RPV/FTC/TDF rilpivirine/emtricitabine/tenofovir disoproxil fumarate
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. Tablet contains 25 mg of the NNRTI rilpivirine plus 200 mg emtricitabine and 300 mg tenofovir DF (TDF).
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.
For adults and children 12 years of age and older weighing at least 77 pounds (35 kg) and having a CrCl of at least 50 mL/min.
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 Complera due to higher rates of virologic failure in these patients.
Take missed dose as soon as possible, unless it’s closer to the time of your next dose. Do not double up on your next dose. Complera should not be used in people with CrCl less than 50 mL/min or severe liver impairment.
See the individual drugs contained in Complera: Edurant and Truvada (co-formulation of Emtriva and Viread).
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. 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 Truvada page for other possible effects on kidney function. 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
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. Do not take with Epivir-HBV, Hepsera, or Vemlidy (TAF), all three used for 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 Complera. Antacids containing aluminum, magnesium hydroxide, or calcium carbonate can be taken at least two hours before or at least four hours after a Complera dose. Stomach acid-reducing drugs such as Pepcid, Tagamet, and Zantac can be taken at least 12 hours before or at least four hours after a Complera dose. Do not take Complera with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, or the herb St. John’s wort (other herbals have not been studied with Complera, but consult with a pharmacist before taking any herbals or OTC supplements). Rifabutin must be taken with an extra Edurant tablet in addition to Complera. 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 of side effects. Reduced methadone levels can occur and while dose adjustments are not necessary, it is recommended to monitor for withdrawal symptoms. Complera should also not be taken with other medications that prolong QTc interval (a heart problem) or medications with a known risk of torsades de pointes. Complera may be taken with Harvoni and Zepatier. Monitor for tenofovir toxicities 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 other drug interactions which are not listed here.
Complera can be relatively difficult to take because of its food requirement and drug interactions. In addition, strict adherence is critical due to its relatively low barrier to the development of resistance. A newer version of Complera, Odefsey, contains tenofovir alafenamide (TAF) instead of tenofovir DF; TAF is safer on kidney and bone health. Also as a result of the TAF, Odefsey can be taken by people with more advanced kidney disease, down to a renal function (CrCL) of 30 mL/min. For pregnant patients who are already on Complera 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:
No comment provided because it has been replaced by Odefsey.
Activist Bridgette Picou says:
Complera is a single-tablet regimen containing three medications. It can be used for new starts if the viral load is under 100,000, or for switching to simplify medication regimens. It is to be taken with food, and should be a meal you chew, not just a protein shake or yogurt snack. Since it does have interactions with other medications like antacids, you may want to consider the time of day you take it. Kidney and liver function should also be monitored on this medication.