• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Evotaz (atazanavir and cobicistat)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Evotaz (atazanavir and cobicistat)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Evotaz is a fixed-dose combination of the HIV-1 antiretroviral drug, atazanavir and the CYP3A inhibitor, cobicistat. 

    Evotaz is specifically indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults.

    Evotaz is supplied as a tablet for oral administration. In treatment-naive and -experienced adults, the recommended dosage of Evotaz is one tablet taken once daily orally with food. Administer Evotaz in conjunction with other antiretroviral agents.

    Clinical Results

    FDA Approval

    The FDA approval of Evotaz was based on comparative Phase III trial data (Gilead Sciences, Inc.’s Study 114). The randomized, double-blind clinical trial (N=692) evaluated the efficacy and safety of Reyataz 300 mg with cobicistat 150 mg (the components of Evotaz) (n=344) versus Reyataz 300 mg with ritonavir 100 mg (Reyataz/ritonavir) (n=348), another pharmacokinetic enhancing agent, in combination with emtricitabine/tenofovir disoproxil fumarate in treatment-naive adults. Patients had a baseline estimated CrCL >70mL/min, a mean baseline plasma HIV-1 RNA of 4.8 log10 copies/mL, and a mean baseline CD4+ cell count of 352 cells/mm. At 48 weeks, 85% of patients in the Evotaz arm achieved HIV-1 RNA levels of <50 copies/mL compared to 87% of patients in the Reyataz/ritonavir arm. Low rates of virologic failure (HIV-1 RNA >50 copies/mL: 6% Evotaz arm; 4% Reyataz/ritonavir arm) were observed at 48 weeks, making Evotaz the only protease inhibitor pharmacoenhanced with cobicistat with virologic failure rates as low as 6%. 

    Side Effects

    Adverse effects associated with the use of Evotaz may include, but are not limited to, the following:

    • jaundice
    • ocular icterus
    • nausea

    Mechanism of Action

    Evotaz is a fixed-dose combination of atazanavir and cobicistat. Atazanavir is an HIV-1 protease inhibitor. Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family.

    Additional Information

    For additional information regarding Evotaz or HIV-1 infection, please visit http://www.bms.com/

    Approval Date: 2015-01-01
    Company Name: Bristol-Myers Squibb
    Back to Listings

    Upcoming Events

    • 26Jan

      Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

    • 27Jan

      Medical Device Clinical Trials in China: Latest Regulatory Developments

    • 11Feb

      Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

    • 23Mar

      Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

    • 26Apr

      MAGI's Clinical Research vConference — Spring 2021

    Featured Products

    • Regenerative Medicine – Steps to Accelerate Development : PDF

      Regenerative Medicine: Steps to Accelerate Development

    • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

      Clinical Trial Agreements: A Guide to Key Words and Phrases

    Featured Stories

    • Virtual Doctoer

      Simple Changes Can Make Trials More Patient Friendly

    • Drug approval

      Two-Thirds of Trial Subjects for Drug Approvals Are Outside the U.S.

    • VaccinewithNeedle-360x240.png

      Rules of Vaccine Approval May Be Changing, But Statistical Analysis Tools Remain Constant

    • AskTheExperts-360x240.png

      Ask the Experts: Trial Operations Adjustments in a Remote World

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing