Symtuza

As darunavir contains a sulfa component, use with caution in patients with sulfa allergies. Side effects most commonly reported in studies include diarrhea (9%), rash (8%), nausea (6%), fatigue (4%), headache (3%), abdominal discomfort (2%), and flatulence (2%). While very rare (in less than 0.4% of those taking it), severe rash, accompanied in some cases by fever and/or elevations of AST/ALT (liver enzymes), can be life-threatening. Seek medical attention immediately. New data associate TAF with weight gain. See the online version of this drug page. Observational cohort studies reported an association between some PIs (including darunavir taken with ritonavir) and an increased risk of cardiovascular (CV) events. Data with darunavir plus cobicistat are too limited to make these conclusions. With PIs, there can be increased bleeding in hemophiliacs. Cobicistat can cause a small, reversible increase in serum creatinine (SCr, which indicates the eGFR or estimated CrCl lab values) within the first few weeks of treatment without affecting actual kidney function (see Tybost for more information). While cobicistat does not affect actual kidney function, its effect on SCr can make monitoring of impaired kidney function more difficult or less accurate. However, people experiencing a confirmed increase in serum creatinine of greater than 0.4 mg/dL from baseline should be closely monitored for renal safety. Serum phosphorus in patients with or at risk for kidney impairment should also be monitored. Prior to initiation, people should be tested for hepatitis B virus (HBV) infection. Severe exacerbations of hepatitis B have been reported in people co-infected with hepatitis B who have discontinued Symtuza (due to elimination of the emtricitabine and TAF components, which also treat HBV). Monitor liver enzymes closely in people co-infected with hepatitis B and, if appropriate, initiation of anti-hepatitis B therapy may be warranted upon Symtuza discontinuation. Call your health care provider right away if you develop any of the following signs or symptoms of hepatitis: yellowing of the skin or whites of the eyes; dark or tea-colored urine; pale-colored bowel movements; nausea or vomiting; loss of appetite; or pain, aching, or tenderness on the right side below the ribs.

Go to positivelyaware.com/articles/weighty-concerns and positivelyaware.com/articles/fatty-tissues. Weight gain is becoming more recognized as a side effect of TAF. In the community, enlargement of the stomach and waist area can be distressing. According to DHHS HIV treatment guidelines, “Weight gain has been associated with initiation of ART [antiretroviral therapy] and subsequent viral suppression. The increase appears to be greater with INSTIs than with other drug classes. Greater weight increase has also been reported with TAF than with TDF, and greater with DOR than EFV.” Other factors have been associated with weight gain in addition to medication used, including race, sex, and previous overweight status. There is no word yet on reversibility, but the race is on to find more answers.

Do not take with Cimduo or Temixys, Descovy, Emtriva, Epivir-HBV, Hepsera, Truvada, Vemlidy, or Viread, all used for the treatment of hepatitis B. Use with other protease inhibitors or Intelence, Sustiva, or Viramune is not recommended. Do not take with alfuzosin, betamethasone, budesonide, carbamazepine, dexamethasone, dronedarone, eslicarbazepine, ergot derivatives, fluticasone, triazolam, oral midazolam, lomitapide, lurasidone, methylprednisolone, naloxegol, oxcarbazepine, phenobarbital, phenytoin, pimozide, Revatio, simvastatin, lovastatin, St. John’s wort, ranolazine, or rifampin. Not recommended to be taken with avanafil, ciclesonide, dabigatran etexilate (in renal impairment), everolimus, Intelence, irinotecan, mometasone, rifabutin, rifapentine, rivaroxaban, salmeterol, ticagrelor, triamcinolone, or voriconazole. Beclomethasone, prednisolone, and prednisone as alternative corticosteroids 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. Apixaban (Eliquis) dose may need to be adjusted. Do not take with colchicine if there is kidney or liver impairment.

Start metformin at lowest dose and titrate based on tolerability and clinical effect. Cannot be taken with Zepatier. Based on the mechanism, drug interactions with other hepatitis C medications are probably similar to the interactions with Prezcobix + 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.

Symtuza 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. 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.

Dr. Melanie Thompson:

Symtuza, a four-drug STR, is the only single-tablet regimen containing a protease inhibitor (darunavir). DHHS guidelines recommend it as initial therapy only “in certain clinical situations” when an INSTI cannot be used, largely because it contains cobicistat as a booster. It has a long laundry list of drug-drug interactions associated with both cobicistat and darunavir and also has the potential to raise triglycerides and cholesterol. (See Prezista and Tybost.) On the positive side, it does have a high barrier to resistance, thanks to boosted darunavir. A single-arm study sponsored by Janssen showed favorable outcomes when Symtuza was used as rapid ART prior to the return of baseline labs. The drug was effective even when certain drug resistance mutations were present.

Symtuza is the most expensive STR, with a Wholesale Acquisition Cost (WAC) of over $42K. Although patient assistance copays may take the sting out of the actual out-of-pocket cost for consumers, it’s very hard to justify the astronomic cost when less expensive and equally effective regimens are available. Even the separate components are cheaper than the STR. Again, time to advocate for controls on HIV (and other) drug prices. Symtuza should not be taken by persons who are pregnant, due to insufficient levels associated with cobicistat.

Activist Bridgette Picou:

Symtuza can be used in both initial ART therapy and in patients who are stable and whom have achieved viral suppression. This STR contains a protease inhibitor component, making it different from other single-tab regimens. Darunavir, the main component in Symtuza, has a high barrier to resistance, which you want in a medication. Take it with food; discuss all your medications with your clinician to avoid drug-drug interactions, since Symtuza also contains a booster.