Genvoya and Stribild
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide EVG/COBI/FTC/TAF and elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate EVG/COBI/FTC/TDF
Standard DoseOne tablet once daily with food. For people taking HIV treatment for the first time (treatment-naïve) or individuals with suppressed viral load on a stable HIV regimen for at least 6 months who have no known resistance to the elvitegravir, emtricitabine, or tenofovir components of the regimen. Tablets contain 150 mg of the INSTI elvitegravir boosted by 150 mg cobicistat plus 200 mg emtricitabine, with 10 mg TAF in Genvoya and 300 mg TDF in Stribild.
Genvoya: For adults and children weighing at least 55 pounds (25 kg) and having a creatinine clearance (CrCl) of at least 30 mL/min (measurement of kidney function), as well as adults with creatinine clearance below 15 mL/min who are receiving chronic hemodialysis (HD). For people on chronic hemodialysis, take tablet once daily and administer after completion of hemodialysis on days of HD treatment. Dose cannot be adjusted for people with liver problems. Genvoya is not recommended for people who have severe liver problems, a CrCl between 15–30 mL/min, or a CrCl less than 15 mL/min who are not receiving chronic hemodialysis.
Stribild: For adults and children age 12 and older weighing at least 77 pounds (35 kg). Dose cannot be adjusted for people with kidney or liver problems. Stribild should not be started by individuals with estimated CrCl less than 70 mL/min and should be discontinued if CrCl decreases to less than 50 mL/min.
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.
- See the individual drugs: Emtriva, Viread, and Tybost. Elvitegravir is not available separately. TAF is not available separately for HIV, but is used to treat hepatitis B under the brand name Vemlidy.
- See package insert for more complete information on potential side effects and interactions.
ManufacturerGilead Sciences, Inc.
(800) GILEAD-5 (445-3235)
Potential Side Effects and Toxicity
Common side effects include nausea and diarrhea. INSTIs and TAF have been associated with weight gain. Cobicistat can cause a small, reversible increase in serum creatinine within the first few weeks of treatment without affecting actual kidney function. While cobicistat does not affect actual kidney function, its effect on SCr can make monitoring of impaired kidney function more difficult or less accurate. INSTIs have been associated with adverse neuropsychiatric effects (such as sleep disturbances, depression, anxiety, suicidal ideation) in some retrospective cohort studies and case series. DHHS guidelines recommend closely monitoring people on an INSTI who have pre-existing psychiatric conditions. Prior to initiation, people should be tested for hepatitis B virus (HBV) infection. Severe exacerbations of HBV have been reported in people co-infected with HBV who have discontinued Genvoya or Stribild (due to elimination of the emtricitabine and tenofovir components, which also treat hepatitis B). Monitor liver enzymes closely in co-infection. HBV therapy may be warranted upon discontinuation. Call your health care provider right away if you develop any of the following signs 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.
Before taking Genvoya or Stribild, kidney function testing should be conducted, including serum creatinine (SCr), serum phosphorus, urine glucose, and urine protein. These measurements should continue to be monitored while taking Genvoya or Stribild.
Potential Drug Interactions
Do not take with Cimduo or Temixys, Descovy, Emtriva, Epivir-HBV, Hepsera, Truvada, Vemlidy, or Viread. Separate by at least 2 hours from antacids containing aluminum, magnesium hydroxide, or calcium carbonate. Safe to take with other medications used for heartburn and GERD such as Aciphex, Dexilant, Nexium, Pepcid, Prevacid, Prilosec, and Zantac. Cobicistat has many drug interactions similar to Norvir. Do not take with lovastatin or simvastatin, alfuzosin, carbamazepine, phenobarbital, phenytoin, ergotamine, dihydroergotamine, methyl-ergonovine, oral midazolam, lurasidone, pimozide, Revatio, rifampin, rifabutin, rifapentine, Serevent, triazolam, St. John’s wort, clopidogrel, or ticagrelor. Rosuvastatin and atorvastatin should be used with caution and started at the lowest dose possible. Monitor closely for increased side effects, such as muscle pain, from these medications. An alternative corticosteroid to systemic dexamethasone should be considered. Risks versus benefits of using with voriconazole should be assessed with expert consultation. Concentrations of antidepressants such as fluoxetine, paroxetine, bupropion, or amitriptyline may be increased, and their doses may need to be reduced. Levels of many nasal and inhaled steroids like fluticasone may be increased, which may lead to symptoms of Cushing’s syndrome. An alternative corticosteroid is recommended. 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. Effectiveness of oral contraceptives may be decreased; consider using alternative or additional contraception methods. Start metformin at lowest dose and titrate based on tolerability and clinical effect. Reduce Daklinza dose to 30 mg. Taking with Olysio, Viekira Pak, or Zepatier is not recommended. 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.
Genvoya: Dose of clarithromycin may need to be reduced based on kidney function. Can be taken with Harvoni or Epclusa.
Stribild: No significant interactions with beclomethasone or prednisolone. Use caution with beta blockers and calcium channel blockers. Co-administer bosentan and immunosuppressants such as Prograf, Gengraf, Neoral, and Sandimmune with caution. Taking with Harvoni, Olysio, Viekira Pak, or Zepatier is not recommended. Monitor kidney function more closely with Epclusa.
Genvoya and Stribild are not recommended during pregnancy. Switching regimens should be considered for anyone who is pregnant. Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; go to apregistry.com.
Dr. Melanie Thompson:
These STRs are no longer recommended for initial therapy for most people because elvitegravir requires a cobicistat booster, introducing many drug-drug interactions, and because of its genetic fragility compared to dolutegravir and bictegravir. The difference between them is that Genvoya uses TAF while Stribild uses TDF. Compared head-to-head, Genvoya was noninferior to Stribild up to 96 weeks, but Genvoya was superior at 144 weeks, although this was not a primary endpoint.
When taken together, TDF and COBI sometimes have been associated with kidney toxicity and low bone density, so close monitoring is important.
Activist Michael Broder:
Gilead’s rationale for developing Genvoya was to switch out an earlier incarnation of tenofovir (TDF) in Stribild for its safer chemical cousin (TAF). So far so good, but with newer options, scarcely anyone needs to be on a boosted anything these days, and the fact that elvitegravir needs cobicistat is a big downside.