Odefsey and Complera
For adults and children 12 years of age and older weighing at least 77 pounds (35 kg) and having a CrCl of at least 30 mL/min for Odefsey or 50 mL/min for Complera. Odefsey should be used with caution in adults with end-stage renal disease (ESRD) with an estimated CrCl below 15 mL/min who are receiving chronic hemodialysis (HD). Take the Odefsey dose after completion of dialysis. Complera should not be used in people with CrCl less than 50 mL/min or severe liver impairment.
Must be taken with food that you chew—not just nutritional drinks, protein shakes or a light snack. Taking rilpivirine without enough food could result in up to a 40% decrease in drug absorption and may lead to resistance.
According to HHS guidelines, people taking HIV treatment for the first time should have an HIV RNA (viral load) of less than 100,000 copies/mL and CD4 T cell count must be above 200 cells/mm3 before starting rilpivirine due to higher rates of virologic failure in these people. The CD4 requirement, however, is no longer on the drug label.
Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose.
- See the individual drugs: Edurant and Descovy (coformulation of Emtriva and TAF), or Truvada (coformulation of Emtriva and TDF).
- See package insert for more complete information on potential side effects and interactions.
gilead.com; genvoya.com
(800) GILEAD-5 (445-3235)
Janssen Therapeutics
janssentherapeutics.com
(800) JANSSEN (526-7736)
$4,144.75/month
Complera AWP
$4,144.75/month
JO-ANN JOSE, MD, MPH:
Odefsey and Complera are both single-tablet regimens that differ by the tenofovir component. Complera contains tenofovir with the greater potential for kidney and bone density side effects. Odefsey contains TAF, which has a lower risk of these side effects. Both contain rilpivirine, which means there are some precautions around potential drug interactions with proton pump inhibitors, and a calorie requirement for meals. Side effects can include new or worsening symptoms of depression.
Proton pump inhibitors (PPIs, heartburn or stomach acid drugs such as Aciphex, Dexilant, Nexium, Prevacid, Prilosec, Protonix, etc.) cannot be taken. Antacids containing aluminum, magnesium hydroxide or calcium carbonate can be taken two hours before or four hours after Odefsey or Complera. Stomach acid-reducing drugs such as Pepcid, Tagamet and Zantac can be taken 12 hours before or four hours after a dose of Odefsey or Complera. Do not take with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine or the herb St. John’s wort. Do not take with more than one dose of the injectable steroid dexamethasone (sometimes given in the ER or hospital). Use caution if taken with fluconazole, itraconazole, ketoconazole, posaconazole or voriconazole. Use azithromycin when possible, instead of the antibiotics clarithromycin, erythromycin or telithromycin, because these drugs increase rilpivirine levels, which can increase the risk of side effects. Reduced methadone levels can occur; while dose adjustments are not necessary, it is recommended to monitor for withdrawal symptoms. Taking Odefsey with rifabutin is not recommended. Co-administration of rifabutin with Complera requires an extra Edurant 25 mg tablet in addition to Complera. Odefsey should not be taken with other medications that prolong QTc interval (these abnormal heart rhythms can make the heart stop) or medications with a known risk for torsades de pointes. Odefsey may be taken with Harvoni and Zepatier, but Complera cannot. Odefsey can be taken with Epclusa but monitor for tenofovir toxicity with Complera. Tell your provider or pharmacist about all medications, herbals and supplements you are taking or thinking of taking, prescribed or not, as there are other drug interactions which are not listed here.
Moderate to severe side effects are uncommon; insomnia, headache, nausea and depressive disorders (depression, negative thoughts, suicidal thoughts or actions) were observed. Cases of rash, angioedema (swelling), urticaria (itchy rash) and increased liver enzymes have also been reported with regimens containing rilpivirine. TAF has been associated with potential weight gain. There may be a small increase in serum creatinine (SCr) and decrease in estimated creatinine clearance (CrCl) associated with rilpivirine. Prior to initiation, people should be tested for hepatitis B virus (HBV) infection. Severe exacerbations of HBV have been reported in people co-infected with HBV who have discontinued Odefsey or Complera (due to elimination of the emtricitabine, TAF and TDF components, which also treat hepatitis B). Monitor liver enzymes closely in co-infection. Initiation of HBV therapy may be warranted upon discontinuation. Call your health care provider right away if you develop any of the following signs or symptoms of hepatitis: yellowing of the skin or whites of the eyes; dark or tea-colored urine; pale-colored bowel movements; nausea or vomiting; loss of appetite or pain, aching or tenderness on the right side below the ribs. SEE Descovy and Truvada pages for more possible effects on kidney function. Increased monitoring for adverse events is recommended for people with ESRD who are taking Odefsey.
Odefsey is an option for people with impaired kidney function. 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. Odefsey is one of the smallest STRs, which may be advantageous to individuals who have difficulty swallowing. Pregnant individuals virologically suppressed on Odefsey or Complera may continue taking it. 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:
Odefsey and Complera are well tolerated drugs that have to be taken with food but can’t be taken with antacids. That last part is essential to keep in mind. I’ve known people who experienced virologic failure after forgetting this and developed resistance to two classes of drugs. Given those consequences, I think it’s safe to say there are better options for treatment.