EVG/COBI/FTC/TAF elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
Standard DoseOne tablet once daily with food. For people taking HIV treatment for the first time (treatment-naïve) or individuals with a 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. The 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 a tablet once daily and administer after completion of hemodialysis on days of HD treatment.
Take the 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. The 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.
ManufacturerGilead Sciences, Inc.
(800) GILEAD-5 (445-3235)
AWP$3,885.97/month in certain clinical situations
Potential Side Effects and Toxicity
Common side effects reported in at least 5% of study participants include nausea, diarrhea, headache, and fatigue. New data associate INSTIs and TAF with weight gain; see “Weighty Concerns,” beginning on page 8, and go to aidsinfo.nih.gov. Before taking Genvoya, 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. 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 on an INSTI who have pre-existing psychiatric conditions. 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.
Potential Drug Interactions
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, methyl-ergonovine, 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.
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.
Dr. Ross Slotten says:
Before Biktarvy, Genvoya was one of my “go-to” drugs. It contains TAF, which has less potential for kidney toxicity and bone density loss than TDF-containing regimens like Atripla or Stribild. But now that Biktarvy is available, there’s no reason to prescribe Genvoya as a first-line therapy. And, in fact, it has dropped from A1 status to B1. For those individuals already on Genvoya who have no significant co-morbidities, I have not made the switch to Biktarvy. At this point, there’s absolutely no compelling reason to do so. It is an excellent drug, with few side effects and high potency.
Activist Bridgette Picou says:
This single-tablet regimen came out in 2015 and was an “update” so to speak to Stribild. Containing TAF (tenofovir alafenamide fumarate), Genvoya is considered less bone and kidney toxic. Since it also contains the booster cobicistat, consideration should be given if you take certain other medications. Discuss all medicines and anything you take over the counter with your doctor before starting it, and if prescribed new medication from an outside physician.