Juluca

Juluca is a fixed-dose combination tablet containing two anti-HIV drugs, dolutegravir and rilpivirine. Juluca is manufactured and marketed by ViiV Healthcare.

Dolutegravir is an integrase inhibitor also marketed alone as Tivicay and combination with lamivudine and abacavir as Triumeq. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) also marketed alone as Edurant, in combination with tenofovir disoproxil and emtricitabine as Eviplera and in combination with tenofovir alafenamide and emtricitabine as Odefsey.

Juluca is licensed for the treatment of HIV in people who already have an undetectable viral load for six months and no resistance to integrase inhibitors or NNRTIs. Juluca does not need to be combined with other anti-HIV drugs.

Juluca was approved in the United States in November 2017 and in the European Union in May 2018. Juluca was approved on the basis of results from the SWORD 1 & 2 studies, in which 1024 adults with viral load < 50 copies/ml were randomised to continue their existing antiretroviral regimen or switch to Juluca. After 48 weeks there was no significant difference in the proportions with undetectable viral load (95% in each arm). (Llibre)

Juluca is taken as one pink tablet once a day with food. Juluca contains 50mg of dolutegravir and 25mg of rilpivirine. An additional dose of 25mg of rilpivirine should be taken as a separate tablet when Juluca is taken at the same time as treatment with rifabutin.

Common side-effects of Juluca include:

  • difficulty in sleeping, abnormal dreams, depression, depressed mood, anxiety, headache, dizziness, drowsiness, fatigue
  • nausea, diarrhoea, abdominal pain, vomiting, flatulence, dry mouth, decreased appetite
  • increased liver enzymes or bilirubin or creatinine phosphokinase or lipase or pancreatic amylase
  • decreased white blood cell count, haemoglobin or platelet count, increased total or LDL cholesterol, increased triglycerides
  • rash, itching.

You should not take Juluca if you are currently taking medicines from the following groups:

  • products that contain St John’s wort (a herbal remedy used for depression and anxiety)
  • rifampicin and rifapentine (used to treat some bacterial infections such as tuberculosis)
  • carbamazepine, oxcarbazepine, phenobarbital and phenytoin (used to treat epilepsy and prevent seizures)
  • proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (used to treat acid reflux)
  • systemic dexamethasone (anti-inflammatory steroid, many uses for treatment of serious conditions)
  • dofetilide (treatment for irregular heartbeat).

H2-recepter antagonists such as famotidine, used to reduce the amount of stomach acid, should be taken at least 4 hours after or 12 hours before Juluca.

Antacids containing magnesium should be taken at least 6 hours before or 4 hours after Juluca.

Glossary

undetectable viral load

A level of viral load that is too low to be picked up by the particular viral load test being used or below an agreed threshold (such as 50 copies/ml or 200 copies/ml). An undetectable viral load is the first goal of antiretroviral therapy.

non-nucleoside reverse transcriptase inhibitor (NNRTI)

Non-nucleoside reverse transcriptase inhibitor, the family of antiretrovirals which includes efavirenz, nevirapine, etravirine, doravirine and rilpivirine. Non-nucleoside reverse transcriptase inhibitors (NNRTIs) bind to and block HIV reverse transcriptase (an HIV enzyme), preventing HIV from replicating.

viral load

Measurement of the amount of virus in a blood sample, reported as number of HIV RNA copies per milliliter of blood plasma. The VL is an important indicator of HIV progression and of how well treatment is working. 

 

anxiety

A feeling of unease, such as worry or fear, which can be mild or severe. Anxiety disorders are conditions in which anxiety dominates a person’s life or is experienced in particular situations.

depression

A mental health problem causing long-lasting low mood that interferes with everyday life.

Calcium supplements, iron supplements or multivitamins should be taken at the same time as Juluca, with a meal.

Juluca is not recommended for women who are pregnant or who might become pregnant. Juluca should be used with effective contraception. Juluca is not recommended if you are breastfeeding.

For further information about side-effects and drug resistance, see entries for the individual agents dolutegravir and rilpivirine.

References

Llibre JM et al. Phase III SWORD 1&2: switch to DTG+RPV maintains virologic suppression through 48 wks. Conference on Retroviruses and Opportunistic Infections, Seattle, abstract 44LB, February 13-16, 2017.

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