European regulators have granted marketing authorisation to Gilead's Odefsey for the treatment of certain patients with HIV-1 infection.
Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide or TAF) is Gilead's third TAF-based regimen to receive a Euroean nod, following the approval of Genvoya (elvitegravir, cobicistat, emtricitabine and TAF) and Descovy.
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 has also shown an improvement in renal and bone safety versus.
Odefsey has been cleared for the treatment of adults and adolescents (ages 12 years and older with body weight at least 35 kg) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load less than 100,000 HIV-1 RNA copies/ml.
"People living with HIV today are increasingly likely to be receiving treatment for other conditions - such as heart and liver disease because they are living longer than ever before, exposing them for longer periods of time to the virus and to the medications used to treat it. Therefore, we need new treatment options that are not only efficacious but also tolerable, and with convenient dosing," said Andy Ustianowski, MD, North Manchester General Hospital.
"Odefsey combines the antiviral efficacy and safety profile of the new Descovy backbone with the established tolerability profile of rilpivirine as a third agent."