SYMTUZA (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide tablet )

SYMTUZA (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide tablet )

SELF-ADMINISTRATION – ORAL

Indications for Prior Authorization:

• Indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults:
  • Who have no prior antiretroviral treatment history OR
  • Who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir

Patients must meet the following criteria for the indication(s) above:

• Diagnosis of HIV, AND
• 18 years or older, AND
• Renewal/continuation: Viral load <50 and stable/increasing CD4 count indicating that patient is stable on Symtuza™
• Treatment experienced: a documented resistance test within the past 3 months demonstrating virologic susceptibility to all of the following components of Symtuza™: darunavir, cobicistat, emtricitabine, and tenofovir alafenamide, AND tried and failed any antiretroviral agent
• Treatment naïve patients: a documented resistance test within the past 3 months demonstrating virologic susceptibility to all of the following components of Symtuza™: darunavir, cobicistat, emtricitabine and tenofovir alafenamide, AND tried and failed Symfi or Symfi Lo
• Not recommended in patients with severe renal impairment (CrCL < 30 mL/min)
• Not recommended in patients with severe hepatic impairment (Child-Pugh Class C)
• Not recommended during pregnancy
• Patients with HIV-1 should be tested for the presence of chronic hepatitis B before starting antiretroviral therapy
• Contraindicated with the following co-administered drugs due to the potential for serious and/or life-threatening events or loss of therapeutic effect: Alpha 1-adrenoreceptor antagonist: alfuzosin, Antianginal: ranolazine, Antiarrhythmic: dronedarone, Anticonvulsants: carbamazepine, phenobarbital, phenytoin, Anti-gout: colchicine, in patients with renal and/or hepatic impairment, Antimycobacterial: rifampin, Antipsychotics: lurasidone, pimozide, Ergot derivatives, e.g., dihydroergotamine, ergotamine, methylergonovine, GI motility agent: cisapride, Herbal product: St. John's wort (Hypericum perforatum), Hepatitis C direct-acting antiviral: elbasvir/grazoprevir, Lipid modifying agents: lomitapide, lovastatin, simvastatin, PDE-5 inhibitor: sildenafil when used for treatment of pulmonary arterial hypertension, Sedatives/hypnotics: orally administered midazolam, triazolam

Dosing:

• One tablet once daily with food
• For those unable to swallow a whole tablet, Symtuza™ may be split into two pieces using a tablet-cutter, and the entire dose should be consumed immediately after splitting

Approval:

• 1 year