FDA approves Gilead Sciences’ Odefsey to treat HIV-1 infection

Emtricitabine and tenofovir alafenamide are from Gilead Sciences, while rilpivirine is from Janssen Sciences Ireland UC.

Odefsey is Gilead’s second TAF-based regimen to secure FDA approval and represents the smallest pill of any single tablet regimen to treat HIV.

It 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.

Odefsey is also indicated as replacement for a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for about six months with no history of treatment failure and no known substitutions related with resistance to its individual components.

Gilead said no dosage adjustment of Odefsey is needed in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.

The FDA approval was based on a bioequivalence study, which showed that Odefsey achieved same drug levels of emtricitabine and TAF in the blood as Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) and similar drug levels of rilpivirine as Edurant (rilpivirine 25 mg).

Gilead Sciences chairman and CEO John Martin said: "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 and represents Gilead’s commitment to innovation in the field of HIV."