Edurant
A long-acting injectable form is available; see Cabenuva page.
According to HHS guidelines, viral load (HIV RNA) should be less than 100,000 copies/mL and CD4 T cell count must be above 200 cells/mm3 before starting Edurant due to higher rates of virologic failure in people who don't meet these levels. The CD4 requirement, however, is no longer on the drug label.
Take missed dose as soon as possible with a meal, as long as it is at least 12 hours before your next dose. Do not double up on your next dose.
Must be taken with a meal that you chew—not just a nutritional drink or a protein shake or a light snack. Taking rilpivirine without food could result in up to a 40% decrease in drug absorption and may lead to resistance.
- See package insert for more complete information on potential side effects and interactions.
edurant.com
(800) JANSSEN (526-7736)
JO-ANN JOSE, MD, MPH:
Edurant is the oral version of rilpivirine, which is a component of the single-tablet regimens Odefsey, Complera and Juluca. Rilpivirine is also used in intramuscular form with cabotegravir as part of the long-acting injectable treatment Cabenuva. Rilpivirine comes with a lot of rules and interactions, so talk with your doctor about all the medications, drugs and supplements you take. Drug interactions of oral rilpivirine are different from the injectable version. (When you take a drug orally, there is a potential for interaction with other things that might be in the stomach. That’s not the case with an injectable, because the drug is avoiding the GI tract.)
Edurant cannot be taken with the antiseizure medications carbamazepine, oxcarbazepine, phenobarbital or phenytoin; the anti-TB drugs rifampin and rifapentine; proton pump inhibitors (Aciphex, Dexilant, Nexium, Prevacid, Protonix and Prilosec) or St. John’s wort. Do not take with more than one dose of the injectable steroid dexamethasone (sometimes given in the emergency department or hospital). Antacids or other products containing aluminum, calcium carbonate or magnesium hydroxide should be taken two hours before or at least four hours after Edurant. Acid-reducing drugs (Pepcid, Tagamet, Zantac and Axid) should be taken 12 hours before or four hours after an Edurant dose. If administered with rifabutin, the dose of Edurant should be increased to two 25 mg tablets once daily with a meal. When rifabutin is stopped, Edurant dose should be decreased to 25 mg daily. Monitor for worsening of any fungal infections when Edurant is used with antifungal medications such as fluconazole, itraconazole, ketoconazole, posaconazole and voriconazole; dose adjustment for these medications may be needed. Use azithromycin when possible, instead of clarithromycin, erythromycin and telithromycin. Methadone levels are reduced slightly, and people should be monitored for symptoms of withdrawal. Edurant should be used with caution when taken with other medications with a known risk for torsades de pointes or QT prolongation (these abnormal heart rhythms can make the heart stop).
Edurant is a very tolerable medication. Moderate to severe side effects are uncommon. Most common side effects occurring in 3–5% of study subjects were insomnia, headache, rash and depressive disorders. Stop taking Edurant and see a medical provider right away if allergic reaction or rash occurs with any of the following: fever, trouble breathing or swallowing, blisters, mouth sores, redness or swelling of the eyes or swelling of the face, lips, mouth, tongue or throat. Tell your doctor right away if you experience feelings of sadness, hopelessness, anxiety or restlessness or have suicidal thoughts or actions. A small study showed a higher rate of depressive disorders in adolescents (19.4%—seven out of 36 youths—vs. 9% for adults), which may or may not have been related to Edurant. Edurant also has minimal negative effects on LDL (“bad”) cholesterol, total cholesterol and triglycerides compared to Sustiva. Edurant improved HDL (“good”) cholesterol slightly less than Sustiva. Liver problems can occur but are very rare. The risk may be greater for people with a history of hepatitis B or C, but may occur in people without a history of liver disease. Edurant can cause an increase in kidney function test (serum creatinine) within the first four weeks of treatment. The changes are not considered clinically relevant.
Rilpivirine is combined with dolutegravir as a complete regimen; see Juluca. A long-acting injectable formulation of rilpivirine was approved in 2021 along with a long-acting injectable formulation of cabotegravir to form a complete regimen taken once a month or once every two months; see Cabenuva. This regimen is approved to replace oral ART in people with virologic suppression and no history of resistance to RPV or INSTIs. Drug interactions differ between the oral and the injectable rilpivirine. Edurant is not HHS recommended for treatment-naïve people with a pre-treatment viral load greater than 100,000 copies/mL and CD4 T cell count below 200 cells/mm3. The CD4 requirement, however, is no longer on the drug label. A rilpivirine-based regimen may be advantageous for people with high risk for heart disease due to its relatively low impact on lipid profile. The clinical benefit of these findings has not been demonstrated. While its tolerability and safety profiles are advantages for Edurant, the greater potential for virologic failure in people with high viral loads, food restrictions and cross-resistance to the other NNRTIs puts Edurant at a disadvantage for first-time treatment—people may not be able to switch to another NNRTI if their HIV develops NNRTI-resistant mutations to Edurant. Data for use of rilpivirine in combination with an abacavir/lamivudine background are insufficient to recommend at this time. For individuals with HIV-2, primarily found in West Africa but also present in other countries, an NNRTI would not be recommended as HIV-2 is inherently resistant to NNRTIs. Edurant can be used during pregnancy and is listed as an HHS alternative NNRTI to use during pregnancy in combination with a two-NRTI backbone. According to the FDA, lower exposures of rilpivirine were observed during pregnancy; therefore, viral load should be monitored closely. Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; GO TO apregistry.com.
JUAN MICHAEL PORTER II:
Edurant is a standalone non-nucleoside that is in Complera and Odefsey. It has to be taken with food and as one friend put it, “The only reason to take it is perhaps with a boosted PI. But as a standalone agent? No.”