Evotaz (atazanavir and cobicistat)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved January 2015

Specific Treatments:

HIV-1 infection

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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/