Two New HIV-1 Drugs Get FDA Approval

On September 25, the Food and Drug Administration (FDA) approved two HIV-1 drugs by Gilead: Tybost (cobicistat) and Vitekta (elvitegravir).

Tybost, a CYP3A inhibitor, is indicated to increase systemic exposure of atazanavir or darunavir in combination with other antiretroviral agents in the treatment of HIV-1 infection.

Its approval was based on data from Phase 2 and 3 trials in treatment-naïve adults comparing atazanavir/cobicistat 300/150mg vs. atazanavir/ritonavir 300/100mg once daily each in combination with Truvada. Study results showed that the atazanavir/cobicistat-based regimen was non-inferior to the atazanavir/ritonavir-based regimen.

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Vitekta, an HIV-1 integrase strand transfer inhibitor, is indicated in combination with an HIV protease inhibitor coadministered with ritonavir and with other antiretroviral drugs for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults.

Its approval was based on data from Study 145, a Phase 3 trial of treatment-experienced adult patients with HIV-1 that received Vitekta (N=354) or raltegravir (N=358), each administered with a background regimen consisting of a fully active protease inhibitor coadministered with ritonavir and with other antiretroviral drug(s) for at least 96 weeks. The mean increase from baseline in CD4+ cell count at Week 96 was 205 cells/mm3 in Vitekta-treated patients and 198 cells/mm3 in raltegravir-treated patients.

Tybost will be available in 150mg strength tablets in 30-count bottles. Vitekta will be available in 85mg and 150mg strength tablets.

For more information call (800) 445-3235 or visit Gilead.com.

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