|What is Edurant?
- Edurant is a non-nucleoside reverse transcriptase inhibitor (NNRTI) manufactured by Janssen Therapeutics. It was approved by the U.S. Food and Drug Administration (FDA) in May 2011. Edurant is approved for people living with HIV starting antiretroviral therapy for the first time. It is not approved for people living with HIV who have already used antiretrovirals.
- Edurant works by blocking HIV’s reverse transcriptase enzyme. After HIV's genetic material is deposited inside a cell, its RNA must be converted (reverse transcribed) into DNA. NNRTIs stop this process and prevent HIV from infecting the CD4 cell and producing new virus particles.
- Edurant will need to be used in combination with other drugs.
- Janssen Therapeutics has established a co-pay program and a patient assistance program (PAP) for people living with HIV who do not have private or public health insurance and are unable to afford Edurant. To learn more about the co-pay program or the PAP for Intelence, call 866-836-0114 or refer to Janssen's website for more information.
What is already known about Edurant?
- The Edurant dose is one 25 mg tablet taken by mouth once a day. It should be taken with a high-fat meal (e.g., breakfast and dinner).
- Edurant is approved only for people living with HIV starting HIV treatment for the first time. It is listed as an "alternative" NNRTI 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)—frequently used together as Atripla—in clinical trials, people with high pre-treatment viral loads (greater than 100,000 copies) who used Edurant plus Truvada were more likely to see their viral loads rebound while on treatment. Patients using Edurant plus Truvada 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.
- Like other NNRTIs, Edurant might interact with other medications, including those used to treat HIV. It is important that your personal physician and/or the research nurse or study investigator be aware of all drugs you are taking, including those you buy without a prescription.
- A long-acting version of rilpivirine is being explored in clinical trials. Rilpivirine LA (long acting) may allow for injectable administration, once a week or a few times a month.
What about drug interactions?
- Edurant is broken down (metabolized) by the liver, like many medications used to treat HIV and AIDS. This means that Edurant can interact with other medications. Edurant can lower or raise the levels of other medications in the body. Similarly, other medications can lower or raise the levels of Edurant 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 Edurant:
Anti-seizure medications: Tegretol (carbamazepine), Trileptal (oxcarbazepine), Luminal (phenoparbital), Dilantin (phenytoin)
Antibiotics: Rifadin (rifampin), Mycobutin (rifabutin), Priftin (rifapentine)
Acid reflux medications: Nexium (esomeprazole), Prevacid (lansoprazole), Prilosec (omeprazole), Protonix (pantroprazole), Aciphex (rabeprazole)
Steroids: dexamethasone (more than a single dose)
- Edurant should not be taken with other NNRTIs.
- HIV protease inhibitors can interact with Edurant. Both Norvir-boosted and unboosted PIs can increase blood levels of Edurant, whereas Edurant is not likely to affect PI blood levels. However, there does not appear to be a need to adjust the Edurant dose.
- Antacids, such as Tums or Pepto-Bismol, can prevent Edurant from being absorbed properly. They should be used at least two hours before or at least four hours after taking Edurant. H2-receptor antagonists—such as Zantac (ranitidine), Pepcid (famotidine), Tagamet (cimetidine) or Axid (nizatidine)—used for acid reflux, should also be used cautiously. These should be taken at least 12 hours before or at least four hours after taking Edurant..
- Several medications used to treat fungal infections may increase Edurant blood levels. However, there does not appear to be a need to adjust the Edurant dose.
- Several antibiotics, such as Biaxin (clarithromycin), erythromycin, and Tao (troleandomycin), can increase Edurant blood levels. Where possible, alternatives such as Zithromax (azithromycin) should be used.
- Methadone levels may decrease when used with Edurant. Increasing the Methadone dose may be necessary if it stops working effectively while using Edurant.
What is known about side effects?
- Edurant 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 Edurant include trouble sleeping (insomnia), headache and rash.
- At doses above 25mg, which may be necessary to treat people with HIV resistance to other NNRTIs, Edurant was found to disturb the heart's rhythm, a syndrome called QT-prolongation. The 25mg dose was no more likely than Sustiva to cause heart rhythm disturbances in clinical trials.
Who should not take Edurant?
- It is not known whether Edurant will harm an unborn baby. It is very important to treat HIV/AIDS during pregnancy to reduce the risk of infecting your baby. Talk to your doctor about your treatment options.
- It is not known whether Edurant passes into breast milk and what effect it may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed.
Where can I learn more about clinical trials of Edurant?
- If you would like to find out if you are eligible for any clinical trials that include Edurant, 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 email@example.com.