Gilead Sciences, Inc. (GILD) announced that the European Commission has granted marketing authorization for once-daily Tybost™, a pharmacokinetic enhancer that boosts blood levels of certain HIV medicines.
The company said Tybost is indicated as a boosting agent for the HIV protease inhibitors atazanavir 300 mg once daily and darunavir 800 mg once daily as part of antiretroviral combination therapy in adults with HIV-1 infection. The approval allows for the marketing of Tybost in all 28 countries of the European Union or EU.
Gilead noted that the EU approval of Tybost is supported by 48-week data from a pivotal Phase 3 study which found that Tybost was non-inferior to ritonavir when administered with an antiretroviral regimen of atazanavir plus Truvada® in HIV-infected treatment-naïve adults.
Approval is also supported by pharmacokinetic data demonstrating that Tybost boosts blood levels of atazanavir and darunavir similar to ritonavir. Tybost should only be co-administered with atazanavir or darunavir, the company commented.
In Study 114, Tybost was well tolerated and most adverse events were mild to moderate. The most common adverse reactions were jaundice, ocular icterus and nausea.
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