The labeling for Evotaz (atazanavir and cobicistat; Bristol-Myers Squibb) has been updated to include data from Trial 114 as well as updates to the drug interactions and specific populations sections.

Trial 114 evaluated the safety and efficacy of atazanavir co-administered with cobicistat in HIV-1 infected treatment-naive patients with baseline estimated creatinine clearance (CrCl) >70mL/min. New Week 144 data showed that 10 patients (2.9%) treated with atazanavir co-administered with cobicistat and tenofovir DF, and 11 patients (3.2%) treated with atazanavir co-administered with ritonavir and tenofovir DF discontinued the study drug due to a renal adverse event. Seven subjects in the cobicistat group and seven patients in the ritonavir group showed laboratory findings consistent with proximal renal tubulopathy.  

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The labeling now states that prior to and during treatment with Evotaz, patients with underlying hepatitis B or C viral infections should undergo hepatic laboratory testing. In addition, Evotaz is not recommended in HIV-1 treatment-experienced patients with end-stage renal disease managed with hemodialysis. Co-administration with tenofovir disoproxil fumarate (DF) is not recommended in patients with estimated CrCl <70mL/min. Co-administration of Evotaz and tenofovir DF in combination with concomitant or recent use of a nephrotoxic agent is also not recommended. 

The table of contraindicated drugs has been modified to add elbasvir/grazoprevir. Concomitant use of this drug may increase the risk of ALT elevations due to a significant increase in grazoprevir plasma concentrations caused by OATP1B1/3 inhibition. 

In addition, the Pharmacodynamics section was updated with Cmax information and additional Week 144 study data.

Evotaz, a HIV-1 protease inhibitor + CYP3A inhibitor combination drug, is indicated to treat HIV-1 infection in combination with other antiretroviral agents. It is available as 300mg/150mg strength tablets in 30-count bottles. 

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