elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF)
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 10 mg tenofovir alafenamide (TAF).
For adults and children weighing at least 55 pounds (25 kg) and having a creatinine clearance 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 those on HD, take tablet after completion of hemodialysis on days of HD treatment.
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 liver problems. Genvoya is not recommended for people who have severe liver problems, a CrCl between 15 to 30 mL/min, or a CrCl less than 15 mL/min who are not receiving chronic hemodialysis.
➤ See the individual drugs contained in Genvoya: Emtriva and Tybost (elvitegravir is not available separately, and neither is TAF for use in HIV, but see Descovy).
➤ See package insert for more complete information on potential side effects and interactions.
Gilead Sciences, Inc.
(800) GILEAD-5 (445–3235)
• See the individual drugs contained in Genvoya: Emtriva and Tybost (elvitegravir is not available separately, and neither is TAF for use in HIV, but see Descovy).
• See package insert for more complete information on potential side effects and interactions.
Common side effects reported in at least 5% of study participants include nausea, diarrhea, headache, and fatigue. Before taking Genvoya, 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 Genvoya. 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). 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. 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. Safe to take with other medications used for heartburn and GERD such as Nexium, Pepcid, Prevacid, Prilosec, and Zantac. Cobicistat has many drug interactions similar to Norvir. Do not take with cholesterol-lowering drugs containing lovastatin or simvastatin (Advicor, Altoprev, Mevacor, Simcor, Vytorin, Zocor), alfuzosin, carbamazepine, phenobarbital, phenytoin, ergotamine, dihydroergotamine, methylergonovine, oral midazolam, lurasidone, pimozide, Revatio, rifampin, rifabutin, rifapentine, Serevent, triazolam, or St. John’s wort. Dose of clarithromycin may need to be reduced based on kidney function. An alternative corticosteroid to systemic dexamethasone should be considered. Risks versus benefits of using with voriconazole should be assessed with expert consultation. Some cholesterol-lowering drugs such as 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, and their doses may need to be reduced. Genvoya 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. 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. Reduce Daklinza dose to 30 mg. Can be taken with Harvoni. Taking with 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.
For a while very popular, 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. Last year, Genvoya was approved for use in patients on hemodialysis; however, doctors are also using off-label prescribing of Biktarvy or Juluca for patients on hemodialysis. Genvoya 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 regimens should be considered for pregnant women 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. Consult your provider to discuss guidance on how to manage regimens containing an integrase inhibitor if there is any possibility of conception.
Clinical trials have shown that Genvoya is similar to (just as good as) Stribild for treating HIV, and it has significantly fewer negative side effects on both kidneys and bones. Further, additional small studies proved that Genvoya can be safely used in PLWH with pre-existing mild to moderate kidney disease. Like Stribild, however, Genvoya contains a “booster” (cobicistat or Tybost) which is associated with interactions with other medications which PLWH may take. Of note, the most recent versions of both the DHHS and IAS-USA guidelines have removed both Stribild and Genvoya from their first line of “recommended for all PLWH” categories and placed them in a category for special situations.
Because cobicistat, a booster contained in Genvoya, is metabolized by the liver, you will have to monitor for many drug-drug interactions that can cause serious problems. Among them you will find commonly prescribed medications such as statins and erectile dysfunction drugs.