FDA approves Odefsey for treatment of HIV

The FDA recently approved Odefsey, a tenofovir alafenamide-based regimen, for the treatment of HIV-1 infection, according to a press release from the drug’s manufacturer.

The new regimen contains 200 mg emtricitabine (Gilead Sciences; F), 25 mg Edurant (rilpivirine, Janssen Therapeutics; R) and 25 mg tenofovir alafenamide (Gilead Sciences; TAF), and represents the smallest pill of any single tablet regimen, the release said. It is the second TAF-based regimen approved by the FDA and is indicated for patients aged 12 years and older with no history of ART and maximum HIV-1 RNA levels of 100,000 copies/mL. R/F/TAF also may be used as a substitute for a stable ART regimen in patients who have been virologically suppressed for at least 6 months.

The approval is based on the results of clinical trials that assessed the safety, efficacy and tolerability of rilpivirine-based therapy administered as R/F/Viread (tenofovir disoproxil fumarate, Gilead Sciences; TDF) and R plus F/TDF, and F/TAF-based therapy administered as Genvoya (elvitegravir/cobicistat/emtricitabine/TAF, Gilead Sciences; E/C/F/TAF) in various HIV-positive populations including treatment-naive adults and adolescents and virologically suppressed adults with or without mild-to-moderate renal impairment who switched from protease inhibitor-, non-nucleoside reverse-transcriptase inhibitor-, and integrase strand-transfer inhibitor-based regimens. A bioequivalence study demonstrated that R/F/TAF achieved similar drug levels as E/C/F/TAF and F in the blood.

TAF is administered in a lower dose compared with TDF and reduces the amount of tenofovir in the bloodstream by 90%, the release said. Data from clinical trials also demonstrated that TAF improved renal and bone safety vs. TDF.

John C. Martin

“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,” John C. Martin, PhD, chairman and chief executive officer of Gilead Sciences, said in the release. “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.”

The new treatment carries a boxed warning alerting health care providers of the risk for lactic acidosis and severe hepatomegaly with steatosis, and the worsening of hepatitis B in coinfected patients post treatment.

The most common adverse events associated with rilpivirine are depression, insomnia and headaches, according to the release. The most frequent adverse event associated with emtricitabine and TAF is nausea.

Disclosure: Martin is an employee of Gilead Sciences.