rilpivirine/emtricitabine/tenofovir disoproxil fumarate, or RPV/FTC/TDF
Standard DoseOne tablet once daily, with a standard meal (more than 390 calories) for adults and children 12 years of age and older weighing at least 77 pounds (35 kg). 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.
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 like 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 Daklinza, Harvoni, Olysio, Sovaldi, and Zepatier. Monitor for tenofovir toxicities with Epclusa. Complera 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.
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.
Dr. David Hardy says:
Complera was the second STR approved in the U.S., in 2011. At that time, it was the first alternative STR to Atripla and offered PLWH a single, once-a-day pill which could (and was recommended) to be taken with food. It does not have the pesky grogginess and vivid dreams associated with Atripla. While Complera’s side effects are better than Atripla’s, its potency has always been somewhat questionable in PLWH with high initial viral loads (greater than 100,000 copies/mL). On the other hand, Complera’s side effects have been minimal and therefore well tolerated by PLWH. Primarily due to its lack of potency, it has never been recommended as a starting regimen for all PLWH. Since the development of the “new and improved” version of Complera, called Odefsey, Complera’s use has decreased and, because it has fallen further out of the recommended ART guidelines due to the issues above, it is rarely prescribed today.
Activist Moisés Agosto-Rosario says:
Complera is the combination of three HIV medicines contained in one single tablet and taken once a day. It is comparable to Odefsey as it combines rilpivirine with emtricitabine and the original tenofovir disoproxil fumarate while Odefsey contains tenofovir alafenamide. Complera is recommended as an initial therapy in certain clinical situations for individuals with a viral load less than 100,000 copies. It could also be prescribed to those wanting to replace their current regimen and have had suppressed viral load (less than 50 copies) for at least six months. It is not recommended if the reason for replacement is due to developing resistance to other antivirals, more so those contained in Complera. You need to watch for drug-drug interactions and changes in liver and kidney functions.