rilpivirine/emtricitabine/tenofovir alafenamide (RPV/FTC/TAF)
Standard DoseOne tablet once daily, with a standard meal (more than 390 calories). 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.
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.
ManufacturerGilead Sciences, Inc.
(800) GILEAD-5 (445-3235)
(800) JANSSEN (526-7736)
Potential Side Effects and Toxicity
• 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.
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 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 Vemildy (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 Daklinza, Harvoni, Olysio, Sovaldi, Zepatier, or Epclusa. Cannot be taken with Viekira Pak. 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.
Dr. David Hardy says:
Odefsey is the sixth STR approved, in 2016, and is commonly considered the “new and improved” version of Complera. Clinical trials have shown that switching PLWH who are receiving Atripla or Complera to Odefsey results in similar (as good as) results in terms of suppressing their HIV compared to keeping them on their initial ART regimen. Those PLWH switched from Atripla to Odefsey also had decreased side effects (grogginess, vivid dreams) compared to those who continued Atripla. Odefsey continues to have the same potency problems that Complera has, that is, it is not as effective in suppressing initial high viral loads in PLWH (>100,000 copies/ml). Similar to Complera, Odefsey is well tolerated by PLWH, with minimal to rare side effects. Therefore, Odefsey has not been recommended for initial treatment for all PLWH, but rather only those with low initial viral loads (less than 100,000 copies/ml). Although not specifically studied, Odefsey’s use as an ART switch regimen for PLWH with undetectable viral loads off of a regimen associated with side effects (e.g., protease inhibitor) would probably work well as it did with Complera.
Activist Moisés Agosto-Rosario says:
Odefsey is a once-a-day single-tablet regimen that contains two HIV nucleoside analog reverse transcriptase inhibitors (emtricitabine, tenofovir alafenamide) and a non-nucleoside reverse transcriptase inhibitor (rilpivirine). Odefsey is comparable to Complera; the difference is that Odefsey contains tenofovir alafenamide instead of tenofovir disoproxil, reducing the risk for kidney toxicity and loss of bone density. This single-tablet regimen is recommended in certain clinical situations for individuals who have not yet been treated for HIV, and have a viral load less than or equal to 100,000 copies. It is also prescribed to individuals with previous HIV antiretroviral treatment who are virally suppressed (less than 50 copies) for at least six months, with no history of treatment failure related to developing resistance to the other medicines contained in Odefsey. Consult your doctor about all medications you are taking, prescribed or over-the-counter. Serious drug interactions can occur. If you feel extremely depressed or suffering insomnia, tell your doctor. Damage to the liver or kidneys is a possibility when taking Odefsey. Make sure your doctor monitors liver and kidney functions. If you experience an allergic reaction call your doctor immediately and stop taking Odefsey.