FDA approves gentler combo

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06 Nov 2015

The first HIV drug combination containing the new tenofovir — Genvoya — has been approved by the US Food and Drug Administration (FDA). Developed by Gilead, Genvoya is a fixed-dose, single-tablet regimen comprising of elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (or TAF).

Genvoya is, in essence, an improved version of Gilead’s Stribild which contains the first generation tenofovir (TDF). In comparison to TDF, TAF has shown to be less toxic and gentler on the kidneys and bones. This is because a much lower dose is required.

Genvoya is intended for adults and adolescents 12 and older living with HIV. The FDA is reviewing three other regimens containing TAF, including a reformulated Truvada. In September, European Union regulators recommended approval of Genvoya; the application will now sit before the European Commission for final sign off.

Genvoya is up for S-100 approval by the Pharmaceutical Benefits Advisory Committee (PBAC) later this month. If approved, it will be made available in Australia early next year.