FDA Approves Juluca Dual Single-Tablet Regimen

On November 21, the U.S. Food and Drug Administration approved Juluca, a fixed-dose coformulation containing dolutegravir and rilpivirine, for the treatment of adults with HIV who have undetectable viral load on their current antiretroviral regimen. Juluca, a joint product of ViiV Healthcare and Janssen, is the first complete single-tablet regimen containing only 2 drugs.

Juluca’s safety and efficacy were evaluated in 2 identical trials, SWORD 1 and SWORD 2, that together included 1024 participants whose virus was suppressed on their current anti-HIV drugs. They were randomly to switch to Juluca or stay on their current regimen. At 48 weeks, 95% of people in both treatment arms had HIV RNA <50 copies/mL.

In addition, the label information for dolutegravir (sold separately as Tivicay) was updated to state that it can be used in a 2-drug regimen with rilpivirine (sold separately as Edurant) for people with suppressed viral load.

Below is an edited excerpt from an FDA press release describing the approval.

FDA Approves First Two-Drug Regimen for Certain Patients with HIV

The U.S. Food and Drug Administration 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 a fixed-dose tablet containing two previously approved drugs (dolutegravir and rilpivirine) to treat adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.

“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.

HIV weakens a person’s immune system by destroying important cells that fight disease and infection. According to the Centers for Disease Control and Prevention, an estimated 1.1 million people in the United States are living with HIV, and the disease remains a significant cause of death for certain populations.

Juluca’s safety and efficacy in adults were evaluated in two clinical trials of 1,024 participants whose virus was suppressed on their current anti-HIV drugs. Participants were randomly assigned to continue their current anti-HIV drugs or to switch to Juluca. Results showed Juluca was effective in keeping the virus suppressed and comparable to those who continued their current anti-HIV drugs.

The most common side effects in patients taking Juluca were diarrhea and headache. Serious side effects include skin rash and allergic reactions, liver problems and depression or mood changes. Juluca should not be given with other anti-HIV drugs and may have drug interactions with other commonly used medications.

11/30/17

Sources

Food and Drug Administration. FDA approves first two-drug regimen for certain patients with HIV. Press release. November 21, 2017.

Janssen. Janssen Announces U.S. FDA Approval of First and Only Complete, Single-Pill, Two-Drug Regimen, JULUCA (Dolutegravir and Rilpivirine), for the Treatment of HIV-1 Infection. Press release. November 21, 2017.

ViiV Healthcare. ViiV Healthcare Announces US FDA Approval for Juluca. Press release. November 21, 2017.