FDA approves Odefsey for HIV-1 treatment
Odefsey combines emtricitabine and tenofovir alafenamide with rilpivirine to treat 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 (
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.
- U.S. Food and Drug Administration approves Gilead's second TAF-based single tablet regiment Odefsey® (emitricitabine, rilpivirine, tenofovir, alafenamide) for the treatment of HIV-1 infection [news release]. Foster City, CA: Gilead Sciences. Published March 1, 2016.