The US Food and Drug Administration has approved Gilead’s Genvoya - which combines four medicines in a single pill - giving certain patients with HIV a new treatment option.
Genvoya is now licensed to treat HIV-1 infection in adults and paediatric patients 12 years of age and older, who either have no antiretroviral treatment history or to replace the current regimen in those virologically-suppressed (with no history of treatment failure or resistance to any Genvoya’s individual components).
The therapy - which contains elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (E/C/F/TAF) - is the first TAF-based regimen to win US clearance. TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate, TDF).
Because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a lower dose and there is 91% less tenofovir in the bloodstream, Gilead notes. The drug has also shown an improvement in renal and bone safety versus TDF, which is crucial given that HIV patients are at increased risk from age- and treatment-related comorbidities such as low bone mineral density and renal impairment.
“Given its demonstrated efficacy and safety profile, Genvoya represents an important new treatment option for a range of patients who are either new to therapy or who choose to switch treatments,” said David Wohl, Associate Professor of Medicine, Division of Infectious Diseases, University of North Carolina at Chapel Hill and lead author of the Genvoya efficacy analysis.
On the down side, the therapy does carry a boxed warning on the risk of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.