Evotaz, New Once-Daily HIV Drug, Approved by FDA

January 30, 2015

On Jan. 29, the U.S. Food and Drug Administration (FDA) approved Evotaz, a once-daily combination tablet, for the treatment of HIV in adults.

The new single-tablet drug contains 300 mg of the protease inhibitor atazanavir (Reyataz) and 150 mg of the pharmacokinetic booster cobicistat (Tybost). Evotaz is recommended to be taken once a day with food, and in conjunction with other antiretroviral agents.

One Evotaz tablet provided similar levels of atazanavir when compared to taking atazanavir and cobicistat separately, according to the FDA press release.

A previous study showed that cobicistat was non-inferior to ritonavir (Norvir) when used to boost atazanavir, while another study found that cobicistat was well-tolerated by HIV-positive patients with mild to moderate renal impairment who made the switch from ritonavir as a booster.

In another study comparing safety profiles, the most common side effects when taking atazanavir with cobicistat were jaundice (13%), ocular icterus (15%) and nausea (12%). These side effects were similar for patients taking atazanavir with ritonavir, according to the FDA press release.

The approval of Evotaz may help patients reduce the number of pills in their regimen, potentially relieving pill burden and increasing adherence.

"Use of Evotaz in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions," the FDA states.

Evotaz is manufactured by the pharmaceutical company Bristol-Myers Squibb.

[CORRECTION 1/30: An earlier version of this article incorrectly stated that Evotaz is a single-pill regimen. We have corrected the text to reflect that Evotaz is meant to be taken in combination with other antiretroviral agents.]

Warren Tong is the senior science editor for and

Follow Warren on Twitter: @WarrenAtTheBody.

Copyright © 2015 Remedy Health Media, LLC. All rights reserved.

This article was provided by TheBodyPRO.


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