Juluca

• See the individual drugs contained in Juluca: Tivicay and Edurant.

• See package insert for more complete information on potential side effects and interactions. 

Both dolutegravir and rilpivirine are generally well tolerated. Side effects observed in greater than 2% of study participants were diarrhea and headache. Dolutegravir and rilpivirine can each cause a small, reversible increase in a kidney function test (serum creatinine) within the first few weeks of treatment without affecting actual kidney function. There have been rare reports of depression and suicidal ideation, primarily in patients with a history of psychiatric illnesses, in people receiving INSTI-based regimens. The DHHS guidelines recommend closely monitoring patients with pre-existing psychiatric conditions on an INSTI. Liver enzymes should be monitored in people with hepatitis B or C and taking dolutegravir. Call your health care provider right away if you develop any of the following signs or symptoms: 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. There may be a possibility of birth defects—see “More information.”

Do not take Juluca with the anti-arrhythmic dofetilide. If taking rifabutin, add an Edurant tablet to Juluca dose. If you take antacids, laxatives, or other products that contain aluminum, calcium carbonate, magnesium, or buffered medicines, Juluca should be taken (with a meal, as always) at least 4 hours before or 6 hours after you take these medicines. Alternatively, these medications can be taken at the same time with Juluca and the meal. Take Juluca with a meal 4 hours before or 12 hours after you take H-2 blocker acid reducers (Pepcid, Zantac, Tagamet) or buffered medications. Juluca should not be taken with proton pump inhibitors (such as Aciphex, Dexilant, Prilosec, Prevacid, Protonix, Nexium). Avoid taking Juluca with some seizure medicines (carbamazepine, oxcarbazepine, phenobarbital, and phenytoin) or St. John’s wort. HIV treatment guidelines suggest that metformin be started at the lowest dose and titrated based on glycemic control. Monitor for metformin adverse effects. When starting or stopping Juluca in people on metformin, dose adjustment of metformin may be necessary to maintain optimal glycemic control. Not intended to be taken with other HIV medications, unless prescribed that way. 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.

Juluca is the first two-drug combination approved as a complete regimen for HIV. It replaces a three- or four-drug therapy for people with undetectable viral loads who want to switch to a simpler or smaller tablet regimen. People switching to Juluca must be virologically suppressed (with viral loads of less than 50 copies per mL) on a stable antiretroviral regimen for at least six months. This is a new HIV treatment strategy and potentially a game changer, especially with other dual-drug antiviral medications on the way. Those able to take their medications correctly, consistently, and achieve undetectable viral loads can take advantage of this drug-sparing strategy. Currently people taking HIV treatment must start out with a three-drug regimen (which may include the use of one of the single-tablet regimens, or STRs), then switch to Juluca after being undetectable for six months. Juluca still works against two steps of the life cycle of the virus, similar to 3-drug regimens. This is how the combination was used in clinical studies to date. This combination was listed in U.S. HIV guidelines as a “Strategy with good supporting evidence” around the time of its FDA approval. The guidelines also called Juluca “a reasonable option when using nucleoside drugs is not desirable” (for example, due to previous toxicity), with an A1 rating (strong recommendation based on randomized controlled trials). Juluca is the first nucleoside-free STR. Currently, all the STRs contain two nucleoside drugs. Juluca contains two currently available medications. Dolutegravir (available separately under the brand name Tivicay, from ViiV Healthcare) is available in the STR Triumeq. Rilpivirine (available separately under the brand name Edurant, from Janssen Therapeutics) is available in the STRs Complera and Odefsey. The benefits of taking Juluca, a two-drug regimen for HIV-1, include less exposure to HIV medications while maintaining viral suppression. Juluca is the smallest STR, which may be advantageous to individuals who have difficulty swallowing. New preliminary data from an observational study in Botswana suggest that there may be an increased risk of birth defects in infants born to those who were receiving dolutegravir at the time of conception. Until more information is available, regimens containing dolutegravir are not recommended for use in ART-naïve patients who are pregnant and within 12 weeks of conception. Consult with your provider to discuss guidance on how to manage regimens containing dolutegravir or a different integrase inhibitor if there is any possibility of conception.  

Dr. David Hardy says:

Juluca, the seventh STR approved by the FDA, in late 2017, is a departure from the six previous STRs. This is because instead of being approved for initial treatment of PLWH and/or for use as a “switch regimen,” Juluca is specifically and only approved as a “switch regimen” in PLWH with undetectable viral loads and no previous history of failed ART regimens. Juluca is also the first two-drug, instead of a three-drug, STR. What, you may ask, is the idea behind using only two drugs to keep HIV suppressed rather than the usual three drugs? The approval of Juluca as a two-drug “maintenance” ART regimen is unique and follows on the results of two large Phase 3 studies (SWORD 1 & 2) which enrolled more than 1,000 PLWH with undetectable viral loads receiving an NNRTI-, boosted PI-, or integrase inhibitor-containing ART regimen and no previous failed ART regimens. Half of the PLWH were switched to Juluca, the other half remained on their previous ART regimen. Ninety-five percent of both groups of PLWH maintained undetectable viral loads a year later; 89% of those switched initially maintained their undetectable viral loads two years later. More PLWH receiving Juluca reported side effects and stopped taking Juluca than those PLWH who stayed on their previous ART regimens, but no new or unexpected side effects were reported. The use of Juluca has shown a slow but steady rise since its approval among prescribing healthcare providers and PLWH. This may be due to reluctance to change virally suppressive ART with a multi-tablet regimen or uncertainty with a two-drug regimen.

Juluca was approved for patients who have been virally suppressed for at least six months and never experienced drug resistance to either of its component medications. If you are concerned about the exposure to HIV medicines and their side effects but want to make sure your viral load continues to be suppressed, Juluca might be your option. Keep an eye on your liver functions while taking Juluca.