Generic Name: rilpivirine + tenofovir disoproxil fumarate + emtricitabine
Other Market Name: Eviplera
Drug Class: Single-Tablet Regimens
Pharmaceutical Company: Gilead Sciences and Janssen Therapeutics
Approval Status: Approved
Generic Version Available: No
Experimental Code: N/A
An alternative treatment regimen for antiretroviral-naive people living with HIV (with viral loads below 100,000 copies and CD4 cell counts above 200), as indicated by the U.S. Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. Visit https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/0 for the full DHHS guidelines.
Complera is a single-tablet regimen for HIV. It contains two different types of HIV drugs: one non-nucleoside reverse transcriptase inhibitor and two nucleoside reverse transcriptase inhibitors. It was approved by the U.S. Food and Drug Administration in August 2011 and can be prescribed for use by people living with HIV who are 12 years of age or older and who are either:
- starting HIV treatment for the first time and have a pre-treatment viral load of no more than 100,000 copies (Complera may be less effective than other single-tablet regimens for those with higher viral loads at the time therapy is started);
- or those wishing to switch their current regimens (provided that they have been on a stable regimen for at least six months, have an undetectable viral load and no history of HIV treatment failure or resistance to any of the drugs in Complera.)
Complera is a combination of three drugs: Edurant (rilpivirine), Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine). All three drugs can be purchased individually for use in combination with other HIV drugs.
Adult Dose: Each tablet contains 25 mg rilpivirine + 300 mg tenofovir disoproxil fumarate + 200 mg emtricitabine.
Pediatric Dose: N/A
Dosing Info: This is a complete one-pill, once-daily drug regimen. Take with a meal.
Possible side effects include rash, depression, insomnia, and headache.
Complera may lead to new or worsening kidney problems, including kidney failure. Your healthcare provider may do blood tests to check your kidneys before and during treatment with Complera. If you develop kidney problems, your healthcare provider may tell you to take Complera less often, or to switch the drug for other HIV medications.
Complera may lead to bone problems, including bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones.If you also have hepatitis B virus (HBV) and take Complera, your hepatitis may become worse if you stop taking Complera. Do not stop taking Complera without first talking to your healthcare provider.
The following medications should not be taken while you are being treated with Complera:
Corticosteroids: dexamethasone (more than a single dose)
Acid reflux/heartburn medications: Nexium or Vimovo (esomeprazole), Prevacid (lansoprazole), Prilosec or Zegerid (omeprazole), Protonix (pantoprazole), Aciphex (rabeprazole), or Dexilant (dexlansoprazole)
Antibiotics: Mycobutin (rifabutin), Rifamate (rifampin), Priftin (rifapentine)
Anti-seizure medications: Tegretol (carbamazepine), Trileptal (oxcarbazepine), Luminal (phenobarbital), Dilantin (phenytoin)
Herbal products: St. John's wort (or products containing St. John's wort
Antivirals: Hepsera (adefovir)
Complera should not be combined with any HIV medications that contain any of the active ingredients in Complera. These include: Atripla, Edurant (unless recommended by your health care provider and you are taking rifabutin), Emtriva, Genvoya, Stribild, or Viread. Combining Complera with HIV medications containing active ingredients similar to those in Complera should also be avoided. These include: Combivir, Epivir, Epzicom, Rescriptor, Sustiva, Triumeq, Trizivir, and Viramune.
Complera should not be taken at the same time as common antacids, particularly those containing aluminum, magenesium hydroxide, or calcium carbonate; they should be taken at least two hours before or after Complera. Acid-block H2-receptor antagonists, such as Tagemet (cimetidine, Pepcid (famotidine), Axid (nizatidine), or Zantac (ranitidine), should be take at least 12 hours before or at least 4 hours after taking Complera.
Caution is also necessary when combining Complera with Biaxin (clarithromycin), erythromycin, Diflucan (fluconazole), Sporanox (itraconazole), Nizoral (ketoconazole), methadone, Noxafil (posaconazole), Ketek (telithromycin), Vfend (voriconazole). Consult the Complera package insert for details regarding these and other possible drug interactions: http://www.gilead.com/~/media/Files/pdfs/medicines/hiv/complera/complera_pi.pdf
Before taking this medication, tell your doctor if you have kidney disease, liver disease (including hepatitis B), or a history of depression/suicidal thoughts. In addition, tell your doctor if you are pregnant or planning to become pregnant, if you are breast feeding, and all your medical conditions, including all prescription and over-the-counter medications and supplements you are taking.
Co-Pay Program Info: https://www.poz.com/basics/hiv-basics/drug-assistance-programs
Patient Assistance Program Info: https://www.poz.com/basics/hiv-basics/drug-assistance-programs
Last Revised: January 15, 2016