New Single Tablet Regimen Odefsey Approved for Treating HIV Infection
March 2, 2016
On March 1, 2016, a new single tablet regimen (STR) was approved by the FDA for treating HIV infection. Called Odefsey, the new once-a-day pill is comprised of three HIV drugs: emtricitabine, rilpivirine andtenofovir alafenamide (TAF).
Odefsey differs slightly from Complera, another STR approved in 2013 which also contains emtricitabine and rilpivirine, but it substitutes tenofovir disoproxil fumarate (TDF) for TAF. TAF accumulates at significantly higher levels inside cells, which is where the drug needs to go, leaving blood levels much lower. This has led to improved lab markers of bone and kidney health. Odefsey is also the second STR to be approved with TAF, right after Genvoya.
The new pill can be prescribed for people who are going on HIV treatment for the first time so long as their viral load comes under 100,000 copies HIV RNA. Odefsey can also be used in people whose current regimen has maintained an undetectable level below 50 copies for at least six months with no history of treatment failure or no known mutations to any of the drugs in the pill. People with reduced kidney function (such as an eCrCl above or equal to 30 mL/min) can take Odefsey.
FDA approval was based upon the results from bioequivalence studies that compared the drug blood levels of emtricitabine and TAF in the Odefsey regimen to that of Genvoya (evitegravir/cobicistat/emtricitabine/TAF). As well, the drugs in the Odefsey regimen were compared to the drugs in the Complera regimen for equal control of HIV. These studies were done in a variety of patients, including those new to treatment, those experienced with treatment who switched and those with mild to moderate kidney dysfunction.
The newer version of tenofovir, TAF, is a smaller molecule than the older TDF version, allowing TAF to enter immune cells much more efficiently to suppress HIV. This results in 90% less TAF in the bloodstream, thereby reducing the drug's exposure to cells, tissues and organs. Further, two improvements have been seen in clinical studies from using TAF vs. TDF: improved kidney health and improved bone health.
For people who need financial assistance with covering the costs of Odefsey, one of the medication's manufacturers offers its Advancing Access Copay Program (www.gileadadvancingaccess.com) which helps patients to cover out-of-pocket costs and its Advancing Access Patient Assistance Program (same URL) which covers the cost of the medication in full for those who qualify.
The newer version of tenofovir, TAF, is a smaller molecule than the older TDF version, allowing TAF to enter immune cells much more efficiently to suppress HIV. This results in 90% less TAF in the bloodstream, thereby reducing the drug's exposure to cells, tissues and organs. Further, two improvements have been seen in clinical studies from using TAF vs. TDF: improved kidney health and improved bone health.
For people who need financial assistance with covering the costs of Odefsey, one of the medication's manufacturers offers its Advancing Access Copay Program (www.gileadadvancingaccess.com) which helps patients to cover out-of-pocket costs and its Advancing Access Patient Assistance Program (same URL) which covers the cost of the medication in full for those who qualify.
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