Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved Evotaz (atazanavir and cobicistat) in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

Evotaz combines atazanavir (Reyataz), a protease inhibitor, and cobicistat (Tybost; Gilead), a CYP3A4 inhibitor. Atazanavir selectively inhibits the virus-specific processing of viral Gag and Gag-Pol polyproteins in HIV-1 infected cells, thus preventing formation of mature virions. Cobicistat enhances the systemic exposure of CYP3A4 substrates through its selective mechanism-based inhibition.

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The FDA approval is based on a Phase 3 randomized, double-blind clinical study (n=692) that evaluated the efficacy and safety of atazanavir 300mg plus cobicistat 150mg vs. atazanavir 300mg plus ritaonavir 100mg, in combination with emtricitabine/tenofovir disoproxil fumarate in treatment-naive adults. The study showed at Week 48, 85% of patients in the atazanavir plus cobicistat arm achieved HIV-1 RNA levels of <50 copies/mL vs. 87% of those in the atazanavir plus ritonavir arm. Also, low rates of virologic failure were seen at Week 48, making atazanavir plus cobicistat the only protease inhibitor enhanced with cobicistat with virologic failure rate as low as 6%.

Evotaz will be available in 300mg/150mg fixed-dose tablets in 30-count bottles.

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