FDA: First 2-Drug HIV Regimen Approved

The US Food and Drug Administration recently approved Juluca for the treatment of adults with human immunodeficiency virus-type 1 (HIV-1) infection currently suppressed on a stable regimen for at least 6 months with no history of treatment failure.

Juluca is the first approved fixed-dose tablet that only contains dolutegravir and rilpivirine instead of the standard 3 or more drugs used for the treatment of HIV.
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Approval was based on 2 clinical trials that included 1024 participants receiving current anti-HIV drugs who had achieved viral suppression. Results of both trials showed that Juluca effectively maintained viral suppression compared with those who continued to receive standard treatment.

Common adverse effects associated with the Juluca include diarrhea and headache, and serious adverse effects include skin rash, allergic reactions, liver problems, and depression or mood changes. Patients receiving other anti-HIV therapies should not receive Juluca.

—Melissa Weiss

Reference:

FDA approves first two-drug regimen for certain patients with HIV [press release]. FDA. November 21, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm586305.htm?utm_campaign=11212017_FDA%20approves%20two%20drug%20regimen%20for%20HIV&utm_medium=email&utm_source=Eloqua. Accessed November 21, 2017.