Tybost (cobicistat; Gilead) is a boosting agent to be used in combination with protease inhibitors (PIs) as part of treatment regimens for HIV-1 infection. It is also a component of the single-tablet regimen Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate). Tybost has no inherent antiretroviral activity. It inhibits cytochrome P450 3A4, an enzyme that metabolizes drugs, including PIs. This enables enhanced pharmacokinetics of PIs, allowing decreased dosing and a reduction in adverse events.
A failure to provide any clinical advantage over the current standard-of-care boosting agent Norvir (ritonavir; AbbVie) means that Tybost (cobicistat; Gilead) will struggle to compete as a standalone agent to be used in combination with protease inhibitors (PIs) or integrase inhibitors. Tybost’s best chance of commercial success is as a component of Gilead’s single-tablet regimens (STRs) Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate [TDF]) and Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate [TAF]), and as a component of fixed-dose combinations (FDCs) with PIs.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Tybost : HIV
LIST OF FIGURES
11 Figure 1: Tybost for HIV-1 infection – SWOT analysis
11 Figure 2: Datamonitor Healthcare drug assessment summary of Tybost in HIV-1
12 Figure 3: Datamonitor Healthcare drug assessment summary of Tybost in HIV-1
LIST OF TABLES
4 Table 1: Tybost drug profile
6 Table 2: Tybost pivotal trial data in HIV-1 infection
9 Table 3: Tybost late-phase trial data in HIV-1 infection
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