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Juluca

50 mg dolutegravir, 25 mg rilpivirine DTG (INSTI), RPV (NNRTI)
Recommended as continuation therapy for people with undetectable HIV viral load for at least 6 months
Standard Dose
One 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 six months and who have no history of treatment failure or resistance mutations associated with rilpivirine or dolutegravir.

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. 
Manufacturer
ViiV Healthcare
viivhealthcare.com; juluca.com
(877) 844-8872
AWP
$4,383.28/month
Activist Comments

JUAN MICHAEL PORTER II:

Juluca is another two-drug-in-one pill, but you already have to be virally suppressed to use it. It also has to be taken with food but can’t be taken with certain foods or vitamins or drugs. I’ve had friends who switched to Juluca while they were searching for a new regimen. None of them stayed with it. My doctor friends tell me that it basically has the same drugs that are in long-acting injectable ART and could be used to determine whether injectable therapy would work for someone. Having known many people who’ve struggled with diarrhea while using it, I think it’s a hard no.

Doctor Comments

JO-ANN JOSE, MD, MPH:

Juluca is a two-drug regimen containing dolutegravir and rilpivirine for people who do not have [drug resistance] mutations. Juluca does not treat hepatitis B (HBV), so it should not be taken unless a drug such as entecavir that is active against HBV is also given. Weight gain can be a concern with any INSTI, so optimizing your lifestyle with diet and exercise is recommended. Juluca should be taken 2 hours before or 6 hours after aluminum, magnesium, zine, calcium or iron supplements. Because it also contains rilpivirine, it should be taken with a moderately-sized meal of 393 calories for proper absorption. If you currently take proton pump inhibitors used to treat acid reflux, you should not take Juluca. In clinical trials of this medicine, the most common side effects were diarrhea and headache. Rarer side effects include a potential for new or worsening symptoms of depression.

Potential Drug Interactions

Do not take Juluca with rifampin, rifapentine or the anti-arrhythmic dofetilide (a heart medication). 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 a meal. Take Juluca with a meal 4 hours before or 12 hours after you take H2 blocker acid reducers (Pepcid, Zantac, Tagamet). 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, eslicarbamazepine, oxcarbazepine, phenobarbital and phenytoin) or St. John’s wort. HHS HIV treatment guidelines suggest metformin be started at the lowest dose and titrated based on tolerability and clinical effect. Monitor for metformin adverse effects. When starting or stopping Juluca in people taking 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.

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. Data associate INSTIs with weight gain. 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 with INSTIs, primarily in people with a history of psychiatric illnesses. HHS guidelines recommend closely monitoring anyone with pre-existing psychiatric conditions. Liver enzymes should be monitored in people with hepatitis B or C and taking dolutegravir. Unlike other HIV meds, Juluca does not treat hepatitis B. Call your health care provider right away if you develop any of the following signs 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.

More Information

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. Juluca still works against two stages of the virus life cycle, as do the three-drug regimens. The guidelines cite Juluca as “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 one of the smallest STRs, which may be advantageous to individuals who have difficulty swallowing. 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. Rilpivirine is an alternative drug for use during pregnancy, and although dolutegravir is now a preferred medication in pregnancy as well as for people who are trying to conceive, U.S. HIV perinatal treatment guidelines suggest using three-drug regimens. Find the discussion on page C-55 of perinatal guidelines at hivinfo.nih.gov. Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; GO TO apregistry.com.