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 and pediatric patients weighing at least 35 kg. 

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.

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.

Side Effects

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

• jaundice
• rash

Clinical Trial Results

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%.