Standard DoseOne tablet once daily, with a meal (see Edurant), for adults who are virologically suppressed (have an undetectable viral load of less than 50 copies per mL) on a current ART (antiretroviral therapy) regimen for at least 6 months and who have no history of treatment failure or resistance mutations associated with rilpivirine or dolutegravir. Tablet contains 50 mg of the INSTI dolutegravir plus 25 mg of the NNRTI rilpivirine.
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. For proper absorption, rilpivirine must be taken with a meal that you chew—not just nutritional drinks or protein shakes.
See the individual drugs contained in Juluca: Tivicay and Edurant.
See package insert for more complete information on potential side effects and interactions.
Potential Side Effects and Toxicity
Both dolutegravir and rilpivirine are generally well tolerated. Side effects observed in greater than 2% of study participants were diarrhea and headache. New data associate INSTIs and TAF with weight gain; see “Weighty Concerns,” beginning on page 8, and go to aidsinfo.nih.gov. 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.
Potential Drug Interactions
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 H2 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. When taking rifampin, take an additional dose of dolutegravir (in the form of one Tivicay tablet) 50 mg 12 hours after taking your Juluca dose. 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 was 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 load 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 except Dovato and Juluca contain two nucleoside drugs. Juluca contains two currently available medications. The benefits of taking Juluca 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. Dolutegravir is now a preferred medication in pregnancy as well as an alternative drug for those who are trying to conceive, according to U.S. HIV perinatal treatment guidelines updated in December 2019 (go to aidsinfo.nih.gov/guidelines/html/3/perinatal-guidelines/0). This clears preliminary concerns over the potential for birth defects with dolutegravir raised in 2018 by a study in Botswana.
Dr. Ross Slotten says:
Approved in 2017, Juluca is another highly effective STR, but it does not include 2 NRTIs. It is a unique two-drug regimen: an INSTI and NNRTI (non-nucleoside reverse transcriptase inhibitor). NRTIs have been implicated in a number of adverse events, like lactose acidosis (all NRTIs), kidney toxicity (TDF), lipodystrophy (AZT/Retrovir and D4T/Zerit), heart attacks (abacavir), and bone density loss (TDF). Juluca contains dolutegravir and rilpivirine, a second generation non-nucleoside reverse transcriptase inhibitor distantly related to efavirenz (Sustiva). The drug has a special place in my heart because it is the first STR that I have been able to prescribe to people who were heavily pre-treated in the early days of HIV treatment and developed multiple resistance mutations to the NRTI class of drugs. Thus, Biktarvy and Triumeq, yet to be proven otherwise, are probably not good choices in this setting. It is very well tolerated and, like Triumeq, a very tiny pill. The main drawback to Juluca is that rilpivirine has a low barrier to resistance. The medication must be taken with a high caloric meal (more than 400 calories) that must be chewed (no protein drinks; chewing increases its absorption). It can’t be taken with a proton pump inhibitor (PPI), like Prilosec, Nexium, or Prevacid, which interferes with rilpivirine’s absorption. Other acid blockers, like Tagamet, Pepcid, and Zantac, will not interfere with absorption if taken 12 hours apart. Juluca is a niche drug but one that has reduced the pill burden in a number of my heavily pre-treated patients.
Activist Bridgette Picou says:
Juluca is indicated as a switch regimen. Specifically, patients virally suppressed for more than six months and stable on their current regimen. It is two drugs rather than three, which is a long-term-use benefit since it should reduce drug effects on the body over time. Less drug, less toxicity. Juluca should also be taken with a meal.