CLINICAL TRIALS PROFILE FOR REYATAZ

All Clinical Trials for Reyataz

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006604 ↗	Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2	2000-11-01	The purpose of this study was to find a safe and tolerable dose of the protease inhibitor (PI) atazanavir (ATV), with or without a low-dose boost of the PI ritonavir (RTV), when taken with other anti-HIV drugs in HIV infected infants, children, and adolescents. Advancements in anti-HIV drugs for HIV infected children and adolescents have been hard to make, in part because these patients often do not take the drugs as prescribed. ATV may be a better option because it is available in the form of powder which children and adolescents may be more willing to take regularly. Using a low dose of RTV as a boosting agent for ATV may also increase the chances of virologic response of highly active antiretroviral treatment (HAART)-experienced patients. This study aimed to find safe and tolerable doses of ATV with or without low-dose RTV boost in infants, children, and adolescents. For this study, participants were enrolled in the United States and South Africa.
NCT00006604 ↗	Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents	Completed	International Maternal Pediatric Adolescent AIDS Clinical Trials Group	Phase 1/Phase 2	2000-11-01	The purpose of this study was to find a safe and tolerable dose of the protease inhibitor (PI) atazanavir (ATV), with or without a low-dose boost of the PI ritonavir (RTV), when taken with other anti-HIV drugs in HIV infected infants, children, and adolescents. Advancements in anti-HIV drugs for HIV infected children and adolescents have been hard to make, in part because these patients often do not take the drugs as prescribed. ATV may be a better option because it is available in the form of powder which children and adolescents may be more willing to take regularly. Using a low dose of RTV as a boosting agent for ATV may also increase the chances of virologic response of highly active antiretroviral treatment (HAART)-experienced patients. This study aimed to find safe and tolerable doses of ATV with or without low-dose RTV boost in infants, children, and adolescents. For this study, participants were enrolled in the United States and South Africa.
NCT00006604 ↗	Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2	2000-11-01	The purpose of this study was to find a safe and tolerable dose of the protease inhibitor (PI) atazanavir (ATV), with or without a low-dose boost of the PI ritonavir (RTV), when taken with other anti-HIV drugs in HIV infected infants, children, and adolescents. Advancements in anti-HIV drugs for HIV infected children and adolescents have been hard to make, in part because these patients often do not take the drugs as prescribed. ATV may be a better option because it is available in the form of powder which children and adolescents may be more willing to take regularly. Using a low dose of RTV as a boosting agent for ATV may also increase the chances of virologic response of highly active antiretroviral treatment (HAART)-experienced patients. This study aimed to find safe and tolerable doses of ATV with or without low-dose RTV boost in infants, children, and adolescents. For this study, participants were enrolled in the United States and South Africa.
NCT00035932 ↗	Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV	Completed	Bristol-Myers Squibb	Phase 3	2001-11-01	The purpose of this study is to learn how well atazanavir (ATV) works in combination with ritonavir (RTV) or saquinavir (SQV) with tenofovir (TDF) and a nucleoside to reduce the viral load of treatment experienced subjects with human immunodeficiency virus (HIV). There is a comparison arm with lopinavir (LPV)/RTV and TDF and a nucleoside.
NCT00067782 ↗	A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on Their First PI-Based Antiretroviral Therapy	Completed	Bristol-Myers Squibb	Phase 3	2002-12-01	The purpose of this clinical research study is to learn if atazanavir is associated with serum LDL cholesterol in HIV-infected subjects following a substitution of atazanavir for their previously administered protease inhibitor.
NCT00074581 ↗	Preventing Sexual Transmission of HIV With Anti-HIV Drugs	Completed	HIV Prevention Trials Network	Phase 3	2005-02-01	This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.

Clinical Trial Conditions for Reyataz

Condition Name

Condition Name for Reyataz
Intervention	Trials
HIV Infections	33
HIV	10
HIV Infection	6
HIV-1 Infection	3

Condition MeSH

Condition MeSH for Reyataz
Intervention	Trials
HIV Infections	44
Acquired Immunodeficiency Syndrome	7
Immunologic Deficiency Syndromes	6
Hepatitis C	3

Clinical Trial Locations for Reyataz

Trials by Country

Trials by Country for Reyataz
Location	Trials
United States	201
South Africa	29
Mexico	22
Brazil	20
Argentina	17

Trials by US State

Trials by US State for Reyataz
Location	Trials
California	18
Florida	16
Texas	15
New Jersey	14
North Carolina	12

Clinical Trial Progress for Reyataz

Clinical Trial Phase

Clinical Trial Phase for Reyataz
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	14
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Reyataz
Clinical Trial Phase	Trials
Completed	56
Unknown status	4
Terminated	3

Clinical Trial Sponsors for Reyataz

Sponsor Name

Sponsor Name for Reyataz
Sponsor	Trials
Bristol-Myers Squibb	39
Merck Sharp & Dohme Corp.	5
National Institute of Allergy and Infectious Diseases (NIAID)	5

Sponsor Type

Sponsor Type for Reyataz
Sponsor	Trials
Industry	53
Other	36
NIH	8

REYATAZ (Atazanavir): Clinical Trials, Market Analysis, and Projections

Introduction to REYATAZ

REYATAZ, also known as atazanavir, is a protease inhibitor used in the treatment of HIV-1 infection. It is often coadministered with other antiretroviral medications to enhance its efficacy. Here, we will delve into the clinical trials, market analysis, and future projections for REYATAZ.

Clinical Trials Overview

Study 114: A Phase III Clinical Trial

One of the significant clinical trials for REYATAZ is Study 114, a randomized, double-blind, Phase III clinical trial. This study involved 692 treatment-naive adults and compared the efficacy and safety of REYATAZ 300 mg once-daily coadministered with either cobicistat 150 mg or ritonavir 100 mg, both in combination with emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg once-daily[1].

• Patient Characteristics: Participants had a baseline estimated creatinine clearance (CrCL) greater than 70 mL/min, a mean baseline plasma HIV-1 RNA of 4.8 log10 copies/mL, and a mean baseline CD4+ cell count of 352 cells/mm³.
• Outcomes: The study aimed to evaluate the virologic and immunologic responses, as well as the safety profile of the different treatment regimens.

96-Week Clinical Trial

Another key clinical trial involved a 96-week comparison of a REYATAZ and ritonavir-based treatment regimen to a lopinavir/ritonavir-based regimen. This trial included 878 adults living with HIV-1 and focused on achieving undetectable viral loads and increasing CD4+ T cell counts. The trial defined undetectable viral load as fewer than 50 copies/mL, depending on the lab test used[4].

Efficacy and Safety

Achieving Undetectable Viral Load

REYATAZ has been shown to be effective in helping patients achieve undetectable viral loads. In the 96-week clinical trial, the regimen containing REYATAZ and ritonavir demonstrated comparable efficacy to the lopinavir/ritonavir regimen in achieving and maintaining undetectable viral loads[4].

Common and Serious Side Effects

While REYATAZ is generally well-tolerated, it can cause several side effects. Common side effects include nausea, jaundice/scleral icterus, rash, headache, abdominal pain, vomiting, insomnia, peripheral neurologic symptoms, dizziness, myalgia, diarrhea, depression, and fever. Serious side effects can include new onset or exacerbations of diabetes mellitus/hyperglycemia, immune reconstitution syndrome, and redistribution/accumulation of body fat[3][4].

Market Analysis

Current Market Position

REYATAZ is part of the broader antiretroviral therapy market, which has seen significant advancements and competition. The HIV treatment market is characterized by a wide range of therapeutic options, including protease inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and integrase inhibitors.

Market Projections

While specific market projections for REYATAZ alone are not readily available, the overall HIV treatment market is expected to grow, albeit at a moderate pace. The introduction of new antiretroviral therapies and the continued need for effective HIV treatments drive this growth.

However, the market for HIV treatments is also subject to challenges such as the emergence of generic and biosimilar versions of branded drugs. For instance, the use of ritonavir, a common booster for protease inhibitors like REYATAZ, may see increased competition from generic versions, which could impact the market share of branded products[3].

Competitive Landscape

Comparison with Other Treatments

REYATAZ competes with other protease inhibitors and antiretroviral therapies. The choice of treatment often depends on factors such as patient tolerance, resistance profiles, and the presence of comorbidities.

Impact of Generic and Biosimilar Competition

The HIV treatment market is expected to face significant competition from generic and biosimilar products. This competition can erode the market share of branded drugs like REYATAZ, similar to what is observed in other therapeutic areas like rheumatoid arthritis and non-small cell lung cancer (NSCLC), where biosimilars significantly impact market dynamics[2][5].

Future Projections

Emerging Trends in HIV Treatment

The future of HIV treatment is likely to be shaped by advancements in antiretroviral therapy, including the development of new classes of drugs and improved formulations. For REYATAZ, maintaining its market position will depend on its continued efficacy, safety profile, and the ability to adapt to changing treatment paradigms.

Potential for Combination Therapies

REYATAZ is often used in combination with other antiretroviral drugs. The trend towards combination therapies is expected to continue, with a focus on regimens that offer improved efficacy, reduced side effects, and simpler dosing schedules.

Key Takeaways

• Clinical Efficacy: REYATAZ has demonstrated efficacy in achieving undetectable viral loads and increasing CD4+ T cell counts in clinical trials.
• Safety Profile: While generally well-tolerated, REYATAZ can cause common and serious side effects that need to be monitored.
• Market Dynamics: The HIV treatment market is competitive, with emerging generic and biosimilar competition that could impact the market share of branded products.
• Future Trends: The future of HIV treatment will be driven by advancements in antiretroviral therapy, including new drug classes and improved formulations.

FAQs

What is REYATAZ used for?

REYATAZ (atazanavir) is used in the treatment of HIV-1 infection, often in combination with other antiretroviral medications.

What are the common side effects of REYATAZ?

Common side effects include nausea, jaundice/scleral icterus, rash, headache, abdominal pain, vomiting, insomnia, peripheral neurologic symptoms, dizziness, myalgia, diarrhea, depression, and fever.

How does REYATAZ compare to other HIV treatments?

REYATAZ competes with other protease inhibitors and antiretroviral therapies. The choice of treatment depends on factors such as patient tolerance, resistance profiles, and the presence of comorbidities.

What are the potential impacts of generic and biosimilar competition on REYATAZ?

Generic and biosimilar versions of branded HIV treatments can erode the market share of products like REYATAZ, similar to trends seen in other therapeutic areas.

What are the future trends in HIV treatment that could affect REYATAZ?

The future of HIV treatment will be shaped by advancements in antiretroviral therapy, including new drug classes and improved formulations, with a focus on combination therapies that offer improved efficacy and reduced side effects.

Sources

1. EVOTAZ HCP: Study Design - EVOTAZ® (atazanavir/cobicistat) HIV Treatment.
2. GlobalData: Rheumatoid Arthritis - Global Drug Forecast and Market Analysis to 2029.
3. FDA: Safety Evaluator: Paula Gish, RPh Division.
4. REYATAZ: Getting to Undetectable Viral Load | REYATAZ® (atazanavir).
5. GlobalData: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.