Gilead‘s Genvoya HIV Treatment gets FDA Approval

11.11.2015 -

The US Food and Drug Administration (FDA) has approved Gilead Sciences’ Genvoya to treat HIV-1 infection. Genvoya combines four treatments – elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (E/C/F/TAF) – in a single pill and is the first TAF-based substance to get US clearance.,TAF is a novel targeted prodrug of tenofovir that has shown high antiviral efficacy similar to and at a dose less than one-tenth of Gilead’s Viread (teneofovir disoproxil fumarate, TDF). Because TAF enters cells, including HIV-infected cells, more efficiently than TDF it can be given at a lower dose with 91% less tenofovir in the bloodstream.

The drug is said to have also demonstrated an improvement in renal and bone safety, an important factor given that HIV patients face an increased risk of developing age-  and treatment-related comorbidities, including low bone mineral density and renal impairment. Indications are for adult and pediatric patients aged 12 and older who have no history of antiretroviral treatment, or to replace a current regime for those who suffer from viral suppression.

Gilead Sciences said Genvoya is the first in a portfolio of TAF-based products that could potentially advance long-term treatment of HIV. The FDA is currently evaluating two other investigational TAF-based treatments. The first is a fixed-dose combination of emtricitabine and tenofovir alafenamide for use with other antiretroviral agents. The second is a once-daily single pill that combines emtricitabine, tenofovir alafenamide from Gilead and rilpivirine from Janssen Sciences Ireland.