On August 10 2011, the US Food and Drug AdministrationThe U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the nation's blood supply. The Australian equivalent is the Therapeutic Goods Administration (TGA). approved Complera, a fixed-dose combination (FDC) drug containing the new Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), rilpivirine, plus 2NRTIs (tenofovir and emtricitabine).
Its approval is based on Phase IIIA large clinical trial designed to establish whether a drug is effective and safe enough for widespread use. Phase III studies include expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. clinical trials that compared it to the other FDC: Atripla (efavirenz, tenofovir, emtricitabine) and had similar outcomes.
Overall, the proportion of people with undetectable viral loads at 48 weeks was 83% for those on rilpivirine, compared to 81% for those on efavirenz.
Complera is currently available only for people in the US starting HIV therapy for the first time.
Update: Eviplera is due to be listed on the PBS[Pharmaceutical Benefits Scheme] The federal government program which subsidises medication costs in Australia. Anti-HIV drugs are part of a special part of the PBS called Section 100 (S100) which is used for expensive, highly specialised drugs. in Australia on 1 June 2012.
| Generic name: |
rilpivirine + tenofovir + emtricitabine |
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| Pronunciation: | Evee-PLAIR-a |
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| Brand name: | Eviplera |
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| Also known as: | Complera |
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| Drug class: | multi-class formulation |
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| Pregnancy safe? | Not suitable for use in pregnancy. If you are pregnant or may become pregnant, you should not take this treatment. |
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| Availability in Australia: | - Not available on the Pharmaceutical Benefits Scheme (PBS).
- This drug may be available through clinical trials in Australia.
- You may be able to import this drug from overseas for your personal use.
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| Presentation: | 25 mg rilpivirine; 300mg tenofovir; 200mg emtricitabine |
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| Links: | |
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This product contains multiple medicines which comprise a complete antiretroviral regimen for most people. However your doctor may prescribe other antiretrovirals to be taken in combination with rilpivirine + tenofovir + emtricitabine if needed. Your doctor will advise you on the right combination of drugs to suit your circumstances.
Dosage
One tablet once a day
Regardless of what you read on this website or elsewhere, you should always take your medications according to your doctor's instructions. If you're unsure, speak to your doctor or pharmacist.
With or without food?
Rilpivirine + tenofovir + emtricitabine must be taken with a high-fat meal.
Side effects
All drugs can produce side effects in some people. These may be mild, moderate or severe, so you should be aware of potential side effects before starting any drug, and speak to your doctor if you experience side effects that concern you.
- Common side effects may include rash, insomnia, headaches.
- Less common side effects may include depression, mood swings.
It's unlikely you will experience all of these side effects, and you may not experience any side effects at all. Before starting any new drug, ask your doctor about side effects you might experience and discuss strategies for dealing with side effects if they do occur. If you experience any significant side effect you should continue taking your medicine and see your doctor as soon as possible.
Interactions with other drugs
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).
Positive Living article • AIDSmeds • 26 May 2011
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The table below shows all the clinical trials in the database with the keyword multi-class formulations.
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