Today the FDA approved Bristol-Myers Squibb Company’s new HIV antiretroviral combination EVOTAZ. Evotaz is a combination of atazanavir and Cobicistat and is approved for the treatment of HIV-1 infection in adults in combination with other antiretroviral agents.
Evotaz is a once daily pill that has shown in studies to suppress HIV through 48 weeks.
The pill is the first protease inhibitor pharmacoenhanced by cobicistat and is supported by Phase III clinical trial data from the Gilead Sciences, Inc.’s Study 114. The trial was a randomized, double-blind clinical trial that looked at 692 individuals received either EVOTAZ or reyataz 300mg and ritonavir 100mg along with Truvada. At 48 weeks the patients on EVOTAZ showed lower HIV-RNA levels than the comparator arm.
Low rates of virologic failure were seen at 48 weeks for the Evotaz arm, which means the pill is the only protease inhibitor pharmacoenhanced with cobicistat with virologic failure rates as low as 6%. No protease inhibitor resistance was detected throughout the study period, as well.
Most common side effects reported were rash, jaundice, ocular icterus (yellowing of the eyes) and nausea