Odefsey® (emtricitabine/rilpivirine/tenofovir alafenamide) – New Drug Approval • On March 1, 2016, Gilead announced the FDA approval of Odefsey (emtricitabine/ rilpivirine/ tenofovir alafenamide), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in patients ≥ 12 years of age as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA ≤ 100,000 copies per mL; or to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA < 50 copies/mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey.
• Odefsey is a fixed dose combination tablet containing emtricitabine and tenofovir alafenamide, both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTI), and rilpivirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI).
• Gilead’s Genvoya® (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) was the first tenofovir alafenamide-based regimen that was recently FDA-approved.
• The safety and efficacy of Odefsey is supported by clinical studies of rilpivirine-based therapy and emtricitabine/ tenofovir alafenamide-based therapy in a range of patients with HIV, including treatment- naïve adults and adolescents, virologically suppressed adults who switched from protease inhibitor-, NNRTI-, and integrase strand transfer inhibitor-based regimens, and virologically suppressed adults with mild-to-moderate renal impairment.
• A bioequivalence study demonstrated that Odefsey achieved similar drug levels of emtricitabine and tenofovir alafenamide as Genvoya and similar drug levels of rilpivirine as Edurant® (rilpivirine).
• Odefsey carries a boxed warning for lactic acidosis/severe hepatomegaly with steatosis and post- treatment acute exacerbation of hepatitis B.
• Odefsey is contraindicated when co-administered with certain medications as significant decreases in rilpivirine plasma concentrations may occur due to cytochrome P450 3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance to Odefsey or to the class of NNRTIs.
• Other warnings and precautions of Odefsey include skin and hypersensitivity reactions, prolongation of QTc interval with higher than recommended dosages, depressive disorders, hepatotoxicity, fat redistribution, immune reconstitution syndrome, new onset or worsening renal impairment, and bone loss and mineralization defects.
• The most common adverse reactions with rilpivirine use (≥ 2%, grades 2-4) were depressive disorders, insomnia, and headache. The most common adverse reaction with emtricitabine and tenofovir alafenamide use (≥ 10%, all grades) was nausea.
• The recommended dosage of Odefsey is one tablet taken orally once daily with a meal in adults and/or pediatric patients ≥ 12 years of age with a body weight ≥ 35 kg and a creatinine clearance ≥ 30 mL/min.
— Prior to initiation of Odefsey, patients should be tested for hepatitis B virus infection. — Estimated creatinine clearance, urine glucose, and urine protein should be assessed prior to and monitored during therapy.
Continued . . . — In virologically-suppressed patients, additional monitoring of HIV-1 RNA and regimen tolerability is recommended after replacing therapy to assess for potential virologic failure or rebound.
• Gilead plans to launch Odefsey (emtricitabine 200 mg/ rilpivirine 25 mg/ tenofovir alafenamide 25 mg) as a fixed-dose combination tablet this week.
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