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The United States Food and Drug Administration (USFDA) has approved new drug regimen that includes Odefsey (Emtricitabine 200 mg, Rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for treatment of HIV-1 infection. The drug is to be manufactured by Gilead Sciences.
The drug is indicated for HIV patients who are 12 years of age and older, treatment-naïve with HIV-1 RNA levels less than or equal to 100,000 copies/mL. Odefsey is also a suitable replacement for stable antiretroviral regimen in virologically-suppressed patients without drug resistance to any individual drug of Odefsey.
Odefsey is to be marketed with Boxed Label Warning about the potential risk of developing severe hepatomegaly with steatosis, lactic acidosis and worsening of hepatitis B after Odefsey therapy.