Complera

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.

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.