combination tablet[3].

Ongoing and Completed Trials

PREZISTA has been involved in numerous clinical trials to evaluate its efficacy, safety, and pharmacokinetics. For instance, the Phase 2/3 clinical trial conducted by Gilead Sciences (NCT02016924) established the efficacy, safety, and tolerability of cobicistat-boosted darunavir in younger children with HIV-1[3].

Market Analysis

Global HIV Drugs Market

The global HIV drugs market, which includes protease inhibitors like PREZISTA, was valued at $34.13 billion in 2023 and is projected to grow to $58.24 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 6.2% from 2024 to 2032. The combination HIV medicines segment, which includes fixed-dose combinations like PREZCOBIX, is expected to lead the market during this period[5].

Market Share and Distribution

North America, particularly the U.S., dominates the HIV drugs market due to the high prevalence of HIV infection and increased awareness among the population. Hospital pharmacies are expected to hold the dominant share in the distribution channel, driven by rising patient visits and the increasing sales of prescribed antiretroviral drugs[5].

Key Players

Janssen Products, LP, in collaboration with Gilead Sciences, Inc., is a major player in the global HIV drugs market. Other key players include ViiV Healthcare, which also contributes significantly to the market[5].

Market Projections

Growth Drivers

The growth of the PREZISTA market is driven by several factors:

• Increased Prevalence of HIV: The rising number of individuals living with HIV, particularly in regions like North America, increases the demand for antiretroviral therapies.
• New Product Launches: Expansions in indications, such as the proposed pediatric indication, and the development of new combination therapies like PREZCOBIX, contribute to market growth.
• Affordability and Accessibility: Efforts to make HIV drugs more affordable and accessible, such as generic licensing for certain treatments, are expected to boost market growth[5].

Challenges

Despite the positive projections, there are challenges to consider:

• Cost and Accessibility: The high cost of some HIV treatments, including newer formulations, can limit accessibility for at-risk populations, especially in low-income countries.
• Adherence and Resistance: Issues related to adherence to treatment regimens and the emergence of drug-resistant mutations can impact the long-term efficacy of treatments like PREZISTA[2][4].

Key Takeaways

• PREZISTA is a protease inhibitor used in combination with other antiretroviral drugs for HIV-1 treatment.
• The drug is undergoing regulatory review for expanded pediatric indications.
• The global HIV drugs market is expected to grow significantly, driven by increased prevalence, new product launches, and greater affordability.
• North America, particularly the U.S., is a dominant market due to high HIV prevalence and awareness.
• Key players like Janssen and Gilead Sciences are driving innovation and market growth.

FAQs

What is PREZISTA used for?

PREZISTA (darunavir) is used in the treatment of HIV-1 infection in combination with other antiretroviral medicinal products.

Who can use PREZISTA?

PREZISTA is indicated for adult and pediatric patients (from the age of 3 years and at least 15 kg) with HIV-1 infection, and there are ongoing efforts to expand its indication to younger pediatric patients.

What are the common co-administrations with PREZISTA?

PREZISTA is commonly co-administered with either low-dose ritonavir or cobicistat to enhance its pharmacokinetic properties.

What is the market outlook for PREZISTA?

The market for PREZISTA is expected to grow as part of the broader HIV drugs market, driven by increased prevalence, new product launches, and greater affordability.

Are there generic versions of PREZISTA available?

Yes, a generic version of darunavir was approved by TEVA PHARMS USA in 2017[2].

What are the challenges facing the PREZISTA market?

Challenges include the high cost of treatment, issues with adherence, and the potential emergence of drug-resistant mutations.