Odefsey: New HIV Combination Pill is More Gentle on Bones, Kidneys
The FDA has approved a new once-daily drug regimen for the treatment of HIV. Odefsey, by Gilead Sciences, is composed of emtricitabine (200 mg), rilpivirine (25 mg), and tenofovir alafenamide (25 mg).
Odefsey contains the same drugs as Complera, except it replaces disoproxil fumarate (TDF) with tenofovir alafenamide (TAF). TAF is a prodrug of tenofovir that delivers high antiviral efficacy at a much lower dose than TDF. The lower dose of TAF that can be used to treat HIV means that it has a better safety profile—and is easier on the kidneys and bones—than TDF.
“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 C. Martin, PhD, chairman and chief executive officer of Gilead Sciences. “Odefsey’s safety, efficacy and tolerability profile offers a new treatment option to support the needs of a range of patients and represents Gilead’s commitment to innovation in the field of HIV.”
Odefsey is approved to treat HIV infection in people age 12 and older with no prior antiretroviral therapy history and viral load less than or equal to 100,000 copies/mL. It is also approved to replace an existing stable ARV regimen in people who are virally suppressed below 50 copies/mL for at least six months with no history of treatment failure.
This is the second TAF-containing once-daily pill approved by the FDA for the treatment of HIV. Genvoya, also developed by Gilead Sciences, was approved by the FDA in November, 2015.
Gilead’s Patient Assistance Program provides information and assistance to people who are uninsured, under-insured or need financial assistance to pay for their medications. Learn more about the assistance program at www.gileadadvancingaccess.com or by calling 1-800-GILEAD-5.