Odefsey

Moderate to severe side effects are uncommon; insomnia, headache, and depressive disorders (depression, negative thoughts, suicidal thoughts or actions) were each reported in 2% of study participants on rilpivirine-containing regimens. Cases of rash, angioedema (swelling), urticaria (itchy rash), and increased liver enzymes have also been reported with regimens containing rilpivirine. New data associate TAF with potential weight gain; see “More information.” go to positivelyaware.com/articles/weighty-concerns and positivelyaware.com/articles/fatty-tissues. There may be a small increase in serum creatinine (SCr) and decrease in estimated creatinine clearance (CrCl) associated with rilpivirine. See Descovy page for other possible effects on kidney function. The most common (greater than 10%) side effect observed in clinical trials with Descovy (the fixed-dose combination of Emtriva and TAF), is nausea. Prior to initiation, people should be tested for hepatitis B virus (HBV) infection. Severe exacerbations of hepatitis B have been reported in people co-infected with hepatitis B who have discontinued Odefsey (due to elimination of the emtricitabine and TAF components, which also treat HBV).

Monitor liver enzymes closely in people co-infected with hepatitis B and, if appropriate, initiation of anti-hepatitis B therapy may be warranted upon Odefsey 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.

Do not take with Cimduo or Temixys, Descovy, Emtriva, Epivir-HBV, Hepsera, Truvada, Vemlidy, or Viread, all used for the treatment of hepatitis B. Proton pump inhibitors (PPIs, heartburn or stomach acid drugs like Aciphex, Dexilant, Nexium, Prevacid, Prilosec, Protonix, etc.) cannot be taken with Odefsey. Antacids containing aluminum, magnesium hydroxide, or calcium carbonate can be taken two hours before or four hours after Odefsey. Stomach acid-reducing drugs such as Pepcid, Tagamet, and Zantac can be taken 12 hours before or four hours after a dose of Odefsey. Do not take with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, or the herb St. John’s wort. Taking Odefsey with rifabutin is not recommended.

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, and while dose adjustments are not necessary, it is recommended to monitor for withdrawal symptoms. Odefsey should not be taken with other medications that prolong QTc interval (a heart problem) or medications with a known risk for torsades de pointes. May be taken with Harvoni, Zepatier, or Epclusa. 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.

Odefsey is a single-tablet regimen that is an option for people with impaired kidney function. Rilpivirine-containing regimens can be relatively difficult to take because of their food requirement and drug interactions. In addition, strict adherence is critical due to the relatively low barrier to the development of resistance. The Odefsey tablet is very small in size, which may be advantageous to individuals who have difficulty swallowing. Weight gain is increasingly recognized as a side effect of TAF. In the community, enlargement of the stomach and waist area can be distressing.

According to the DHHS HIV treatment guidelines, “Weight gain has been associated with initiation of ART [antiretroviral therapy] and subsequent viral suppression. The increase appears to be greater with INSTIs than with other drug classes. Greater weight increase has also been reported with TAF than with TDF, and greater with DOR than EFV.” Other factors have been associated with weight gain in addition to medication used, including race, sex, and previous overweight status. There is no word yet on reversibility, but the race is on to find more answers. For individuals with HIV-2, more commonly found outside the U.S., an NNRTI would not be recommended as HIV-2 is inherently resistant to NNRTIs. Pregnant patients virologically suppressed on Odefsey may continue taking it. Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.

Dr. Melanie Thompson:

Odefsey is Complera with TAF instead of TDF. It also contains the NNRTI rilpivirine, which has fewer side effects than efavirenz, and the NRTI emtricitabine (FTC). 

Like Complera, Odefsey is recommended for initial therapy only in “certain situations” when INSTI-based treatment cannot be used. While kidney and bone side effects are a consideration with TDF, there are now concerns about weight gain with TAF, as well as mildly elevated lipids. For people just starting therapy, I see little role for either Odefsey or Complera these days.

There are a number of notable drawbacks to rilpivirine. (See Edurant.) Rilpivirine is recommended only when viral load is less than 100,000 copies/mL and CD4 T cell count must be above 200 cells/mm3. It should not be used with proton-pump inhibitors such as Prilosec and Nexium, and dosing must be managed if taken with other acid-blockers. It also has been associated with kidney stones.

Odefsey carries a high price tag, requiring a copay card to partially defray out-of-pocket costs in order to be affordable.

Activist Bridgette Picou:

Most comparable to Complera, Odefsey is a once-daily, single-tablet pill. It is a switch option for patients stable on other ART and for people whose viral load is less than 100,000, and can be used for initial therapy. Using TAF instead of TDF means less toxicity to the kidneys, and less damage to the bones, but both should still be followed. If you take antacids for heartburn, let your provider know. Additionally, if you feel depressed or hopeless while taking Odefsey, speak to your healthcare provider.