New TAF-Based HIV Treatment Odefsey Approved

The FDA has approved emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg (Odefsey) as a new treatment for HIV-1 infection in certain patients.

Odefsey is Gilead’s second tenofovir alafenamide-based HIV regimen to receive FDA approval, and it is the smallest pill of any single-tablet regimen for HIV.

The treatment is designed for patients who are aged 12 years or older, have no antiretroviral treatment history, and have HIV-1 RNA levels ≤100,000 copies/mL. Odefsey can also be used as a replacement for a stable antiretroviral regimen for patients who are virologically suppressed for at least 6 months with no history of treatment failure.

For patients with estimated creatinine clearance of ≥30 mL per minute, no dosage adjustment of Odefsey is necessary.

Pharmacists should make sure patients are aware that the treatment carries a boxed warning about the risks for lactic acidosis/severe hepatomegaly with steatosis and post-treatment acute exacerbation of hepatitis B.

“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 CEO of Gilead Sciences, in a press 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 FDA’s nod to Odefsey was based on a bioequivalence study showing that the treatment lead to similar drug levels of emtricitabine and tenofovir alafenamide in the blood as Genvoya, and similar rilpivirine levels as Edurant.