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Edurant

March/April 2012

Edurant

Brand name: Edurant

Generic name: rilpivirine hydrochloride (rilpivirine), or RPV

Class: Non-nucleoside reverse transcriptase inhibitor (non-nucleoside, NNRTI, or non-nuke)

Manufacturer: Janssen Therapeutics, www.janssentherapeutics.com, (800) JANSSEN (526-7736)

AWP: $804.39/month

Standard Dose: One 25 mg tablet once daily with a meal of at least 400 calories. Take missed dose as soon as possible with a meal, unless it is closer to the time of your next dose. Do not double up on your next dose.

Potential side effects and toxicity: Insomnia, headache, rash, and depressive disorders (depression, negative thoughts, and suicidal thoughts or actions). When looking at pooled data of the two Phase 3 studies (ECHO and THRIVE), Edurant had significant tolerability advantages when compared to Sustiva. There were lower rates of discontinuation due to side effects. Edurant also has a favorable lipid profile when compared to Sustiva. There were minimal increases in LDL ("bad" cholesterol), total cholesterol, and triglycerides. See chart for potential drug class side effects.

Potential drug interactions: Non-nukes interact with many other drugs. See package insert for the most complete list. Tell your provider or pharmacist about all medications, herbs, and supplements you are taking or thinking of taking, prescribed or not. Do not take with Complera, which already has Edurant in it. Do not take with Sustiva, Atripla, Intelence, or Rescriptor. Antacids should be taken two hours before or at least four hours after an Edurant dose. H2 receptor antagonists, such as Pepcid, Tagamet, and Zantac, should be taken 12 hours before or four hours after an Edurant dose. Proton pump inhibitors, such as Nexium, Prevacid, and Prilosec, should not be taken. Cannot be taken with the anti-seizure medications carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the anti-TB drugs rifabutin, rifampin, and rifapentine; or the herb St. John's wort. Do not take with more than one injectable dose of the steroid dexamethasone; repeated topical use is okay. Clinically monitor the anti-fungals fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), Noxafil (posaconazole), and Vfend; dose-adjustment for these medications may be needed. Use azithromycin when possible instead of the antibiotics Biaxin, erythromycin, and troleandomycin (Tao). Methadone levels are reduced slightly and patients should be monitored for symptoms of withdrawal. Should be used with caution when taken with medications with a known risk of Torsade de Pointes or QT prolongation (these are abnormal heart rhythms and can make the heart stop).

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More information: Approved by the FDA in 2011 for adults who have not taken HIV medications before, as a stand-alone medication and in a fixed dose pill with Truvada (one pill, once-a-day regimen -- see Complera) as well. Studies ECHO and THRIVE showed that Edurant is non-inferior (a term used in scientific research that means the drug is no worse nor better than those it's compared to) to Sustiva in efficacy -- 84% vs. 82% of patients achieved a viral load of less than 50 copies/mL (undetectable) and CD4 count increases of 190 vs. 172 when comparing Edurant and Sustiva, respectively. Although individuals were less likely to stop treatment due to side effects on Edurant vs. Sustiva, they were more likely to experience virologic failure on Edurant (9% vs. 4.8% for Sustiva at 48 weeks), and their HIV was more likely to develop drug resistance mutations when compared to Sustiva. Of those with virologic failure, a new NRTI resistance mutation was developed by 68% vs. 32% and a new NNRTI resistance mutation was developed by 63% vs. 54% respectively. More cross-resistance to Intelence, Sustiva, and Viramune was seen with Edurant treatment failures than with Sustiva failures. These findings can be explained in part by looking at an individual's baseline viral load and their adherence to medication. With the combination of high viral load (more than 100,000 copies per mL) and poor adherence, individuals in the study were three times more likely to experience virologic failure with Edurant when compared to Sustiva. The 25 mg Edurant dose was selected because the 75 mg and 150 mg doses studied were associated with a risk of abnormal heart rhythm (prolonged QT interval). While its tolerability and safety profiles are advantages for Edurant, the greater potential for virologic failure and cross-resistance to the other NNRTIs compared to Sustiva puts Edurant at a disadvantage for first-time treatment, since people may not be able to switch to another NNRTI if their HIV develops NNRTI resistance mutations with Edurant. For proper absorption, it must be taken with a meal that you chew. Nutritional drinks, even high-calorie protein shakes or products like Ensure, won't be enough. Taken with a protein shake, Edurant levels were still half of what they are with a meal. The amount of fat doesn't matter. Meal examples include two slices of whole wheat toast with peanut butter, fresh fruit, and orange juice; a roast beef sandwich on a hard roll with mayo and cheese; and two cups of spaghetti with marinara sauce and a slice of bread. Edurant is a tiny pill about the size of a baby aspirin. While Sustiva is associated with a risk of birth defects, Edurant is Pregnancy Category B (found safe in animal studies), but no studies in humans have been conducted, and Edurant should be used in pregnancy only if the potential benefit justifies the potential risk. (Most HIV medications are Pregnancy Category B.) See package insert for complete information on potential side effects and drug interactions.


Doctor's Comments

Edurant was approved for initial therapy by the FDA in 2011, followed by approval of Complera, a single-tablet combination of rilpivirine, tenofovir, and FTC. The combination of Edurant plus two NRTIs was shown to be better tolerated than Atripla in two large clinical trials. Overall results were similar, but Atripla was somewhat more effective in people with viral loads above 100,000, and there was more virologic failure and resistance, including cross-resistance to Intelence, in people who took Edurant. Current guidelines list Edurant-based regimens as "alternatives" to the preferred regimens. Edurant must be taken with a full meal and should not be taken with drugs that reduce stomach acid.

-- Joel Gallant, M.D., M.P.H.


Activist's Comments

A refreshing addition to the HIV arsenal, Edurant is a tiny pill! I haven't heard anyone complaining of side effects yet, and most importantly, there's been a mass migration of folks who can't tolerate Atripla and kept having the vivid dreams. I've had friends switch and they are thrilled -- with no side effects (yet) and labs improving for them, they're content. Clearly not for all, and in combination, this once-daily therapy is just what the doctor ordered for many! Edurant has a niche in the rainbow of needs and situations for the people who need specialized HIV therapy.

-- Joey Wynn


Got a comment on this article? Write to us at publications@tpan.com.


  
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This article was provided by Positively Aware. It is a part of the publication Positively Aware. Visit Positively Aware's website to find out more about the publication.
 
See Also
The 16th Annual HIV Drug Guide
More on Edurant (Rilpivirine, TMC278)
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