Complera (NNRTIs)

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Complera is manufactured by Gilead Sciences and Janssen Therapeutics. They have a web site that includes the full prescribing information:


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Complera (rilpivirine + tenofovir + emtricitabine)

Pronunciation(s): com-PLAIR-uh; ril-PI-vih-reen; te-NOE-fo-veer; em-tri-SIT-uh-bean



What is Complera?
  • Complera is an HIV medication. It contains two different types of HIV drugs: one non-nucleoside reverse transcriptase inhibitor (NNRTI) and two nucleoside reverse transcriptase inhibitors (NRTIs).
     
  • Complera is marketed by two companies: Gilead Sciences and Janssen Therapeutics. It was approved by the U.S. Food and Drug Administration (FDA), exclusively for people starting HIV treatment for the first time, in August 2011.
     
  • Complera is a combination of three drugs: 25 mg of Edurant (rilpivirine), 300mg of Viread (tenofovir DF) and 200mg of Emtriva (emtricitabine). Complera should be prescribed by a healthcare provider for patients who need all three of these drugs. All three drugs can still be purchased individually for use in combination with other HIV drugs.
     
  • Complera is considered to be a complete one-pill, once-daily HIV treatment regimen.
     
  • Both the tenofovir and emtricitabine in Complera are active against the hepatitis B virus (HBV), the virus responsible for causing hepatitis B. See What about side effects? below for more important information regarding Viread, Emtriva, and hepatitis B.

What is known about Complera?
  • The Complera dose is one tablet taken by mouth once a day. It should be taken with a meal (e.g., breakfast or dinner).
     
  • Complera is approved only for people living with HIV starting HIV treatment for the first time. It is listed as an "alternative" option for people living with HIV starting therapy for the first time by the U.S. Department of Health and Human Services. To learn more about when to start HIV treatment and which medications to use, click here.  
     
  •  Compared with patients who took the NNRTI Sustiva (efavirenz) plus Truvada (tenofovir/emtricitabine) in clinical trials, people with high pre-treatment viral loads (greater than 100,000 copies) who used the three active drugs (rilpivirine, tenofovir and emtricitabine) that make up Complera were more likely to see their viral loads rebound while on treatment. Patients using rilpivirine, tenofovir and emtricitabine were also more likely to develop drug resistance to other NNRTIs, including the second-line drug Intelence (etravirine), and/or Truvada, compared with those using Sustiva plus Truvada.
     
  • Complera should not be any more or less effective than Edurant, Viread, and Emtriva taken as separate pills together. However, it is considered to be a much more convenient way of taking these three HIV drugs.
     
  • See the "What is known about..." sections of Edurant, Viread and Emtriva for information about each drug.

What about drug interactions?
  •  Complera can lower or raise the levels of other medications in the body. Similarly, other medications can lower or raise the levels of Complera in the body. While many interactions are not a problem, some can cause your medications to be less effective or increase the risk of side effects.
     
  • Tell your doctors and pharmacists about all medicines you take. This includes those you buy over-the-counter and herbal or natural remedies, such as St. John's Wort. Bring all your medicines when you see a doctor, or make a list of their names, how much you take, and how often you take them. Your doctor can then tell you if you need to change the dosages of any of your medications.
     
  • 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 (esomeprazole), Prevacid (lansoprazole), Prilosec (omeprazole), Protonix (pantoprazole), Aciphex (rabeprazole)
    Antibiotics: Mycobutin (rifabutin), Rifamate (rifampin), Priftin (rifapentine)
    Anti-seizure medications: Tegretol (carbamazepine), Trileptal (oxcarbazepine), Solfoton (phenobarbital), Dilantin (phenytoin)
    Herbal products: St. John's wort (or products containing St. John's wort.
     
  • Complera should not be taken at the same time as Edurant, Emtriva, Viread, Hepsera, Truvada (tenofovir plus emtricitabine), Epivir (lamivudine) or other combination tablets that contain Epivir (for example, Epzicom, Combivir or Trizivir). This is because these medications contain the same or similar active ingredients as Complera.

What is known about side effects?
  • Complera can cause depression or mood changes. Be sure to contact your health care provider immediately if you are feeling said or hopeless, feeling anxious or restless, or have thoughts of hurting yourself (suicide) or have tried to hurt yourself.
     
  • Changes in body fat can happen in people taking HIV medicines. This is called lipodystrophy. To learn more about lipodystrophy, click here.
     
  • Common side effects of Complera include trouble sleeping (insomnia), headache and rash.
     
  • See the "What about side effects?" sections of Edurant, Viread and Emtriva for additional possible side effects.

Who should not take Complera?
  • Before taking this medication, tell your doctor if you have: kidney disease; liver disease (including hepatitis B); or bone problems. 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 if you have ever had mental illness or are using drugs or alcohol, if you have ever had seizures or are taking medications for seizures.

Where can I learn more about clinical trials involving Complera?
  • If you would like to find out if you are eligible for any clinical trials that include Complera, visit ClinicalTrials.gov, a site run by the U.S. National Institutes of Health. The site has information about all HIV-related clinical studies in the United States. For more info, you can call their toll-free number at 1-800-HIV-0440 (1-800-448-0440) or email contactus@aidsinfo.nih.gov.

Last Revised: October 17, 2011

This content is written by the POZ and AIDSmeds editorial team. For more information, please visit our "About Us" page.


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