The US Food and Drug Administration has cleared Gilead’s Odefsey for the treatment of certain patients with HIV-1 infection.
Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide or TAF) is Gilead’s second TAF-based regimen to receive a US nod, following the approval of Genvoya (elvitegravir, cobicistat, emtricitabine and TAF) in November last year.
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 is indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per mL.
The therapy can also be used as replacement for a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey.
“As people are living longer with HIV, there is an increasing need to develop new treatments that are tolerable and help address long-term health for patients,” said John Martin, Gilead’s chief executive. “Odefsey’s safety, efficacy and tolerability profile offers a new treatment option to support the needs of a range of patients.”
On the safety side, the therapy does carry a boxed warning on the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.