European regulators have approved Gilead’s Genvoya for the treatment of HIV, giving adult and adolescent patients the potential to access a novel, once daily, single-tablet regimen that offers viral suppression alongside other important long-term health benefits.

The therapy - which contains elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (E/C/F/TAF) - is the first TAF-based regimen to win both EU and US regulatory 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, thereby offering additional long-term health benefits.

Viral supression non-inferior, better tolerability

Genvoya’s marketing authorisation is supported by 48-week data from two ongoing Phase III studies among 1,733 treatment-naïve adult patients, in which the regimen met its primary endpoint of non-inferiority compared to its single pill HIV therapy Stribild (elvitegravir, cobicistat, emtricitabine and TDF). 

In the combined analysis of the studies, 92% of Genvoya patients and 90% of Stribild patients had HIV-1 RNA levels less than 50 copies/mL at Week 48, while tests of certain renal and bone laboratory parameters also favoured Genvoya, the firm said.

“As people living with HIV can now expect to live a normal life expectancy it is critically important that the treatment choices we make consider our long-term health. New medicines with improved tolerability are vital to ensure we remain in the best health,” Robert Fieldhouse, HIV activist and editor and publisher of BASELINE, told PharmaTimes, commenting on the drug’s approval.

A spokesperson for Gilead said Genvoya’s final cost is yet to be confirmed, as the reimbursement process is still ongoing.