November 21, 2017
The FDA today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment. Juluca is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.
“Juluca provides a two-drug maintenance regimen for select individuals who are virologically suppressed. This group of select individuals will clearly benefit from this once-daily NRTI-sparing regimen. As we recognize World AIDS Day 2017, we are also aware that this approval represents a paradigm shift in the treatment of HIV-infected patients" said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.
The recommended dosage of JULUCA is one tablet taken orally once daily with a meal.
Juluca’s safety and efficacy in adults were evaluated in two identical clinical trials (SWORD 1 and SWORD 2) in 1,024 participants whose virus was suppressed on their current anti-HIV drugs. Participants were randomly assigned to continue on their current anti-HIV drugs or to switch to dolutegravir and rilipivirine, the components of Juluca. Results showed Juluca was effective in keeping the virus suppressed and comparable to those who continued their current anti-HIV drugs.
The primary efficacy endpoint for the SWORD trials was the proportion of subjects with plasma HIV-1 RNA less than 50 copies per mL at Week 48.
The proportion of subjects with HIV-1 RNA less than 50 copies per mL at Week 48 was 95% for both treatment groups; treatment difference and 95% CI was -0.2% (-3.0%, 2.5%). The proportion of subjects with HIV-1 RNA greater than or equal to 50 copies per mL (virologic failure) at Week 48 was 0.6% and 1.2% for the dolutegravir plus rilpivirine treatment group and the current antiretroviral regimen treatment groups, respectively; treatment difference and 95% CI was -0.6% (-1.7%, 0.6%).
The most common adverse events in patients taking Juluca were diarrhea (2%) and headache (2%).
Juluca is contraindicated with dofetilide. Juluca is also contraindicated with drugs where significant decreases in rilpivirine plasma concentrations may occur, which may result in loss of virologic response including anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital and phenytoin), antimycobacterials (rifampin and rifapentine), systemic glucocorticoids (dexamethasone: more than a single-dose treatment), herbal products (St John’s wort) and proton pump inhibitors (such as esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole).
Because Juluca is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.
The following warnings and precautions are included in the labeling. Please refer to the package insert for the full WARNINGS AND PRECAUTIONS:
The FDA today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment. Juluca is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.
“Juluca provides a two-drug maintenance regimen for select individuals who are virologically suppressed. This group of select individuals will clearly benefit from this once-daily NRTI-sparing regimen. As we recognize World AIDS Day 2017, we are also aware that this approval represents a paradigm shift in the treatment of HIV-infected patients" said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.
The recommended dosage of JULUCA is one tablet taken orally once daily with a meal.
Juluca’s safety and efficacy in adults were evaluated in two identical clinical trials (SWORD 1 and SWORD 2) in 1,024 participants whose virus was suppressed on their current anti-HIV drugs. Participants were randomly assigned to continue on their current anti-HIV drugs or to switch to dolutegravir and rilipivirine, the components of Juluca. Results showed Juluca was effective in keeping the virus suppressed and comparable to those who continued their current anti-HIV drugs.
The primary efficacy endpoint for the SWORD trials was the proportion of subjects with plasma HIV-1 RNA less than 50 copies per mL at Week 48.
The proportion of subjects with HIV-1 RNA less than 50 copies per mL at Week 48 was 95% for both treatment groups; treatment difference and 95% CI was -0.2% (-3.0%, 2.5%). The proportion of subjects with HIV-1 RNA greater than or equal to 50 copies per mL (virologic failure) at Week 48 was 0.6% and 1.2% for the dolutegravir plus rilpivirine treatment group and the current antiretroviral regimen treatment groups, respectively; treatment difference and 95% CI was -0.6% (-1.7%, 0.6%).
The most common adverse events in patients taking Juluca were diarrhea (2%) and headache (2%).
Juluca is contraindicated with dofetilide. Juluca is also contraindicated with drugs where significant decreases in rilpivirine plasma concentrations may occur, which may result in loss of virologic response including anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital and phenytoin), antimycobacterials (rifampin and rifapentine), systemic glucocorticoids (dexamethasone: more than a single-dose treatment), herbal products (St John’s wort) and proton pump inhibitors (such as esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole).
Because Juluca is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.
The following warnings and precautions are included in the labeling. Please refer to the package insert for the full WARNINGS AND PRECAUTIONS:
- Severe skin and hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported with the individual components. Discontinue Juluca immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction.
- Hepatotoxicity has been reported in patients receiving a dolutegravir- or rilpivirine-containing regimen. Monitoring for hepatotoxicity is recommended.
- Depressive disorders have been reported with the use of rilpivirine- or dolutegravir-containing regimens. Immediate medical evaluation is recommended for severe depressive symptoms.
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Division of Antiviral Products
Food and Drug Administration
Visit the FDA Patient Network for more Information about the HIV Liaison Program
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