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Genvoya and Stribild

150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, 10 mg tenofovir AF EVG (INSTI), COBI (PK booster), FTC and TAF (two NRTIs) 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, 300 mg tenofovir DF EVG (INSTI), COBI (PK booster), FTC
No longer HHS recommended for initial therapy in certain clinical situations
Standard Dose
One 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.

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. Use is not recommended in people with severe liver problems.

Take missed dose as soon as possible, as long as it is at least 12 hours before 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. 
Manufacturer
Gilead Sciences, Inc.
gilead.com; genvoya.com
(800) GILEAD-5 (445-3235)
AWP
Genvoya AWP
$4,554.29/month

Stribild AWP
$4,777.46/month
Activist Comments

JUAN MICHAEL PORTER II:

Almost everyone I know who has used Genvoya or Stribild has complained about violent gastrointestinal problems. The main difference between the two drugs is that they use different versions of the drug tenofovir. Genvoya uses the new version, TAF, while Stribild uses TDF, the older version. One of my doctor friends—who is living with HIV—told me, “I really have no idea why anybody is still on Genvoya or Stribild,” because their integrase inhibitors need boosting, are not even the best in their class and it’s easy to switch from them to something better. Another doctor friend said, “I cannot think of a single person who needs to remain on these drugs.”

Doctor Comments

JO-ANN JOSE, MD, MPH:

Genvoya and Stribild contain exactly the same ingredients, except that Genvoya contains TAF, which has been shown to reduce the risk of kidney and bone density side effects associated with TDF. For people with COVID, there is a substantially increased risk of drug interaction. There is also a relatively low barrier to drug resistance regimen to consider.  If these medications are not taken perfectly, people can accumulate integrase mutations. Integrase inhibitors are some of the best medicines for HIV, so accumulating resistance to that class of medicine is something we should try very hard to avoid.

Potential Drug Interactions

Do not take with Cimduo, Descovy, Emtriva, Epivir-HBV, Hepsera, Truvada, Vemlidy or Viread, all for the treatment of hepatitis B, as the emtricitabine and tenofovir components already treat HBV. 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. 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. Use caution with beta blockers and calcium channel blockers. 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. Take lower dose of colchicine, but do not use colchicine if there is renal or hepatic impairment. 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: 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.

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. HHS 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. 

More Information

Switching regimens should be considered for anyone who is pregnant, especially during the third trimester, due to lower drug levels. Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; GO TO apregistry.com.