RPV/FTC/TAF rilpivirine/emtricitabine/tenofovir alafenamide
Standard DoseOne tablet once daily, with a standard meal (more than 390 calories). For people taking HIV therapy for the first time (treatment-naïve) or people with suppressed viral load on a stable HIV regimen for at least 6 months who have no known resistance to the rilpivirine, emtricitabine, or tenofovir components of the regimen. See below. Tablet contains 25 mg of the NNRTI rilpivirine plus 200 mg emtricitabine and 25 mg tenofovir alafenamide (TAF).
Must be taken with a meal that you chew—not just nutritional drinks or protein shakes. Taking rilpivirine without food could result in a 40% decrease in drug absorption and may lead to resistance.
People taking HIV treatment for the first time must have an HIV RNA (viral load) of less than 100,000 copies/mL and a CD4 T cell count of more than 200 cells/mm3 before starting Odefsey due to higher rates of virologic failure in these patients.
For adults and children 12 years of age and older weighing at least 77 pounds (35 kg) and having a CrCl of at least 30 mL/min, or people with a CrCl less than 15 mL/min who are receiving dialysis.
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 contained in Odefsey: Edurant and Descovy (co-formulation of Emtriva and TAF).
See package insert for more complete information on potential side effects and interactions.
ManufacturerGilead Sciences, Inc.
(800) GILEAD-5 (445-3235)
(800) JANSSEN (526-7736)
Potential Side Effects and Toxicity
Moderate to severe side effects are uncommon; insomnia, headache, and depressive disorders (depression, negative thoughts, suicidal thoughts or actions) were each reported in 2% of study participants on rilpivirine-containing regimens. Cases of rash, angioedema (swelling), urticaria (itchy rash), and increased liver enzymes have also been reported with regimens containing rilpivirine. There may be a small increase in serum creatinine (SCr) and decrease in estimated creatinine clearance (CrCl) associated with rilpivirine. See Descovy page for other possible effects on kidney function. The most common (greater than 10%) side effect seen in clinical trials with Descovy (the fixed-dose combination of Emtriva and TAF) is nausea. 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. Proton pump inhibitors (PPIs, heartburn or stomach acid drugs like Aciphex, Dexilant, Nexium, Prevacid, Prilosec, Protonix, etc.) can’t be taken with Odefsey. Antacids containing aluminum, magnesium hydroxide, or calcium carbonate can be taken two hours before or four hours after Odefsey. Stomach acid-reducing drugs like Pepcid, Tagamet, and Zantac can be taken 12 hours before or four hours after a dose of Odefsey. Do not take with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, or the herb St. John’s wort. Taking Odefsey with rifabutin is not recommended. Do not take with more than one dose of the injectable steroid dexamethasone (sometimes given in the ER or hospital). Use caution if used with fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole. Use azithromycin when possible instead of the antibiotics clarithromycin, erythromycin, or telithromycin, because these drugs increase rilpivirine levels, which can increase the risk for side effects. Reduced methadone levels can occur and while dose adjustments are not necessary, it is recommended to monitor for withdrawal symptoms. Odefsey should also not be taken with other medications that prolong QTc interval or medications with a known risk of torsades de pointes. May be taken with Harvoni, Zepatier, or 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 other drug interactions which are not listed here.
Odefsey is a single-tablet regimen that is an option for people with impaired kidney function. Rilpivirine-containing regimens can be relatively difficult to take because of their food requirement and drug interactions. In addition, strict adherence is critical due to the relatively low barrier to the development of resistance. The Odefsey tablet is very small in size, which may be advantageous to individuals who have difficulty swallowing. For pregnant patients who are already on Odefsey prior to pregnancy and who are virologically suppressed, one tablet taken once daily may be continued. Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.
Dr. Ross Slotten says:
Approved in 2016, Odesfey is another excellent STR. It is well tolerated and has few side effects. Its main deficiencies are that it is has to be taken with a high caloric meal (it contains the somewhat fussy drug, rilpivirine) and cannot be taken with a PPI. At higher doses, rilpivirine rarely can affect heart function, which is unfortunate because in its current lower dose formulation it is less potent in patients with an HIV viral load greater than 100,000 copies. It therefore has earned a BI rating from DHHS and is not considered a first-line agent.
Activist Bridgette Picou says:
Odefsey is a good “switch” option for people who are virally suppressed (less than 50 copies) and stable on current medication regimens and also for new starts when the viral load is less than 100,000. Containing TAF makes it less kidney toxic and more bone friendly, but they should still be monitored. Be open in discussing other medications prescribed by other providers and over-the-counter medications you take to avoid potential drug-drug interactions. This is important if you take certain antacids so discuss this with your doctor or specialty pharmacist (a pharmacist certified in HIV medications is your best option next to your HIV specialist).