FDA approval for the treatment of HIV-1

Evotaz received FDA approval for the treatment of HIV-1 in adults

US-FDA has approved the drug Evatoz for the treatment of human immunodeficiency virus (HIV-1) infection in January 2015. Evatoz is a fixed-dose combination of protease inhibitor, Atazanavir and the CYP3A inhibitor, cobicistat prescribed for the treatment of HIV-1 infection. These tablets has been prescribed to be taken in combination with other antiretroviral drugs for treating HIV in adult patients. Evotaz is the first and only protease inhibitor pharmacoenhanced by cobcistat with virologic failure rates falling to 6 per cent or low observed at 48 weeks.

Evotaz is formulated to be one pill combining antiretroviral agent Atazavir marketed as Reyataz and cobicistat, a pharmacokinetic enhancer. Atazanavir is an HIV-1 protease inhibitor. Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family.The recommended dosage of Evotaz in treatment-naïve and treatment-experienced patients is one pill taken daily once orally with food.

Evotaz and  do not cure HIV infection or AIDS but increases the possibility of suppressing HIV by joining reduced pill burden with lower rate of virologic failure and zero protease inhibitor. None of the patients in the Evotaz developed tenofovir-associated resistance K65R. Two patients developed emtricitabine resistance M184V. In the Reyataz /ritonavir arm, zero resistance was observed. Evotaz is contraindicated in patients possessing clinically significant hypersensitivity to any of its components and when giving in combination with certain drugs.

Evotaz is the first and only protease inhibitor pharmacoenhanced by cobicistat. These drug combination is supported by comparative Phase III trial data (Gilead Sciences Inc.’s Study 114). The efficacy and safety of Reyataz 300 mg with cobicistat 150 mg was tested in a 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. 

In 48 weeks of study, protease inhibitor resistance was detected as zero. None of the patients developed tenofovir‐associated resistance, and two patients in the Evotaz arm developed emtricitabine‐associated resistance. Different degrees of resistance and cross resistance have been observed with protease inhibitors. Resistance to Atazanavir do not prohibit the usage of other protease inhibitors. The drug has showed more safety profile compared to Reyataz/rironavir. The adverse events associated with the usage of Evotaz were jaundice, oral icterus, nausea and rashes which is not restricted to one symptom only. The discontinuation of Evotaz due to adverse events is similar to Reyataz which is as low as 7% respectively.

Evotaz is not recommended to use in patients with previously demonstrated clinically significant hypersensitivity. Should not be used in combination with drugs that dependant on CYP3A and induce CYP3A which may lead to lower exposure of Evotaz and loose its therapeutic efficacy and development of resistance. Evotaz is not recommended for patients with hepatic impairment. Evotaz is not recommended in combination with products containing Atazanavir or cobicistat, individual components of Evotaz or in combination with products having ritonavir.