FDA Approves Odefsey, New One-Pill-A-Day Regimen

On March 1, the U.S. Food and Drug Administration approved Odefsey, a new one-pill-a-day HIV regimen. The tablet contains three HIV drugs: 1) the non-nuke rilpivirine made by Janssen Therapeutics; 2) the nuke emtricitabine (FTC) made by Gilead Sciences; and 3) a newer form of the nuke tenofovir called tenofovir alafenamide, or TAF for short. TAF is also made by Gilead.

"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, Gilead Science. "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 older form of tenofovir, called tenofovir disoproxil fumarate or TDF, was approved by the FDA in 2001. TDF is a component in most current HIV treatment regimens, as well as in the only FDA-approved pill to prevent HIV transmission (Truvada). TAF is not available as a stand-alone pill. The only other HIV combination pill containing TAF -- Genvoya --was approved by FDA last fall.

Odefsey is essentially an updated version of an earlier once-daily HIV regimen called Complera. Both tablets contain rilpivirine and FTC, but in the case of Odefsey, the TAF form of tenofovir replaces the TDF from in Complera.

The TAF form of tenofovir provides lower levels of drug in the bloodstream, but higher levels within the cells, where the HIV virus replicates. TAF was developed to help reduce drug side effects, including decreased bone density and kidney toxicity, sometimes seen in persons taking the older form of tenofovir (TDF). Consequently, the substitution of TAF for TDF is designed to significantly reduce the risk of such side effects.

Gilead notes that the approval is supported by a bioequivalence study demonstrating that Odefsey achieved similar 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). The safety, efficacy and tolerability of Odefsey is supported by clinical studies of rilpivirine-based therapy (administered as R+F/TDF or R/F/TDF) and F/TAF-based therapy (administered as E/C/F/TAF) in a range of patients with HIV, including treatment-na�ve adults and adolescents, virologically suppressed adults who switched from PI-, NNRTI- and INSTI-based regimens and virologically suppressed adults with mild-to-moderate renal impairment.