FDA Green Lights Odefsey for Treating HIV-1

Officials with the FDA this week approved the smallest pill of any single tablet regimen for the treatment of HIV in certain patients.

Combining emtricitabine and tenofovir alafenamide (Gilead Sciences) and rilpivirine (Janssen Sciences),   Odefsey is Gilead’s second tenofovir alafenamide-based regimen to receive FDA approval. 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 at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of the medication. No dosage adjustment of Odefsey is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.

The medication has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.