Symtuza
DRV/COBI/FTC/TAF darunavir/cobicistat/emtricitabine/tenofovir alafenamide

Standard Dose
One tablet once daily with food for treatment-naïve people or people with suppressed viral load on a stable HIV regimen for at least 6 months who have no known resistance to the darunavir or tenofovir components of the regimen. Tablet contains 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine, and 10 mg tenofovir alafenamide.Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose. Dose cannot be adjusted for people with kidney or liver problems. Symtuza can be used in people with an estimated creatinine clearance of at least 30 mL/ min. It should not be used in people with severe kidney or liver impairment.
See the individual drugs contained in Symtuza: Prezista, Tybost, and Descovy.
See package insert for more complete information on potential side effects and interactions.
Manufacturer
Janssen Therapeutics(800) JANSSEN (526-7736)
janssen.com
symtuza.com
AWP
$4,667.71/monthPotential Side Effects and Toxicity
Do not take with Epivir-HBV, Hepsera, or Vemlidy (TAF), all three used for the treatment of hepatitis B. Use with other protease inhibitors or Intelence, Sustiva, or Viramune is not recommended. Do not take with betamethasone, budesonide, carbamazepine, dexamethasone, dronedarone, eslicarbazepine, ergot derivatives, fluticasone, triazolam, oral midazolam, lurasidone, methylprednisolone, oxcarbazepine, phenobarbital, phenytoin, pimozide, Revatio, simvastatin, lovastatin, St. John’s wort, alfuzosin, ranolazine, or rifampin. Not recommended to be taken with apixaban, avanafil, dabigatran etexilate (in renal impairment), everolimus, rifampentine, rivaroxaban, salmeterol, ticagrelor, or voriconazole. Beclomethasone and prednisone as alternative corticosteriods may be considered, particularly for long-term use. Atorvastatin and rosuvastatin dose should not exceed 20 mg daily. Clinical monitoring is recommended with drospirenone, due to potential for hyperkalemia. Do not take with colchicine if there is kidney or liver impairment. Cannot be taken with Zepatier. Based on the mechanism, drug interactions with other hepatitis C medications are probably similar to the interactions with Prezista + Norvir + Descovy. Not intended to be taken with other HIV medications, unless prescribed that way. Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not, as there are other drug interactions which are not listed here.
Potential Drug Interactions
Do not take with Epivir-HBV, Hepsera, or Vemlidy (TAF), all three used for the treatment of hepatitis B. Use with other protease inhibitors or Intelence, Sustiva, or Viramune is not recommended. Do not take with betamethasone, budesonide, carbamazepine, dexamethasone, dronedarone, eslicarbazepine, ergot derivatives, fluticasone, triazolam, oral midazolam, lurasidone, methylprednisolone, oxcarbazepine, phenobarbital, phenytoin, pimozide, Revatio, simvastatin, lovastatin, St. John’s wort, alfuzosin, ranolazine, or rifampin. Not recommended to be taken with apixaban, avanafil, dabigatran etexilate (in renal impairment), everolimus, rifampentine, rivaroxaban, salmeterol, ticagrelor, or voriconazole. Beclomethasone and prednisone as alternative corticosteriods may be considered, particularly for long-term use. Atorvastatin and rosuvastatin dose should not exceed 20 mg daily. Clinical monitoring is recommended with drospirenone, due to potential for hyperkalemia. Do not take with colchicine if there is kidney or liver impairment. Cannot be taken with Zepatier. Based on the mechanism, drug interactions with other hepatitis C medications are probably similar to the interactions with Prezista + Norvir + Descovy. Not intended to be taken with other HIV medications, unless prescribed that way. Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not, as there are other drug interactions which are not listed here.
More Information
This medication was approved in 2018 and is the first STR containing a protease inhibitor. This formulation is much more convenient and reduces the number of co-pays to one. It is not the same as Prezcobix plus Descovy, because Symtuza contains a lower dose of TAF than Descovy. A benefit of the PIs is their high genetic barrier to the development of drug resistance. While medical providers may hate to say it out loud, this means greater forgiveness of missed doses; missing a dose here and there is never advisable but does happen. As such, a PI-based regimen such as Symtuza suits some people who may have trouble with the near-perfect drug adherence required of HIV treatment. In fact, the FDA allowed Janssen to advertise Symtuza as “help[s] protect against resistance.” Symtuza may be used in rapid initiation, treatment given within 7 days of HIV diagnosis, before resistance test results are available. Treatment-experienced individuals with undetectable viral loads for at least six months may switch to Symtuza. Darunavir is available under the brand name Prezista and is also found in the co-formulated pill Prezcobix (with cobicistat). Symtuza is not recommended during pregnancy due to substantially lower exposures of darunavir and cobicistat components during pregnancy. Compared with tenofovir DF, the tenofovir alafenamide in Symtuza is safer on kidney and bone health. Also as a result of the TAF, Symtuza can be taken by people with more advanced kidney disease, down to a renal function (CrCL) of 30 mL/min.
Doctor Comments
Dr. Ross Slotten says:
FDA-approved in July 2018, Symtuza contains the protease inhibitor darunavir (Prezista), boosting agent cobicistat, and 2 NRTIs (TAF and FTC). Because of the presence of cobicistat, it will not be considered an A1 agent by DHHS. Symtuza is the first and perhaps last STR containing a PI, at least for the foreseeable future unless a PI can be found that doesn’t require boosting. That said, I don’t see a special role for this medication, except for people who are already on Prezista and 2 NRTIs, and for those patients who may not be ideally adherent to their HIV regimen because darunavir has a high barrier to resistance, if one believes that PIs are superior to INSTIs in this scenario. I’m not knocking Symtuza. It’s as potent as Biktarvy and Triumeq but the presence of a boosting agent increases the chances of drug-to-drug interactions. It also has more side effects, mainly GI, than INSTI-containing regimens.
Activist Comments
Activist Bridgette Picou says:
Symtuza is considered unique because it is the only boosted protease inhibitor single-tablet regimen (STR). It can be used as both a start therapy regimen and also as a switch option for those who are stable with no resistance. This medication should be taken with food, or within half an hour or so of eating. The darunavir component has a high barrier to resistance. There are drug-drug interactions to consider so discuss your medications with your doctor since the booster component of Symtuza may affect how well they work.