Stribild
elvitegravir / cobicistat / emtricitabine / tenofovir, or EVG / COBI / FTC / TDF
STR: Single-tablet regimen | boosted integrase inhibitor and NRTIs
image of drug

MANUFACTURER:
Gilead Sciences, Inc. gilead.com
(800) GILEAD-5 (445–3235)

AWP:
$2,463.37 / month

Standard Dose:

One tablet (150 mg elvitegravir / 150 mg cobicistat / 200 mg emtricitabine /300 mg tenofovir) once daily with food.

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 problems, therefore it should not be started in individuals with estimated creatinine clearance (CrCl) less than 70 mL/minute and should be discontinued if CrCl decreases to less than 50 mL/minute.

Potential side effects and toxicity

See the individual drugs contained in Stribild: elvitegravir, Emtriva (emtricitabine), Viread (tenofovir), and cobicistat. Note that since elvitegravir and cobicistat are newly approved drugs (as components of this combination), their long-term side effects are not known at this time. Most common are nausea, diarrhea, and headache. Abnormal dreams and fatigue have also been seen. Others include changes in kidney function tests (see cobicistat for more, and reassuring, information), increases in total cholesterol, bone problems, and elevated liver function tests.

Check for potential drug class side effects.

Potential drug interactions

See package insert for the most complete list. Tell your provider or pharmacist about all medications, herbs, and supplements you are taking or thinking of taking, prescribed or not. Do not take with Atripla, cobicistat, Combivir, Complera, elvitegravir, Emtriva, Epivir, Epivir-HBV, Epzicom, Hepsera, Isentress, Kaletra, Norvir, 572-Trii, Tivicay, Trizivir, Truvada, or Viread, since these medications are already in Stribild or it has equivalent medications. Do not take at the same time with antacids. Separate by at least 2 hours from antacids containing aluminum, magnesium hydroxide, or calcium carbonate. Stribild is safe to take with proton pump inhibitors (Nexium, Prevacid, Prilosec) or acid reducers (Pepcid, Tagamet, Zantac). Elvitegravir can decrease blood levels of many medications. Cobicistat is expected to have many drug interactions similar to those seen with Norvir. Do not take Stribild with Advicor, alfuzosin, Altoprev, methylergonovine, Mevacor, oral midazolam, pimozide, Revatio, rifabutin, Rifadin, rifampin, Simcor, triazolam, Uroxatral, Vytorin, Zocor, or St. John’s wort. Risks vs. benefits of using Stribild and voriconazole together should be assessed.  Alternative cholesterol-lowering drugs are Crestor, Lipitor, and Pravachol, but should be used with caution and started at the lowest dose possible. Monitor closely for increased side effects from these medications, such as muscle pain. Concentrations of antidepressants such as trazodone or Prozac may be increased by Stribild, and their doses may need to be reduced. Use with caution and therapeutic monitoring, if available, for antiarrhythmic drugs like digoxin. Stribild increases levels of fluticasone (found in Advair, Flonase, and Flovent) and should be monitored for signs of Cushing’s syndrome (such as rounded face). Use caution with anti-convulsants such as carbamazepine, phenobarbital, and phenytoin, and calcium channel blockers. Cialis, Levitra, and Viagra levels are increased; doses should not exceed 10 mg Cialis or 2.5 mg Levitra per 72 hours, or 25 mg Viagra per 48 hours. Effectiveness of birth control pills may be decreased, consider the use of alternative other contraception methods. Use with caution with bosentan, salmeterol, and immunosuppressants like Prograf, Gengraf, Neoral, and Sandimmune. Taking with Olysio is not recommended. Use of Incivek at regular dose should be fine. Victrelis with Stribild can potentially reduce the effectiveness of both drugs—combined use is not recommended.

More information

Stribild was approved by the FDA in 2012 and listed as an alternative regimen for HIV treatment-naïve people in U.S. treatment guidelines, but it is now recommended as a preferred regimen. Approval was initially based on 48-week data with 1,400 individuals showing Stribild was non-inferior (no better, no worse) at achieving undetectable viral load of less than 50 copies per mL, compared to Atripla and to Norvir-boosted Reyataz with Truvada. In October 2013, the Department of Health and Human Services (DHHS) updated recommendations on Stribild to make it one of the preferred regimens, as 96-week data from Phase 2 and 3 clinical trials and additional data through 144 weeks confirmed that Stribild remained non-inferior to Atripla and Norvir-boosted Reyataz with Truvada. Stribild should not be started in people with severe liver impairment or impaired kidney function (creatinine clearance less than 70 mL per minute). People should be checked for hepatitis B before starting therapy (see Emtriva). Insurance companies may require prior authorization. See package insert for more complete details about potential side effects and drug interactions.

Doctor’s comments

Stribild is a good choice for initial therapy. It’s well tolerated and effective at high and low viral loads.  It’s important to know that cobicistat (COBI) reduces excretion of creatinine by the kidneys. This increases the creatinine level in the blood, which isn’t a problem except that it can give the appearance of kidney toxicity, which is detected by measurement of creatinine. This effect occurs within the first few weeks and tends to be mild, but since tenofovir can sometimes cause true kidney toxicity, it’s important to take larger or progressive creatinine elevations seriously. Other commonly used drugs, such as Tivicay (dolutegravir), ritonavir, and trimethoprim-sulfamethoxazole (Bactrim, Septra), have the same effect, but to a slightly lesser degree than COBI. Because it’s a pharmacologic booster like ritonavir, cobicistat has many drug interactions. If a drug interacts with ritonavir, it’s likely to interact with cobicistat.
—JOEL GALLANT, MD, MPH

Activist’s comments

The “quad” pill, as it is affectionately known in the community, has yet to conquer the universe as once predicted. An impressive combination of classes coupled with a unique boosting agent in cobicistat does offer a fresh approach to boosting regimens and sampling drug classes packaged up all neatly sort of like a TV dinner. As awesome as simple dosing regimens are, the old schooler in me still likes to know what is doing what.  If something goes wrong with Stribild (or any STR for that matter), you sort of have to throw the baby out with the bathwater (and overcome the hang- up that it all has to be in a single pill).
—DAWN AVERITT


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