HIV/AIDS Treatment Complera HIV Antiretroviral Drug Information Fixed dose combination drugs offers once-daily, single-pill therapy By James Myhre & Dennis Sifris, MD Dennis Sifris, MD, is an HIV specialist and Medical Director of LifeSense Disease Management. James Myhre is an American journalist and HIV educator. Learn about our editorial process James Myhre & Dennis Sifris, MD Medically reviewed by Medically reviewed by Latesha Elopre, MD, MSPH on October 25, 2020 linkedin Latesha Elopre, MD, is a board-certified internist specializing in HIV. She is an assistant professor of infectious diseases at the University of Alabama at Birmingham. Learn about our Medical Review Board Latesha Elopre, MD, MSPH on October 25, 2020 Print Gilead Sciences Table of Contents View All Formulation Dosage Side Effects Contraindications Other Considerations Treatment Update Complera is a single-tablet, fixed dose combination drug used in the treatment of HIV, which is comprised of three different antiretroviral agents: rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI)emtricitabine, a nucleotide reverse transcriptase inhibitor (NtRTI)tenofovir disoproxil fumarate (TDF), another NtRTI Complera was approved by the U.S. Food and Drug Administration (FDA) on August 10, 2011 for use in both adults and children over the age of 12 who have never been on HIV therapy, who have a viral load of 100,000 cells/m or under, and weigh 77 pounds (35kg) or more. Complera can also be used to replace a current therapy if the patient has had an undetectable viral load. Formulation Complera is a pink, capsule-shaped, film-coated tablet, comprised of 25mg of rilpivirine, 200mg of emtricitabine, and 300mg of TDF. It is embossed with "GSI" on one side and is plain on the other. Dosage One tablet daily taken with food. Complera should not be taken with any other antiretroviral drug used to treat HIV. Side Effects A number of drug side effects have been noted in clinical trial patients taking Complera, the most common of which were: NauseaHeadacheInsomniaDepression Side effects were generally transient, with few patients discontinuing as a result of treatment intolerance. Contraindications Complera should not be taken with the following drugs or supplements: Anti-convulsive medication: Tegretol, Trilepta, phenobarbital, phenytoinAnti-tuberculosis medication: Mycobutin, Rifater, Rifamate, Rimactane, Rifadin, PriftinProton pump inhibitors (PPIs): Nexium, Kapidex, Dexilant, Prevacid, Losec, Prilosec, Protonix, Aciphex or any other PPISteroid medication: dexamethasone (although it may be administered in a single dose if medically indicated)St. John's Wort Always inform your doctor of any drug or supplement, prescribed or non-prescribed, that you may be taking before starting any antiretroviral therapy. Other Considerations Complera is not recommended for patients with kidney impairment (defined as having an estimated creatinine clearance of less than 30mL per minute). Please advise your doctor if you have been or are being treated for any kidney disorder by another physician. Complera is not recommended for patients with liver impairment or for those with chronic hepatitis B (HBV) infection as it can severely exacerbate liver problems. It is advised that persons with HIV be screened for HBV before prescribing Complera. Please advise your doctor if you have any liver problems and/or a history of hepatitis. The rilpivirine component of Complera may cause a hypersensitivity reaction in a small number of patients, often in the form of a rash, eye inflammation ("pink eye"), facial swelling, fever, or other allergic responses. Typically, hypersensitivity reactions present 1-6 weeks after the commencement of therapy. Advise your doctor immediately of any such symptoms appears. In severe cases, therapy will likely need to be discontinued. Treatment Update A newer formulation of Complera was approved by the FDA on March 1, 2016, marketed under the name Odefsey. This newer formulation replaces the TDF component with a drug called tenofovir alafenamide (TAF), the latter of which is classified as a pro-drug. Unlike TDF, TAF has no active drug but rather uses the body's own metabolism to convert it into its active form. As such, the drug is delivered more effectively to cells at far lower doses, as well as with far lower drug toxicity (particularly in regards to kidney impairment associated with TDF use). Was this page helpful? Thanks for your feedback! Get information on prevention, symptoms, and treatment to better ensure a long and healthy life. Sign Up You're in! Thank you, {{form.email}}, for signing up. There was an error. Please try again. What are your concerns? Other Inaccurate Hard to Understand Submit Article Sources Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy. Gilead Sciences. Complera - Highlights of Prescribing Information. Reuters. BRIEF - Gilead Sciences Says U.S. FDA Approves Odefsey. U.S. Food and Drug Administration. Approval of Complera: emtricitabine/rilpivirine/tenofovir DF fixed dose combination.