FDA Approves Evotaz as New HIV Treatment

January 29, 2015
Meghan Ross, Associate Editor

The FDA today approved Bristol-Myers Squibb Company's atazanavir and cobicistat for the treatment of HIV-1 infection in adults in combination with other antiretroviral agents.

The FDA today approved Bristol-Myers Squibb Company’s atazanavir and cobicistat (Evotaz) for the treatment of HIV-1 infection in adults in combination with other antiretroviral agents.

Evotaz is a once-daily pill that has been proven to suppress HIV through 48 weeks, according to the manufacturer’s press release.

The pill is the first and only protease inhibitor pharmacoenhanced by cobicistat that is supported by Phase III trial data, Bristol-Myers Squibb stated. Researchers examined 692 people who either received Evotaz or Reyataz 300mg with ritonavir 100mg, along with emtricitabine/tenofovir disoproxil fumarate. At the 48-week mark, the patients who took Evotaz saw lower HIV-RNA levels in comparison.

In addition, 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.

“Evotaz increases the possibility of providing HIV suppression by combining reduced pill burden with a low rate of virologic failure and zero protease inhibitor mutations,” Murdo Gordon, head of Worldwide Markets, Bristol-Myers Squibb, said in a press release.

Some of the common side effects reported were rash, jaundice, ocular icterus, and nausea.