elvitegravir/cobicistat/emtricitabine/tenofovir DF (EVG/COBI/FTC/TDF)
Recommended initial regimen for most people in certain clinical situations
One tablet once daily with food. Tablet contains 150 mg of the INSTI elvitegravir boosted by 150 mg cobicistat plus 200 mg emtricitabine and 300 mg tenofovir DF (TDF).
For adults and children 12 years of age and older weighing at least 77 pounds (35 kg).
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. Stribild should not be started in individuals with estimated CrCl less than 70 mL/min and should be discontinued if CrCl decreases to less than 50 mL/min. Stribild is not recommended for patients with severe liver problems, or during pregnancy.
Gilead Sciences, Inc.
(800) GILEAD-5 (445–3235)
• See the individual drugs contained in Stribild: Emtriva, Viread, and Tybost (elvitegravir is not available separately).
• See package insert for more complete information on potential side effects and interactions.
Common side effects reported in 10% or more of study participants include nausea and diarrhea. Other less common side effects include abnormal dreams and headache. Before taking Stribild, kidney function testing should be conducted including serum creatinine, serum phosphorus, urine glucose, and urine protein. These measurements should continue to be monitored while taking Stribild. Cobicistat can cause a small, reversible increase in serum creatinine within the first few weeks of treatment without affecting actual kidney function (see Tybost for more information). There have been rare reports of depression and suicidal ideation, primarily in patients with a history of psychiatric illnesses, in people receiving INSTI-based regimens. The DHHS guidelines recommend closely monitoring patients with pre-existing psychiatric conditions on an INSTI. Prior to initiation, people should be tested for hepatitis B (HBV) infection. Severe exacerbations of hepatitis B have been reported in people who are co-infected with hepatitis B and have discontinued the emtricitabine and/or tenofovir components. Monitor liver enzymes closely in people co-infected with hepatitis B and, if appropriate, initiation of anti-hepatitis B therapy may be warranted.
Do not take with Epivir-HBV, Hepsera, or Vemlidy (TAF), all three used for the treatment of hepatitis B. Separate by at least 2 hours from antacids containing aluminum, magnesium hydroxide, or calcium carbonate. Stribild is safe to take with other medications used for heartburn and GERD, such as Nexium, Pepcid, Prevacid, Prilosec, and Zantac. Do not take Stribild with alfuzosin, carbamazepine, phenobarbital, phenytoin, ergotamine, dihydroergotamine, methylergonovine, oral midazolam, pimozide, Revatio, rifampin, rifabutin, rifapentine, Serevent, triazolam, or St. John’s wort. An alternative corticosteroid to systemic dexamethasone should be considered. No significant interactions with beclomethasone or prednisolone. Risks versus benefits of using Stribild and voriconazole together should be assessed with expert consultation. Do not use with lovastatin or simvastatin (Advicor, Altoprev, Mevacor, Simcor, Vytorin, and Zocor). Cholesterol-lowering drugs such as rosuvastatin and atorvastatin 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 fluoxetine, paroxetine, bupropion, or amitriptyline 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 many nasal and inhaled steroids like fluticasone, which may lead to symptoms of Cushing’s syndrome. An alternative corticosteroid to fluticasone is recommended. Use caution with beta blockers 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. Monitor for increased side effects of these medications, such as visual disturbances. Effectiveness of oral contraceptives may be decreased; consider using alternative or additional contraception methods. Co-administer bosentan and immunosuppressants like Prograf, Gengraf, Neoral, and Sandimmune with caution. Reduce Daklinza dose to 30 mg. Taking with Harvoni, Olysio, Viekira Pak, or Zepatier is not recommended. Monitor kidney function more closely with Epclusa. 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 many other drug interactions not listed here.
The newer version of this drug, Genvoya, was approved for use in patients on hemodialysis last year; however, doctors are also using off-label prescribing of Biktarvy or Juluca for patients on hemodialysis. Genvoya along with its sister med Stribild were recently downgraded in U.S. HIV treatment guidelines, from “recommended initial therapy for most people” to “recommended initial therapy in certain clinical situations.” The change was made due to the presence of the booster cobicistat, which has many drug interactions, and because these meds do not have the high barrier to drug resistance that Biktarvy, Tivicay, and Triumeq have. Stribild is not recommended for use in pregnancy due to substantially lower exposures of cobicistat and elvitegravir during the second and third trimesters as well as reports of viral breakthrough. Switching regimen or close monitoring should be considered for those already taking this regimen. New preliminary data from an observational study in Botswana suggest that there may be an increased risk of birth defects in infants born to those who were receiving dolutegravir at the time of conception. It is unclear whether dolutegravir is the only integrase inhibitor with the potential to cause these birth defects (neural tube defects), or if other integrase inhibitors also carry this risk. Consult your provider to discuss guidance on how to manage regimens containing dolutegravir or a different integrase inhibitor if there is any possibility of conception.
It is important to monitor the kidneys and bone density while taking Stribild. If there are changes in your bone density or your kidney functions, ask your doctor to switch you to Genvoya or Biktarvy. Because of cobicistat, Stribild has serious drug interactions that either increase or decrease the levels of commonly prescribed drugs such as some statins, benzos, and erectile dysfunction drugs. Remember to take it with food.