FDA clears Gilead’s Odefsey, a Single-Pill for HIV Therapy
The US Food and Drug Administration has cleared Gilead’s Odefsey for the treatment of certain patients with HIV-1 infection.
Odefsey is Gilead’s second TAF-based regimen to receive approval from the US FDA, after the approval of Genvoya in November last year.
TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to a dose less than one-tenth that of Gilead’s Viread. Because TAF enters cells, including HIV-infected cells more efficiently than TDF, it can be given at a lower dose. The drug has also shown an improvement in renal and bone safety versus.
Odefsey is designated as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older who have no previous antiretroviral treatment 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.
John Martin, Gilead’s chief executive stated “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. Odefsey’s safety, efficacy and tolerability profile offers a new treatment option to support the needs of a range of patients.”
Although with regards to safety, 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.